Nutrition | Conference Update: ICAAC and IDSA

J a n u a r y + F ebruary 2012

Living on A Prayer Can faith help sustain us when living with HIV?

The HIV Treatment & Health Journal of TPAN COMPLERA is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV medicines before. COMPLERA does not cure HIV or AIDS or help prevent passing HIV to others.

one The for me New COMPLERA A complete HIV treatment in only 1 pill a day. Ask your healthcare provider if it’s the one for you.

Patient model. Pill shown is not actual size.

INDICAINDICATIONTION DoDo not not take take COMPLERA COMPLERA if if you you are are taking taking the the following following medicines: medicines: BeforeBefore taking taking COMPLERA, COMPLERA, tell tell your your healthcare healthcare provider provider if if you: you: CommonCommon side side effects effects associated associated with with COMPLERA: COMPLERA: • •other other HIV HIV medicines medicines (COMPLERA (COMPLERA provides provides a a complete complete treatment treatment for for HIV HIV infection.) infection.) • •have have liver liver problems, problems, including including hepatitis hepatitis B B or or C C virus virus infection infection • • trouble trouble sleeping sleeping (insomnia), (insomnia), abnormal abnormal dreams, dreams, headache, headache, dizziness, dizziness, diarrhea, diarrhea, COMPLERACOMPLERA®® (emtricitabine (emtricitabine 200 200 mg/rilpivirine mg/rilpivirine 25 25 mg/tenofovir mg/tenofovir disoproxil disoproxil fumarate fumarate • • the the anti-seizure anti-seizure medicines medicines carbamazepine carbamazepine (Carbatrol (Carbatrol®®, Equetro, Equetro®®, T, egretolTegretol®®, , • •have have kidney kidney problems problems nausea,nausea, rash, rash, tiredness, tiredness, and and depression depression 300300 mg) mg) is is a a prescription prescription HIV HIV medicine medicine that that contains contains 3 3 medicines, medicines, EMTRIV EMTRIVAA®® Tegretol-XRTegretol-XR®®, T, erilTeril®®, Epitol, Epitol®®),), oxcarbazepine oxcarbazepine (T (Trileptalrileptal®®),), phenobarbital phenobarbital (Luminal (Luminal®®),), • •have have ever ever had had a a mental mental health health problem problem (emtricitabine),(emtricitabine), EDURANT EDURANT™™ (rilpivirine), (rilpivirine), and and VIREAD VIREAD®® (tenofovir (tenofovir disoproxil disoproxil fumarate) fumarate) OtherOther side side effects effects associated associated with with COMPLERA: COMPLERA: phenytoinphenytoin (Dilantin (Dilantin®®, Dilantin-125, Dilantin-125®®, Phenytek, Phenytek®®) ) • •have have bone bone problems problems combinedcombined in in one one pill. pill. COMPLERA COMPLERA is is used used as as a a complete complete single-tablet single-tablet regimen regimen to to treat treat • • vomiting, vomiting, stomach stomach pain pain or or discomfort, discomfort, skin skin discoloration discoloration (small (small spots spots or or freckles), freckles), • • ®® • • are are It It is is not not known known if if COMPLERA COMPLERA can can harm harm the the anti- anti-tuberculosis medicines medicines rifabutin rifabutin (Mycobutin), (Mycobutin), rifampin rifampin (Rifater (Rifater, , pregnantpregnant or or plan plan to to become become pregnant. pregnant. andand pain pain HIVHIV-1-1 infection infection in in adults adults (age (age 18 18 and and older) older) who who have have never never taken taken HIV HIV medicines medicines before. before. RifamateRifamate®®, Rimactane, Rimactane®®, Rifadin, Rifadin®®) )and and rifapentine rifapentine (Priftin (Priftin®®) ) youryour unborn unborn child child COMPLERACOMPLERA does does not not cure cure HIV HIV and and has has not not been been shown shown to to prevent prevent pa passingssing HIV HIV • • a aproton proton pump pump inhibitor inhibitor medicine medicine for for certain certain stomach stomach or or intestinal intestinal problems, problems, • • are are breastfeeding; breastfeeding; women women with with HIV HIV should should not not breast-feed breast-feed because because they they can can pass pass TellTell your your healthcare healthcare provider provider if if you you have have any any side side effect effect that that bothers bothers you you or or that that toto others. others. It It is is important important to to always always practice practice safer safer sex, sex, use use latex latex or or polyurethane polyurethane includingincluding esomeprazole esomeprazole (Nexium (Nexium®®, V, imovoVimovo®®),), lansoprazole lansoprazole (Prevacid (Prevacid®®),), HIVHIV through through their their milk milk to to the the baby baby doesdoes not not go go away away. These. These are are not not all all the the possible possible side side effects effects of of COMPLERA. COMPLERA. For For more more ®® ®® ®® information,information, ask ask your your healthcare healthcare provider provider or or pharmacist. pharmacist. Call Call your your healthcare healthcare provider provider condomscondoms to to lower lower the the chance chance of of sexual sexual contact contact with with any any body body fl fluids, uids, and and to to never never omeprazoleomeprazole (Prilosec (Prilosec),), pantoprazole pantoprazole sodium sodium (Protonix (Protonix),), rabeprazole rabeprazole (Aciphex (Aciphex) ) ContactContact your your healthcare healthcare provider provider right right away away if if you you experience experience a anyny of of the the • • forfor medical medical advice advice about about side side effects. effects. re-usere-use or or share share needles. needles. Do Do not not stop stop taking taking COMPLERA COMPLERA unless unless directed directed by by your your more more than than 1 1 dose dose of of the the steroid steroid medicine medicine dexamethasone dexamethasone or or dexamethasone dexamethasone followingfollowing serious serious or or common common side side effects: effects: healthcarehealthcare provider provider. See. See your your healthcare healthcare provider provider regularly regularly. . sodiumsodium phosphate phosphate SeriousSerious side side effects effects associated associated with with COMPLERA: COMPLERA: YouYou are are encouraged encouraged to to report report negative negative side side effects effects of of prescripti prescriptionon drugs drugs to to the the • • St. St. John’ John’s swort wort (Hypericum (Hypericum perforatum) perforatum) • • New New or or worse worse kidney kidney problems problems can can happen happen in in some some people people who who take take COMPLERA. COMPLERA. FDA.FDA. Visit Visit www www.fda.gov/medwatch.fda.gov/medwatch or or call call 1-800-FDA-1088. 1-800-FDA-1088. • • other other medicines medicines that that contain contain tenofovir tenofovir (VIREAD (VIREAD®®, TRUV, TRUVADAADA®®, A, TRIPLAATRIPLA®®) ) IfIf you you have have had had kidney kidney problems problems in in the the past past or or take take other other medicines medicines that that can can cause cause TakeTake COMPLERA COMPLERA exactly exactly as as your your healthcare healthcare provider provider tells tells you you to to t aketake it it IMPORTIMPORTANTANT SAFETY SAFETY INFORMA INFORMATIONTION • • other other medicines medicines that that contain contain emtricitabine emtricitabine or or lamivudine lamivudine (EMTRIV (EMTRIVAA®®, Combivir, Combivir®®, , kidneykidney problems, problems, your your healthcare healthcare provider provider may may need need to to do do blood blood tests tests to to check check your your • •Always Always take take COMPLERA COMPLERA with with a a meal. meal. T akingTaking COMPLERA COMPLERA with with a a meal meal is is important important to to ContactContact your your healthcare healthcare provider provider right right away away if if you you get get the the foll followingowing side side effects effects EpivirEpivir®® or or Epivir Epivir-HBV-HBV®®, Epzicom, Epzicom®®, T, rizivirTrizivir®®) ) kidneyskidneys during during your your treatment treatment with with COMPLERA COMPLERA helphelp get get the the right right amount amount of of medicine medicine in in your your body body. A. A protein protein drink drink does does not not replace replace oror conditions conditions while while taking taking COMPLERA: COMPLERA: • •rilpivirine rilpivirine (Edurant (Edurant™™) ) • •Depression Depression or or mood mood changes changes can can happen happen in in some some people people who who take take COMPLERA. COMPLERA. aa meal meal • • Nausea, Nausea, vomiting, vomiting, unusual unusual muscle muscle pain, pain, and/or and/or weakness. weakness. These These m mayay be be • •adefovir adefovir (HEPSERA (HEPSERA®®) ) TellTell your your healthcare healthcare provider provider right right away away if if you you have have any any of of the the following following symptoms: symptoms: • • Stay Stay under under the the care care of of your your healthcare healthcare provider provider during during treatmen treatment twith with signssigns of of a a buildup buildup of of acid acid in in the the blood blood (lactic (lactic acidosis), acidosis), whic whichh is is a a serious serious InIn addition, addition, also also tell tell your your healthcare healthcare provider provider if if you you take: take: feelingfeeling sad sad or or hopeless, hopeless, feeling feeling anxious anxious or or restless, restless, or or if if you you have have thoughts thoughts of of COMPLERACOMPLERA and and see see your your healthcare healthcare provider provider regularly regularly medicalmedical condition condition • • an an antacid antacid medicine medicine that that contains contains aluminum, aluminum, magnesium magnesium hydroxide, hydroxide, or or calcium calcium hurtinghurting yourself yourself (suicide) (suicide) or or have have tried tried to to hurt hurt yourself yourself • • Light-colored Light-colored stools, stools, dark-colored dark-colored urine, urine, and/or and/or if if your your skin skin o or rthe the whites whites of of your your carbonate.carbonate. T akeTake antacids antacids at at least least 2 2 hours hours before before or or at at least least 4 4 hours hours after after you you • •Bone Bone problems problems can can happen happen in in some some people people who who take take COMPLERA. COMPLERA. Bone Bone problems problems PleasePlease see see Patient Patient Information Information for for COMPLERA COMPLERA on on the the following following pa pages.ges. eyeseyes turn turn yellow yellow. These. These may may be be signs signs of of serious serious liver liver problems problems (hepatotoxicity) (hepatotoxicity), , taketake COMPLERA COMPLERA includeinclude bone bone pain, pain, softening softening or or thinning thinning (which (which may may lead lead to to fractures). fractures). Y ourYour withwith liver liver enlargement enlargement (hepatomegaly), (hepatomegaly), and and fat fat in in the the liver liver (st (steatosis)eatosis) • • a ahistamine-2 histamine-2 blocker blocker medicine, medicine, including including famotidine famotidine (Pepcid (Pepcid®®),), cimetidine cimetidine healthcarehealthcare provider provider may may need need to to do do additional additional tests tests to to check check your your bones bones • • If If you you have have HIV-1 HIV-1 and and hepatitis hepatitis B B virus virus (HBV), (HBV), your your liver liver disea diseasese may may suddenly suddenly (T(Tagametagamet®®),), nizatidine nizatidine (Axid (Axid®®),), or or ranitidine ranitidine hydrochloride hydrochloride (Zantac (Zantac®®).). T akeTake these these • •Changes Changes in in body body fat fat can can happen happen in in people people taking taking HIV HIV medicine. medicine. These These changes changes getget worse worse if if you you stop stop taking taking COMPLERA. COMPLERA. Do Do not not stop stop taking taking COMPL COMPLERAERA without without medicinesmedicines at at least least 12 12 hours hours before before or or at at least least 4 4 hours hours after after you you take take COMPLERA COMPLERA maymay include include increased increased amount amount of of fat fat in in the the upper upper back back and and neck neck (“buffalo (“buffalo hump”), hump”), fi first rst talking talking to to your your healthcare healthcare provider provider. Y. ourYour healthcare healthcare provider provider will will monitor monitor • • the the antibiotic antibiotic medicines medicines clarithromycin clarithromycin (Biaxin (Biaxin®®),), erythromycin erythromycin (E-Mycin (E-Mycin®®, Eryc, Eryc®®, , breast,breast, and and around around the the main main part part of of your your body body (trunk). (trunk). Loss Loss of of fat fat from from the the legs, legs, youryour condition condition Ery-TEry-Tabab®®, PCE, PCE®®, Pediazole, Pediazole®®, Ilosone, Ilosone®®),), and and troleandomycin troleandomycin (T (TAOAO®®) ) armsarms and and face face may may also also happen. happen. The The cause cause and and long-term long-term health health effect effect of of these these COMPLERACOMPLERA may may affect affect the the way way other other medicines medicines work, work, and and other other med medicinesicines may may • • an an antifungal antifungal medicine medicine by by mouth, mouth, including including fl fluconazole uconazole (Difl (Difl ucan ucan®®),), itraconazole itraconazole conditionsconditions are are not not known known affectaffect how how COMPLERA COMPLERA works, works, and and may may cause cause serious serious side side effects. effects. (Sporanox(Sporanox®®),), ketoconazole ketoconazole (Nizoral (Nizoral®®),), posaconazole posaconazole (Noxafi (Noxafi l® l®),), voriconazole voriconazole (Vfend (Vfend®®) ) • •Changes Changes in in your your immune immune system system (Immune (Immune Reconstitution Reconstitution Syndrome) Syndrome) can can happen happen • • methadone (Dolophine (Dolophine®®) ) whenwhen you you start start taking taking HIV HIV medicines. medicines. Y ourYour immune immune system system may may get get stronger stronger and and beginbegin to to fi fight ght infections infections that that have have been been hidden hidden in in your your body body for for a a long long time. time. T ellTell ThisThis list list of of medicines medicines is is not not complete. complete. Discuss Discuss with with your your healt healthcarehcare provider provider all all LearnLearn more more at at www www.COMPLERA.COMPLERA.com.com youryour healthcare healthcare provider provider if if you you start start having having new new symptoms symptoms after after starting starting your your prescriptionprescription and and nonprescription nonprescription medicines, medicines, vitamins, vitamins, or or herbal herbal supplements supplements you you HIVHIV medicine medicine areare taking taking or or plan plan to to take. take.

PALIO Date: 11.15.11 • Client: Gilead • Product: Complera • File Name: 20178_pgitvd_pt_ad_PositivelyAware.indd Ad page 1 POSITIVELY PALIO Date: 11.15.11 • Client: Gilead • Product: Complera • File Name: 20178_pgitvd_pt_ad_PositivelyAware.indd POSITIVELY • Trim: 8” x 10” • Bleed: 8.5” x 11’” • Live area: 7” x 9.5” AWARE Ad page 2 • Trim: 8” x 10” • Bleed: 8.5” x 11’” • Live area: 7” x 9.5” AWARE COMPLERA is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV medicines before. COMPLERA does not cure HIV or AIDS or help prevent passing HIV to others. one The for me New COMPLERA A complete HIV treatment in only 1 pill a day. Ask your healthcare provider if it’s the one for you.

Patient model. Pill shown is not actual size.

INDICAINDICATIONTION DoDo not not take take COMPLERA COMPLERA if if you you are are taking taking the the following following medicines: medicines: BeforeBefore taking taking COMPLERA, COMPLERA, tell tell your your healthcare healthcare provider provider if if you: you: CommonCommon side side effects effects associated associated with with COMPLERA: COMPLERA: • •other other HIV HIV medicines medicines (COMPLERA (COMPLERA provides provides a a complete complete treatment treatment for for HIV HIV infection.) infection.) • •have have liver liver problems, problems, including including hepatitis hepatitis B B or or C C virus virus infection infection • • trouble trouble sleeping sleeping (insomnia), (insomnia), abnormal abnormal dreams, dreams, headache, headache, dizziness, dizziness, diarrhea, diarrhea, COMPLERACOMPLERA®® (emtricitabine (emtricitabine 200 200 mg/rilpivirine mg/rilpivirine 25 25 mg/tenofovir mg/tenofovir disoproxil disoproxil fumarate fumarate • • the the anti-seizure anti-seizure medicines medicines carbamazepine carbamazepine (Carbatrol (Carbatrol®®, Equetro, Equetro®®, T, egretolTegretol®®, , • •have have kidney kidney problems problems nausea,nausea, rash, rash, tiredness, tiredness, and and depression depression 300300 mg) mg) is is a a prescription prescription HIV HIV medicine medicine that that contains contains 3 3 medicines, medicines, EMTRIV EMTRIVAA®® Tegretol-XRTegretol-XR®®, T, erilTeril®®, Epitol, Epitol®®),), oxcarbazepine oxcarbazepine (T (Trileptalrileptal®®),), phenobarbital phenobarbital (Luminal (Luminal®®),), • •have have ever ever had had a a mental mental health health problem problem (emtricitabine),(emtricitabine), EDURANT EDURANT™™ (rilpivirine), (rilpivirine), and and VIREAD VIREAD®® (tenofovir (tenofovir disoproxil disoproxil fumarate) fumarate) OtherOther side side effects effects associated associated with with COMPLERA: COMPLERA: phenytoinphenytoin (Dilantin (Dilantin®®, Dilantin-125, Dilantin-125®®, Phenytek, Phenytek®®) ) • •have have bone bone problems problems combinedcombined in in one one pill. pill. COMPLERA COMPLERA is is used used as as a a complete complete single-tablet single-tablet regimen regimen to to treat treat • • vomiting, vomiting, stomach stomach pain pain or or discomfort, discomfort, skin skin discoloration discoloration (small (small spots spots or or freckles), freckles), • • ®® • • are are It It is is not not known known if if COMPLERA COMPLERA can can harm harm the the anti-tuberculosis anti-tuberculosis medicines medicines rifabutin rifabutin (Mycobutin), (Mycobutin), rifampin rifampin (Rifater (Rifater, , pregnantpregnant or or plan plan to to become become pregnant. pregnant. andand pain pain HIVHIV-1-1 infection infection in in adults adults (age (age 18 18 and and older) older) who who have have never never taken taken HIV HIV medicines medicines before. before. RifamateRifamate®®, Rimactane, Rimactane®®, Rifadin, Rifadin®®) )and and rifapentine rifapentine (Priftin (Priftin®®) ) youryour unborn unborn child child COMPLERACOMPLERA does does not not cure cure HIV HIV and and has has not not been been shown shown to to prevent prevent pa passingssing HIV HIV • • a aproton proton pump pump inhibitor inhibitor medicine medicine for for certain certain stomach stomach or or intestinal intestinal problems, problems, • • are are breastfeeding; breastfeeding; women women with with HIV HIV should should not not breast-feed breast-feed because because they they can can pass pass TellTell your your healthcare healthcare provider provider if if you you have have any any side side effect effect that that bothers bothers you you or or that that toto others. others. It It is is important important to to always always practice practice safer safer sex, sex, use use latex latex or or polyurethane polyurethane includingincluding esomeprazole esomeprazole (Nexium (Nexium®®, V, imovoVimovo®®),), lansoprazole lansoprazole (Prevacid (Prevacid®®),), HIVHIV through through their their milk milk to to the the baby baby doesdoes not not go go away away. These. These are are not not all all the the possible possible side side effects effects of of COMPLERA. COMPLERA. For For more more ®® ®® ®® information,information, ask ask your your healthcare healthcare provider provider or or pharmacist. pharmacist. Call Call your your healthcare healthcare provider provider condomscondoms to to lower lower the the chance chance of of sexual sexual contact contact with with any any body body fl fluids, uids, and and to to never never omeprazoleomeprazole (Prilosec (Prilosec),), pantoprazole pantoprazole sodium sodium (Protonix (Protonix),), rabeprazole rabeprazole (Aciphex (Aciphex) ) ContactContact your your healthcare healthcare provider provider right right away away if if you you experience experience a anyny of of the the • • forfor medical medical advice advice about about side side effects. effects. re-usere-use or or share share needles. needles. Do Do not not stop stop taking taking COMPLERA COMPLERA unless unless directed directed by by your your more more than than 1 1 dose dose of of the the steroid steroid medicine medicine dexamethasone dexamethasone or or dexamethasone dexamethasone followingfollowing serious serious or or common common side side effects: effects: healthcarehealthcare provider provider. See. See your your healthcare healthcare provider provider regularly regularly. . sodiumsodium phosphate phosphate SeriousSerious side side effects effects associated associated with with COMPLERA: COMPLERA: YouYou are are encouraged encouraged to to report report negative negative side side effects effects of of prescripti prescriptionon drugs drugs to to the the • • St. St. John’ John’s swort wort (Hypericum (Hypericum perforatum) perforatum) • • New New or or worse worse kidney kidney problems problems can can happen happen in in some some people people who who take take COMPLERA. COMPLERA. FDA.FDA. Visit Visit www www.fda.gov/medwatch.fda.gov/medwatch or or call call 1-800-FDA-1088. 1-800-FDA-1088. • • other other medicines medicines that that contain contain tenofovir tenofovir (VIREAD (VIREAD®®, TRUV, TRUVADAADA®®, A, TRIPLAATRIPLA®®) ) IfIf you you have have had had kidney kidney problems problems in in the the past past or or take take other other medicines medicines that that can can cause cause TakeTake COMPLERA COMPLERA exactly exactly as as your your healthcare healthcare provider provider tells tells you you to to t aketake it it IMPORTIMPORTANTANT SAFETY SAFETY INFORMA INFORMATIONTION • • other other medicines medicines that that contain contain emtricitabine emtricitabine or or lamivudine lamivudine (EMTRIV (EMTRIVAA®®, Combivir, Combivir®®, , kidneykidney problems, problems, your your healthcare healthcare provider provider may may need need to to do do blood blood tests tests to to check check your your • •Always Always take take COMPLERA COMPLERA with with a a meal. meal. T akingTaking COMPLERA COMPLERA with with a a meal meal is is important important to to ContactContact your your healthcare healthcare provider provider right right away away if if you you get get the the foll followingowing side side effects effects EpivirEpivir®® or or Epivir Epivir-HBV-HBV®®, Epzicom, Epzicom®®, T, rizivirTrizivir®®) ) kidneyskidneys during during your your treatment treatment with with COMPLERA COMPLERA helphelp get get the the right right amount amount of of medicine medicine in in your your body body. A. A protein protein drink drink does does not not replace replace oror conditions conditions while while taking taking COMPLERA: COMPLERA: • •rilpivirine rilpivirine (Edurant (Edurant™™) ) • •Depression Depression or or mood mood changes changes can can happen happen in in some some people people who who take take COMPLERA. COMPLERA. aa meal meal • • Nausea, Nausea, vomiting, vomiting, unusual unusual muscle muscle pain, pain, and/or and/or weakness. weakness. These These m mayay be be • •adefovir adefovir (HEPSERA (HEPSERA®®) ) TellTell your your healthcare healthcare provider provider right right away away if if you you have have any any of of the the following following symptoms: symptoms: • • Stay Stay under under the the care care of of your your healthcare healthcare provider provider during during treatmen treatment twith with signssigns of of a a buildup buildup of of acid acid in in the the blood blood (lactic (lactic acidosis), acidosis), whic whichh is is a a serious serious InIn addition, addition, also also tell tell your your healthcare healthcare provider provider if if you you take: take: feelingfeeling sad sad or or hopeless, hopeless, feeling feeling anxious anxious or or restless, restless, or or if if you you have have thoughts thoughts of of COMPLERACOMPLERA and and see see your your healthcare healthcare provider provider regularly regularly medicalmedical condition condition • • an an antacid antacid medicine medicine that that contains contains aluminum, aluminum, magnesium magnesium hydroxide, hydroxide, or or calcium calcium hurtinghurting yourself yourself (suicide) (suicide) or or have have tried tried to to hurt hurt yourself yourself • • Light-colored Light-colored stools, stools, dark-colored dark-colored urine, urine, and/or and/or if if your your skin skin o or rthe the whites whites of of your your carbonate.carbonate. T akeTake antacids antacids at at least least 2 2 hours hours before before or or at at least least 4 4 hours hours after after you you • •Bone Bone problems problems can can happen happen in in some some people people who who take take COMPLERA. COMPLERA. Bone Bone problems problems PleasePlease see see Patient Patient Information Information for for COMPLERA COMPLERA on on the the following following pa pages.ges. eyeseyes turn turn yellow yellow. These. These may may be be signs signs of of serious serious liver liver problems problems (hepatotoxicity) (hepatotoxicity), , taketake COMPLERA COMPLERA includeinclude bone bone pain, pain, softening softening or or thinning thinning (which (which may may lead lead to to fractures). fractures). Y ourYour withwith liver liver enlargement enlargement (hepatomegaly), (hepatomegaly), and and fat fat in in the the liver liver (st (steatosis)eatosis) • • a ahistamine-2 histamine-2 blocker blocker medicine, medicine, including including famotidine famotidine (Pepcid (Pepcid®®),), cimetidine cimetidine healthcarehealthcare provider provider may may need need to to do do additional additional tests tests to to check check your your bones bones • • If If you you have have HIV-1 HIV-1 and and hepatitis hepatitis B B virus virus (HBV), (HBV), your your liver liver disea diseasese may may suddenly suddenly (T(Tagametagamet®®),), nizatidine nizatidine (Axid (Axid®®),), or or ranitidine ranitidine hydrochloride hydrochloride (Zantac (Zantac®®).). T akeTake these these • •Changes Changes in in body body fat fat can can happen happen in in people people taking taking HIV HIV medicine. medicine. These These changes changes getget worse worse if if you you stop stop taking taking COMPLERA. COMPLERA. Do Do not not stop stop taking taking COMPL COMPLERAERA without without medicinesmedicines at at least least 12 12 hours hours before before or or at at least least 4 4 hours hours after after you you take take COMPLERA COMPLERA maymay include include increased increased amount amount of of fat fat in in the the upper upper back back and and neck neck (“buffalo (“buffalo hump”), hump”), fi first rst talking talking to to your your healthcare healthcare provider provider. Y. ourYour healthcare healthcare provider provider will will monitor monitor • • the the antibiotic antibiotic medicines medicines clarithromycin clarithromycin (Biaxin (Biaxin®®),), erythromycin erythromycin (E-Mycin (E-Mycin®®, Eryc, Eryc®®, , breast,breast, and and around around the the main main part part of of your your body body (trunk). (trunk). Loss Loss of of fat fat from from the the legs, legs, youryour condition condition Ery-TEry-Tabab®®, PCE, PCE®®, Pediazole, Pediazole®®, Ilosone, Ilosone®®),), and and troleandomycin troleandomycin (T (TAOAO®®) ) armsarms and and face face may may also also happen. happen. The The cause cause and and long-term long-term health health effect effect of of these these COMPLERACOMPLERA may may affect affect the the way way other other medicines medicines work, work, and and other other med medicinesicines may may • • an an antifungal antifungal medicine medicine by by mouth, mouth, including including fl fluconazole uconazole (Difl (Difl ucan ucan®®),), itraconazole itraconazole conditionsconditions are are not not known known affectaffect how how COMPLERA COMPLERA works, works, and and may may cause cause serious serious side side effects. effects. (Sporanox(Sporanox®®),), ketoconazole ketoconazole (Nizoral (Nizoral®®),), posaconazole posaconazole (Noxafi (Noxafi l® l®),), voriconazole voriconazole (Vfend (Vfend®®) ) • •Changes Changes in in your your immune immune system system (Immune (Immune Reconstitution Reconstitution Syndrome) Syndrome) can can happen happen • •methadone methadone (Dolophine (Dolophine®®) ) whenwhen you you start start taking taking HIV HIV medicines. medicines. Y ourYour immune immune system system may may get get stronger stronger and and beginbegin to to fi fight ght infections infections that that have have been been hidden hidden in in your your body body for for a a long long time. time. T ellTell ThisThis list list of of medicines medicines is is not not complete. complete. Discuss Discuss with with your your healt healthcarehcare provider provider all all LearnLearn more more at at www www.COMPLERA.COMPLERA.com.com youryour healthcare healthcare provider provider if if you you start start having having new new symptoms symptoms after after starting starting your your prescriptionprescription and and nonprescription nonprescription medicines, medicines, vitamins, vitamins, or or herbal herbal supplements supplements you you HIVHIV medicine medicine areare taking taking or or plan plan to to take. take.

