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WHat About CondOms? Conference Update: T EPHE CROI R ORT WHY I RIDE: Ou t and open IN The RIDE FOR AIDS CHICAGO

POSITIVELY AWARE The HIV Treatment Journal of Test Positive Aware Network MAY+JUNE 2015

T HE BIGGES CHANGES IN 20 YEARS ARE COMING

REIn THINK NG HIV NEW APPROACHES TO TREATMENT n CHASING THE CURE n 3D animation of hIV Client Name: GSK/Triumeq Healthcare This advertisement prepared by: Product: Triumeq Havas Worldwide Job Number: 200 Hudson Street 65013 Filename 65013_58522_M02_DTR045R0_CouchSpread_ Last Modified 1-14-2015 12:41 PM User / PrevUs- Derrick.Edwin / Aileen.Boyce Client GSK Triumeq Art Director M. Culbreth Bleed 16.25” x 10.75” Path Premedia:Volumes:Premedia:Pre- CMYK press:65013_58522:Final:Pre- 0000065013_0000058522_M02_DTR045R0_FCAD – Positively Aware New York, New York 10013 Create 1-14-2015 10:42 AM Artist Kerry Trim 16” x 10.5” press:65013_58522_M02_DTR045R0_ CouchSpread_FCAD-for PREPRESS. Proof Caption: “I have the courage to start HIV…” (Man on Couch) 3 Traffic R. Rodriguez Saftey 15” x 10” indd Fonts Helvetica Neue LT Std (75 Bold, 77 Bold Condensed, 57 Condensed, 55 Roman, 47 Light Condensed, 67 Medium Condensed, 47 Light Condensed Oblique; OpenType), Minion Pro (Regular; OpenType), TT Slug Media: 4/C Magazine Spread + PBW +PBW + ½ PBW AD: M. Culbreth OTF (Regular; OpenType) PAR # DTR045R0 AE: M. Halle Art TRIU_58522_01_CeasarCouchAd_SW_V6_HR.tif (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:TRIU_58522_01_CeasarCouch- Ad_SW_V6_HR.tif), ViiVHCcmyk.ai (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:ViiVHCcmyk.ai), Triumeq_US_CMYK_Reg_NEW. Prod: I. Waugh ai (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:Triumeq_US_CMYK_Reg_NEW.ai), TRIU_58522_02_ItsTimeLogo_SW_V1_130_ B: 16.25” x 10.75” T: 16” x 10.5” Bill Studio Labor OOP to: 0000065013 S: 15” x 10” Gutter Safety = 1”

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TRIUMEQ is a once-a-day pill used to treat HIV-1. TRIUMEQ should not be used by itself in some people. Take TRIUMEQ exactly as your healthcare provider tells you. Is it time for you? Ask your doctor. APPROVED USES TRIUMEQ is a prescription medicine used to treat Human Immunodeﬁ ciency Virus-1 (HIV-1) infection in adults. HIV-1 is the virus that causes AIDS. It is not known if TRIUMEQ is safe or effective in children under the age of 18. TRIUMEQ is not for use by itself in people who have or have had resistance to abacavir, dolutegravir, or lamivudine. TRIUMEQ does not cure HIV-1 or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illness. IMPORTANT SAFETY INFORMATION yellow skin, or the white part of the eyes turns yellow; dark urine; What is the most important information I should know about light-colored stools; nausea; itching; or stomach-area pain. TRIUMEQ? • Worsening of hepatitis B virus in people who have HIV-1 infection. If you have HIV-1 and hepatitis B virus infections, your • Serious allergic reaction (hypersensitivity reaction). TRIUMEQ hepatitis virus infection may get worse if you stop taking TRIUMEQ. contains abacavir. Patients taking TRIUMEQ may have a serious Do not stop taking TRIUMEQ without ﬁ rst talking to your healthcare allergic reaction to abacavir that can cause death. Your risk is provider, so he or she can monitor your health. much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have • Resistant hepatitis B virus. If you have HIV-1 and hepatitis B, this gene variation. If you get symptoms from 2 or more of the the hepatitis B virus can change (mutate) during your treatment with following groups while taking TRIUMEQ, call your healthcare TRIUMEQ and become harder to treat (resistant). provider right away: 1. fever; 2. rash; 3. nausea, vomiting, • Use with interferon and ribavirin-based regimens. If you’re diarrhea, or stomach pain; 4. generally ill feeling, extreme taking TRIUMEQ and interferon, with or without ribavirin, tell your tiredness, or achiness; 5. shortness of breath, cough, or sore healthcare provider about any new symptoms. Liver disease might throat. Your pharmacist will give you a Warning Card with a list of get worse in patients who are taking HIV-1 medicines and interferon. these symptoms. Carry this Warning Card with you at all times. Who should not take TRIUMEQ?