PALIO Date: 11.15.11 • Client: Gilead • Product: Complera • File Name: 20178_pgitvd_pt_ad_PositivelyAware.indd Ad page 1 POSITIVELY PALIO Date: 11.15.11 • Client: Gilead • Product: Complera • File Name: 20178_pgitvd_pt_ad_PositivelyAware.indd POSITIVELY • Trim: 8” x 10” • Bleed: 8.5” x 11’” • Live area: 7” x 9.5” AWARE Ad page 2 • Trim: 8” x 10” • Bleed: 8.5” x 11’” • Live area: 7” x 9.5” AWARE FDA-Approved Patient Labeling COMPLERA may help: Also tell your healthcare provider if you take: The most common side effects of COMPLERA include: Patient Information • Reduce the amount of HIV in your blood. This is called your “viral load”. • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium • trouble sleeping (insomnia) ® COMPLERA (kom-PLEH-rah) • Increase the number of white blood cells called CD4+ (T) cells that help fight off carbonate. Take antacids at least 2 hours before or at least 4 hours after you take • abnormal dreams (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets other infections. COMPLERA. • headache • ® Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your a histamine-2 blocker medicine, including famotidine (PEPCID ), cimetidine • dizziness Important: Ask your doctor or pharmacist about medicines that should not be (TAGAMET®), nizatidine (AXID®), or ranitidine hydrochloride (ZANTAC®). Take these immune system. This may reduce your risk of death or infections that can happen when • diarrhea taken with COMPLERA. For more information, see the section “What should I tell my medicines at least 12 hours before or at least 4 hours after you take COMPLERA. your immune system is weak (opportunistic infections). • nausea healthcare provider before taking COMPLERA?” • the antibiotic medicines clarithromycin (BIAXIN®), erythromycin (E-MYCIN®, ERYC®, • rash Read this Patient Information before you start taking COMPLERA and each time you COMPLERA does not cure HIV infections or AIDS. ERY-TAB®, PCE®, PEDIAZOLE®, ILOSONE®), and troleandomycin (TAO®) • Always practice safer sex. • tiredness get a refill. There may be new information. This information does not take the place of • an antifungal medicine by mouth, including fluconazole (DIFLUCAN®), itraconazole • Use latex or polyurethane condoms to lower the chance of sexual contact with any • talking to your healthcare provider about your medical condition or treatment. (SPORANOX®), ketoconazole (NIZORAL®), posaconazole (NOXAFIL®), voriconazole depression body fluids such as semen, vaginal secretions, or blood. (VFEND®) Additional common side effects include: • What is the most important information I should know about COMPLERA? Never re-use or share needles. • ® methadone (DOLOPHINE ) • vomiting Ask your healthcare provider if you have any questions about how to prevent passing COMPLERA can cause serious side effects, including: Ask your healthcare provider or pharmacist if you are not sure if your medicine is • stomach pain or discomfort HIV to other people. 1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in one that is listed above. • skin discoloration (small spots or freckles) some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic Who should not take COMPLERA? • pain acidosis is a serious medical emergency that can lead to death. Know the medicines you take. Keep a list of your medicines and show it to your • Do not take COMPLERA if your HIV infection has been previously treated with healthcare provider and pharmacist when you get a new medicine. Your healthcare Tell your healthcare provider if you have any side effect that bothers you or that does Lactic acidosis can be hard to identify early, because the symptoms could seem like HIV medicines. provider and your pharmacist can tell you if you can take these medicines with not go away. symptoms of other health problems. Call your healthcare provider right away if you • Do not take COMPLERA if you are taking certain other medicines. For more COMPLERA. Do not start any new medicines while you are taking COMPLERA without get any of the following symptoms which could be signs of lactic acidosis: information about medicines that must not be taken with COMPLERA, see “What first talking with your healthcare provider or pharmacist. You can ask your healthcare These are not all the possible side effects of COMPLERA. For more information, ask your • feeling very weak or tired should I tell my healthcare provider before taking COMPLERA?” provider or pharmacist for a list of medicines that can interact with COMPLERA. healthcare provider or pharmacist. • have unusual (not normal) muscle pain Call your doctor for medical advice about side effects. You may report side effects to • have trouble breathing What should I tell my healthcare provider before taking COMPLERA? How should I take COMPLERA? FDA at 1-800-FDA-1088 (1-800-332-1088). • have stomach pain with Before you take COMPLERA, tell your healthcare provider if you: • Stay under the care of your healthcare provider during treatment with COMPLERA. - nausea (feel sick to your stomach) • • have liver problems, including hepatitis B or C virus infection Take COMPLERA exactly as your healthcare provider tells you to take it. How do I store COMPLERA? - vomiting • • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important have kidney problems • • feel cold, especially in your arms and legs Store COMPLERA at room temperature 77 °F (25 °C). • have ever had a mental health problem to help get the right amount of medicine in your body. A protein drink does not • feel dizzy or lightheaded • Keep COMPLERA in its original container and keep the container tightly closed. • have bone problems replace a meal. • have a fast or irregular heartbeat • Do not use COMPLERA if the seal over the bottle opening is broken or missing. • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm • Do not change your dose or stop taking COMPLERA without first talking with your 2. Severe liver problems. Severe liver problems can happen in people who take your unborn child healthcare provider. See your healthcare provider regularly while taking COMPLERA. Keep COMPLERA and all other medicines out of reach of children. COMPLERA or similar medicines. In some cases these liver problems can lead to death. Pregnancy Registry. There is a pregnancy registry for women who take antiviral • If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take Your liver may become large (hepatomegaly) and you may develop fat in your liver medicines during pregnancy. Its purpose is to collect information about the health your dose of COMPLERA with a meal as soon as possible. Then, take your next dose General information about COMPLERA: (steatosis) when you take COMPLERA. of you and your baby. Talk to your healthcare provider about how you can take part of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by Medicines are sometimes prescribed for purposes other than those listed in a in this registry. more than 12 hours of the time you usually take it, wait and then take the next dose Call your healthcare provider right away if you have any of the following symptoms Patient Information leaflet. Do not use COMPLERA for a condition for which it was • are breast-feeding or plan to breast-feed. The Centers for Disease Control and of COMPLERA at the regularly scheduled time. of liver problems: not prescribed. Do not give COMPLERA to other people, even if they have the same Prevention recommends that mothers with HIV not breastfeed because they can pass • Do not take more than your prescribed dose to make up for a missed dose. • your skin or the white part of your eyes turns yellow (jaundice). symptoms you have. It may harm them. the HIV through their milk to the baby. It is not known if COMPLERA can pass through • When your COMPLERA supply starts to run low, get more from your healthcare provider • dark “tea-colored” urine your breast milk and harm your baby. Talk to your healthcare provider about the best or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in This leaflet summarizes the most important information about COMPLERA. If you • light-colored bowel movements (stools) way to feed your baby. your blood may increase if the medicine is stopped for even a short time. would like more information, talk with your healthcare provider. You can ask your • loss of appetite for several days or longer • If you take too much COMPLERA, contact your local poison control center or go to the healthcare provider or pharmacist for information about COMPLERA that is written • nausea Tell your healthcare provider about all the medicines you take, including prescription nearest hospital emergency room right away. • stomach pain and nonprescription medicines, vitamins, and herbal supplements. for health professionals. For more information, call (1-800-445-3235) or go to www.COMPLERA.com. You may be more likely to get lactic acidosis or severe liver problems if you are COMPLERA may affect the way other medicines work, and other medicines may What are the possible side effects of COMPLERA? affect how COMPLERA works, and may cause serious side effects. If you take certain female, very overweight (obese), or have been taking COMPLERA or a similar COMPLERA may cause the following serious side effects, including: What are the ingredients of COMPLERA? medicine containing nucleoside analogs for a long time. medicines with COMPLERA, the amount of COMPLERA in your body may be too low and • See “What is the most important information I should know about COMPLERA?” Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil it may not work to help control your HIV infection. The HIV virus in your body may become 3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection • New or worse kidney problems can happen in some people who take COMPLERA. fumarate resistant to COMPLERA or other HIV medicines that are like it. and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A If you have had kidney problems in the past or take other medicines that can cause Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not take COMPLERA if you also take these medicines: kidney problems, your healthcare provider may need to do blood tests to check your COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV • COMPLERA provides a complete treatment for HIV infection. Do not take other HIV kidneys during your treatment with COMPLERA. cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The therapy with your healthcare provider. medicines with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, ® ® ® • Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare • the anti-seizure medicines carbamazepine (CARBATROL , EQUETRO , TEGRETOL , any of the following symptoms: triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow provider before your COMPLERA is all gone. TEGRETOL-XR®, TERIL®, EPITOL®), oxcarbazepine (TRILEPTAL®), phenobarbital - feeling sad or hopeless #6 aluminum lake. ® ® ® ® • Do not stop taking COMPLERA without first talking to your healthcare provider. (LUMINAL ), phenytoin (DILANTIN , DILANTIN-125 , PHENYTEK ) - feeling anxious or restless ® ® • If you stop taking COMPLERA, your healthcare provider will need to check your health • the anti-tuberculosis medicines rifabutin (MYCOBUTIN ), rifampin (RIFATER , - have thoughts of hurting yourself (suicide) or have tried to hurt yourself This Patient Information has been approved by the U.S. Food and Drug Administration ® ® ® ® often and do regular blood tests to check your HBV infection. Tell your healthcare RIFAMATE , RIMACTANE , RIFADIN ) and rifapentine (PRIFTIN ) • Bone problems can happen in some people who take COMPLERA. Bone problems Manufactured and distributed by: provider about any new or unusual symptoms you may have after you stop taking • a proton pump inhibitor medicine for certain stomach or intestinal problems, include bone pain, softening or thinning (which may lead to fractures). Your Gilead Sciences, Inc. ® ® ® COMPLERA. including esomeprazole (NEXIUM , VIMOVO ), lansoprazole (PREVACID ), omeprazole healthcare provider may need to do additional tests to check your bones. Foster City, CA 94404 ® ® ® (PRILOSEC ), pantoprazole sodium (PROTONIX ), rabeprazole (ACIPHEX ) • Changes in body fat can happen in people taking HIV medicine. These changes may What is COMPLERA? • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium include increased amount of fat in the upper back and neck (“buffalo hump”), breast, Issued: August 2011 COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that: phosphate and around the main part of your body (trunk). Loss of fat from the legs, arms and • is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the • St. John’s wort (Hypericum perforatum) face may also happen. The cause and long term health effect of these conditions are COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and virus that causes AIDS (Acquired Immunodeficiency Syndrome). If you are taking COMPLERA, you should not take: not known. the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies. • contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) • Changes in your immune system (Immune Reconstitution Syndrome) can happen ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, COMBIVIR®, when you start taking HIV medicines. Your immune system may get stronger trademarks referenced herein are the property of their respective owners. virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an EPIVIR® or EPIVIR-HBV®, EPZICOM®, TRIZIVIR®) and begin to fight infections that have been hidden in your body for a long time. HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). © 2011 Gilead Sciences, Inc. All rights reserved. • rilpivirine (EDURANT™) Tell your healthcare provider if you start having new symptoms after starting your It is not known if COMPLERA is safe and effective in children under the age of 18 years. • adefovir (HEPSERA®) HIV medicine. 202123-GS-000 02AUG2011 CON11252 11/11

PALIO Date: 11.15.11 • Client: Gilead • Product: Complera • File Name: 20178_pgitvd_pt_ad_PositivelyAware.indd POSITIVELY PALIO Date: 11.15.11 • Client: Gilead • Product: Complera • File Name: 20178_pgitvd_pt_ad_PositivelyAware.indd POSITIVELY BS page 1 • Trim: 8” x 10” • Bleed: 8.5” x 11’” • Live area: 7” x 9.5” AWARE BS page 2 • Trim: 8” x 10” • Bleed: 8.5” x 11’” • Live area: 7” x 9.5” AWARE FDA-Approved Patient Labeling COMPLERA may help: Also tell your healthcare provider if you take: The most common side effects of COMPLERA include: Patient Information • Reduce the amount of HIV in your blood. This is called your “viral load”. • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium • trouble sleeping (insomnia) ® COMPLERA (kom-PLEH-rah) • Increase the number of white blood cells called CD4+ (T) cells that help fight off carbonate. Take antacids at least 2 hours before or at least 4 hours after you take • abnormal dreams (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets other infections. COMPLERA. • headache • ® Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your a histamine-2 blocker medicine, including famotidine (PEPCID ), cimetidine • dizziness Important: Ask your doctor or pharmacist about medicines that should not be (TAGAMET®), nizatidine (AXID®), or ranitidine hydrochloride (ZANTAC®). Take these immune system. This may reduce your risk of death or infections that can happen when • diarrhea taken with COMPLERA. For more information, see the section “What should I tell my medicines at least 12 hours before or at least 4 hours after you take COMPLERA. your immune system is weak (opportunistic infections). • nausea healthcare provider before taking COMPLERA?” • the antibiotic medicines clarithromycin (BIAXIN®), erythromycin (E-MYCIN®, ERYC®, • rash Read this Patient Information before you start taking COMPLERA and each time you COMPLERA does not cure HIV infections or AIDS. ERY-TAB®, PCE®, PEDIAZOLE®, ILOSONE®), and troleandomycin (TAO®) • Always practice safer sex. • tiredness get a refill. There may be new information. This information does not take the place of • an antifungal medicine by mouth, including fluconazole (DIFLUCAN®), itraconazole • Use latex or polyurethane condoms to lower the chance of sexual contact with any • talking to your healthcare provider about your medical condition or treatment. (SPORANOX®), ketoconazole (NIZORAL®), posaconazole (NOXAFIL®), voriconazole depression body fluids such as semen, vaginal secretions, or blood. (VFEND®) Additional common side effects include: • What is the most important information I should know about COMPLERA? Never re-use or share needles. • ® methadone (DOLOPHINE ) • vomiting Ask your healthcare provider if you have any questions about how to prevent passing COMPLERA can cause serious side effects, including: Ask your healthcare provider or pharmacist if you are not sure if your medicine is • stomach pain or discomfort HIV to other people. 1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in one that is listed above. • skin discoloration (small spots or freckles) some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic Who should not take COMPLERA? • pain acidosis is a serious medical emergency that can lead to death. Know the medicines you take. Keep a list of your medicines and show it to your • Do not take COMPLERA if your HIV infection has been previously treated with healthcare provider and pharmacist when you get a new medicine. Your healthcare Tell your healthcare provider if you have any side effect that bothers you or that does Lactic acidosis can be hard to identify early, because the symptoms could seem like HIV medicines. provider and your pharmacist can tell you if you can take these medicines with not go away. symptoms of other health problems. Call your healthcare provider right away if you • Do not take COMPLERA if you are taking certain other medicines. For more COMPLERA. Do not start any new medicines while you are taking COMPLERA without get any of the following symptoms which could be signs of lactic acidosis: information about medicines that must not be taken with COMPLERA, see “What first talking with your healthcare provider or pharmacist. You can ask your healthcare These are not all the possible side effects of COMPLERA. For more information, ask your • feeling very weak or tired should I tell my healthcare provider before taking COMPLERA?” provider or pharmacist for a list of medicines that can interact with COMPLERA. healthcare provider or pharmacist. • have unusual (not normal) muscle pain Call your doctor for medical advice about side effects. You may report side effects to • have trouble breathing What should I tell my healthcare provider before taking COMPLERA? How should I take COMPLERA? FDA at 1-800-FDA-1088 (1-800-332-1088). • have stomach pain with Before you take COMPLERA, tell your healthcare provider if you: • Stay under the care of your healthcare provider during treatment with COMPLERA. - nausea (feel sick to your stomach) • • have liver problems, including hepatitis B or C virus infection Take COMPLERA exactly as your healthcare provider tells you to take it. How do I store COMPLERA? - vomiting • • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important have kidney problems • • feel cold, especially in your arms and legs Store COMPLERA at room temperature 77 °F (25 °C). • have ever had a mental health problem to help get the right amount of medicine in your body. A protein drink does not • feel dizzy or lightheaded • Keep COMPLERA in its original container and keep the container tightly closed. • have bone problems replace a meal. • have a fast or irregular heartbeat • Do not use COMPLERA if the seal over the bottle opening is broken or missing. • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm • Do not change your dose or stop taking COMPLERA without first talking with your 2. Severe liver problems. Severe liver problems can happen in people who take your unborn child healthcare provider. See your healthcare provider regularly while taking COMPLERA. Keep COMPLERA and all other medicines out of reach of children. COMPLERA or similar medicines. In some cases these liver problems can lead to death. Pregnancy Registry. There is a pregnancy registry for women who take antiviral • If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take Your liver may become large (hepatomegaly) and you may develop fat in your liver medicines during pregnancy. Its purpose is to collect information about the health your dose of COMPLERA with a meal as soon as possible. Then, take your next dose General information about COMPLERA: (steatosis) when you take COMPLERA. of you and your baby. Talk to your healthcare provider about how you can take part of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by Medicines are sometimes prescribed for purposes other than those listed in a in this registry. more than 12 hours of the time you usually take it, wait and then take the next dose Call your healthcare provider right away if you have any of the following symptoms Patient Information leaflet. Do not use COMPLERA for a condition for which it was • are breast-feeding or plan to breast-feed. The Centers for Disease Control and of COMPLERA at the regularly scheduled time. of liver problems: not prescribed. Do not give COMPLERA to other people, even if they have the same Prevention recommends that mothers with HIV not breastfeed because they can pass • Do not take more than your prescribed dose to make up for a missed dose. • your skin or the white part of your eyes turns yellow (jaundice). symptoms you have. It may harm them. the HIV through their milk to the baby. It is not known if COMPLERA can pass through • When your COMPLERA supply starts to run low, get more from your healthcare provider • dark “tea-colored” urine your breast milk and harm your baby. Talk to your healthcare provider about the best or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in This leaflet summarizes the most important information about COMPLERA. If you • light-colored bowel movements (stools) way to feed your baby. your blood may increase if the medicine is stopped for even a short time. would like more information, talk with your healthcare provider. You can ask your • loss of appetite for several days or longer • If you take too much COMPLERA, contact your local poison control center or go to the healthcare provider or pharmacist for information about COMPLERA that is written • nausea Tell your healthcare provider about all the medicines you take, including prescription nearest hospital emergency room right away. • stomach pain and nonprescription medicines, vitamins, and herbal supplements. for health professionals. For more information, call (1-800-445-3235) or go to www.COMPLERA.com. You may be more likely to get lactic acidosis or severe liver problems if you are COMPLERA may affect the way other medicines work, and other medicines may What are the possible side effects of COMPLERA? affect how COMPLERA works, and may cause serious side effects. If you take certain female, very overweight (obese), or have been taking COMPLERA or a similar COMPLERA may cause the following serious side effects, including: What are the ingredients of COMPLERA? medicine containing nucleoside analogs for a long time. medicines with COMPLERA, the amount of COMPLERA in your body may be too low and • See “What is the most important information I should know about COMPLERA?” Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil it may not work to help control your HIV infection. The HIV virus in your body may become 3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection • New or worse kidney problems can happen in some people who take COMPLERA. fumarate resistant to COMPLERA or other HIV medicines that are like it. and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A If you have had kidney problems in the past or take other medicines that can cause Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not take COMPLERA if you also take these medicines: kidney problems, your healthcare provider may need to do blood tests to check your COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV • COMPLERA provides a complete treatment for HIV infection. Do not take other HIV kidneys during your treatment with COMPLERA. cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The therapy with your healthcare provider. medicines with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, ® ® ® • Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare • the anti-seizure medicines carbamazepine (CARBATROL , EQUETRO , TEGRETOL , any of the following symptoms: triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow provider before your COMPLERA is all gone. TEGRETOL-XR®, TERIL®, EPITOL®), oxcarbazepine (TRILEPTAL®), phenobarbital - feeling sad or hopeless #6 aluminum lake. ® ® ® ® • Do not stop taking COMPLERA without first talking to your healthcare provider. (LUMINAL ), phenytoin (DILANTIN , DILANTIN-125 , PHENYTEK ) - feeling anxious or restless ® ® • If you stop taking COMPLERA, your healthcare provider will need to check your health • the anti-tuberculosis medicines rifabutin (MYCOBUTIN ), rifampin (RIFATER , - have thoughts of hurting yourself (suicide) or have tried to hurt yourself This Patient Information has been approved by the U.S. Food and Drug Administration ® ® ® ® often and do regular blood tests to check your HBV infection. Tell your healthcare RIFAMATE , RIMACTANE , RIFADIN ) and rifapentine (PRIFTIN ) • Bone problems can happen in some people who take COMPLERA. Bone problems Manufactured and distributed by: provider about any new or unusual symptoms you may have after you stop taking • a proton pump inhibitor medicine for certain stomach or intestinal problems, include bone pain, softening or thinning (which may lead to fractures). Your Gilead Sciences, Inc. ® ® ® COMPLERA. including esomeprazole (NEXIUM , VIMOVO ), lansoprazole (PREVACID ), omeprazole healthcare provider may need to do additional tests to check your bones. Foster City, CA 94404 ® ® ® (PRILOSEC ), pantoprazole sodium (PROTONIX ), rabeprazole (ACIPHEX ) • Changes in body fat can happen in people taking HIV medicine. These changes may What is COMPLERA? • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium include increased amount of fat in the upper back and neck (“buffalo hump”), breast, Issued: August 2011 COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that: phosphate and around the main part of your body (trunk). Loss of fat from the legs, arms and • is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the • St. John’s wort (Hypericum perforatum) face may also happen. The cause and long term health effect of these conditions are COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and virus that causes AIDS (Acquired Immunodeficiency Syndrome). If you are taking COMPLERA, you should not take: not known. the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies. • contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) • Changes in your immune system (Immune Reconstitution Syndrome) can happen ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, COMBIVIR®, when you start taking HIV medicines. Your immune system may get stronger trademarks referenced herein are the property of their respective owners. virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an EPIVIR® or EPIVIR-HBV®, EPZICOM®, TRIZIVIR®) and begin to fight infections that have been hidden in your body for a long time. HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). © 2011 Gilead Sciences, Inc. All rights reserved. • rilpivirine (EDURANT™) Tell your healthcare provider if you start having new symptoms after starting your It is not known if COMPLERA is safe and effective in children under the age of 18 years. • adefovir (HEPSERA®) HIV medicine. 202123-GS-000 02AUG2011 CON11252 11/11

PALIO Date: 11.15.11 • Client: Gilead • Product: Complera • File Name: 20178_pgitvd_pt_ad_PositivelyAware.indd POSITIVELY PALIO Date: 11.15.11 • Client: Gilead • Product: Complera • File Name: 20178_pgitvd_pt_ad_PositivelyAware.indd POSITIVELY BS page 1 • Trim: 8” x 10” • Bleed: 8.5” x 11’” • Live area: 7” x 9.5” AWARE BS page 2 • Trim: 8” x 10” • Bleed: 8.5” x 11’” • Live area: 7” x 9.5” AWARE JAN+FEB 2012 v o l u m e 2 4 n u m b e r 1

INSIDE

Departments

6 editor’s Note Keeping the faith.