If you stop taking TRIUMEQ because of an allergic reaction, B:10.75” T:10.5”

• Do not take TRIUMEQ if you: S:10” never take TRIUMEQ or any other medicine that contains have the HLA-B*5701 gene variation abacavir or dolutegravir again. If you take TRIUMEQ or any other have ever had an allergic reaction to abacavir, dolutegravir, or abacavir-containing medicine again after you have had an allergic lamivudine reaction, within hours you may get life-threatening symptoms that take dofetilide (Tikosyn®) may include very low blood pressure or death. If you stop TRIUMEQ have certain liver problems for any other reason, even for a few days, and you are not allergic to TRIUMEQ, talk with your healthcare provider before taking it again. What are other possible side effects of TRIUMEQ? • People with a history of hepatitis B or C virus may have an increased Taking TRIUMEQ again can cause a serious allergic or life-threatening Not an actual patient. Testimonial is based on risk of developing new or worsening changes in certain liver tests reaction, even if you never had an allergic reaction to it before. If your a collection of real patient experiences. healthcare provider tells you that you can take TRIUMEQ again, during treatment with TRIUMEQ. Your healthcare provider may do tests start taking it when you are around medical help or people who to check your liver function before and during treatment with TRIUMEQ. can call a healthcare provider if you need one. • When you start taking HIV-1 medicines, your immune system may get stronger and begin to ﬁ ght infections that have been hidden in • A buildup of acid in your blood (lactic acidosis). Lactic acidosis What should I tell my healthcare provider before taking TRIUMEQ? can happen in some people who take TRIUMEQ. This serious your body for a long time. Tell your healthcare provider right away medical emergency can cause death. Call your healthcare provider if you start having new symptoms after starting your HIV-1 medicine. • Before you take TRIUMEQ, tell your healthcare provider if you: have been tested and know whether or not you have a gene variation called HLA-B*5701. right away if you feel very weak or tired; have unusual muscle • Changes in body fat can happen in people who take HIV-1 medicines. pain; have trouble breathing; have stomach pain with nausea and have or had liver problems, including hepatitis B or C infection; have kidney problems; • Some HIV-1 medicines, including TRIUMEQ, may increase your risk have heart problems, smoke, or have diseases that increase your risk of heart disease vomiting; feel cold, especially in your arms and legs; feel dizzy/light- of heart attack. headed; or have a fast/irregular heartbeat. such as high blood pressure, high cholesterol, or diabetes; drink alcoholic beverages; or The most common side effects of TRIUMEQ include: trouble have any other medical condition. • Severe liver problems. Severe liver problems can happen in people sleeping, headache, and tiredness. are pregnant or plan to become pregnant. It is not known if TRIUMEQ will harm your who take TRIUMEQ. In some cases, these severe liver problems can unborn baby. lead to death. You may be more likely to get lactic acidosis or serious These are not all the possible side effects of TRIUMEQ. Tell your are breastfeeding or plan to breastfeed. Do not breastfeed if you take TRIUMEQ. liver problems if you are female, very overweight, or have been taking healthcare provider if you have any side effect that bothers you or that nucleoside analogue medicines for a long time. Call your healthcare does not go away. • You should not take TRIUMEQ if you also take: abacavir (EPZICOM, TRIZIVIR, or ZIAGEN) provider right away if you get any of the following signs or symptoms: Important Safety Information continued on next page. lamivudine (COMBIVIR®, EPIVIR, EPIVIR-HBV®, EPZICOM, or TRIZIVIR) ® ® ® ® ® You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. emtricitabine (EMTRIVA , ATRIPLA , COMPLERA , STRIBILD , TRUVADA ) Please see brief summary of Prescribing Information for TRIUMEQ on the following pages. • Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines (for example, antacids; laxatives; vitamins such as iron or calcium supplements; anti-seizure medicines; other medicines to treat HIV-1, hepatitis, or ©2014 ViiV Healthcare group of companies. All rights reserved. tuberculosis; metformin; and methadone) and herbal supplements (for example, St. John’s Printed in USA. DTR045R0 November 2014 wort). TRIUMEQ may affect the way they work, and they may affect how TRIUMEQ works.