7 In Box

8 Readers’ poll

9 Ask the HIV specialist For what ails the soul.

10 Briefly The Quad goes to the FDA for approval. Drug makers sign deals for new fixed- dose combo pills. HIV treatment guidelines updated. New side effect warnings for Isentress.

23 What’s GOIN’ ON? Faith without works is dead.

36 HIV Wellness series Nutrition and HIV.

43 The Buzz The path to a cure.

45 Salient Ramblings Questioning theology.

Cover Photo by Chris Knight ARTICLES OF FAITH In times of crisis, many people turn to religion, church, or prayer. Can faith help sustain us when living with HIV? Follow us starts on page 24 on Facebook and Twitter

READ it on POSITIVELYAWARE.COM, then comment online

scan this qR code at left with your smartphone to connect to POSITIVELYAWARE.com

4 | January+February 2012 P o s i t i v e lyAwa r e . c o m Positively Aware

5537 N. Broadway St. Chicago, IL 60640 cover features phone: (773) 989–9400 fax: (773) 989–9494 24 Faith-based organizations and HIV [email protected] The good, the bad, and the ugly. www.positivelyaware.com

28 Of faith and compassion Black leaders urge the church to tend to its people. e D i t o r i a l editor-in-Chief Jeff Berry 32 The hidden people associate editor Enid Vázquez Courage and brotherhood bring the Muslim community into the light. copy Editor Sue Saltmarsh Web Master Joshua Thorne conference update art & Design director Rick Guasco

17 ICAAC Chicago and IDSA Boston proofreaders Switching to the new Complera; four years of Isentress; HIV risk Jason Lancaster, Camille Smith perception; and other news from the 51st Interscience Conference on Antimicrobials and Chemotherapy (ICAAC, held in Chicago in contributing writers September) and the 49th annual meeting of the Infectious Diseases Keith R. Green, Liz Highleyman, Society of America (IDSA, held in Boston in October). Sal Iacopelli, Laura Jones, Jim Pickett, Matt Sharp feature photographers 41 Come ride with us John gress, Chris Knight, Get into gear for the 2012 Ride for AIDS Chicago. Joshua Thorne

M e d i c a l a dv i s o r s Daniel S. Berger, MD Gary Bucher, MD ONLINE Michael Cristofano, PA Joel Gallant, MD

EXCLUSIVELY ON Positivelyaware .com Swarup Mehta, PharmD

The ‘Plan B’ question Are we prepared for when health care reform fails? a D V e r t i s i n G & D i s t r i b u t i o n www.positivelyaware.com/2012/12_01/planb.shtml advertising inquiries LORRAINE HAYES Getting to the bottom of anal health, Part II [email protected] High-resolution anoscopy and treatment of anal cancer. www.positivelyaware.com/2012/12_01/anal.shtml distribution coordinator Bradley P Mazzie Grocery list for healthy eating [email protected] Use this list for nutrition that packs a healthy punch. www.positivelyaware.com/2012/12_01/grocery.shtml

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P o s i t i v e lyAwa r e . c o m January+February 2012 | 5 EDITOR’S NOTE JEFF BERRY

Keeping the faith

I FONDLY REMEMBER, FROM WHEN I WAS GROWING UP AND AS always presented with a choice in how we a young boy, visits with my mom’s parents during family gatherings. perceive what is happening in the world around us. And that choice gives us the My grandfather, Daniel, was a Methodist minister (and his mother power, and the strength, to create change, was also a Methodist minister, which was uncommon for a woman or at least a change in perception. in those days). He would tell me from time to time that he hoped So here I am, all these years later, a minister of sorts, I guess. I feel extremely I would follow in his footsteps and become a minister myself one privileged and grateful to be able to do day. He apparently saw something in me that I didn’t, and which work which allows me to have a voice, to suggested to him that I had been “called.” reach out with a message of hope and inspiration about living and thriving with I was petrified and at the same time a the standard dogma and tenets of modern HIV, and provide information and support bit curious—I was intrigued by the idea of religion. There are the ongoing scandals of to help people live healthier and more pro- ministering to others, but I somehow knew child sexual abuse at the hands of priests, ductive lives in the face of HIV/AIDS. that a life in the church just wasn’t for me. and the cover-ups by those in authority I know from experience it’s important Since I never really had the heart (or was it that took place afterwards which allowed to hear these messages of hope. My mom the guts?) to tell him so, I would just smile it to continue. And there is the fire-and- told me years ago, not long after I tested and kind of nod my head whenever he brimstone mentality of those who take the positive, that she somehow just knew that would bring it up in conversation. gospel word for word, and use it against I was going to be okay. I believed her, and I had forgotten all about this piece of those whose lifestyles or sexual orienta- it turns out she was right. That was 1989, my childhood until the other day, when tion they either don’t agree with or can’t over 22 years ago. She gave me the faith I was going through some old papers of even attempt to understand. to carry on, even while she was fighting mine that my brother had passed along It’s no wonder that people have lost her own struggle with metastatic breast to me during a recent visit. I came across faith. But faith is much more than brick and cancer. Even though she eventually lost an old birthday card from my grandfather mortar or words on the page of a book. her battle, she fought bravely and valiant- with the words “I’m counting on you!” My parents would make us go to church ly, and I now feel a sense of responsibility that he had scrawled along the bottom. It every Sunday when I was growing up, and to share my own story in the hopes of got me thinking about the different ways I came to dislike it and would sometimes helping others—and to try to be as authen- in which we minister to others, and the pretend I was sick just so I wouldn’t have tic as possible while doing so. Hey, I’m by meaning of faith, and how it plays a role in to go. But I look back at it now and I’m no means perfect, and I make mistakes our day-to-day lives. grateful for those experiences, because it just like everyone else. But I do believe I’m This issue of Positively Aware delves instilled in me a faith in something greater in the right place, at the right time, doing into the topic of faith and HIV, with a than myself, something beyond this exactly what I need to be doing. And that’s specific focus on religion, and encompass- world and this realm of experience, which what keeps me going. I have faith that ing, as one writer puts it, “The Good, the became unshakeable. I stopped attending Grandpa, and Mom, would both be proud. Bad, and the Ugly.” It’s hard for many church years ago, but my faith in a higher people to separate the concepts of faith power remained firm—it’s something that I Take care of yourselves, and each other. and religion—for some the two go hand believe lies within me, and within all of us. I in hand. Unfortunately, these days I think have also come to believe that, regardless

many people have been disillusioned with of the circumstances in our lives, we are PHOTO: CHRIS KNIGHT

6 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM IN BOX Reading as self-empowerment I JUST GOT MY LATEST COPY OF YOUR I really enjoy reading about the new show [www.adaywithhiv.com]. I got magazine and wanted to write and let meds out there and how people are able a $1,000 hormone shot on the official you know that it helps. to deal with this monster of a virus that ADWHIA shoot day—Lupron—for pros- I am a 36-year-old, mostly gay man we fight every day. In 1999, I started treat- tate cancer treatment. Then three gold locked up on a four-year term in Chino, ment with Ziagen and Combivir, but due to markers were inserted inside my prostate . I was diagnosed positive in an allergic reaction, was put on Reyataz, for radiation treatments to find the wal- 2006 and have had Epivir, and Viread. After nut during radiation zaps for 8 weeks, 5 to make a lot of deci- about a year, lots of biliru- days a week. Testosterone range is 7.2 sions about life with- bin built up in my liver and - 24.0. Guess my count—0.2! Can’t stop out any up-to-date my eyes and skin turned singing “I’m EVERY Woman!” information. yellow. I then took a three- Cheers for the great work you do; I find myself try- year “vacation” before especially Rick on this project! ing to advocate to starting Atripla. Wow! It’s Mark A. Davis the very people who amazing—I’ve been on the Philadelphia, PA are the hardest to treatment for almost four reach because, in a years now and I haven’t A DAY WITH HIV IN AMERICA WAS A VERY very real way, they had any problems yet! engaging photo essay project created by too live with HIV on a Thanks for providing Positively Aware. The idea behind the daily basis. information and support project was to broaden the way people I am very out and giving me faith in this understand what it means to live with HIV and very loud about fight. It’s a daily struggle today and to combat the overwhelming the fact that I am positive. It’s weird, dealing with the depression, stress, and stigma associated with the disease. The though—all people want to know is why fear, but I know I can make it —I only have result was an exciting photo collage of the or when or how I got it, and the way I see four years left. experiences of various people with HIV in it, those things pale in comparison to the —Matthew G. this country. fact that I’m positive and what choices I Buford, GA Styx bassist Chuck Panozzo was one of make now. People who don’t know bet- the judges charged with the considerable ter freak out about having social contact undertaking of narrowing down the sub- with me and it gets really hard. MARKING “A DAY” mitted photos. Mr. Panozzo, a co-founder Thank you for your help. of the legendary rock band, is also openly Jeremy Riley I’D LIKE TO ORDER A COPY OF THE gay and HIV-positive. He’s extremely Chino, CA 2010 Nov.+Dec. edition. My photo was proud to be out and open about who he is one selected for that first “A Day with and feels he has “a responsibility to send HIV in America” spread. Look for my a message to the audience.” He added, FAITH TO FIGHT Miss Noon in Miss America stance with “How can we expect others to respect us if official wave on a red carpet. I’ve since we can’t respect ourselves?” I’M A 29-YEAR-OLD MAN WHO’S BEEN subscribed to Positively Aware, but could This photo project is an excellent living with HIV for about 12 years. I’ve been not get my hands on a hard copy of instrument to help people gain more in prison for the past 10 years and, on sev- the 2010 edition. respect for themselves and their com- eral occasions, have run across issues of I’m happy to see my rear end at munities, and the outspoken Panozzo was your magazine. 9:37 a.m. in 3-D on the Internet slide a perfect fit for it. There are still very few artists and entertainers who are out about their HIV status, so Panozzo stands out DO THE WRITE THING as someone bold enough to speak about Positively Aware treats all communications (letters, faxes, e-mail, etc.) as letters to what it means to have HIV today. One the editor unless otherwise instructed. We reserve the right to edit for length, style, of his goals is to educate people about or clarity. Unless you tell us not to, we will use your name and city. what it’s like to live with this disease and he says, “Being out and being open is the POSITIVELY AWARE 5537 N. Broadway St., Chicago, IL 60640 best form of education.” E-MAIL: [email protected] It’s refreshing to encounter a performer CONTINUED ON PAGE 8 >>

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 7 IN BOX READERS’ POLL

Do you think the new >> CONTINUED FROM PAGE 7 community has never been stronger and health care reforms will who isn’t shy about expressing an opinion better prepared to meet these challenges. help, hurt, or not affect or speaking candidly about his life experi- Today, HIV is a story of having survived the fight against HIV ence. Panozzo’s life experience of living the worst to now have the opportunity to in the U.S.? with HIV for over 20 years and still touring thrive. When I look at the various photos RESULTS FROM THE READERS’ POLL demonstrates how dramatically the world in the project and when I think of Chuck IN THE NOVEMBER+DECEMBER ISSUE: of HIV has shifted and that people who Panozzo, I see a community that is thriving have AIDS can now flourish. and working hard to fight stigma, organiz- If there were a theme for the Day with ing to protect the rights of people with NO HIV in America project, it would be some- HIV, and establishing a culture for people EFFECT: thing like “thriving.” Of course, people whose days in America are impacted by 16% still endure the challenge of living with HIV but no longer destroyed by it. HIV in America, and economic disparities —from a blog post by Alex Garner and social injustice make HIV a profound Editor-at-Large HELP: struggle. We have a ways to go, but our FrontiersLA.com HURT: 52% 32%

YOUR COMMENTS: “I fear that the Ryan White program will cease to exist.”

“It will have no effect at all… I would think whatever changes that will be made, HIV-positive people won’t be included.”

”There will end up being no benefit to anyone since the Republicans will never let it be enacted and funded.”

“Hurry and Wait and Hope for Help! Jayson Conner submitted this picture for A Day with HIV in America. (photograph by What?” Jeffrey L. Newman) ”With the current political environment,

© 2012. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), extending Ryan White seems nearly 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and impossible and with the efforts toward support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, contact Sue Saltmarsh. Six issues mailed bulk rate repealing the Affordable Care Act, it for $30 donation; mailed free to those living with HIV or those unable to contribute. appears we will soon be up the creek. We accept contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or Advocates must begin to get a consis- decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use tent voice, know who and for what we your actual name or a pseudonym for publication, but please include your name and phone number. are voting for, and get behind efforts to Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, fight for health care.” Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that THIS ISSUE’S POLL QUESTION: all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed Is religion and/or spirituality medical practitioner, preferably a personal physician. important to you in maintaining A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively your health? Aware, association with TPAN, or contributions to this journal.

Distribution of Positively Aware is supported in part through an unrestricted grant from ViiV Healthcare. CAST YOUR VOTE AT POSITIVELYAWARE.COM

8 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM ASK THE HIV SPECIALIST FATHER DREW A. KOVACH, MD, MDIV, ABFM, AAHIVS

For what ails the soul

Q: I RECENTLY FOUND OUT THAT I’M HIV-POSITIVE. SO FAR I how conflicted one can be about such haven’t told anyone except my best friend and just thinking of matters of sexual preference and what religion has to say about such things. God people finding out I’m gay and have HIV makes me want to crawl the Creator is bigger than religion. Again, into a cave! I was raised in a religious family and my faith commu- let it be clear, God loves us just the way we nity, which is very important to me, is very conservative. are and for who we are.

Over the years, I’ve heard them con- A: Faith and a solid spiritual foundation is THE REVEREND FATHER DREW A. KOVACH, demn homosexuals and theorize that AIDS essential in living well with HIV. HIV affects MD, MDIV, ABFM, AAHIVS is an ordained is God’s punishment for being gay. Now is the mind, the body, and the spirit and all Episcopal/Orthodox priest, as well as a a time when I need my faith and I feel like must be in balance to be whole and well. board certified Family Medicine Physician, that, as well as my health, has been taken Religion is a man-made construct to try an HIV/AIDS Specialist, and Director of HIV from me and I’m really depressed about to understand God. God loves all of us, no Services at Kaiser Permanente Hawaii. it all. I have a friend who’s some sort of matter that we are gay, lesbian, bisexual, pagan and he talks about how important or transgender, or if we have HIV! Disease the mind/body/spirit connection is to your is never a punishment from God. In the SEARCH FOR AN HIV SPECIALIST™ health and well-being—I believe that may Christian belief, Jesus turned no one away Finding an HIV Specialist™ is easy be true, but I just can’t abandon what I’ve and healed all who came to him. He wants with AAHIVM’s Referral Link at always believed in for something that’s not us to be well, whole, and holy. Religion www.aahivm.org. Enter your ZIP true for me. I’ve prayed and prayed and is simply a vehicle to things spiritual. No code on the home page, and click haven’t gotten any clarity. What do you more, no less. As a physician and a priest on the “Go” button for a list of HIV think? How important is my faith to my and as a gay man taking care of HIV Specialists™ near you. health? patients now for over 30 years, I know

Seize the Day.

Select pictures from A Day with HIV in America are featured in a new book published by Positively Aware. Keep for yourself some of the most compelling images of our 2011 anti-stigma project. Limited supply.

Order your book for a $20 donation to cover the cost of printing, plus $2 for shipping.

To order, go to www.adaywithhiv.com/book BRIEFLY REPORTED BY ENID VÁZQUEZ

New all-in-one Gilead Sciences to get that company’s background because it has twice-daily new boosting medication, cobicistat, into dosing and greater toxicity than the HIV drug, the Quad, a fixed dose pill with BMS’s Reyataz and medications Truvada and Epzicom. goes before FDA Tibotec’s Prezista. The two HIV protease However, Combivir remains preferred inhibitors, along with a booster medica- for the treatment of pregnant women Good news for HIV treatment options: tion, are the two PIs recommended for due to its demonstrated ability to stop in October, Gilead Sciences submitted first-time antiviral therapy by U.S. treat- HIV transmission to infants. a New Drug Application (NDA) to the ment guidelines. Currently, Reyataz and n Lexiva has been removed as a Food and Drug Administration (FDA) Prezista use Norvir as a boosting agent, protease inhibitor (PI) option because for approval of the “Quad,” a complete but that medication can be very intoler- of inferior potency and the potential single-tablet HIV regimen. The other two able. While the agreement with BMS is for developing resistance to Prezista, such complete medications on the market for a boosted Reyataz pill, the agreement a recommended PI for first-time are Atripla and Complera. with Tibotec is for a complete HIV regi- therapy. All three medications contain Truvada men in one tablet that includes Prezista, n Viramune (nevirapine), a non- (Viread and Emtriva) from Gilead cobicistat, Emtriva, and Gilead’s GS-7340, nucleoside, is now considered Sciences as the background drug. Atripla a pro-drug (an inactive substance that “acceptable” (but not “recommended” also contains Sustiva, from Bristol-Myers metabolizes into active form in the body) or “alternative”) for first-time therapy Squibb, while Complera’s third drug is of its popular Viread (tenofovir, also (depending on the sex and beginning Edurant, from Tibotec Therapeutics (now found in Truvada, Atripla, and Complera). T-cell count of the patient); see the Janssen Therapeutics). Both Sustiva and guidelines for its upgrading and Edurant are from the drug class called downgrading information. non-nucleoside reverse transcriptase HIV treatment n Videx or Videx-EC plus Epivir were inhibitors, or NNRTIs. guidelines updated removed as an option for dual The Quad would be different in that its nucleoside background because they principle drug is elvitegravir, an HIV inte- On October 14, the Department of have the least study data and greater grase inhibitor medication like Isentress. Health and Human Services (DHHS) toxicity than other background drugs The Quad also contains the new drug updated its HIV treatment guidelines. available. level-boosting medication called cobicistat, The revised guidelines can be found at which allows for once-daily use of elvite- www.AIDSinfo.nih.gov. Many changes gravir. Therefore, the Quad is taken as one were made by the panel of experts that pill once daily, as are Atripla and Complera. updates the guidelines. These changes, Ziagen and The NDA is based on results from two listed below, all apply to the recommen- the heart Phase 3 (advanced) studies showing non- dations of what to use for people going inferiority (an FDA standard) at 48 weeks on HIV therapy for the first time. The updated HIV treatment guidelines of research compared to either Atripla or n The new HIV non-nucleoside drug (see above) also expanded the discus- boosted Reyataz. Both drugs are recom- Edurant (rilpivirine, in the same sion of a possible risk of heart attack mended by U.S. HIV treatment guidelines class as Sustiva) was added as an with abacavir (Ziagen, also found in for first-time therapy. acceptable option; a number of tables, Epzicom and Trizivir). This association such as the drug interactions table, was first noted years ago, leading various also had Edurant information added. groups of researchers around the world Drug makers sign n Prezista plus Epzicom, and Isentress to try to confirm or eliminate the risk fac- agreements on plus Epzicom were upgraded to an tor. The guidelines added an update on all “alternative regimen” from previously this work, explaining that of the several new fixed-dose being considered “acceptable, but studies looking at this issue, some have combo pills more definitive data are needed.” found an association while others haven’t. n Combivir (the combination of AZT Additional studies have also looked at Kudos to Bristol-Myers Squibb (BMS) and [zidovudine] plus lamivudine) was possible mechanisms of action for such Tibotec (now Janssen) Therapeutics for downgraded from an “alternative” an association, without success. All in signing a commercial agreement with to “acceptable” dual nucleoside all, the latest version of the guidelines

10 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM SIGN UP FOR THE WEEKLY PA E-NEWS. GO TO POSITIVELYAWARE.COM

states that “to date, no consensus has (e.g., yellowing of the skin or whites of Kaletra), headache (7% vs. 6%), abdominal been reached either on the association of the eyes, dark or tea colored urine, pale pain (6% for each), and rash (6% vs. 7%). [abacavir] use with MI [myocardial infarc- colored stools/bowel movements, nau- Prezista was developed by Tibotec tion, or heart attack] risk or a possible sea, vomiting, loss of appetite, or pain, (now Janssen) Therapeutics. It is one of mechanism for the association.” aching or sensitivity on the right side two protease inhibitors recommended by below the ribs). Patients should under- U.S. HIV treatment guidelines for people stand that if severe rash occurs, they will taking antiretrovirals for the first time. New side effect be closely monitored, laboratory tests warnings for will be ordered, and appropriate therapy will be initiated.” AMA supports Isentress research on HIV The FDA added warnings in November to the package insert for the popular Prezista label organ transplants HIV drug Isentress (raltegravir). Although adds longer-term The American Medical Association (AMA) known for tolerability, the following voted in November to support amending adverse reactions have been seen with data a federal law that bars clinical research Isentress. of organ donations from HIV-positive The “Warnings and Precautions” The Food and Drug Administration (FDA) donors, calling such research “a poten- section now includes “severe skin and in October approved a label update tially lifesaving measure for people living hypersensitivity [allergic] reactions.” to the HIV protease inhibitor Prezista with HIV infection.” Also added was rash with eosinophilia (darunavir) to add new 192-week data. Indeed, according to an AMA press (elevated levels of a specific type of white “Since its launch in 2006, Prezista release, “Advances in the medical man- blood cells), systemic symptoms [those has become one of the most prescribed agement of HIV infection coupled with that occur throughout the body, such antiretroviral agents in the protease improvements in transplant outcomes as fever], and cerebellar ataxia, which is inhibitor class,” said Vanessa Broadhurst, could make organ transplantation a sudden, uncoordinated movement due to the president of Janssen Therapeutics, viable clinical option for many HIV- disease or injury of the cerebellum (part in a press release. “Having data show- infected patients. Despite these scientific of the brain). ing the efficacy, safety, and tolerability advances, the Federal National Organ According to the updated information, of Prezista over 192 weeks should give Transplant Act of 1984 precludes dona- “Delay in stopping Isentress treatment or added confidence to healthcare providers tions of HIV-infected organs, thereby other suspect agents after the onset of who are considering Prezista as an option prohibiting investigational studies on severe rash may result in a life-threaten- for their patients who are starting treat- a source of organs for HIV-infected ing reaction.” The new information also ment for the first time.” patients. It is estimated that there are states that, “Patients should be advised Prezista showed superiority to Kaletra approximately 500-600 potential HIV- to immediately contact their healthcare at 192 weeks in the ARTEMIS study of infected kidney and liver donors per year provider if they develop rash. Instruct people on HIV therapy for the first time in the . Organs from these patients to immediately stop taking (Prezista is always boosted with Norvir donors have the potential to save the Isentress and other suspect agents, and and Kaletra has Norvir boosting in it). lives of approximately 1,000 HIV-infected seek medical attention if they develop a Seventy percent of the 343 individuals patients each year.” rash associated with any of the following taking Prezista achieved undetectable The release goes on to quote symptoms as it may be a sign of a more viral load (less than 50 copies per mL) AMA Board Member Ardis D. Hoven, serious reaction such as Stevens-Johnson compared to 61% of the 346 people tak- MD. “Research is needed to fully evaluate syndrome, toxic epidermal necrolysis, or ing Kaletra. Virologic failure (not main- the clinical risks and benefits of organ severe hypersensitivity: fever, general ill taining undetectable viral load) was 12% transplantation between HIV-infected feeling, extreme tiredness, muscle or joint for Prezista vs. 15% for Kaletra. individuals,” said Dr. Hoven. “The new aches, blisters, oral lesions, eye inflamma- The most common adverse reactions policy adopted today extends the AMA’s tion, facial swelling, swelling of the eyes, of moderate intensity (greater or equal to support for a change in federal law lips, mouth, breathing difficulty, and/or grade 2, with 5 being the highest) were that will permit the necessary scientific signs and symptoms of liver problems diarrhea (9% for Prezista and 16% for investigation.”

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 11 BRIEFLY COMPILED FROM THE WEEKLY E-NEWS

First clinical trial screening potential participants, 3,475 women at sites in five African will enroll 48 healthy, HIV-negative countries. of ARV vaginal ring women ages 18–40 at the University of As part of IPM’s strategy to license underway Pittsburgh, Fenway Institute in Boston the dapivirine ring, IPM will conduct The and the University of Alabama at Ring Study (IPM 027), which will be done In the first clinical trial of a vaginal ring Birmingham. Researchers will evaluate in parallel with ASPIRE, and collect long- combining two antiretroviral (ARV) drugs, the ring’s safety and how well women term safety and efficacy data about the researchers from the Microbicide Trials like or are willing to use the ring. In addi- ring among approximately 1,650 women Network (MTN) are collaborating with the tion, different tests will be performed to at multiple research centers in Africa. International Partnership for Microbicides help determine how much of each drug (IPM) to evaluate whether the ring is safe is taken up by the cells usually targeted for use in women. If the ring does prove to by HIV and whether drug levels are Capsaicin patch be safe, it could be considered for further sustained throughout the four weeks for neuropathy testing, and eventually be evaluated for the ring is worn. Women will wear their its effectiveness as a microbicide for assigned ring for 28 days. Different tests gets FDA review protecting women against HIV infection and procedures will be conducted dur- through vaginal sex. ing this time as well as during a 24-day NeurogesX, Inc., a biopharmaceutical The study, which is funded by the follow-up period. company focused on developing and National Institutes of Health and goes by “IPM has been a pioneer in developing commercializing novel pain management the name MTN-013/IPM 026, is evaluating vaginal rings for delivery of antiretrovi- therapies, announced on November 14 a ring that contains dapivirine, a non- rals. Our collaboration marks an impor- that the Food and Drug Administration nucleoside reverse transcriptase inhibitor tant juncture for the field as we begin to (FDA) has accepted for review the com- (NNRTI) and the entry inhibitor Selzentry explore drugs with different mechanisms pany’s supplemental new drug applica- (maraviroc). The dapivirine-maraviroc ring of action and methods that we hope will tion (sNDA) for Qutenza (capsaicin) for is the first combination microbicide to give women new, easy-to-use options for the management of neuropathic pain enter clinical trials. It is also the first vagi- preventing HIV,” remarked MTN principal caused by HIV-associated peripheral neu- nal microbicide containing an entry inhibi- investigator Sharon Hillier, PhD, who ropathy (HIV-PN). The FDA has granted tor. The belief is that combining the two is professor and vice chair for faculty Qutenza a priority six month review drugs, which act at different points in the affairs, and director of reproductive classification. HIV life cycle, may provide greater protec- infectious disease research in the depart- “The FDA’s filing and priority review tion against HIV than a single drug alone. ment of obstetrics, gynecology, and of our sNDA for Qutenza in HIV-PN is a The ring was developed by IPM, a non- reproductive sciences at the University of significant achievement for NeurogesX as profit product development partnership Pittsburgh School of Medicine. we seek to expand our pain management headquartered in Silver Spring, , “Our partnership with MTN on the first franchise,” said Anthony DiTonno, presi- in collaboration with Queens University combination microbicide to enter clinical dent and CEO of NeurogesX in a press Belfast (Belfast, Northern Ireland). trials is an important milestone for the HIV release. “This takes us another step for- Globally, women comprise half of prevention field,” said Zeda F. Rosenberg, ward in our effort to provide lasting relief the 34 million people living with HIV. In ScD, IPM chief executive officer. “With from one of the most challenging chronic most cases, women acquire HIV through extensive pre-clinical data on both drugs pain conditions. We look forward to our unprotected heterosexual sex with an to support the combination ring’s devel- continued discussion with the FDA during infected partner. Because the use of opment, we hope this product will one day the review of this application.” condoms is often not an option, there is expand women’s HIV prevention options The Qutenza sNDA seeks approval an urgent need for effective prevention and open the door to developing other for a 30-minute application for the treat- strategies that women can control them- combination HIV prevention methods.” ment of neuropathic pain associated selves. To that end, vaginal microbicides Next year, the MTN will launch a Phase with HIV-PN. Qutenza is currently FDA in the form of a gel or a ring are being 3 effectiveness trial of the dapivirine- approved as a 60-minute application for developed to provide women with new only ring. The study, called ASPIRE—A the management of neuropathic pain tools to protect themselves against HIV. Study to Prevent Infection with a Ring for associated with postherpetic neuralgia MTN-013/IPM 026, which is now Extended Use—will enroll approximately (PHN). If approved, the company believes

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that Qutenza would be the first and only drug’s potential earlier in the pipeline of independent Data and Safety Monitoring product approved to treat HIV-PN in the drug development.” Board (DSMB) recommended stop- United States. In the trial, researchers tested a ping the 1% tenofovir gel being studied formulation of the gel that was created because it was also no more effective for vaginal use in human trials and that than placebo (fake substance). The Early trial suggests contained two concentrations of UC781. women given either the gel or the pla- rectal microbicide They enrolled 36 male and female sub- cebo had the same incidence of acquiring jects at UCLA who were not infected HIV from their sex partners, 6% in each is safe, effective with HIV, and they collected blood and group. A topically applied microbicide gel con- rectal tissue samples at baseline, before Tenofovir 1% gel was found to be taining a potent anti-HIV drug has been participants were randomized to either effective in preventing HIV in women in found to significantly reduce infection a placebo group or to receive one of two the landmark CAPRISA 004 study, and it when applied to rectal tissue that was concentrations of UC781. All participants continues to be studied for prevention in subsequently exposed to HIV in the were given the placebo or active drug as FACTS 001, an advanced Phase 3 study. laboratory, according to a new study by a single exposure by the team’s clinicians, VOICE, which stands for Vaginal the UCLA AIDS Institute. The gel was also with research samples collected 30 min- and Oral Interventions to Control the found to be safe and acceptable to users. utes later for analysis. Epidemic, will continue to study the The Phase 1 clinical trial of the rectal After two to three weeks, the partici- daily use of Truvada pills for prevention. HIV-prevention drug known as UC781, pants resumed the second part of the The study is being carried out by the a non-nucleoside reverse transcriptase trial by applying the gel or placebo once Microbicide Trials Network (MTN) in 15 inhibitor, is described in the current edi- daily over seven days on their own at sites throughout Uganda, South Africa, tion of the online journal PLoS ONE. home. Afterwards, they returned to the and Zimbabwe, and has enrolled more While anal-receptive intercourse is clinic for another collection of samples. than 5,000 women. known to be the main route for new HIV All participants completed the study once In a press release, AVAC, a U.S. infections in men who have sex with men, they were enrolled. In-depth interviews organization working on global advo- far more women than men worldwide with each participant assessed their cacy for HIV prevention, reported, “The practice anal intercourse. The risk of HIV acceptability of the current form of the announcement that the 1% tenofovir gel infection, per sex act, is anywhere from product. arm of a large-scale HIV prevention trial 20 to 2,000 times greater with receptive Though the microbicide used for this known as VOICE will stop early is disap- anal sex than receptive vaginal sex — study was formulated for vaginal use, pointing but is not the end of the road particularly if there are other infections the same team of researchers has also for tenofovir gel or antiretroviral (ARV)- present, such as herpes, gonorrhea or developed a rectal-specific microbicide based microbicides.” chlamydia, according to the study’s lead gel, which they plan to start testing in a “This is a blow to the HIV prevention author, Dr. Peter Anton, a professor of clinical trial in January 2012. field but is not the definitive answer medicine in the division of digestive about whether 1% tenofovir gel is an diseases at the David Geffen School of effective HIV prevention product for Medicine at UCLA, and a member of the women,” said Mitchell Warren, AVAC UCLA AIDS Institute. Another setback executive diirector. “While the main goal of this trial for women’s was also to evaluate safety, these new tests enabled us to evaluate, indirectly, HIV prevention whether this drug and route of deliv- ery might potentially reduce new HIV In the November/December issue of PA, 15.9 infections,” said Anton. “Of course, it is it was reported that the VOICE study had very gratifying that the results were so stopped the use of Viread (tenofovir) tab- MILLION impressive. This approach reflects the lets in its investigation of HIV prevention women are living with kind of intensive analyses these dedi- for women because it proved to be no HIV/AIDS worldwide. cated participants in these early trials are better than a placebo. SOURCE: AVERT.ORG willing to tolerate to help us evaluate a In December, news came that an

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 13 When ISENTRESS has been given with other anti-HIV drugs, side effects included nausea, headache, headache, Mildnausea, rash occurred moreincluded often in patientseffects takingside ISENTRESS plusdrugs, anti-HIV tiredness,other weakness,with troublegiven sleeping,been stomach pain,has dizziness, depression,ISENTRESS and suicidalWhen thoughts and actions. kidney damage. taking ISENTRESS.Thisisbecause onrareoccasionsmuscleproblemscanbeserious andcanleadto Contact yourdoctorimmediately ifyouexperienceunexplainedmusclepain,tenderness, orweaknesswhile Call yourdoctorrightawayifyounoticeanysignsorsymptoms ofaninfectionafterstartingISENTRESS. infections mayoccurasthemedicinesworktotreat theHIVinfectionandstrengthenimmunesystem. infection (AIDS)whenanti-HIVtreatmentisstarted.Signs andsymptomsofinflammationfromopportunistic A conditioncalledImmuneReconstitutionSyndromecan happeninsomepatientswithadvancedHIV IMPORTANT RISK INFORMATION ISENTRESS willnotcure HIVorreduce yourchancesof passingitontoothers. ISENTRESS hasnotbeenstudiedinchildren. other HIVmedicinestoimprove yourchancesoffighting thevirus. You must remain underyourdoctor’s care. ISENTRESS isamedicineusedtotreat thehumanimmunodeficiencyvirus(HIV). INDICATIONS Model Prezista than with either drug alone. ISENTRESS mustbetakenwith

B:16.5” S:15” T:16” For more information about ISENTRESS, please read the Patient Information on the following FDA. page. the to www.fda.gov/medwatch, orcall1-800-FDA-1088. Visit drugs prescription of effects side negative report to encouraged Youare to treat infectionssuchastuberculosis), non-prescription medicines,vitamins,andherbalsupplements. Tell yourdoctoraboutallthemedicinesyoutake,includingprescription medicineslikerifampin(amedicineused breast milk. pregnancy. Women withHIVshouldnotbreast-feed because theirbabiescouldbeinfectedwithHIVthrough their become pregnant, orare breast-feeding orplantobreast-feed. ISENTRESS isnotrecommended foruseduring Tell yourdoctoraboutallofmedicalconditions,includingifyouhaveanyallergies, are pregnant orplanto occur withHIVinfection. People takingISENTRESSmaystilldevelopinfections,includingopportunisticinfectionsorotherconditionsthat Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Prezista Truvada Sustiva IMMU-1001562-0004-08/11(112) Need help paying for ISENTRESS? is a registered trademark of Bristol-Myers Squibb is a registered trademark of Tibotec,Inc. is a registered trademark of Gilead Sciences, Inc. I am HIV positive. I am a world traveler. I am romantic. I am a go-getter. first timewhotookISENTRESSplusTruvada : In clinicalstudieslasting96weeks,patientsbeingtreated withHIVmedicationforthe that mayfityourneedsandlifestyle. to startHIVtherapy, talktoyourdoctorabout amedication And soisyourpathtomanagingHIV. Whenyou’reready You arespecial,unique,anddifferentfrom anyoneelse. Not sure where to start? Visit Ask your doctor about — Experiencedlesseffect onLDLcholesterol (“bad”cholesterol) — Hadalowrateofsideeffects — Cholesterol increased anaverageof7mg/dLwithISENTRESS plus ISENTRESS plus When— they began the study, the average LDL cholesterol of patients on versus 21 mg/dLwithSustivaplusTruvada

(4%) versusSustivaplusTruvada (3%) This side effect occurred more often in patients taking ISENTRESS plus with orkeptpatientsfrom performingdailyactivities)wastrouble sleeping Themostcommonsideeffect ofmoderatetosevere intensity (thatinterfered Sustiva Call 1-

866- plus Merck & Co., Inc. 350-9232 Truvada Truvada All rights reserved. ISENTRESS was 96 mg/dL versus 93 mg/dL for those on

isentress.com/questions .

Truvada Truvada

S:9.5 in S:9.5

T:10.5 in T:10.5 B:11 in B:11

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Saved at 6-3-2011 2:15 PM Save Path Macintosh HD:Users:juanpineros...S_M_11091_Bren- Job info Approvals Fonts & Images Job MIS_M_11091_Brendan_PositivelyA Art Director Yuri Fonts Client Merck Isentress Copywriter Michelle Mulligan Helvetica Neue LT Std (63 Medium Extended, Client # 3298496/10001 Account Mgr Anjoli Bido 55 Roman, 65 Medium, 56 Italic, 47 Light Con- Media Type Magazine Studio Mgr Juan densed, 77 Bold Condensed, 47 Light Condensed Bleed 16.5” x 11” Proofreader Lorna Smedman Oblique, 43 Light Extended), Optima (Bold) Trim 16” x 10.5” Live 15” x 9.5” Notes Images Pubs Positively Aware Sep ob_432_r.eps (19.19%), 8036-bren.FLT_v4.tif None (CMYK; 309 ppi; 96.95%), MRK24286_ISEN- Special Instructions TRESS_CMYK_R.eps (32.64%), Supportv2. eps (89.28%), DiamondBullet.eps (33.49%) None Ad Name Brendan Size Spread Inks Color 4 Color Cyan, Magenta, Yellow, Black Spell Checked No -- DATE______When ISENTRESS has been given with other anti-HIV drugs, side effects included nausea, headache, headache, Mildnausea, rash occurred moreincluded often in patientseffects takingside ISENTRESS plusdrugs, anti-HIV tiredness,other weakness,with troublegiven sleeping,been stomach pain,has dizziness, depression,ISENTRESS and suicidalWhen thoughts and actions. kidney damage. taking ISENTRESS.Thisisbecause onrareoccasionsmuscleproblemscanbeserious andcanleadto Contact yourdoctorimmediately ifyouexperienceunexplainedmusclepain,tenderness, orweaknesswhile Call yourdoctorrightawayifyounoticeanysignsorsymptoms ofaninfectionafterstartingISENTRESS. infections mayoccurasthemedicinesworktotreat theHIVinfectionandstrengthenimmunesystem. infection (AIDS)whenanti-HIVtreatmentisstarted.Signs andsymptomsofinflammationfromopportunistic A conditioncalledImmuneReconstitutionSyndromecan happeninsomepatientswithadvancedHIV IMPORTANT RISK INFORMATION ISENTRESS willnotcure HIVorreduce yourchancesof passingitontoothers. ISENTRESS hasnotbeenstudiedinchildren. other HIVmedicinestoimprove yourchancesoffighting thevirus. You must remain underyourdoctor’s care. ISENTRESS isamedicineusedtotreat thehumanimmunodeficiencyvirus(HIV). INDICATIONS Model Prezista than with either drug alone. ISENTRESS mustbetakenwith

B:16.5” S:15” T:16” For more information about ISENTRESS, please read the Patient Information on the following FDA. page. the to www.fda.gov/medwatch, orcall1-800-FDA-1088. Visit drugs prescription of effects side negative report to encouraged Youare to treat infectionssuchastuberculosis), non-prescription medicines,vitamins,andherbalsupplements. Tell yourdoctoraboutallthemedicinesyoutake,includingprescription medicineslikerifampin(amedicineused breast milk. pregnancy. Women withHIVshouldnotbreast-feed because theirbabiescouldbeinfectedwithHIVthrough their become pregnant, orare breast-feeding orplantobreast-feed. ISENTRESS isnotrecommended foruseduring Tell yourdoctoraboutallofmedicalconditions,includingifyouhaveanyallergies, are pregnant orplanto occur withHIVinfection. People takingISENTRESSmaystilldevelopinfections,includingopportunisticinfectionsorotherconditionsthat Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Prezista Truvada Sustiva IMMU-1001562-0004-08/11(112) Need help paying for ISENTRESS? is a registered trademark of Bristol-Myers Squibb is a registered trademark of Tibotec,Inc. is a registered trademark of Gilead Sciences, Inc. I am HIV positive. I am a world traveler. I am romantic. I am a go-getter. first timewhotookISENTRESSplusTruvada : In clinicalstudieslasting96weeks,patientsbeingtreated withHIVmedicationforthe that mayfityourneedsandlifestyle. to startHIVtherapy, talktoyourdoctorabout amedication And soisyourpathtomanagingHIV. Whenyou’reready You arespecial,unique,anddifferentfrom anyoneelse. Not sure where to start? Visit Ask your doctor about — Experiencedlesseffect onLDLcholesterol (“bad”cholesterol) — Hadalowrateofsideeffects — Cholesterol increased anaverageof7mg/dLwithISENTRESS plus ISENTRESS plus When— they began the study, the average LDL cholesterol of patients on versus 21 mg/dLwithSustivaplusTruvada (4%) versusSustivaplusTruvada (3%) This side effect occurred more often in patients taking ISENTRESS plus with orkeptpatientsfrom performingdailyactivities)wastrouble sleeping Themostcommonsideeffect ofmoderatetosevere intensity (thatinterfered Sustiva Call 1-

866- plus Merck & Co., Inc. 350-9232 Truvada Truvada All rights reserved. ISENTRESS was 96 mg/dL versus 93 mg/dL for those on

isentress.com/questions .

Truvada Truvada

S:9.5 in S:9.5

T:10.5 in T:10.5 B:11 in B:11

Round 3 MIS_M_11091_Brendan_PositivelyA.indd Date Created 4-14-2011 3:03 PM from Juan Pineros’s Mac Pro by Juan Pineros / Carl Printed At None

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Patient Information ISENTRESS® (eye sen tris) (raltegravir) Tablets Read the patient information that comes with ISENTRESS1 before you start taking If you fail to take ISENTRESS the way you should, here’s what to do: it and each time you get a refill. There may be new information. This leaflet is a • If you miss a dose, take it as soon as you remember. If you do not summary of the information for patients. Your doctor or pharmacist can give you remember until it is time for your next dose, skip the missed dose and go additional information. This leaflet does not take the place of talking with your back to your regular schedule. Do NOT take two tablets of ISENTRESS at the doctor about your medical condition or your treatment. same time. In other words, do NOT take a double dose. What is ISENTRESS? • If you take too much ISENTRESS, call your doctor or local Poison Control • ISENTRESS is an anti-HIV (antiretroviral) medicine used for the treatment Center. of HIV. The term HIV stands for Human Immunodeficiency Virus. It is the Be sure to keep a supply of your anti-HIV medicines. virus that causes AIDS (Acquired Immune Deficiency Syndrome). ISENTRESS • When your ISENTRESS supply starts to run low, get more from your doctor is used along with other anti-HIV medicines. ISENTRESS will NOT cure or pharmacy. HIV infection. • Do not wait until your medicine runs out to get more. • People taking ISENTRESS may still develop infections, including What are the possible side effects of ISENTRESS? opportunistic infections or other conditions that happen with HIV infection. • Stay under the care of your doctor during treatment with ISENTRESS. When ISENTRESS has been given with other anti-HIV drugs, side effects • The safety and effectiveness of ISENTRESS in children has not been studied. included: • nausea ISENTRESS must be used with other anti-HIV medicines. • headache How does ISENTRESS work? • tiredness • ISENTRESS blocks an enzyme which the virus (HIV) needs in order to make • weakness more virus. The enzyme that ISENTRESS blocks is called HIV integrase. • trouble sleeping • When used with other anti-HIV medicines, ISENTRESS may do two things: • stomach pain 1. Reduce the amount of HIV in your blood. This is called your “viral load”. • dizziness 2. Increase the number of white blood cells called CD4 (T) cells. • depression • ISENTRESS may not have these effects in all patients. • suicidal thoughts and actions Does ISENTRESS lower the chance of passing HIV to other people? Other side effects include: rash, severe skin reactions, feeling anxious, paranoia, No. ISENTRESS does not reduce the chance of passing HIV to others through sexual low blood platelet count, diarrhea, liver failure. contact, sharing needles, or being exposed to your blood. A condition called Immune Reconstitution Syndrome can happen in some • Continue to practice safer sex. patients with advanced HIV infection (AIDS) when combination antiretroviral • Use latex or polyurethane condoms or other barrier methods to lower the treatment is started. Signs and symptoms of inflammation from opportunistic chance of sexual contact with any body fluids. This includes semen from a infections that a person has or had may occur as the medicines work to treat man, vaginal secretions from a woman, or blood. the HIV infection and help to strengthen the immune system. Call your doctor • Never re-use or share needles. right away if you notice any signs or symptoms of an infection after starting Ask your doctor if you have any questions about safer sex or how to prevent ISENTRESS with other anti-HIV medicines. passing HIV to other people. Contact your doctor promptly if you experience unexplained muscle pain, What should I tell my doctor before and during treatment with ISENTRESS? tenderness, or weakness while taking ISENTRESS. This is because on rare Tell your doctor about all of your medical conditions. Include any of the following T:10.5” occasions, muscle problems can be serious and can lead to kidney damage. S:9.5” that applies to you: • You have any allergies. Rash occurred more often in patients taking ISENTRESS and darunavir together • You are pregnant or plan to become pregnant. than with either drug separately, but was generally mild. - ISENTRESS is not recommended for use during pregnancy. Tell your doctor if you have any side effects that bother you. ISENTRESS has not been studied in pregnant women. If you take ISENTRESS while you are pregnant, talk to your doctor about how These are not all the side effects of ISENTRESS. For more information, ask your you can be included in the Antiretroviral Pregnancy Registry. doctor or pharmacist. • You are breast-feeding or plan to breast-feed. How should I store ISENTRESS? - It is recommended that HIV-infected women should not breast-feed • Store ISENTRESS at room temperature (68 to 77°F). their infants. This is because their babies could be infected with HIV • Keep ISENTRESS and all medicines out of the reach of children. through their breast milk. - Talk with your doctor about the best way to feed your baby. General information about the use of ISENTRESS Tell your doctor about all the medicines you take. Include the following: Medicines are sometimes prescribed for conditions that are not mentioned in • prescription medicines, including rifampin (a medicine used to treat some patient information leaflets. infections such as tuberculosis) • Do not use ISENTRESS for a condition for which it was not prescribed. • non-prescription medicines • Do not give ISENTRESS to other people, even if they have the same • vitamins symptoms you have. It may harm them. • herbal supplements This leaflet gives you the most important information about ISENTRESS. Know the medicines you take. • If you would like to know more, talk with your doctor. • Keep a list of your medicines. Show the list to your doctor and pharmacist • You can ask your doctor or pharmacist for additional information about when you get a new medicine. ISENTRESS that is written for health professionals. • For more information go to www.ISENTRESS.com or call 1-800-622-4477. How should I take ISENTRESS? What are the ingredients in ISENTRESS? Take ISENTRESS exactly as your doctor has prescribed. The recommended Active ingredient: Each film-coated tablet contains 400 mg of raltegravir. dose is as follows: • Take only one 400-mg tablet at a time. Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, calcium • Take it twice a day. phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% • Take it by mouth. butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium • Take it with or without food. stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide Do not change your dose or stop taking ISENTRESS or your other anti-HIV and black iron oxide. medicines without first talking with your doctor.

IMPORTANT: Take ISENTRESS exactly as your doctor prescribed and at the Distributed by: right times of day because if you don’t: • The amount of virus (HIV) in your blood may increase if the medicine is Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. stopped for even a short period of time. Whitehouse Station, NJ 08889, USA • The virus may develop resistance to ISENTRESS and become harder to treat. • Your medicines may stop working to fight HIV. • The activity of ISENTRESS may be reduced (due to resistance).

1Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Revised February 2011 Copyright © 2007, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. 9795112 All rights reserved. U.S. Patent Nos. US 7,169,780 IMMU-1001562-0004-08/11(112)

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protein (or enzyme) CYP34A. be clinically relevant in sup- Reports from the 51st Interscience This is the same enzyme that pressed patients [those with the body uses to metabolize undetectable viral loads],” Conference on Antimicrobial Agents & the Edurant in Complera. since all viral loads were Chemotherapy (ICAAC), which met in Sustiva has a long half-life undetectable at 12 weeks. Chicago, and the 49th Annual Meeting and therefore drops the blood The study also reported that of the Infectious Diseases Society of levels of Edurant; because Complera was well tolerated. there’s too much metabolism America (IDSA), held in Boston. of Edurant going on, the body eliminates it. ISENTRESS FOR That interaction was rec- FOUR YEARS COMPLERA AND discontinuation rate for ognized thanks to an earlier ATRIPLA NEWS adverse events was 4% for study that found a drop in The longest-term data on Complera compared to 9% Edurant blood levels of about Isentress to date, presented Last summer, 48-week for Atripla, a statistically 25% for approximately four at IDSA, show better virologic data won FDA approval significant difference. These weeks in volunteers switching (viral load) and immunologic for Complera (see the figures were about double from Sustiva to Edurant. (T-cell count) results than November+December 2011 those of week 48 (2% vs. 5% Fortunately, an HIV study Sustiva, out to 192 weeks Briefly for the complicated respectively). presented at both ICAAC (nearly four years). details). At IDSA, 96-week As leading HIV specialist and IDSA has now shown STARTMRK is a non-infe- data were presented from the and researcher Cal Cohen that patients were able to riority study, but was able to ECHO and THRIVE studies of the Community Research maintain undetectable viral demonstrate virologic supe- that pitted the new Complera Initiative of New England loads when switching from riority over Sustiva at 192 against Atripla. Complera said, “For the right person, Atripla to Complera, out to weeks based on pre-specified continued to be non-inferior Complera is a good drug. and three months. There was only data standards. to Atripla, but also contin- it’s important to consider for a small temporary drop in At 192 weeks, 76.2% of ued to have more virologic those who want the benefit Edurant blood levels. the 281 people on Isentress failure in people who started of taking a single tablet once At ICAAC, Dr. Tony Mills vs. 67% of the 282 individuals therapy at viral loads greater daily, and for whom Atripla of Los Angeles made a taking Sustiva had undetect- than 500,000. isn’t the right choice.” poster presentation on the 49 able viral load of less than 50 There was bad news for patients switching from Atripla copies per mL. The Isentress people who began Complera to Complera because of prob- group also saw a greater with a viral load of greater SWITCHING FROM lems with tolerability. Atripla increase in their CD4+ T-cell than 100,000, as well. The ATRIPLA TO was their first HIV regimen and counts, 361 vs. 301 for those researchers conducted a so- COMPLERA they had been taking it for at on Sustiva. called “snapshot” analysis, least three months (the aver- Isentress was also more looking at viral load measure- Now that the best-selling age was 2.5 years). At week 12 tolerable, with 50% of the ments made between 96 and Atripla has a real competitor, after the switch, all 49 still had people taking it experienc- 103 weeks. Here, the virologic an important question undetectable viral loads of less ing a “drug-related clinical failure was almost twice as becomes, can people switch than 50 copies per mL. adverse event” compared to high for Complera: 22% vs. 12% from Atripla to the new The study did see lower 80% of those taking Sustiva. for Atripla. Moreover, virologic Complera? than expected blood levels Discontinuations due to failures leading to treatment While switching to a new of Edurant at week one, but adverse events were also discontinuation were also and improved drug or regi- not at the other weeks in lower with Isentress: 5% vs. higher with Complera: 12% vs. men is common, there was a which bloodwork was col- 8.2% for Sustiva. In terms of 4% for Atripla. concern about switching here lected (2, 4, 6, 8, and 12). The what’s called “serious adverse On the plus side, Complera because of the way these study concluded that “brief events,” there was a similar also continued to be more drugs act in the body. The [Sustiva] inductive effects on rate: 17.8% for Isentress and tolerable. The treatment Sustiva in Atripla activates the [Edurant] metabolism may not 18.4% for Sustiva.

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 17 CONFERENCE UPDATE ICAAC & IDSA BY JEFF BERRY & ENID VÁZQUEZ

Isentress, like Sustiva, that their male partners are being surveyed, including at Presenter Dr. Thana is one of the medications engaging in sex with other least one new sex partner in Khawcharoenporn said recommended by the men while incarcerated, that time period. the participants showed a Department of Health and whether consensual or not, The majority of participants disassociation between their Human Services HIV treat- nor do they recognize other also reported high levels of high level of knowledge of ment guidelines for people incarceration risk factors such inconsistent condom use (81 risk factors and the assess- taking antiviral therapy for as sharing needles for drug to 96%), with both vaginal ment of their own risk. the first time. use or tattooing. and anal intercourse. One- Included in the presenta- Dr. Smith said that when fifth (21%) of both men and tion was information on an talking with heterosexual or women reported having had earlier study by Denise Dion RISKY BUSINESS bisexual men who have been anal intercourse. Hallfors and colleagues that AND PrEP INTEREST incarcerated or have HIV, Other risk factors included found blacks in the U.S. are at IN CHICAGO they will often have kept their drinking alcohol or using higher risk of HIV despite nor- STI CLINIC sexual contact with other men drugs at least half of the time mative (the same) behavior or their HIV infection a secret when having sex, and having as whites, that they perceive Chicago researchers surveyed from female sex partners. a sexually transmitted infec- themselves to be at low risk patients at a clinic treating According to U.S. govern- tion (STI) within the past year. based on their own actions sexually transmitted diseases ment data, the prevalence of Some risk factors were instead of the risk behaviors about condom use, perception AIDS among U.S. prisoners is based on a partner’s behavior of their sex partners, and that of HIV risk, and acceptance of three times that of the general (STI within past year; ever the perception of low risk may PrEP (pre-exposure prophy- population, and approximately exchanging sex for money or be associated with ongoing laxis, the use of medication to one in five people with HIV drugs; drug use within past risky behavior and lack of prevent HIV infection). will be incarcerated at some 30 days; and ever being in jail prevention strategies. At ICAAC, they presented point. A factsheet from the or prison). Kudos to the researchers an analysis of 359 heterosex- Centers for Disease Control When asked about taking at Rush, CORE Center, and uals deemed at high risk for and Prevention (CDC), states medication for the prevention Stroger Hospital (Chicago’s HIV infection and found that that incarceration risk factors of HIV, 83% of the partici- public hospital) for gathering the vast majority (84%) saw of unsafe tattooing, sex, and pants said they would take a this information. themselves as being at no drug use “coupled with the pill for PrEP. Their preference or low risk of HIV infection. sexual relationships and socio- for taking PrEP was lowest The two risk factors that economic consequences faced for daily use (63%) and 75% GERM STORIES —A were significantly different by persons with histories of preferred taking it an hour CHILDREN’S BOOK between the men and the incarceration, make prisons a before sex, a day before sex, women were having ever risk factor for HIV infection.” or a week before sex. The organizer of ICAAC, been in a jail or prison (55% The majority of the indi- Among the audience at the American Society for of men and 23% of women) viduals surveyed in Chicago the presentation were doctors Microbiology, took on a very and having ever exchanged were people of color (75% who thanked the researchers different project by lending sex for money or drugs (6% black and 15% Latino). In this for reminding everyone that photographs by Roberto of men and 15% of women). public clinic (CORE Center), women engage in anal sex Kolter to be used in a chil- HIV specialist Dr. Kimberly there was a high level of and who pointed out that sur- dren’s picture book called Y. Smith of Rush University poverty: nearly half (45%) had veys of gay and bisexual men Germ Stories, by Nobel Prize- Medical Center, one of the household incomes of less have also found low percep- winning enzymologist Arthur leaders of this study, said that than $499 a month. Only a tions of HIV risk in the face of Kornberg. Cute illustrations women may not recognize third of them were employed risky behavior or actual infec- by Adam Alaniz round out the that incarceration increases and 79% had only a high tion. One audience member photos and text. the risk of HIV for their male school education or less. questioned the perception The HIV germ story cen- sex partners and in turn, for Half of the 234 men in this of low risk in light of the fact ters on a schoolboy named Bill the women themselves. The study had two or more sex that these individuals were who has hemophilia. women don’t want to believe partners in the month before being seen in an STI clinic. The very short story goes

18 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM those age 20–29 having age 20–29 have the highest were recruited into the survey. the higher incidence (new HIV incidence rates of any Their age ranged from 22 to infections) in that city. In the age-risk population segment 27. The greatest number of U.S., the majority of MSM with in the city. YMSM are technol- them were white (42.4%), new infections are ages 13–29 ogy savvy and use GPS-based followed by Latinos (33.6%), (nearly four out of 10). social networking ‘apps,’ Asian (14.1%), and African Dr. Landovitz reported such as GRINDR, to facilitate Americans (6.4%). on to explain how unlikely the that GRINDR boasts two mil- sexual partnering. GRINDR Of these, 83.2% had been virus is to be transmitted at lion users worldwide, with has more than [two] milliion tested for HIV in the past school, and how medication 8,000 more joining each day users and more than 46,500 year, with 4.3% reported keeps Bill well. Other germs and 280,000 logged on at users in L.A. GRINDR may be having never been tested for visit other children—yeast and least daily. GRINDR allows a tool to access hard to reach the virus. The men reported food poisoning, pneumonia, its users to locate each other communities.” having had gonorrhea (17.9%), and more. geographically by using GPS Was it? In their abstract Chlamydia (13.6%), and Unfortunately, AIDS is functionality. An example conclusion, they report that, syphilis (9.1%). The average referred to as “acute immuno- put up on the screen was of a “GRINDR was a feasible and number of partners for anal deficiency syndrome” instead 27-year-old Latino located 81 acceptable method to recruit sex in the previous year was of “acquired.” And “dread feet away. He was single and a sample of YMSM. Most com- 10. More than half (56%) had disease” is an unfortunate looking for “dates, friends, plied with CDC-recommended found a sex partner through reference. But did you know and networking.” annual HIV testing. Prevalence GRINDR in the previous three that “a measly grain of sand “Some of you may not be of self-reported HIV was months and 41% reported is 8,000,000,000 times big- familiar with GRINDR,” Dr. similar to data from other inconsistent condom use for ger than a single particle of Landovitz said. “Some of you recruitment techniques in receptive anal sex. While 98% HIV”? All in all, the book is a may be logged on to it right YMSM; this suggests little bias reported sex with men in the dynamic combo of rhyme and now,” at which the audience by HIV status in this sample. previous year, 10% reported science, which may or may not broke out laughing. With high rates of reported having sex with women in delight any particular child. In one slide, Landovitz STIs and risk behavior, the that time period, two report- pretended to show two audi- sample is at high risk for HIV ed sex with transgender ence members logged on. He acquisition. On GRINDR, fewer women, and one reported sex REACHING YOUNG presented their exchange on HIV-positives inquired about with a transgender male. GAY MEN the screen. partners’ HIV status THROUGH GRINDR than HIV-negatives, sug- “Hey—you’re hot [referring to gesting less Raphael J. Landovitz, MD, of the person’s profile photo]!” [picking partners of UCLA said he was going to the same HIV status]. show “how to meet a gay man “Thanks! U2. Where u at?” GRINDR may be a mech- in five easy steps—GRINDR anism for providing HIV 101.” The greater purpose of “ICAAC.” prevention messaging his presentation, however, and interventions.” was to give the results of a “No way. Me too!” The research group survey of young gay men used areas of Los using the social networking “Presentation on GRINDR. Angeles frequented by app and discuss how it might Interesting, but the presenter young MSM. GRINDR be useful for HIV preven- is a dork.” members identified as 18 tion. In Los Angeles, as in They make arrangements to 29 years of age were the United States, he said, to meet up later. eligible for the survey. men who have sex with men According to the research Of 4,808 contacts made (MSM) acquire the majority group’s abstract, “Young over five months, only

GERM STORIES PHOTO: JOSHUA THORNE. GRINDR PHOTO: CHRIS KNIGHT of new HIV infections, with MSM (YMSM) in Los Angeles 375 individuals (7.8%) Cruising for prevention information?

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 19 B:16.5 in T:16 in S:15 in

FILE NAME www.egrifta.com 0027_EGR_AD_SPD_ You HAVE YouR HIV unDER ConTRoL. noW, on To PA_M01.indd DATE 07.29.11 HIV-RELATED EXCESS BELLY FAT. CLIENT Egrifta In two separate clinical trials of HIV-infected people with lipodystrophy, each lasting 6 months, EGRIFTA® reduced PART # HIV-related excess belly fat by an average of 18% in the first trial, and 14% in the second trial. This reduction in excess belly fat resulted in an approximate 1-inch reduction in waist size. Individual results may vary. DESCRIPTION On average, patients on EGRIFTA® did not lose weight. Print Ad Like HIV, HIV-related excess belly fat is a chronic condition. In clinical studies: Positively Aware - Spread • People who used EGRIFTA® continuously for 1 year maintained their results over this time period Release via PDF • People who stopped taking EGRIFTA® after 6 months had their HIV-related excess belly fat come back EGRIFTA® is believed to work with your own body to produce natural growth hormone to reduce your excess belly fat. SPECS Trim: 16 x 10.5” Indication: Bleed: 16.5 x 11” EGRIFTA® is a daily injectable prescription medicine to reduce the excess in abdominal fat in HIV-infected patients with lipodystrophy. Safety: 15 x 9.5” Gutter: 1” Limitations of use: Colors: 4C, CMYK • The impact and safety of EGRIFTA® on cardiovascular health has not been studied MECH. BUILT TO • EGRIFTA® is not indicated for weight-loss management 100% • It’s not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications PRINTED AT • EGRIFTA® is not recommended to be used in children Router printed at 81% T:10.5 in S:9.5 in Important Risk Information: • Injection-site reactions, such as redness, itching, pain, irritation, B:11 in COPY Do not use EGRIFTA® if you: bleeding, rash, and swelling. Change (rotate) your injection site to help AD • Have pituitary gland tumor, pituitary gland surgery or other problems lower your risk for injection-site reactions related to your pituitary gland PROD The most common side effects of EGRIFTA® include: AE • Have or had a history of active cancer (either newly diagnosed or recurrent) • joint pain • numbness and pricking ED • Are allergic to tesamorelin or any of the ingredients in EGRIFTA®, • pain in legs and arms • nausea STU OP including mannitol or sterile water • swelling in your legs • vomiting • Are pregnant or become pregnant • muscle soreness • rash • tingling • itching Before using EGRIFTA®, tell your healthcare provider if you: • Have or have had cancer EGRIFTA® will NOT cure HIV or lower your chance of passing HIV to others. • Have diabetes You are encouraged to report negative side effects of prescription • Are breastfeeding or plan to breastfeed drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. • Have kidney or liver problems • Have any other medical condition Please see Consumer Brief Summary of EGRIFTA® on following page. • Take prescription or non-prescription medicines, vitamins, or herbal supplements Ask your healthcare provider if EGRIFTA®, the first EGRIFTA® may cause serious side effects, including: and only FDA-approved medicine for HIV-related excess • Serious allergic reaction. Stop using EGRIFTA® and get emergency help belly fat, may be right for you. right away if you have any of the following symptoms: rash over your body, For more information, visit www.egrifta.com or call hives, swelling of your face or throat, shortness of breath or trouble the AXIS Center at 1-877-714-AXIS (2947). breathing, fast heartbeat, feeling of faintness or fainting • Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel Actual patient living syndrome) with HIV since 2000 • Increase in glucose (blood sugar) intolerance and diabetes 110628-115709 7/11 B:16.5 in T:16 in S:15 in

FILE NAME www.egrifta.com 0027_EGR_AD_SPD_ You HAVE YouR HIV unDER ConTRoL. noW, on To PA_M01.indd DATE 07.29.11 HIV-RELATED EXCESS BELLY FAT. CLIENT Egrifta In two separate clinical trials of HIV-infected people with lipodystrophy, each lasting 6 months, EGRIFTA® reduced PART # HIV-related excess belly fat by an average of 18% in the first trial, and 14% in the second trial. This reduction in excess belly fat resulted in an approximate 1-inch reduction in waist size. Individual results may vary. DESCRIPTION On average, patients on EGRIFTA® did not lose weight. Print Ad Like HIV, HIV-related excess belly fat is a chronic condition. In clinical studies: Positively Aware - Spread • People who used EGRIFTA® continuously for 1 year maintained their results over this time period Release via PDF • People who stopped taking EGRIFTA® after 6 months had their HIV-related excess belly fat come back EGRIFTA® is believed to work with your own body to produce natural growth hormone to reduce your excess belly fat. SPECS Trim: 16 x 10.5” Indication: Bleed: 16.5 x 11” EGRIFTA® is a daily injectable prescription medicine to reduce the excess in abdominal fat in HIV-infected patients with lipodystrophy. Safety: 15 x 9.5” Gutter: 1” Limitations of use: Colors: 4C, CMYK • The impact and safety of EGRIFTA® on cardiovascular health has not been studied MECH. BUILT TO • EGRIFTA® is not indicated for weight-loss management 100% • It’s not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications PRINTED AT • EGRIFTA® is not recommended to be used in children Router printed at 81% T:10.5 in S:9.5 in Important Risk Information: • Injection-site reactions, such as redness, itching, pain, irritation, B:11 in COPY Do not use EGRIFTA® if you: bleeding, rash, and swelling. Change (rotate) your injection site to help AD • Have pituitary gland tumor, pituitary gland surgery or other problems lower your risk for injection-site reactions related to your pituitary gland PROD The most common side effects of EGRIFTA® include: AE • Have or had a history of active cancer (either newly diagnosed or recurrent) • joint pain • numbness and pricking ED • Are allergic to tesamorelin or any of the ingredients in EGRIFTA®, • pain in legs and arms • nausea STU OP including mannitol or sterile water • swelling in your legs • vomiting • Are pregnant or become pregnant • muscle soreness • rash • tingling • itching Before using EGRIFTA®, tell your healthcare provider if you: • Have or have had cancer EGRIFTA® will NOT cure HIV or lower your chance of passing HIV to others. • Have diabetes You are encouraged to report negative side effects of prescription • Are breastfeeding or plan to breastfeed drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. • Have kidney or liver problems • Have any other medical condition Please see Consumer Brief Summary of EGRIFTA® on following page. • Take prescription or non-prescription medicines, vitamins, or herbal supplements Ask your healthcare provider if EGRIFTA®, the first EGRIFTA® may cause serious side effects, including: and only FDA-approved medicine for HIV-related excess • Serious allergic reaction. Stop using EGRIFTA® and get emergency help belly fat, may be right for you. right away if you have any of the following symptoms: rash over your body, For more information, visit www.egrifta.com or call hives, swelling of your face or throat, shortness of breath or trouble the AXIS Center at 1-877-714-AXIS (2947). breathing, fast heartbeat, feeling of faintness or fainting • Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel Actual patient living syndrome) with HIV since 2000 • Increase in glucose (blood sugar) intolerance and diabetes 110628-115709 7/11 T:8 in S:7 in

Consumer Brief Summary for EGRIFTA® (tesamorelin for injection)

EGRIFTA® (eh-GRIF-tuh) – hives (tesamorelin for injection) for subcutaneous use – swelling of your face or throat – shortness of breath or trouble breathing Read the Patient Information that comes with EGRIFTA® before you start to take – fast heartbeat it and each time you get a refill. There may be new information. This leaflet does not FILE NAME – feeling of faintness or fainting 0027_EGR_AD_PI_PA_ take the place of talking to your healthcare provider about your medical condition or your treatment. • Swelling (fluid retention).EGRIFTA ® can cause swelling in some parts of your M01.indd body. Call your healthcare provider if you have an increase in joint pain, or pain or What is EGRIFTA®? numbness in your hands or wrist (carpal tunnel syndrome). DATE • EGRIFTA® is an injectable prescription medicine to reduce the excess in abdominal 07.29.11 fat in HIV-infected patients with lipodystrophy. EGRIFTA® contains a growth hormone- • Increase in glucose (blood sugar) intolerance and diabetes. Your healthcare provider will measure your blood sugar periodically. CLIENT releasing factor (GRF). • ® EMD Serono The impact and safety of EGRIFTA on cardiovascular health has not • Injection-site reactions. Change (rotate) your injection site to help lower your risk for been studied. injection-site reactions. Call your healthcare provider for medical advice if you have PART # • EGRIFTA ® is not indicated for weight loss management. the following symptoms around the area of the injection site: • I t is not known whether taking EGRIFTA® helps improve compliance with – redness – bleeding DESCRIPTION antiretroviral medications. – itching – rash Print Ad • It is not known if EGRIFTA® is safe and effective in children. EGRIFTA® is not – pain – swelling recommended to be used in children. Positively Aware - – irritation PI Page Who should not use EGRIFTA®? The most common side effects of EGRIFTA® include: Release via PDF Do not use EGRIFTA® if you: – joint pain – nausea • have pituitary gland tumor, pituitary gland surgery or other problems related to your – pain in legs and arms – vomiting pituitary gland – swelling in your legs – rash SPECS • have or had a history of active cancer (either newly diagnosed or recurrent) – muscle soreness – itching Trim: 8 x 10.5” • are allergic to tesamorelin or any of the ingredients in EGRIFTA®. See the end of this – tingling, numbness and pricking leaflet for a complete list of ingredients inEGRIFTA ® Safety: 7 x 9.5” Tell your healthcare provider if you have any side effect that bothers you or that does • are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA® and not go away. talk with your healthcare provider. See “What should I tell my healthcare provider These are not all the possible side effects of EGRIFTA®. For more information, ask your before using EGRIFTA®?” healthcare provider or pharmacist. T:10.5 in What should I tell my healthcare provider before using EGRIFTA®? Call your healthcare provider for medical advice about side effects. To report side effects, S:9.5 in MECH. BUILT TO Before using EGRIFTA®, tell your healthcare provider if you: contact EMD Serono toll-free at 1-800-283-8088 ext. 5563. You may report side effects 100% • have or have had cancer to FDA at 1-800-FDA-1088. PRINTED AT • have diabetes Keep EGRIFTA® and all medicines out of the reach of children. • are breastfeeding or plan to breastfeed. It is not known if EGRIFTA® passes into your ®: breast milk. The Centers for Disease Control and Prevention (CDC) recommends that General information about the safe and effective use of EGRIFTA HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your Medicines are sometimes prescribed for purposes other than those listed in a Patient COPY baby. Talk with your healthcare provider about the best way to feed your baby if you Information leaflet. Do not useEGRIFTA ® for a condition for which it was not prescribed. AD are taking EGRIFTA® Do not give EGRIFTA® to other people, even if they have the same symptoms you have. • have kidney or liver problems PROD It may harm them. • have any other medical condition AE Do not share your EGRIFTA® syringe with another person, even if the needle is changed. Tell your healthcare provider about all the medicines you take, including prescription Do not share your EGRIFTA® needles with another person. ED and nonprescription medicines, vitamins, and herbal supplements. EGRIFTA® may affect the way other medicines work, and other medicines may affect how EGRIFTA® works. This Patient Information leaflet summarizes the most important information about STU OP Know the medicines you take. Keep a list with you to show your healthcare provider and EGRIFTA®. If you would like more information, talk with your healthcare provider. You pharmacist when you get a new medicine. can ask your healthcare provider or pharmacist for information about EGRIFTA® that is written for healthcare professionals. How should I use EGRIFTA®? For more information about EGRIFTA®, go to www.EGRIFTA.com or contact the AXIS • Read the detailed “Instructions for Use” that comes with EGRIFTA® before you start Center toll-free at 1-877-714-2947. using EGRIFTA®. Your healthcare provider will show you how to inject EGRIFTA®. What are the ingredients in EGRIFTA®? • Use EGRIFTA® exactly as prescribed by your healthcare provider. Active ingredient: tesamorelin • Inject EGRIFTA® under the skin (subcutaneously) of your stomach area (abdomen). Inactive ingredients: mannitol and Sterile Water for Injection • Change (rotate) the injection site on your stomach area (abdomen) with each dose. Do not inject EGRIFTA® into scar tissue, bruises or your navel. • Do not share needles or syringes with other people. Sharing of needles can result in the transmission of infectious diseases, such as HIV. What are the possible side effects of EGRIFTA®? EGRIFTA® may cause serious side effects including: • Serious allergic reaction. Some people taking EGRIFTA® may have an allergic reaction. Stop using EGRIFTA® and get emergency help right away if you have any of the following symptoms: – a rash over your body ©2011 EMD Serono, Inc. 110627-101931 7/11 All rights reserved. EGRIFTA is a registered trademark of Theratechnologies Inc. WHAT’S GOIN’ ON? KEITH R. GREEN