FS:7” FS:7” F:8” F:8” Client Name: GSK/Triumeq Healthcare This advertisement prepared by: Product: Triumeq Havas Worldwide Job Number: 200 Hudson Street 65013 Filename 65013_58522_M02_DTR045R0_CouchSpread_ Last Modified 1-14-2015 12:41 PM User / PrevUs- Derrick.Edwin / Aileen.Boyce Client GSK Triumeq Art Director M. Culbreth Bleed 16.25” x 10.75” Path Premedia:Volumes:Premedia:Pre- CMYK press:65013_58522:Final:Pre- 0000065013_0000058522_M02_DTR045R0_FCAD – Positively Aware New York, New York 10013 Create 1-14-2015 10:42 AM Artist Kerry Trim 16” x 10.5” press:65013_58522_M02_DTR045R0_ CouchSpread_FCAD-for PREPRESS. Proof Caption: “I have the courage to start HIV…” (Man on Couch) 3 Traffic R. Rodriguez Saftey 15” x 10” indd Fonts Helvetica Neue LT Std (75 Bold, 77 Bold Condensed, 57 Condensed, 55 Roman, 47 Light Condensed, 67 Medium Condensed, 47 Light Condensed Oblique; OpenType), Minion Pro (Regular; OpenType), TT Slug Media: 4/C Magazine Spread + PBW +PBW + ½ PBW AD: M. Culbreth OTF (Regular; OpenType) PAR # DTR045R0 AE: M. Halle Art TRIU_58522_01_CeasarCouchAd_SW_V6_HR.tif (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:TRIU_58522_01_CeasarCouch- Ad_SW_V6_HR.tif), ViiVHCcmyk.ai (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:ViiVHCcmyk.ai), Triumeq_US_CMYK_Reg_NEW. Prod: I. Waugh ai (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:Triumeq_US_CMYK_Reg_NEW.ai), TRIU_58522_02_ItsTimeLogo_SW_V1_130_ B: 16.25” x 10.75” T: 16” x 10.5” Bill Studio Labor OOP to: 0000065013 S: 15” x 10” Gutter Safety = 1”

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FS:7” FS:7” F:8” F:8” 65013 Filename 65013_58522_M02_DTR045R0_CouchSpread_ Last Modified 1-14-2015 12:41 PM User / PrevUs- Derrick.Edwin / Aileen.Boyce

Client GSK Triumeq Art Director M. Culbreth Bleed 16.25” x 10.75” Path Premedia:Volumes:Premedia:Pre- CMYK press:65013_58522:Final:Pre- Create 1-14-2015 10:42 AM Artist Kerry Trim 16” x 10.5” press:65013_58522_M02_DTR045R0_ CouchSpread_FCAD-for PREPRESS. Proof 3 Traffic R. Rodriguez Saftey 15” x 10” indd Fonts Helvetica Neue LT Std (75 Bold, 77 Bold Condensed, 57 Condensed, 55 Roman, 47 Light Condensed, 67 Medium Condensed, 47 Light Condensed Oblique; OpenType), Minion Pro (Regular; OpenType), TT Slug OTF (Regular; OpenType) Art TRIU_58522_01_CeasarCouchAd_SW_V6_HR.tif (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:TRIU_58522_01_CeasarCouch- Ad_SW_V6_HR.tif), ViiVHCcmyk.ai (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:ViiVHCcmyk.ai), Triumeq_US_CMYK_Reg_NEW. ai (Premedia:Prepress:65013_58522:Original:1.14.15:0000065013_0000058522_M02_DTR045R0_CouchSpread_FCAD Folder:Links:Triumeq_US_CMYK_Reg_NEW.ai), TRIU_58522_02_ItsTimeLogo_SW_V1_130_ Client Name: GSK/Triumeq Healthcare This advertisement prepared by: Product: Triumeq Havas Worldwide Job Number: 0000065013_0000058522_M02_DTR045R0_FCAD – 200 Hudson Street Positively Aware New York, New York 10013 Caption: “I have the courage to start HIV…” (Man on Couch) Media: 4/C Magazine Spread + PBW +PBW + ½ PBW AD: M. Culbreth PAR # DTR045R0 AE: M. Halle Prod: I. Waugh B: 16.25” x 10.75” T: 16” x 10.5” Bill Studio Labor OOP to: 0000065013 S: 15” x 10” Gutter Safety = 1” 2-1/2 PAGE BRIEF SUMMARY - PAGE 1 Left Hand Side