Faith without works is dead —James 2:17 Black men moving from faith to action

A COUPLE OF YEARS AGO, I HAD THE HONOR OF INTERVIEWING wildly respected leaders in the fight, were involved in advocacy that helped change actress and comedian Mo’Nique for a Positively Aware cover story. the way drugs are brought to the market I was genuinely moved by how deeply connected she was to the in this country…or that they got involved impact that HIV/AIDS has had and is having on African American because they saw too many brothers die. communities. There was one thing that she said during the inter- And they don’t know these things because, from what I heard from them, a view, however, that’s been stuck in my mind ever since. solid sense of community is lacking among When speaking about the government treatment-as-prevention strategies for black gay men. Community fellowship, for response (or the lack thereof) to the people who need them most. reasons other than giving its members an epidemic among black people, Mo’Nique Faith without works, however, is dead! opportunity to shake their asses or hear made it clear that if a solution is ever to Acting on faith, advocates fought like hell more bad news about how dispropor- be realized, it would have to come from to make policies such as the NHAS and tionately impacted by disease they are, within. the Affordable Care Act a reality. With is practically non-existent. Communities “When has the government ever said strong faith, researchers poured their share their history and pass on legacies. ‘we’re gonna help black people’?” she blood, sweat, and tears into the scientific Communities mentor their young, and asked. “So now, because we have this advances that continue to demonstrate their young accept mentoring (and the disease, did we really think the cavalry was the possibility of stopping HIV in its tracks. occasional loving correction that comes going to come in?” But at the end of the day, if the people with it). Mo’Nique’s rhetorical question speaks who could benefit most from all of these But then, this issue is not unique to HIV/ to an elephant in the room that many in exciting developments do not believe AIDS. I hear my elders say the same thing the HIV/AIDS service sector have ignored that the buck stops with them and then about my generation being ungrateful for for far too long. Though significant govern themselves accordingly, it’s all in the many privileges that they fought so progress is being made in the era of the vain. Faith in the end of HIV is dead in the hard for, which we now take for granted. Obama administration’s National HIV/AIDS absence of action! At what point do we actually stop com- Strategy (NHAS), the real impact is yet This revelation became exceptionally plaining and wishing for change, and begin to be realized. And, truth be told, public clear to me during a roundtable discussion to facilitate the process of not simply pass- policy interventions are all for naught if with African American service provid- ing but sharing the torch? When do we the communities which they are designed ers at the 2011 United States Conference realize that the “government” isn’t going to help are unwilling or unable to align on AIDS. Miquel Brazil, who is Director to do anything for us that we aren’t willing themselves with their goals and work col- of Prevention Programming at the AIDS to do for ourselves? WE, THE PEOPLE… laboratively to create change. Taskforce of Greater Cleveland, questioned Who else are we waiting on? We have faith that since our country whether the reason for lack of success I was glad to hear that this particular finally has a National HIV/AIDS Strategy, with young black gay and bisexual men is group of brothers has faith that they can “a change is gonna come” for the people because they do not feel connected to the make a difference, and have created blue- most impacted by this disease. The progress that’s been made over the years. prints for a plan of action to be revisited iPrEx trial and HPTN 052 have given They don’t know that it wasn’t just at the African American MSM Leadership us faith that using antiretrovirals as white gay men who “acted up” in the Conference taking place January 19–22 in prevention will lead us to the end of the middle of the streets of San Francisco New Orleans. epidemic. And we have strong faith that and Philadelphia when President Reagan I have faith that we’re heading in the full implementation of healthcare reform wouldn’t even mention the word “AIDS.” right direction. And I’ll be right there with in 2014, if that ever happens, will allow They don’t know that black gay men like them as they get down to action. unfettered access to the aforementioned Phill Wilson and Cornelius Baker, still

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 23 I’ve enjoyed ten years of working in faith-based organizations (FBOs) that fight AIDS, and have seen much to inspire, edu- cate, and horrify me. I’ll base my comments FAITH-BASED on human rights and love, both of which are biblical principles, even if “human rights” isn’t stated in those terms in the Bible. There is a lot that is compelling about ORGANIZATIONS the work of FBOs in AIDS and a lot that, while compatible in theory, is quite contra- dictory and damaging in practice. Because FBOs have received millions of dollars AND AIDS from the U.S. and other nations, and from other funding sources such as the The Good, the Bad, and the Ugly Global Fund to Fight AIDS, it is critical to examine how they are working and what BY JACQUI PATTERSON their impact is on nations, communities, families, and individuals.

WHY ARE FAITH-BASED ORGANIZATIONS ENGAGED “COME UNTO ME ALL YE THAT LABOR AND ARE HEAVY LADEN IN AIDS WORK? and I will give thee rest.” As a Christian and a proponent of social The Bible offers a clear mandate to care for people in need of help and to attempt justice for all, I have some questions regarding churches’ response to balance the scales of justice. Matthew to AIDS. 25:40 says, “Whatsoever you do unto the

24 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM through an FBO. I was focused on sup- restrictions on reproductive health services, porting home-based care and hospices the inability to use generic drugs, and the through Interchurch Medical Assistance “Anti-Prostitution Loyalty Oath,” which World Health and its member organiza- restricts how organizations can use their tions (a variety of mainline Protestant funds to engage in speech or programs churches). The reach of these churches related to sex work. I found that many and FBOs into communities was tremen- FBOs were not ready to buck the system dously helpful—outreach workers were on behalf of those they were supposed to there for families and individuals in need serve. This strongly interfered with my abil- of support and comfort in their final ity to work, and I found myself in constant months. I also witnessed how the spiritual conflict. So, hundreds of thousands are component offered great comfort, result- receiving treatment through FBOs, and ing in a peaceful death for many. that’s a good thing. But I put this on the I’ve also seen churches have a very cusp of the “What Hasn’t Worked” section positive influence in the policy arena. because I still ask, “At what cost?” and The United Methodist Church, Lutheran “Could we have done it better?” Church, Church World Service, and others have invested significant resources in poli- WHAT HASN’T WORKED? cy analysis and mobilizing their congrega- In their AIDS response, churches have tions to advocate for increased funding clearly been constrained by judgment and for AIDS, as well as related issues like debt dogma. Kay Warren of the Saddleback cancellation, which afforded countries Church rightfully pointed out, “The Church the flexibility to assign more resources to is more known for what it is against than health programs. what it is for.” A friend of mine, Dazon Similarly I’ve seen the establishment of Dixon Diallo of SisterLove in Atlanta, the African Network of Religious Leaders once said she wants to make a bumper Living with AIDS, which has worked to sticker that reads, “Jesus, Please Come destigmatize HIV by having religious lead- Back and Save Us from Your Followers!” ers speak out, offering messages of love The words of Martin Luther King, Jr. are PHOTO: JOSHUA THORNE and compassion, without judgment. Cristo also very apt: “Yes, I see the Church as least of these, you do unto me”; Micah 6:8 Greyling and Gideon Byamugisha have the body of Christ. But, oh! How we have states, “What do I require of you…to live encouraged language such as “The Body blemished and scarred that body through justly”; and 1 John 3:17 asks, “If anyone has of Christ has AIDS” to signify that when social neglect and through fear of being enough money to live on and sees a broth- one of us is infected, we all are, and that nonconformists.” er or sister in need and refuses to help, we need to address AIDS as a community On one hand there has been judgment how can God’s love be in that person?” issue—not singling people out for blame. regarding people with HIV and rhetoric So it is not surprising that in sub- In the last two years of my work with around “the wages of sin equal death” Saharan Africa, Latin America, and the IMA World Health, I managed the organi- and “you reap what you sow.” At the Caribbean, FBOs provide up to 40% of zation’s PEPFAR (President’s Emergency 2008 Ecumenical Advocacy Alliance in all health care, and churches are present Plan for AIDS Relief) treatment program. Mexico City, one religious leader spoke in many communities. At times, there is In theory, this should have gone well. of the condemnation and judgment she no other health institution of any sort. In FBOs have the reach, health facilities, has faced since declaring her HIV status. the U.S., there are also many faith-based relationships, and understanding of com- There has also been stigma around certain health centers and other HIV service pro- munities—all of which should lead to a high-risk populations, leading to damaging viders. The sheer presence and capacity successful endeavor. programs or outright neglect. of FBOs puts them in a good position to Indeed, the infrastructure afforded There are many examples of the influ- offer a range of services. Also, in many by the extensive networks of faith-based ence of conservative Christian ideology and communities in Africa, Latin America, the hospitals, clinics, and mobile units was a personalities on policy development. When Caribbean, the U.S., and, to some extent, fantastic resource. Several of our partners PEPFAR was being designed, there were Asia, there are very high percentages of were already successfully running treat- multiple forces influencing its policies, such Christians—so the influence that FBOs ment programs using generic drugs. At first as the Institute for Youth Development and and faith leaders have in the community is the glut of resources and the prospect of the Children’s AIDS Fund, which had an significant, for better or worse. being able to serve hundreds of thousands ideology rooted in conservative Christianity. in need of treatment was all very exhilarat- This challenge to the separation of church WHAT HAS WORKED? ing. But those of us who were concerned and state should have been revealed early My first entrée to global work in AIDS was about nuance came into conflict with the on and dealt with head on. Instead, it led to

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 25 My purpose here is not to sway those in the church who find a biblical basis to oppose homosexuality, but rather to question their application of biblical principles. policies that didn’t follow the scientific lit- I’m embarrassed to say that I would warn the money changers? Does it fit with the erature or the actual experience of gender my gay friends about even visiting there, image of Jesus embracing and blessing inequality and other dynamics. Ideological knowing that they risk life and limb due a sex worker? His directive to her was to policies masqueraded as evidence, like to homophobia.) And when we now have “go and sin no more.” Repentance wasn’t a the Anti-Prostitution Loyalty Oath and the Uganda attempting to pass a law similar to precursor for his embrace. His champion- emphasis on HIV prevention through absti- that in Gambia, with the instigation of this ship of justice was not selective. nence and fidelity to the exclusion of the legislation allegedly resting at the feet of One of the conflicts I experienced in my proven effectiveness of condoms. certain U.S. evangelical churches. work with the AIDS Relief Consortium was The gender inequality in many Where are the voices of churches on the need to include prevention programs churches also permeates the societies these issues? Where is the high-profile with the treatment work we were doing, as where they are influential. This has played public statement condemning such heinous it makes little sense to be doing treatment out in messages stating that being faithful hate crimes? Instead, there is much con- alone. That would be like trying to plug is protection against HIV, when for many demnation of same-sex relationships, and holes in a dam while more spring open. A married women this is a death sentence. the intensity of Christian leaders’ words, group that was in charge of $330 million Both partners have to be HIV negative deeds, and attitudes seem to indicate that of AIDS funding was constrained in the and monogamous for this to be effective. they are more concerned about these acts prevention resources it could provide. The Yet people are offered simple messages of love than acts of hate. One colleague restrictions came from the ideologically without caveats. Church-based instruc- spoke about being invited to dinner and driven PEPFAR guidelines, which mandate tion on submission to one’s husband has learning mid-meal that his host was gay. He how much funding can be used for treat- led women to stay in relationships with said, “There I was eating the food….” And ment and what emphasis must be placed unfaithful husbands and to suffer vio- this is a person who is in charge of HIV pro- on abstinence and fidelity. In addition, the lence at their hands. Often, churches do grams for his denomination! A participant organizational policies of Catholic Relief not offer guidance on the protection of in a workshop I facilitated stated that many Services don’t allow condom distribution or women, focusing instead on the “sanctity in the church are only ready to embrace a full range of reproductive health services. of marriage” and “’til death do us part,” people who are “like us” by whatever Many in the church refer to the regardless of the risk to the often power- notion of self-proclaimed sanctity “we” in AIDS pandemic as an “opportunity for less woman. the church define ourselves. My purpose evangelism.” Ken Isaacs of Samaritan’s At the 2008 Ecumenical Pre-Conference here is not to sway those in the church who Purse stated “AIDS has created an in Mexico City, I appreciated the dialogue find a biblical basis to oppose homosexual- evangelism opportunity for the body of around gender, and specifically patriarchy, ity, but rather to question their application Christ unlike any in history.” Community in the church. But there was no space in of biblical principles. I ask them, what Health Evangelism offers a presentation the program for the LGBT community and would Jesus do? entitled “HIV/AIDS in Asia: A Window its issues—unfortunate, given the early and At Rick Warren’s 2006 Saddleback of Opportunity for Community Health continued epidemiology of HIV as well as Church conference, an awkwardly titled Evangelism.” This is troubling on at least the continued discrimination against LGBT session, “Loving Homosexuals as Jesus two levels. First, there’s the notion that people. How can there be an entire HIV Would?” led to hopes that this evangelical people could be celebrating such a dread conference without space for LGBT matters leader was questioning attitudes toward disease—as if it was sent so that they when we have had activists like Sizekele LGBT people. Instead, it was a panel of could save more souls. Second, the idea Sigasa and Salome Moosa, champions for speakers from the “ex-gay” movement, of “bread in one hand and the Bible in the HIV justice, who were murdered in South not a workshop offering guidance on other” could lead to the coercion of people Africa in a vicious hate crime? When we how churches could be safe spaces that who are in a vulnerable position. have Solomon Adderly Wellington, a noted welcome all and uphold justice within a gay HIV activist in the Bahamas, murdered? range of beliefs. They went beyond many RECOMMENDATIONS When we have the President of Gambia churches in even holding such a workshop, There are critical roles for FBOs that con- vowing to lop off the heads of gay people but they need to take it further. tribute substantially to the well-being of and criminalize any who offer safe harbor? Does being known more for condem- communities, families, and individuals with When we have Steve Harvey, a gay HIV nation of individuals (and cozying up HIV. Some FBOs have used their influence activist from the Jamaica Support Services, to big pharma and other questionable to advocate for needed policies, including slain in a country where there are more allies) instead of fighting for justice and debt cancellation and universal access churches per capita than anywhere in the human rights match the scene of Jesus to treatment. Religious groups have also world? (Jamaica is my country of origin, yet in the temple overturning the tables of used their reach in communities to ensure

26 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM that there is a comprehensive web of sup- Advocacy conducted by FBOs should Finally, let’s reward those FBOs that are port for people with HIV. I applaud these be based on principles of human rights. doing good work, replicate their practices, efforts and hope that these initiatives If this is the guideline, the automatic cor- and emphasize these positive models. persist and multiply. responding principle is “do no harm.” The There are churches that have articulated But FBOs should establish guiding prin- judgment-based advocacy that has result- biblical bases for supporting women’s ciples so that everyone knows where each ed in such policies as the Anti-Prostitution rights and gay rights, and who promote a organization stands. I pushed for the estab- Loyalty Oath and hateful anti-gay leg- broad range of social justice issues. There lishment of such principles and values at islation such as that being discussed in are others who have devoted themselves the Pan African Christian AIDS Network. All Uganda that proposes the death penalty to treatment, the care of orphans and vul- were enthusiastically in favor. But when we for loving persons of the same sex would nerable children, economic development, completed the process, it included a clause not pass the “do no harm” test. peace work, and hospice care through saying, “Marriage should only be between There is a role for abstinence in HIV highly effective work. We need many more a man and a woman.” I decided then that prevention. It’s possible to choose absti- like them. e it was time to bid adieu, as I am an uncom- nence and it’s good to have support in promisingly staunch ally of LGBT rights. adhering to that choice. But doctrines and People within organizations should societal edicts are not enough if someone JACQUI PATTERSON is an activist and expose the underlying forces driving their makes another choice or if people find policy analyst working on women’s rights, agendas, and organizations operating in themselves in situations where they have racial justice, and public health globally. coalition should be encouraged to offer up little or no choice. People who are in these a statement of principles so that hidden circumstances need to know the options Reprinted with permission from Achieve,

PHOTO COURTESY OF ACHIEVE biases can be revealed. for keeping themselves as safe as possible. a publication of ACRIA and GMHC.

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 27 Cheryl B. Anderson, of the Garrett- Evangelical Theological Seminary, leads clergy through an example of contextual bible study—looking at its stories from the perspective of social justice.

28 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM OF FAITH AND COMPASSION

Black leaders urge the church to tend to its people

BY ENID VÁZQUEZ

PERNESSA C. SEELE GREW UP IN THE SMALL, ALL-BLACK TOWN of Lincolnville, South Carolina, where she witnessed firsthand the power of the church to help people. She saw the love and respect her family had for the church and its leaders, and it fostered in her a lifelong passion for faith leadership.

Growing up and moving to New York, this country, I know that those African Seele and her new church in Brooklyn American churches that preach homopho- became involved in the HIV epidemic bia are no more homophobic than any before the terms “HIV” or “AIDS” had been other—white churches, Korean churches, created. They tended to a sick parishioner, Hispanic churches, and so on.” the director of their choir, whom they At the same time, Seele is acutely dearly loved. It was church members who aware of the harmful effects of the went to his home and found his body. homophobia that does exist. “People But later, working at Harlem Hospital, still want to believe the myth that homo- she saw patients with HIV who were not sexuality causes HIV, and because they’re visited by either their families or their against homosexuality, therefore, they do churches, who had been left alone, and in not speak about HIV. That myth has creat- those days, often dying. ed a big problem in the African American “All of these experiences created this community,” she said. In her blog, she passion for what I believe the work of the spoke more forcefully: “The lingering myth church should be: to be there for people,” that homosexuality causes AIDS continues Seele said. to mislead and misguide people to their And so in 1989, she founded The Balm death or destruction.” in Gilead, beginning her efforts with the But she says that 30 years into the epi- Harlem Week of Prayer for the Healing of demic, she and The Balm in Gilead “do not AIDS, now a national project. have time to beat [these churches] over Today, after more than 20 years of the head,” when what they see more often bringing together the worlds of faith and is religious leaders wishing to address HIV, HIV, she says the black church is no more but not knowing how. “The Balm in Gilead homophobic than any other religious wants the church to be a center of HIV institution, despite accusations that prevention, of education and advocacy, are regularly raised in prevention work. and compassionate care,” she said. “We “The black church has taken a bad rep work to mobilize these churches and build on homophobia,” she said. “Because I their capacity to do that.”

PHOTO BY GREGORY TROTTER, COURTESY OF THE AIDS FOUNDATION OF CHICAGOhave traveled the world and I’ve traveled Seele also believes churches don’t

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 29 “It’s amazing to me in how many instances people feel like they are personally threatened by the fact that a person’s sexual orientation is different from their own.”

get credit for just how much they do, “radically inclusive.” He explains that just HIV, but all the things that keep us from especially from the media. People who as there are multiple interpretations of the being the people we need to be in our are not members of the congregation, or Bible, the topic of sexuality is no different. communities. Housing, education, eco- otherwise involved, don’t realize that a lot A homophobic interpretation is not one nomic development, sexism, homopho- of work is actually being done, including that all churches adhere to. Rather, he bia—all of it ends up being part of the housing and case management. believes churches should follow the notion equation of dealing with HIV.” And, she says, they’re in a perfect posi- that all humans are divinely created, and Other speakers in the MICTAN series tion to do the work. “The African American that all life is sacred and worthy of respect of seminars included Gail Wyatt, PhD, a church is the only institution that black and affirmation. clinical psychologist, sex therapist, and people completely own,” said Seele. “It Under his leadership, the Metropolitan professor in the Department of Psychiatry is the second largest employer of black Interdenominational Church established and Biobehavioral Science at UCLA; Cheryl people in this country, and it is the only the Technical Assistance Network, or Anderson, PhD, of the Garrett-Evangelical institution that black people trust. It is the MICTAN, through a grant from the Centers Theological Seminary in Evanston, Illinois; place where people come and gather for for Disease Control and Prevention (CDC), Mindy Thompson Fullilove, MD; and information. We may hear ‘Well, I don’t nearly two decades after the church her husband Robert E. Fullilove, PhD, trust the pastor’ or ‘I don’t trust this or began working on HIV awareness and of Columbia University, who discussed that,’ but every Sunday morning folks are outreach. MICTAN has provided an exten- rebuilding and empowering decimated gathering at the church. My critics say, sive series of seminars around the country black communities. ‘Pernessa, there are a lot of people who to mobilize faith leadership in the black Although Wyatt discussed sexual don’t go to church.’ That’s very true. But community around HIV/AIDS work, and health and knowledge within the context I say to you that everybody in the black will continue to mobilize them to work of black history, Rev. Sanders took on the community knows someone who’s going together. The promotion of HIV testing job of urging faith leaders to become com- to church next Sunday. And those people and awareness is a priority, but so much fortable discussing sexuality as it relates who go bring back the information and of the work depends on the spirit in which to their own history. He said, “We need to disseminate it throughout the community. it is conducted, and it is that the reverend have the ability to talk about any aspect “The church is unique,” she continues. preaches about. When people tell Rev. of human sexuality openly, honestly, and “It’s unique in that it provides support Sanders he’s preaching to the choir, he competently. We have to have the ability in all areas—physical, spiritual, and replies, “In my experience, the choir needs to accept the sexual preference and activi- emotional. That’s different from CBOs preaching to.” In promoting mutual assis- ties of others without feeling personally [community-based organizations]. CBOs tance, he has found homophobic church threatened and without moralizing or do great work, but the church becomes leaders become transformed by working being judgmental. very inclusive. They will go with you to the with gay and bisexual church members. “It’s amazing to me in how many doctor’s office and to the hospital. If you Many such experiences continue to inspire instances people feel like they are person- have children, they support your children. him to promote HIV ministry. ally threatened by the fact that a person’s They embrace your entire family. And they In Chicago last fall, he asked a group sexual orientation is different from their believe in the power of prayer.” of black faith leaders, “Who do you say is own,” he continued. “And in this instance, it not welcome?” He was referring to item goes way beyond the whole issue of same WHOSOEVER number one on a list of six ways to begin gender-loving people or the whole issue ike Seele, the Rev. Edwin C. HIV work (be welcoming). “Stop and think of how the relationship between two men Sanders II of the Metropolitan what that means for the life of your con- or two women manifests itself. In our com- LInterdenominational Church in gregation. Anything you deny, anything munities especially, I’m always intrigued Nashville saw death in his congregation you hold as a secret will kill you. And we by people who go around talking about before anyone had heard of HIV or AIDS. have a community where hiding is killing ‘what we don’t do [in a harsh, hard tone]. He decided then and there that his church us. If we end up being guilty of perpetuat- We don’t do that. That’s what the other folk should get involved in this new reality. ing that, it is ethically unconscionable. do.’ It’s very interesting because I find that Rev. Sanders promotes the concept of “A part of my passion around this most of that is guilt-bound moralizing to “Whosoever,” that congregations should whole business of HIV/AIDS,” he contin- feel more comfortable with themselves.” be inclusive and affirming, including peo- ued, “is that I’m convinced if we do this Pernessa Seele agrees with that. “We ple of all sexual orientations. Churches that work right, it has implications that go way have many faith leaders who take the are accepting of homosexuality are called beyond this disease. We’ll address not just position that their congregations don’t

30 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM “We need to appreciate the fact that sexuality is a gift from God, that needs to be celebrated and needs to be respected and understood that it’s good.”

do anything [considered wrong], and we framed in a way that is negative. I have a people. At its website (www.aidschicago. all know that’s not true. We all know that feeling we might not be here if we were org), the project offers a manual of how every church is full of people living their comfortable in a way we need to be with churches can do work around HIV, includ- everyday lives. A church is not a place this issue.” ing a chapter on homophobia, stigma, and where only the holy and the righteous go. discrimination. They’re all people living their lives to the FAITH IN ACTION ”We are living in interesting times,” said best of their ability.” She remembers that postcard from Faith Responds Pernessa Seele, “and every person of faith— her mother wouldn’t allow their pastor to to AIDS, established by the AIDS every person of faith—whether they are a see her smoke, even though the pastor A Foundation of Chicago, puts it member of a church or not, or part of any himself was a smoker, so she understands more bluntly, “Do or Die.” The card lists institution, has the responsibility to address that people may hide their true selves the statistics affecting African Americans HIV and the suffering that we are seeing where their church is concerned. and what churches can do to promote in this country. That’s what people of faith “I think that if I had to make one simple testing, treatment, and awareness, as should be about—the compassionate busi- statement about how we talk about sexu- well as scriptural evidence supporting the ness of the whole and not just the one. ality in the context of the church it’s to foundational concept of God’s love of all That’s faith that works, faith in action.” e simply say sexuality is a gift from God,” said Rev. Sanders to the faith leaders. “One of the things that has happened to the church is that we have come to interpret sexuality in a way that has put it ARE YOU COMFORTABLE WITH YOUR SEXUALITY? outside the realm of what we are used to thinking of as a gift. But we need to appre- From MICTAN training for faith leaders, taken from The Theology of Sexuality, of ciate the fact that it is a gift from God, the United Methodist Church. that needs to be celebrated and needs to be respected and understood that it’s Sexually comfortable people: good. That will help us get beyond the blinders that we have let get in the way of n Have examined their own personal sexual history what we can learn and what we can do to n Have explored their own sexual attitudes and confronted their own limitations understand ourselves as sexual beings. It’s and biases about sexuality something that can no longer be peripher- n Have listened to the beliefs of others about sexuality, which are different from al, but rather becomes the subject matter their own of the sermon that we preach, of Sunday n Have the ability to speak openly, honestly, and confidently about any aspect of school lessons that we teach, whenever we human sexuality come together for any reason for fellow- n Have the ability to accept the sexual preference (the way they choose to iden- ship and spiritual growth. tify themselves) and activities of others without feeling personally threatened “I think that until we do that we’re and without moralizing and being judgmental going to find ourselves in a place where n Have the ability to discuss sex with the young, middle aged, and elderly the things that are not being talked about n Have the ability to interact with people of all genders, ages, and sexual orienta- are the things that are going to harm us, tions in respectful and appropriate ways and are going to harm us in ways that will n Are knowledgeable or seek to increase their knowledge about human sexuality, continue to perpetuate this disease and including sexual behaviors, sexual response, sexual and gender orientation, and the impact that it has on our community. relationships This begins where I think we need to start, n Will have up-to-date, science-based, factual knowledge and that is, are you comfortable with your n Will have knowledge of different sociocultural and religious beliefs about sexuality? People don’t easily move to human sexuality talk about and think about and deal with the ways their own experiences as sexual EDITOR’S NOTE: The ability to engage in open discussion does not include being beings have evolved. And if they do, in forced into conversations where you are uncomfortable. In such cases, listen to many instances, it’s associated with things your gut feelings, and know you have the right to walk away. that are not necessarily positive. It’s often

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 31 THE HIDDEN PEOPLE Courage and brotherhood bring the Muslim community into the light

BY SUE SALTMARSH

WITH THE HEAVY EMPHASIS CURRENTLY PLACED ON THE Christian response to HIV/AIDS, especially in the black community, the subject of how the Muslim community has dealt with it is intriguing, if not compelling. At the U.S. Conference on AIDS in Chicago in November, a workshop entitled “The Homophobia and Stigma Endured with being Gay, Muslim, and Living with HIV” addressed this very issue.

The three presenters, Shadeed Sadeeq yawning in a gathering as much as pos- Jenkins, Imaad Hafiz Boyd, and Karim sible,” “mix with people and put up with Ishmael Rush, were dressed in, as one their insults” or “check customs and habits attendee put it, “full Muslim gear”—the izar, against Islamic standards.” And then there an oversized, tube-style waist cloth, and the is the praying or salah. As obligatory and Karim Rush, Shadeed Jenkins, and Imaad Boyd at the U.S. Conference on AIDS, in Chicago. kufi, a knit cap. They met withP ositively complicated as Catholic mass can be, Aware before their workshop to talk about salah has many more rules and ritual pro- converted from Christianity) and who is their experiences being gay and Muslim. cedures, including the requirement to pray HIV-positive. “From an early age, it [homo- Their soft-spoken articulateness and gentle at certain times of the day. Being Muslim is sexuality] wasn’t condoned.” The internal smiles lent credence to their stories of not easy to begin with—being gay makes it battle that raged within him between his struggle, unity, and commitment to both even harder. faith and his Truth led Jenkins to fall away their religion and to finding a way to spread When asked to speak about how their from practicing his religion and get caught the message of acceptance within their faith has affected them as gay and/or HIV- in a downward spiral of drug . somewhat rigid faith community. positive men, Karim Rush began with the Like Rush, he has greatly benefitted by simple truth that “Being gay and Muslim having his gay “brothers in faith” around LEADING A DOUBLE LIFE is…difficult.” It was like leading a “double him who can identify with his struggles he rules and expectations placed life,” and he felt uncomfortable going to his and who know the feeling of being sur- on a devout Muslim are daunting masjid (mosque) until he found someone rounded by people and still feeling lonely. and, just as with other religions, else who was going through the same thing, And he has encountered people in the are often unrealistic and unattain- which is how he met Shadeed Jenkins. “It’s Muslim community who’ve found out Table by the average human being. Boyd been a lot easier since then,” said Rush. about his sexuality and actually told him admitted that he “needs help” with the “I was raised Muslim,” explained “there is no such thing as a gay Muslim,” restriction on cursing and foul language. Jenkins, the only one of the three who a common experience he and his friends But that is nothing compared to “avoid was raised in a Muslim family (the others have helped each other through.

32 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM PHOTO: JOSHUA THORNE Karim Rush, Shadeed Jenkins, and Imaad Boyd at the U.S. Conference on AIDS, in Chicago.

SPEAKING OUT great successes. Certainly, the engagement It’s an uphill battle against an his was not the first presentation and enthusiasm of the audience later that entrenched attitude that makes open the three have given at an HIV day was evidence that, though Muslims discussion about homosexuality taboo conference. Their friend, Don are hardly ever mentioned in either the among most Muslims. In fact, almost the Ransom, originally encouraged HIV community in general or in any of same words of condemnation that appear TJenkins to submit an abstract for such a the goals set by agencies to reach out to in the Bible also appear in the Quran. Boyd presentation so the HIV community would “communities of color,” the time is right acknowledges that the judgment and be aware of the challenges that Muslim gay for their presence and their message to be rejection can be “really psychologically men face. He spoke about the reaction at acknowledged. damaging.” Just having someone with other conferences when people saw “those Have they started a movement? They whom to talk about it openly is a great three Muslim brothers” walking around and all laughed, but then mentioned that there relief. Ransom, who is an HIV counselor wondered what they were doing at a con- is a movement already going on with such and sees Muslims totally closed off and ference having to do with gay men and HIV. organizations as Muslims for Progressive resistant coming into his agency to get “I realized then that we as black, gay men Values, with an LGBT outreach program tested, said, “As soon as I’d show them had excluded the Muslim community,” said led by Daayiee Abdullah, an openly gay into a counseling room and shut the door, Ransom. Evidently their presence caused imam (religious leader) in Washington, they’d open up and start telling me about enough curiosity because their first work- D.C. Like any movement for social change, their struggles.” shop and those that followed have been progress is not quick to happen. Jenkins, who has come out to his

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 33 MUSLIMS HAVE NO RESOURCES WITHIN THEIR INSULAR COMMUNITIES—NO MUSLIM HIV TESTING AND TREATMENT CENTERS—SO THE IMPORTANCE OF FEELING WELCOMED At the presentation, a social worker BY NON-MUSLIM PROVIDERS IS KEY TO ANY PREVENTION asked what could be done to open up lines OR TREATMENT EFFORT. of communication to the Muslim community regarding MSM and HIV/AIDS education and prevention. All three of the men shook their heads and said, “Nothing.” But then Jenkins theorized that perhaps one way to get a Muslim parents, said that while they didn’t see them, whether they’re in an airport or foot in the door would be to frame HIV and take it well at first (“My mother cried and an HIV/AIDS agency. From what Jenkins other STDs in terms of health disparities, my father asked me if I was going to start says, it’s not just the knee-jerk reaction of minimizing the association with sex. People wearing dresses.”), now they’ve learned bigotry, but there’s a stigma attached to might respond better if they thought about that just because he’s gay doesn’t mean him even before people know he’s HIV- it as a fight for health care equality. he’s a different person than the son they positive. And such a reaction causes distrust The workshop was indeed the actively know. Unfortunately, his sexuality remains and resistance to seeking help from Muslims engaged, sometimes boisterous, experience a taboo subject among some other fam- who may experience it at places they go to that Rush had predicted. “There’s always lots ily members and even his parents don’t for services. “It goes both ways, though,” of questions – honestly, if we didn’t have a discuss it with other members of their said Jenkins, acknowledging that, in many curriculum and just did a Q&A session, it’d religious community. cases, Muslims themselves create negative be almost endless.” There were several peo- “You have to understand,” said Jenkins, situations by seeming unapproachable or ple in the audience who were Muslim and “Some of the mentality and the retalia- defensive. According to Boyd, “When you thanked the three men for their efforts to tion within the Islamic community can be walk into an agency, you walk in with your educate people and advocate for a popula- really barbaric at times.” The “double- defenses already up, because you know tion that remains, for the most part, hidden. barrel blast” of being Muslim in the U.S. you’re being instantly judged.” One woman admitted being cynical, post-9/11, as well as being marginalized in Muslims have no resources within their perhaps, but what she said was true—that one’s own community, has led to an even insular community—no Muslim health clin- until Muslims become a “targeted popula- heavier burden for many. ics, certainly no HIV testing and treatment tion,” the way African Americans and “It’s a whole deeper level of discrimina- centers, no programs run for Muslims by Hispanics are now, programs aimed at them tion,” said Jenkins, “I’ve talked to them a Muslims, so the importance of feeling wel- will not be funded and until there’s money lot, gotten a lot of backlash—I’m kind of in comed by non-Muslim service providers is involved, not much attention will be paid. the forefront…” key to any prevention or treatment effort. Ironically, since many Muslim MSM are “Forefront? He’s kicking down doors During their presentation, which was to black, they could already fit into programs and taking by storm!” Boyd a full house, they rightly called out the HIV created for that population, but as long interjects. community, , asking them to “open eyes, as they feel threatened by the prospect of Jenkins continues with a sad smile, ears, minds, and hearts to the reality that being outed or by possible negative reac- “I’ve actually questioned not going back there is a population within the MSM/HIV- tions from agencies, they will stay hidden. to serve houses of worship because of the positive community that is being ignored, Rush says there are always other retaliation and not feeling comfortable.” abused, and not shown the same respect as Muslims who identify themselves during Boyd spoke up to share his experience other MSM,” as well as to “better understand or after their presentation and are grate- of converting from Christianity and finding how their own biases and treatment affect ful that the presentation is bringing their that Muslim women had no problem with this population mentally, physically, emo- story to the forefront. “I think it’s good,” his sexuality. “They were willing to have tionally, and spiritually.” Boyd says care pro- he says. “I think it’s a good thing that peo- more discussions with me, to talk about viders, “underestimate themselves and the ple are starting to talk and step up a little issues with me more so than the men.” impact they can have on the community.” bit more, because that just means that the Rush has had the opposite experience, message is continuing to grow and more though. “We don’t cross the rules. It’s not HIDDEN IN PLAIN SIGHT and more people are going to begin to be even permissible to talk to the females o statistics are available about more open and comfortable.” where I go, everything’s totally separated.” the HIV infection rate among There is still plenty of work to be done When speaking about the “bigger Muslims. Boyd points out that by these brave young men. No doubt they picture” of their work, Jenkins says that it’s many men convert to Islam will be familiar faces at future HIV confer- not just about an alternative lifestyle or a Nwhile in prison and may not be aware of ences, including the World AIDS confer- religion, but that their hope is also to get their infection, and thus take the virus with ence in Washington next year. In the words people to take a look at themselves, and them back to the community where they of Mohammed, “A Muslim who meets with take an “inventory” of their own percep- may transmit HIV to their partners, both others and shares their burdens is better tions and reactions. All three talk about the male and female. In this case, silence does than one who lives a life of seclusion and automatic wall that goes up when people indeed equal death. contemplation.” e

34 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM We are TPAN.

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In 2012, thanks to the generosity of supporters like you, TPAN will celebrate 25 years of providing services, information, and hope to those whose lives are impacted by HIV/AIDS.

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TPAN aims to raise $25,000 before January 31st to kick off our 25th anniversary. Please consider supporting our work by donating to our anniversary campaign with a one-time or monthly donation. Simply visit us online at www.tpan.com. HIV WELLNESS SERIES NELSON VERGEL

OUTSMARTING HIV WITH HEALTHY EATING

LIVING WITH A CHRONIC ILLNESS LIKE HIV CAN PRESENT are “macro” or larger quantity nutrients. certain nutritional challenges. Without effective HIV medication The three macro groups that compose the majority of our diets are carbohydrates, treatment, replicating virus can tax the body, destroying lean body proteins, and fats. These three units are mass and impairing immune function and quality of life.1, 2 the basic materials that fuel our activities and metabolism and maintain body com- While this destruction of lean tissue can other conditions like diabetes, cardiovascu- position. Selecting the best sources and be controlled with effective HIV antiretro- lar disease, and obesity. These suggestions amounts of these three macronutrients viral combination therapy, other challenges are aimed at helping the body deal with may help to minimize metabolic disorders like fat accumulation and increases in lipids the effects of HIV or its medications on (such as high cholesterol and blood sugar) (cholesterol and triglycerides) and/or insu- metabolism, body shape, and quality of life and prevent loss of lean body mass and lin resistance may arise in some patients as we live longer with HIV. accumulation of body fat.4, 5, 6 after treatment initiation.3 Although limited research has been done on the effects of THE COMPONENTS THE BEST CARBOHYDRATES nutritional approaches on pre- and post- OF WHOLE FOOD Carbohydrates provide our body’s main HAART (highly active antiretroviral thera- Foods are made up of many different source of quick energy. After carbohy- py) metabolic issues, general suggestions components—some are “micro” or smaller drates are digested and after some pro- can be extracted from studies regarding quantity nutrients, like vitamins, and some cessing by the liver, they are released into

36 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM Mixing carbohydrates with protein, fiber, and good fats is one way to reduce their problematic effect on blood sugar and insulin.

the bloodstream as a sugar called glucose amount of insulin is produced by the HIV medications, and follow a proper diet. to be delivered to the cells. pancreas to accompany it. When there is For instance, a prominent study from Tufts Throughout the majority of the last a large amount of glucose, the pancreas School of Medicine found that HIV-positive million years of our evolution, the human works to produce a large amount of insulin people consuming an overall high-quality diet consisted of animal carcasses, to facilitate its delivery so that cells can diet, rich in fiber and adequate in energy some seeds, nuts, and fibrous vegetable take in as much glucose as possible. Extra and protein, were less likely to develop fat and fruit carbohydrate sources that are glucose that cannot be taken in by the deposition.12 This is why it is best to select generally nutrient-rich with lots of water, cells circulates in the bloodstream and can the majority of your carbohydrate intake but are not calorie-dense like processed be toxic to brain cells, so under normal cir- from fiber-rich, slow-releasing carbohydrate foods of today. The majority of these cumstances, most of it is soon converted sources that do not contain an excessive carbohydrate sources are vegetables, into triglycerides (fat) in the liver to be amount of calories. And these good carbs leaves, roots, and fruits (all rich in fiber). stored for later use. But we have to be should be accompanied by good sources of Because vegetable fiber tends to slow careful with high blood levels of triglycer- protein and fats. down digestion, a majority of the car- ides, since they are what feed fat cells. bohydrates in these foods are absorbed The correct amount of carbohydrate COMBINING CARBOHYDRATES relatively slowly, inducing less blood sugar sources will provide enough sugar to give a WITH PROTEIN, FIBER, AND FAT (glucose) and insulin spikes than pro- healthy amount of glucose to the cells, but Protein, fiber, or fat will slow the absorption cessed sweets that contain no fiber. Some not too much at once. Thus, levels of glu- into the blood of glucose from carbohy- people call these “slow carbs.” cose and insulin in the bloodstream are not drates, which helps to reduce the rise in It was only after the advent of agricul- unusually elevated for any long period of blood sugar and insulin spikes. So, mixing ture that human beings were introduced time. The pancreas works, but it is not over- carbohydrates with protein, fiber, and good to higher intakes of grains as carbohydrate worked trying to keep up with an unusual fats is one way to reduce their problematic sources. Higher intakes of grains deliver demand for insulin.10 However, in the U.S., effect on blood sugar and insulin. Ensure lots of calories. Additionally, some grains much of the diet consists not only of large that every meal and snack you consume deliver their sugar energy relatively quick- amounts of high-calorie carbohydrate has a mix of these three macronutrients. ly, especially if the grain is milled (which sources, but also of carbohydrates from But what are the best fats, protein, and removes the fiber that slows down sugar sweets and sodas, which are very concen- high-fiber carbohydrates sources out there? absorption), as are the grains in breads trated sources of sugar. The net effect that and pasta. Unless you are very active and intake of these calorie-dense carbohydrate Fats and oils. There are a number of exercise enough to metabolize nutrients foods creates is a bloodstream that is different kinds of fats. There is motor oil, more rapidly, this quick glucose release occasionally flooded with large amounts of there is butter, and there are essential into the bloodstream can create a dys- glucose, a pancreas that is overworked, and fatty acids. The most important oil to functional hormonal environment that can large amounts of insulin and triglycerides keep a Honda running right is not the kind ultimately promote obesity, cardiovascular circulating in the bloodstream. Note that with essential fatty acids (EFAs), but if disease, and diabetes. This hormonal shift excess insulin causes increased production you want to help your body stay healthy also has a profound effect on lean body of cholesterol. and your immune system operating at mass and fat metabolism, and possibly Over time, these occasional glucose, its best, you had better consider getting immune function.7, 8, 9 The key hormone triglyceride, and insulin floods can cause these EFAs on a daily basis. They are involved in this problem is called insulin, a decrease in the sensitivity of the cells’ called “essential” because your body can- produced by an organ called the pancreas. response to insulin, which reduces the cells’ not manufacture them, and must obtain ability to take in glucose. Insensitivity to them from an outside source, like food or INSULIN AND INSULIN insulin is called insulin resistance, and it is a supplements. These oils are necessary for RESISTANCE serious consideration in HIV because we are every critical function in your metabolism, The hormone insulin is produced by the now seeing it as one of the core compo- including building lean body mass and pancreas to control blood sugar and store nents of lipodystrophy and metabolic prob- fighting infections. it in muscles for later use as glycogen. lems.11 Some HIV medications can worsen The main point is that since we need Insulin’s main job in the body is to promote insulin resistance, so we need to be aware EFAs and other fats for health, we should the delivery of sugar energy as glucose of nutritional considerations that can help. be getting them in our diets from fresh, to cells. When a small amount of glucose Ways to decrease insulin resistance are to high-quality sources. A proper diet reduces is delivered into the bloodstream, a small exercise, choose more metabolic-friendly the amount of starchy carbohydrates while

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 37 Recent data have shown that mono-unsaturated fats decrease the risk of certain cancers, and have an anti-inflammatory effect. Since AIDS is an inflammatory disease, mono-unsaturated fat intake is a factor in managing AIDS, too. maintaining a certain amount of healthy best oils to cook with. You can also cook should be careful in their selection of milk- fats so that there is a different macronutri- with high-oleic sunflower oil, avocado, based products. Aged cheeses and yogurt ent balance than the old high-carbohy- canola, macadamia, or any oil that is high may be more tolerable for those who can- drate, high-protein, low-fat diets contained. in mono-unsaturated fatty acids. not digest lactose. This means striving to get fatty acids from Avoid cooking with oils made from several sources, the least of which are corn and sesame. These oils contain more Egg protein. Next on the list are egg the saturated fats in butter or animal fat. omega-6 fats, and less mono-unsaturated proteins. The important thing to remember Understand that saturated fats are not fats, so they have a higher potential for is that whole egg is probably somewhat the demons we have been led to believe. spoiling and turning to trans-fats, which better than egg white for lean body mass When we realize that we evolved getting a are bad for the immune system. Try to growth and overall health effect, because certain amount of saturated fat from foods avoid any intake of these oils when they the yolk is a rich nutrient source, and its in the wild, it is only logical that they would are not absolutely fresh. protein content complements the protein have a place in a healthy diet. One recent Also, choose oils that are minimally pro- in the egg white. Together they are a bet- study showed that dietary saturated fat and cessed. Most of the clear oils in supermar- ter source of protein. mono-unsaturated fat were associated with kets are stripped of some of their natural healthy testosterone production in humans, components to make them more suitable Meat protein. While real food like meat while EFAs had no effect. So it appears that for sitting on store shelves for long periods often seems to take a back seat to protein we need a little saturated fat for optimal of time without spoiling. Do not use these powders because of a mindset created hormonal health. However, most people get stripped oils. When you do cook, do not by slick advertising, professional athletes far too much saturated fat, which promotes overheat the oil so that it smokes, which know the value of real food related to lean insulin resistance and metabolic problems, causes the formation of carcinogens and body mass growth. If you do not make real and not enough EFAs, which are needed for destroys the beneficial fatty acids. food and meat fundamentals in your diet, healthy cells and immune function.13 you will not grow lean body mass tissue The other important kind of fat that Avoid margarine, hydrogenated as well. Fish, chicken, turkey, and beef are we should consciously include in our daily fats, or processed oils. Do your best to vitally important foods, not only because diet is mono-unsaturated fat, which we avoid processed fats or oils, as they have of their protein content, but because they get from foods like olive oil. Recent data negative effects on cellular health, overall contain numerous other nutritional com- have shown that mono-unsaturated fats metabolism, and your immune system. ponents that are important for a healthy decrease the risk of certain cancers, and Look out for the words hydrogenated and metabolism. The message is: eat real food, have an anti-inflammatory effect.14 AIDS partially-hydrogenated. These kinds of then supplement food with protein powder is an inflammatory disease, so mono- manipulated fats probably do increase drinks if you need them. unsaturated fat intake logically has a place the risk of cancer and heart disease. They Lean red meat is a superior source for of importance in managing AIDS, too. also weaken healthy cellular immune lean body mass growth and blood-build- metabolism, which means that they might ing nutrients. These include creatine, car- Fatty acid recommendations. EFAs increase HIV progression. Lastly, they are nitine, phenylalanine, conjugated linoleic include the omega-3 and omega-6 fatty also likely to promote high lipid levels and acid (CLA), and heme- (blood) iron, the acids. Most people get an imbalance of insulin resistance. most absorbable form of iron. And meat, these two by consuming too small an in general, is less likely to cause allergic amount of omega-3 fats, which have anti- Protein, food for the immune system. reactions than eggs or dairy proteins, like inflammatory properties, and relatively too Dairy protein fractions, such as caseine casein and whey. The only caution about large an amount of omega-6 fats, which (contained in milk curd) and whey, are at red meat is that the high amount of satu- tend to promote inflammation when out the top of the list of proteins that optimally rated fat most commercial red meat con- of balance.15 To get more omega-3s, eat feed lean body mass growth. In dairy tains could promote metabolic problems. more fish, including salmon, tuna, sar- products, the amino acid balances, insulin- So be moderate about including it in your dines, anchovies, mackerel, rainbow trout, raising potential, and overall growth factor diet and choose leaner meats if you do. and herring. Omega-6s are contained in content add up to one thing: milk proteins Important details on meat: cooking kills common vegetable oils, like sunflower, were created to make mammals grow big- bacteria in meats. Stewed meat is better safflower, and corn oils. Try to reduce your ger. While there is a lot of hoopla related for digestion (chicken soup, beef stew). intake of these. to which dairy protein fractions are best, Roasting is okay. Try not to fry or barbecue there is more misinformation than reality with charcoal. Charred foods are associ- Oils and cooking. Olive oil is one of the in this area. Those with lactose intolerance ated with increased risk of gastrointestinal

38 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM Vegetarian or vegan diets present a challenge to people with HIV or AIDS who need a full spectrum of amino acids and micronutrients. Unless you are vegetarian for ethical reasons, consider eating eggs and fish. system cancers. Any cooking of meat or your doctor’s direction. Those who have sugar should be on your radar when read- vegetable protein that causes the formation liver problems need good protein intake ing labels. Watch this funny video for more of a hard outer skin renders the protein that for the repair of liver tissue, but should details on healthy eating: www.youtube. becomes the skin to be much less digest- also be careful about higher protein intake, com/watch?v=peuLPHuvq1Y. ible because it cross-links the protein. and should also do so only under a doc- Try to eat several smaller balanced tor’s supervision. (protein + good carbs + good fats) meals VEGETARIAN DIETS or snacks instead of two to three large It is very difficult to gain lean muscle CALCIUM AND VITAMIN D—TWO ones. Smaller meals/snacks are more eas- weight on a vegetarian diet. In fact, it is IMPORTANT MICRONUTRIENTS ily digestible, keep blood sugar and insulin almost impossible for most people, espe- Bone loss has been reported in several more constant through the day, and keep cially when they are fighting infections HIV studies. It seems to be caused by the you from binge eating late at night. that burn lean body mass. While I know effect of the virus on the body. Certain Eat more almonds, walnuts, pecans a very few HIV-positive people who can medications like tenofovir (Viread) may and pistachios (good cholesterol-lowering do well adhering to a vegetarian regime, I make this problem worse. We also seem fats). Twice a day, snack on such nuts to find that the vast majority cannot do it and to have a high incidence of vitamin D get your good fats and fiber. If you wish, keep their lean body mass. Additionally, deficiency due to potential HIV medication mix them with some dried fruit. Research vegetarian diets increase the potential for effects or metabolism issues. We know that has shown that people who eat nuts tend anemia because of a lack of blood-building calcium and vitamin D help to strengthen to have lower LDL cholesterol. components such as highly absorbable bone. Many of us chose to take calcium Avoid junk and fast food. The best way heme-iron and vitamin B12. plus vitamin D supplements, but there are to do this is to have enough food at home If you do choose a vegetarian diet, also foods that are rich in these nutrients. and to bring lunch to work. Cook a lot of your best protein sources are beans, seeds Calcium-rich foods include milk, cheese, food on weekends and freeze meals in and nuts. Digestion of nuts and seeds will spinach, fortified orange juice (be careful small containers you can heat up later. be improved by soaking them overnight with the sugar, though!), fish, eggs, and Do not sabotage yourself by bringing to reduce the enzymes they contain that beans. Vitamin D-rich foods include milk, sweets and junk into your home. Watch inhibit digestion of proteins. If you can eat most fish, and eggs. However, most of us your cravings at night, when most people them without digestive problems, many do not consume the 1000 mg and 2000 IU find it the most difficult to avoid overdrink- nuts and seeds are ideal foods because needed per day for calcium and vitamin D, ing alcohol or eating ice cream, cookies, they contain protein, healthy fat, and com- respectively, and need to take over-the- and comfort foods. plex carbohydrates in a very good balance counter supplements. One word of caution: Eat a large breakfast, a moderate for overall health. They also make a great do not take your calcium supplements lunch, and a small dinner. Skipping break- snack between meals. However, the amino with your HIV medications since they may fast makes you more prone to overcom- acid balances in these proteins do not interfere with their absorption (at least two pensate by eating more calories late in the appear to be optimum for lean body mass hours before or after is okay). day. Your body has spent several hours growth for humans. Again, vegetarian or without food and is starved for nutrients vegan diets present a challenge to people MISCELLANEOUS NUTRITION TIPS in the morning. Do not feed it sugar and with HIV or AIDS who need a full spectrum If diet, weight loss, and exercise fail to white flour products at this important of amino acids and micronutrients. Unless lower your LDL cholesterol and triglyc- time. Eggs, oatmeal (the type that has you are vegetarian for ethical reasons, erides, ask your doctor for a prescription no added sugar, and you can add whey consider eating eggs and fish. for lipid-lowering agents (statins, fibrates, protein powder to it!), Greek-style yogurt Caution: People who are on HIV etc.) or to switch your meds to a more with nuts and fiber supplements, low-fat medications like tenofovir (in Viread, lipid-friendly HIV medication combination. cottage cheese with fruit, almond butter Truvada, Atripla, Complera, and the Quad), For your food, shop mostly in the on multigrain (high-fiber) bread, and fruit which may affect kidney function in some outer part of the grocery store where the are all good choices for breakfast. patients, should be careful about increas- fresh produce, meats, and milk products/ For lunch have some soup and a glass of ing their protein intake too high (over 1 eggs are. Avoid overly processed canned water first and wait 10 minutes to trick your gram per pound of body weight per day), or packaged foods, except for frozen body into feeling full faster. Grilled chicken as this can increase the potential for kid- vegetables. Read the labels and avoid with vegetables, tuna salad over greens and ney problems. Ask your doctor if you are products with many preservatives and nuts, a Greek salad with sliced steak, and taking kidney burdening medicines, and, additives. Trans-fats and hydrogenated any Mediterranean food choices are good. if so, only eat a higher protein diet under oils, high fructose corn syrup, and high For dinner, fill yourself with stir-fried

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 39 Consuming sugar daily can affect your metabolism, create insulin resistance, make you fat, and have all kinds of negative health consequences.