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BRIEF SUMMARY Call your healthcare provider right away if you get any of the following TRIUMEQ® (TRI-u-meck) signs or symptoms of liver problems: (abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg) tablets • your skin or the white part of your eyes turns yellow Read this Medication Guide before you start taking TRIUMEQ and each time you • dark “tea-colored” urine get a refill. There may be new information. This information does not take the place • light colored stools (bowel movements) of talking to your healthcare provider about your medical condition or your • nausea treatment. Be sure to carry your TRIUMEQ Warning Card with you at all times. • itching • stomach-area pain What is the most important information I should know about TRIUMEQ? You may be more likely to get lactic acidosis or serious liver problems if • Serious allergic reaction (hypersensitivity reaction). TRIUMEQ ® ® you are female, very overweight, or have been taking nucleoside analogue contains abacavir (also contained in EPZICOM , TRIZIVIR , and medicines for a long time. ZIAGEN®). Patients taking TRIUMEQ may have a serious allergic reaction • Worsening of hepatitis B virus in people who have HIV-1 infection. (hypersensitivity reaction) that can cause death. Your risk of this allergic If you have HIV-1 and hepatitis B virus infections, your hepatitis virus reaction to abacavir is much higher if you have a gene variation called infection may get worse if you stop taking TRIUMEQ. To help avoid this: HLA-B*5701. Your healthcare provider can determine with a blood test Take TRIUMEQ exactly as prescribed. if you have this gene variation. • Do not run out of TRIUMEQ. If you get a symptom from 2 or more of the following groups while • Do not stop TRIUMEQ without talking to your healthcare provider. taking TRIUMEQ, call your healthcare provider right away to find • Your healthcare provider should monitor your health and do regular out if you should stop taking TRIUMEQ. blood tests to check your liver for at least several months if you stop Symptom(s) taking TRIUMEQ. Group 1 Fever • Resistant Hepatitis B Virus (HBV). If you have HIV-1 and hepatitis B, Group 2 Rash the hepatitis B virus can change (mutate) during your treatment with Group 3 Nausea, vomiting, diarrhea, abdominal TRIUMEQ and become harder to treat (resistant). (stomach area) pain • Use with interferon and ribavirin-based regimens. Worsening of Group 4 Generally ill feeling, extreme tiredness, or achiness liver disease has happened in people infected with HIV-1 and hepatitis C virus who are taking anti-HIV medicines and are also being treated for Group 5 Shortness of breath, cough, sore throat hepatitis C with interferon with or without ribavirin. If you are taking A list of these symptoms is on the Warning Card your pharmacist gives TRIUMEQ and interferon with or without ribavirin, tell your healthcare you. Carry this Warning Card with you at all times. provider if you have any new symptoms. If you stop TRIUMEQ because of an allergic reaction, never take T:9.25” What is TRIUMEQ? TRIUMEQ or any other medicines that contain abacavir or dolutegravir (EPZICOM, ZIAGEN, TRIZIVIR, or TIVICAY®) again. If you TRIUMEQ is a prescription medicine used to treat HIV-1 (Human take TRIUMEQ or any other abacavir-containing medicine again after you Immunodeficiency Virus-type 1) infection. TRIUMEQ contains 3 have had an allergic reaction, within hours you may get life-threatening prescription medicines: abacavir (ZIAGEN), dolutegravir (TIVICAY), and ® symptoms that may include very low blood pressure or death. If you lamivudine (EPIVIR ). stop TRIUMEQ for any other reason, even for a few days, and you are not • TRIUMEQ is not for use by itself in people who have or have had allergic to TRIUMEQ, talk with your healthcare provider before taking it resistance to abacavir, dolutegravir, or lamivudine. again. Taking TRIUMEQ again can cause a serious allergic or life- It is not known if TRIUMEQ is safe and effective in children. threatening reaction, even if you never had an allergic reaction to it before. TRIUMEQ may help: If your healthcare provider tells you that you can take TRIUMEQ • reduce the amount of HIV-1 in your blood. This is called “viral load”. again, start taking it when you are around medical help or people • increase the number of white blood cells called CD4+ (T) cells in your who can call a healthcare provider if you need one. blood, which help fight off other infections. • Build-up of acid in your blood (lactic acidosis). Lactic acidosis can Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your happen in some people who take TRIUMEQ. Lactic acidosis is a serious blood may help improve your immune system. This may reduce your risk medical emergency that can lead to death. of death or getting infections that can happen when your immune system Lactic acidosis can be hard to identify early, because the symptoms is weak (opportunistic infections). could seem like symptoms of other health problems. TRIUMEQ does not cure HIV-1 infection or AIDS. You must stay Call your healthcare provider right away if you get the following symptoms on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV- that could be signs of lactic acidosis: related illnesses. • feel very weak or tired Avoid doing things that can spread HIV-1 infection to others. • have unusual (not normal) muscle pain • Do not share or re-use needles or other injection equipment. • have trouble breathing • Do not share personal items that can have blood or body fluids on them, • have stomach pain with nausea and vomiting like toothbrushes and razor blades. • feel cold, especially in your arms and legs • Do not have any kind of sex without protection. Always practice safer sex • feel dizzy or light-headed by using a latex or polyurethane condom to lower the chance of sexual • have a fast or irregular heartbeat contact with semen, vaginal secretions, or blood. • Severe liver problems. Severe liver problems can happen in people Ask your healthcare provider if you have any questions about how to who take TRIUMEQ. In some cases these severe liver problems can lead prevent passing HIV to other people. to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). (continued on the next page) 65013 Filename 65013_58522_M02_DTR045R0_CouchSpread_ Last Modified 1-14-2015 12:41 PM User / PrevUs- Derrick.Edwin / Aileen.Boyce

Client Name: GSK/Triumeq Healthcare This advertisement prepared by: Product: Triumeq Havas Worldwide Job Number: 0000065013_0000058522_M02_DTR045R0_FCAD – 200 Hudson Street Positively Aware New York, New York 10013 Caption: “I have the courage to start HIV…” (Man on Couch) Media: 4/C Magazine Spread + PBW +PBW + ½ PBW AD: M. Culbreth PAR # DTR045R0 AE: M. Halle Prod: I. Waugh B: 16.25” x 10.75” T: 16” x 10.5” Bill Studio Labor OOP to: 0000065013 S: 15” x 10” Gutter Safety = 1” 2-1/2 PAGE BRIEF SUMMARY - PAGE 2 Right Hand Side

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BRIEF SUMMARY (cont’d) • medicines used to treat hepatitis virus infections, such as interferon or ribavirin TRIUMEQ® (abacavir, dolutegravir, and lamivudine) tablets • a medicine that contains metformin • methadone Who should not take TRIUMEQ? • rifampin (RIFATER®, RIFAMATE®, RIMACTANE®, RIFADIN®) Do not take TRIUMEQ if you: • St. John’s wort (Hypericum perforatum) • have a certain type of gene variation called the HLA-B*5701 allele. Your Know the medicines you take. Keep a list of your medicines with you to show healthcare provider will test you for this before prescribing treatment to your healthcare provider and pharmacist when you get a new medicine. with TRIUMEQ. Ask your healthcare provider or pharmacist if you are not sure if you take • have ever had an allergic reaction to abacavir, dolutegravir, or lamivudine one of the medicines listed above. • take dofetilide (TIKOSYN®). Taking TRIUMEQ and dofetilide (TIKOSYN) How should I take TRIUMEQ? can cause side effects that may be life-threatening. • Take TRIUMEQ exactly as your healthcare provider tells you. • have certain liver problems • Do not change your dose or stop taking TRIUMEQ without talking with What should I tell my healthcare provider before taking TRIUMEQ? your healthcare provider. Before you take TRIUMEQ, tell your healthcare provider if you: • Stay under the care of a healthcare provider while taking TRIUMEQ. • have been tested and know whether or not you have a particular gene • You can take TRIUMEQ with or without food. variation called HLA-B*5701 • If you miss a dose of TRIUMEQ, take it as soon as you remember. If it is • have or had liver problems, including hepatitis B or C virus infection within 4 hours of your next dose, skip the missed dose and take the next • have kidney problems dose at your regular time. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider. • have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes • Do not run out of TRIUMEQ. The virus in your blood may become resistant to other HIV-1 medicines if TRIUMEQ is stopped for even a short • drink alcoholic beverages time. When your supply starts to run low, get more from your healthcare • have any other medical condition provider or pharmacy. • are pregnant or plan to become pregnant. It is not known if TRIUMEQ • If you take too much TRIUMEQ, call your healthcare provider or go to the will harm your unborn baby. Tell your healthcare provider if you become nearest hospital emergency room right away. pregnant while taking TRIUMEQ. Pregnancy Registry. There is a pregnancy registry for women who take What are the possible side effects of TRIUMEQ? antiviral medicines during pregnancy. The purpose of the registry is to TRIUMEQ can cause serious side effects including: collect information about the health of you and your baby. Talk to your • See “What is the most important information I should know about T:9.25” healthcare provider about how you can take part in this registry. TRIUMEQ?” • are breastfeeding or plan to breastfeed. Do not breastfeed if you • Changes in liver tests. People with a history of hepatitis B or C virus take TRIUMEQ. You should not breastfeed