(use olive oil!) vegetables and lean meats. than processed grains, but when they does not mean that you should starve Two hours before bed, you can have half are milled into flour the difference is not yourself. Hopefully, this information has an almond butter sandwich or yogurt with that great. The very worst carbohydrate shed some light on healthy food sources fruit. You will not be hungry and desperate sources are sweets, like candies, which and how they can affect health and the with this diet! can deliver as many as 2,000 calories per body. Now that we are living longer, food Eat fruits and vegetables of all pound. Try to eat from the first group of choices can determine how well we do as colors. Each has a different antioxidant slow-release carbohydrate sources most of we age with HIV. So, take charge of your profile. The produce section of the market the time, and if you are relatively healthy, health and take care of your body. It is the is basically a fresh vitamin department and you can have small amounts of milled only one you have. e a medicine chest. Some foods like garlic, wheat products or sweets once in awhile. onions, and ginger have genuine thera- Drink lots of water. Six to eight glasses peutic effects. Eating the widest variety of a day is a good goal. If you get thirsty, you Go to PosItivelyAware.com fresh produce on a daily basis assures you are already dehydrated! for references and an example of getting all the ingredients that nature Eat a high-protein, complex of a healthy shopping list. provides that can help keep your body carbohydrate-rich meal after workouts. strong enough to handle bacteria and Examples: chicken salad with nuts, cottage Nelson Vergel, a chemical engineer from viruses so that you stay healthy. cheese or yogurt and nuts/fruit, celery Venezuela, has been HIV-positive since Avoid sodas, sweet drinks, and fruit sticks and hummus (chickpea butter), etc. 1983, and is a leading treatment advocate juices (fruit sounds healthy, but juice Manage your intake of caffeine (it on HIV disease. He created the Program for contains too much sugar and no fiber to reduces appetite but can increase anxiety). Wellness Restoration (PoWeR) and founded slow down its absorption into the blood).16 Do not have any caffeine after 4 p.m., the Body Positive Wellness Center in Consuming sugar daily can affect your since it can impair your sleep. Houston. Nelson has lectured extensively metabolism, create insulin resistance, Minimize hidden sugars like high around the country and overseas, and make you fat, and have all kinds of nega- fructose corn syrup. Read the labels of with his research partner, Michael Mooney, tive health consequences. The suggested food you buy. Diet sodas tend to make co-authored the book Built to Survive. In pecking order of carbohydrate food your brain crave sweets in general, so they 2010, he wrote and published Testosterone: sources that support your health without are not good substitutes for sugary drinks. A Man’s Guide—Practical Tips for Boosting increasing insulin resistance follows. Best Water, water, water! Physical, Mental and Sexual Vitality. are vegetables in their many forms. Next If you do not consume at least 20 He is currently a member of the DHHS are beans and peas. These deliver more grams of fiber a day, add to your intake Panel on Antiretroviral Guidelines, the calories than vegetables, but the carbo- supplements like Citrucell or Benefiber, AIDS Treatment Activists Coalition, and hydrates release much more slowly than purchased in any grocery store. Fiber moderates PozHealth, one of the largest grains. Next are whole grains, which are improves insulin sensitivity, makes you HIV health discussion listservs online. calorie-dense but contain carbohydrates feel full longer, keeps your gut healthy Read posts from Nelson’s blog, that, in general, release somewhat slowly. (friendly gut bacteria that produce “Surviving HIV,” at http://survivinghiv. At the bottom, and the most likely to vitamins love fiber), keeps you regular blogspot.com/ promote body fat problems, are carbohy- and reduces diarrhea, and can lower the Read Nelson’s blog, “Outsmarting drates from milled grains, like wheat and chances of getting colon cancer.17 HIV: A Survivor’s Perspective,” at www. corn. Whole grains are marginally better Eating healthy is eating smart, and it thebody.com/content/art60473.html

40 | January+February 2012 P o s i t i v e lyAwa r e . c o m COME RIDE WITH US Gearing up for the 2012 Ride for AIDS Chicago

BY RICHARD CORDOVA

AS A FUNDRAISING EVENT, THE RIDE FOR AIDS CHICAGO (RFAC) Shannon Cunningham, 2011 Rider and raises money. As an endurance event, it changes lives. The two-day, Team Co-Captain, 2012 Fundraising Co-Chair: 200-mile bicycling event produced by Test Positive Aware Network “The idea that I could challenge myself (TPAN) raises funding for TPAN and other partner agencies. to ride 200 miles was the primary reason I signed up for the Ride for AIDS Chicago Since its inception in 2004, the Ride and other team leaders help ensure that 2011. for AIDS Chicago has returned over $1.5 participants are successful in their training “I ended up raising almost $4,000, million to TPAN and partner agencies. The and fundraising. making amazing friends, and realizing I do 2012 Ride will mark its 10th anniversary and The months of training and fundraising have the ability to change someone’s life… promises to be bigger and better than ever. are nothing compared to the challenges and I did get to ride all 200 miles. After raising over $525,000 in 2011 alone, HIV-positive people face, but they are “I’m returning this year to help others the 2012 Ride aims to raise over $750,000 challenges nonetheless. Early morning learn how strong they are, both physically to support HIV services in the Chicago area. training rides, expensive equipment, sore and mentally, and how the sum of our The Ride begins in Chicago on a legs (and other body parts), and relentless entire efforts not only changes a commu- Saturday morning for the journey into requests for donations are just some of nity, it creates one. See you on the Ride!” Wisconsin, along the shores of Lake the ways Ride participants commit to this Geneva, and then into camp on Green event. Many of the riders and crew mem- Lauren Kirby, 2010 and 2011 Rider: Lake, part of the Lauderdale Lakes chain. bers are themselves living with HIV. “The Ride meant learning a small part After arriving at camp, riders and crew of the endurance and strength it takes to members enjoy a hot meal, lounge with Here is what some participants have to live with HIV/AIDS. I learned this by being friends, and celebrate the accomplish- say about the Ride for AIDS Chicago: passed by people living with HIV/AIDS and ment of making it halfway. With 100 miles knowing that those people were just as behind them, they get a good night’s sleep Renee DeMann, 2011 Rider, 2012 Team strong as me, if not more! in preparation for the return home. Co-Captain: “In addition, the Ride was in the face Riders and crew members can register “I had no idea what to expect. It was the of a 14-year-old boy who was raised by as part of a team, or as individuals. Riders most difficult, challenging, strenuous conservative Catholics saying, “I teared up are required to raise a minimum of $1,000 experience of my life, and I was in labor when that guy [Richard] talked, I’ve never and crew members are encouraged to set with my child for 13 hours and pushing for felt that way before. It makes me want to

PHOTO: CHAD MILLER a modest goal of $500. Team captains three! Can’t wait ‘til next year!” think differently of people.” The Ride to

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 41 The Ride’s capacity to inspire and transform lives is one of the many rewards experienced by those who participate in the Ride for AIDS Chicago. me is changing people’s attitudes about “Why do I continue to participate? I Unlike other rides of this kind, Ride for those living with HIV/AIDS.” have an addiction to seeing the new riders AIDS Chicago is committed to returning become empowered and overcoming what nearly 100% of the money raised back Jeremiah Miles, 2010 and 2011 Rider, they thought was a weakness.” to the beneficiaries. Through corporate 2012 Training Co-Chair: sponsorship, registration fees, and the “For me, RFAC started out as something to Bill Farrand, TPAN Executive Director, help of dedicated participants, we are able ‘do.’ Then it became a selfish addiction: more 2007 –2010 Crew Member and 2011 Rider: to keep that commitment. In 2011, 97 cents training, more donations. Now I have a self- “After having extremely rewarding experi- of every dollar raised went to help support less passion of involvement and awareness.” ences as an RFAC crew member over the HIV services in the community. previous four years, I made a commit- The Ride’s capacity to inspire and Shaine Wynsma, 2007 to 2011 Rider; ment to myself to ride in 2011 to mark and transform lives is one of the many rewards 2008 to 2011 RFAC Co-Chair; and 2012 celebrate my 50th birthday, as well as 27 experienced by those who participate in RFAC Chair: years being HIV-positive. By doing so, I the Ride for AIDS Chicago. The impossible “What has the Ride done for me? The was able to fully understand that we are becomes the possible. Hard-earned suc- Ride has allowed that part of me that can only limited by the constraints we place cesses become memories of a lifetime. conquer anything set in my path to come upon ourselves through our negative forward, and it gave me the strength to beliefs and preconceptions. By doing the The 2012 Ride for AIDS Chicago will ‘come out’ about my own status. Ride, I proved to myself that a positive take place on July 14 and 15. Registration “What does it do for the community? outlook—and a little training—are the keys opened on December 1, 2011. For more Several things. It keeps the crisis in plain to surviving and thriving. It was an experi- information, visit www.RideForAIDS.org. sight, it gives the crisis a face. It shows ence that has changed my life, and if I can Additional questions may be directed to the community that people who are HIV- do it, I believe anyone can.” Richard Cordova, Athletic Events Director positive are not bedridden, waiting to die. at [email protected].

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42 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM THE BUZZ DANIEL S. BERGER, MD THE PATH TO A CURE The pathway to an HIV cure and other treatments in the pipeline

IS CURING HIV POSSIBLE? I BELIEVE THAT THE ANSWER IS A to treating HIV: being resounding YES! The proof of concept for a cure is derived from researched by Sangamo Biosciences which collaborated with Sigma Life Science, a the famous , Timothy Ray Brown, who many now company which has made zinc finger tech- believe has been “cured.” Also, at least two small pharmaceutical nology widely available. Other scientists companies are researching gene therapy, of which the upshot are looking at Sangamo’s example of how to best use this technology for creating may be to mimic the same effects observed in Mr. Brown. new cell lines and new proteins to help fight additional disease states. Sangamo, At the time of this writing, it has been are involved in looking at gene therapy. with a viral vector (carrier), has created more than five years since Brown’s bone Their focus is to mimic the individuals who a method of using zinc finger nucleases marrow transplant and he continues to are naturally born with this genetic varia- to clip both strands of DNA that selects demonstrate clearance of HIV from blood tion by causing the deletion of the gene for the CCR5 co-receptor. In HIV-positive and other tissues. The transplanted cells that selects for CCR5. While this may be individuals, replacing genes with this dele- were from a donor who harbored the merely a sketch of the possible pathway tion could potentially prohibit any HIV delta 32 variant gene. Moreover, there are to a cure, it is certainly a new road of from infecting those cells. The altered CD4 some individuals who already have this research for HIV disease treatment. cells that lack the co-receptor, known as rare genetic alteration; they do not need Brown suffered from a leukemic SB-728-T, are multiplied in a laboratory a “cure” because they were born with and disease as well as HIV. When treating and infused back into the same patient. harbor this same delta 32 genetic variant. leukemia, patients often undergo stem Recent data from Sangamo’s trial were These individuals cannot become infected cell transplants after all their diseased presented at the 51st ICAAC in Chicago in by exposure to HIV. cells are destroyed by chemotherapy. September. Cohorts from the West Coast To be clearer, HIV requires bonding at This form of chemotherapy is dangerous, (nine patients) and East Coast (six patients) two sites in order to gain entry into human wiping out many immune system cells as had undergone the procedure of altering cells: the CD4 receptor site and a chemo- well, and carries with it a 50% mortality the cells to become SB 728-T-modified CD4 kine receptor site, most commonly CCR5. rate due to severe infections that can arise cells during a Phase 1 trial. When a person has both genes (homo- with a severely crippled immune system. The nine patients from the West Coast zygous) carrying the delta 32 variant, it However, during the post-chemo phase, had baseline undetectable viral loads and results in a deletion of the gene that, under where there should be no evidence of host median CD4 counts of 384 cells/mm3 normal circumstances, selects for the CCR5 cell disease, donor stem cells are infused (384 cells are felt to be suboptimal CD4 chemoreceptor. In other words, it results into the patient with the hope of repopu- recovery after ART). The study partici- in them lacking CCR5, a protein on the lating and replacing the cell lines with the pants, median age of 50 years, had been surface of immune cells that HIV uses to new healthy donor cells. Five years ago, HIV-positive for an average of 20 years. gain entry. In this situation, HIV is disabled Mr. Brown’s physician had the vision to Results showed that the modified cells from gaining entry or infecting human cells. treat his HIV and leukemia at the same persisted for a median of 337 days, with Roughly 1% of Northern Europeans possess time by using donor cells from someone the maximum duration being 561 days. this abnormality. Other individuals that are with the delta 32 variant. Timothy Ray The presence of the CCR5 deletion was heterozygous and have the genetic modifi- Brown is currently the only living example shown in 25% of the patients and all had cation in only one gene are not protected. of a possible HIV cure. CD4 increases of an average of 163 cells. At least two pharmaceutical companies Enter a new possible approach Also, the CD4 cells had normal migrating

POSITIVELYAWARE.COM JANUARY+FEBRUARY 2012 | 43 Since approval, clinicians have been switching selected patients to Complera. This occurs more commonly when patients have been enduring side effects from Atripla, containing Sustiva.

properties. Side effects were minimal and observed in naïve patients of the Phase 3 within the body, or in vivo, which improves short lived, with flu-like symptoms occur- trials, who had baseline viral loads greater bio-availability). 7340 has been thought to ring for 24 hours after their infusion. than 100,000 copies/ml. Thus, physicians have great antiviral activity at low doses, The East Coast cohort underwent a are split between using Complera now, vs. also penetrating tissues at 20-100 times 12-week ART interruption starting four waiting for the Quad to become approved. that of other drugs. At Northstar, we have weeks after receiving SB-728-T-modified However, in present real-world situations, recently completed a Phase 1 dose-finding, CD4 cells. The subjects with CCR5-deleted patients who have already reached unde- 10-day monotherapy study, comparing genes who also had higher CD4 values tectability, being stable on other regimens, several low doses of the drug. We expect showed lower viral loads and as much as are undetectable at this baseline when data to be released from this study in the a .08 to 2-log viral load drop. One of the switching; concerns regarding the effec- near future. Also, Gilead has reported subjects who had the heterozygous form tiveness of Complera should at least be on that they plan to formulate yet another of the delta 32 gene achieved undetect- par with the overall data of non-inferiority single-tablet regimen, to contain GS-7340 ability during the treatment. compared to the standard of care, Atripla. plus Emtriva and the cobicistat-boosted Sangamo is now considering investiga- Of note is that higher levels of rilpiv- integrase inhibitor elvitegravir. tion into treating patients by adding small irine are achieved within the single pill doses of chemotherapy prior to infusing Complera than were observed in the origi- SUMMARY the zinc finger (SB-728-T)-modified CD4 nal Phase 3 trials, in which rilpivirine was 2012 is expected to be an exciting year cells, with the aim of achieving a higher administered as a separate pill. Of course, for development of HIV therapeutics. turnover towards CCR5-deleted CD4 cells prior to any switch, clinicians should Various single-pill regimens will eventually and thus further progress at arriving at a review their patients’ previous genotypic overtake older regimens where previous functional cure. history, ensuring that no underlying rilpiv- treatment-naïve patients were started irine and Truvada resistance is present. on quantities of three or four pills. Many NEW SINGLE-PILL COCKTAILS During the ICAAC conference, new treatment-experienced patients will also Let’s move on to a discussion of two new data on Complera were presented by Dr. be eligible to have treatment simplified single-pill regimens, each containing triple Tony Mills. In this study, 49 patients who towards one-pill therapy. Further down drug therapy in one pill. Complera, recent- were undetectable on Atripla switched to the road, a completely new approach in ly approved, contains the new non-nuke Complera. All 49 patients remained unde- treatment is underway—one that may have rilpivirine (Edurant) plus Truvada (Viread tectable at 12 weeks. the potential to be a functional cure of HIV plus Emtriva). Another pill, nicknamed the Also, two more studies are ongoing to infection. However, challenges still remain Quad, is undergoing Phase 3 studies but better define Complera’s use. In one trial, in the attempt to retard the premature has filed a New Drug Application (NDA) Complera is being pitted against Atripla development of complications associated with the Food and Drug Administration in a study of nearly 800 treatment-naïve with the aging HIV population. (FDA) for approval. If successful, it may patients. The second, which enrolled become available by April 2012. The Quad approximately 500 patients, is study- contains the integrase inhibitor elvitegravir ing treatment-experienced patients on DR. DANIEL S. BERGER is a leading boosted by cobicistat, plus Truvada. boosted protease inhibitors, who were HIV physician in the U.S. and is Clinical Since approval, clinicians have been randomized to either stay on their original Associate Professor of Medicine at the switching selected patients to Complera. regimen or be switched to Complera. I University of Illinois at Chicago. He is This occurs more commonly when patients currently serve as principle investigator founder and medical director of Northstar have been enduring side effects from for all three trials at Northstar Healthcare, Healthcare, has published extensively in Atripla, containing Sustiva (such as sleep while seeing many of our patients on these such prestigious journals as The Lancet disorders, morning lethargy, and anxi- studies. It gives me great pleasure to be and The New England Journal of Medicine, ety), but also when side effects of some observing patients improve their quality of and currently serves as principle investiga- protease inhibitor regimens persist. Also, life while contributing to research and our tor at Northstar Healthcare. Dr. Berger some patients are being transitioned to knowledge base as they are offered these has been honored by Test Positive Aware Complera merely for the sake of treatment new advances in treatment. Network with the Charles E. Clifton simplification. Leadership Award. Dr. Berger can be Some clinicians have been more NEWEST NUKE, GS-7340 reached at [email protected] and reserved, not confident of Complera’s GS-7340 is a pro-drug of tenofovir www.Nstarmedical.com. potency due to higher failure rates (Viread) (pro-drugs get metabolized

44 | JANUARY+FEBRUARY 2012 POSITIVELYAWARE.COM SALIENT RAMBLINGS SAL IACOPELLI

“It is wanting to know the end that makes us believe in God, or witchcraft… to believe, at least, in something.” —Other Voices, Other Rooms, Truman Capote

WHEN STUDYING HISTORY, ONE WILL NOTE THE ROMAN CATHOLIC the death penalty for several other acts. Church has a dark history of being wrong on many issues. Consider Leviticus 17:10–13 prohibits the eating of blood sausage; Leviticus 11:6–7 prohibits their view on Galileo’s work or St. Paul advising slaves to be the eating of “unclean” hares and swine; obedient to their masters. Each time science and knowledge has Leviticus 11:10 declares shellfish “abomina- advanced, the Church fought to hang on to ignorance. tions”; Leviticus 20:9 prescribes the death penalty for cursing one’s father or mother; Medical science and mental health in scripture. Scientific knowledge barely and Leviticus 20:10 prescribes the death knowledge have concluded that homosex- advanced in over 1,000 years from the penalty for adultery. Clearly, Leviticus had uality is a normal phenomenon contrary rise of orthodox Christianity in the fourth some issues. Maybe he’d also been “visited” to the Church’s 13th century teachings century to the 1500s. by the Devil in the womb. on “natural law.” Rather than admit that Not bad enough? Misogyny is funda- Few realize the history of the world is calling gays “inherently disordered” and mental to the writings of Christianity. In filled with same-gender-loving spiritual- worse is simply wrong, an explanation is passage after passage, women are encour- ity. Ancient civilizations, tribes, and sects offered as to why condemning gays is still aged, indeed commanded, to accept an revered homosexuals as spiritual guard- morally acceptable: the Devil causes a sup- inferior role and to be ashamed of them- ians. As religion became more organized, posed malfunction in fetal development in selves for the simple fact that they are millions of these shamans, priests, and the womb and so, a gay child is born. women. From the New Testament we find priestesses were exiled, brutalized, and My biggest dissension with Christianity “Wives, submit yourselves unto your own even killed by the church. is that it is based on fear. There are liberal husbands, as unto the Lord. For the hus- For centuries, in many societies, sex clergy preaching a gospel of love; yet to band is the head of the wife, even as Christ was undifferentiated. Sexual choice was do so, they ignore the bulk of Christian is the head of the church…” (Ephesians merely a matter of taste. In the Middle teachings and Christian history. Throughout 5:22–23) and “These [redeemed] are they East, many non-monotheistic gods and much of its existence, Christianity focused which were not defiled with women…” goddesses presented an image of sexual on fear of the devil and of hell. Even today, (Revelation 14:4). From the Old Testament ambivalence and bisexuality. As late as the existence of the devil and hell are car- we find “How then can man be justified 600 AD, even in Europe, love, friendship, dinal doctrinal tenets of almost all Christian with God? Or how can he be clean that is sex, and pleasure were considered inter- creeds. Many fundamentalist preachers still born of a woman?” (Job 25:4). connected, while marriage was specifically openly resort to terrorizing followers with Finally, Christianity from its begin- for the purpose of procreation. However, lurid, sadistic portraits of the suffering of nings has been markedly homophobic. as the church, prejudiced by strict Biblical nonbelievers after death. The biblical basis for this homophobia interpretation, became a monolithic For over a millennium Christianity lies in the story of Sodom in Genesis, and political force in the West, gay people and arrested the development of science. in Leviticus. Leviticus 18:22 reads: “Thou gay spirituality were brutally denied any From the time of Augustine until the shalt not lie with mankind, as with wom- contribution to human history, and forced Renaissance, systematic investigation of ankind: it is abomination,” and Leviticus to go underground for hundreds of years. the natural world was restricted to theo- 20:13 reads: “If a man lie with mankind The term “homosexuality” wasn’t even logical investigation and the interpretation as he lieth with a woman, both of them coined until late in the 19th Century. of biblical passages. There was no direct have committed an abomination: they If I were not gay, would I be so wary of observation and interpretation of natural shall surely be put to death; their blood Christianity? Indeed. As a thinking being, processes because that was considered a shall be upon them.” Leviticus declares there are myriad reasons to at least ques- useless pursuit, as all knowledge resided many other “abominations” and prescribes tion, if not shun, its teachings.

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