because of the risk of may have an increased risk of developing new or worsening changes in passing HIV-1 to your baby. It is not known if abacavir or dolutegravir certain liver tests during treatment with TRIUMEQ. Your healthcare passes into your breast milk. Lamivudine can pass into your breast milk provider may do tests to check your liver function before and during and may harm your baby. Talk to your healthcare provider about the best treatment with TRIUMEQ. way to feed your baby. • Changes in your immune system (Immune Reconstitution Syndrome) Tell your healthcare provider about all the medicines you take, can happen when you start taking HIV-1 medicines. Your immune system including prescription and over-the-counter medicines, vitamins, and may get stronger and begin to fight infections that have been hidden in your herbal supplements. TRIUMEQ may affect the way other medicines work, body for a long time. Tell your healthcare provider right away if you start and other medicines may affect how TRIUMEQ works. having new symptoms after starting your HIV-1 medicine. You should not take TRIUMEQ if you also take: • Changes in body fat (fat redistribution) can happen in people who • abacavir (EPZICOM, TRIZIVIR, or ZIAGEN) take HIV-1 medicines. These changes may include increased amount of • lamivudine (COMBIVIR®, EPIVIR, EPIVIR-HBV®, EPZICOM, or TRIZIVIR) fat in the upper back and neck (“buffalo hump”), breast, and around the • emtricitabine (EMTRIVA®, ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®) middle of your body (trunk). Loss of fat from the legs, arms, and face Tell your healthcare provider if you take: may also happen. The exact cause and long-term health effects of these • antacids, laxatives, or other medicines that contain aluminum, magnesium, problems are not known. sucralfate (CARAFATE®), or buffered medicines. TRIUMEQ should be • Heart attack (myocardial infarction). Some HIV medicines including taken at least 2 hours before or 6 hours after you take these medicines. TRIUMEQ may increase your risk of heart attack. • anti-seizure medicines: The most common side effects of TRIUMEQ include: • oxcarbazepine (TRILEPTAL®) • trouble sleeping • phenytoin (DILANTIN®, DILANTIN®-125, PHENYTEK®) • headache • phenobarbital • tiredness ® ® ® ® • carbamazepine (CARBATROL , EQUETRO , TEGRETOL , TEGRETOL -XR, Tell your healthcare provider if you have any side effect that bothers you or ® ® TERIL , EPITOL ) that does not go away. • any other medicine to treat HIV-1 These are not all the possible side effects of TRIUMEQ. For more • iron or calcium supplements taken by mouth. Supplements containing information, ask your healthcare provider or pharmacist. calcium or iron may be taken at the same time with TRIUMEQ if taken Call your doctor for medical advice about side effects. You may report side with food. Otherwise, TRIUMEQ should be taken at least 2 hours before effects to FDA at 1-800-FDA-1088. or 6 hours after you take these medicines. 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BRIEF SUMMARY (cont’d) This Medication Guide has been approved by the U.S. Food and Drug TRIUMEQ® (abacavir, dolutegravir, and lamivudine) tablets Administration.

How should I store TRIUMEQ? Manufactured for: by: • Store TRIUMEQ at room temperature between 68°F to 77°F (20°C to 25°C). • Store TRIUMEQ in the original bottle. • Keep the bottle of TRIUMEQ tightly closed and protect from moisture. • The bottle of TRIUMEQ contains a desiccant packet to help keep your ViiV Healthcare GlaxoSmithKline medicine dry (protect it from moisture). Keep the desiccant packet in the Research Triangle Park, NC 27709 Research Triangle Park, NC 27709 bottle. Do not remove the desiccant packet. Keep TRIUMEQ and all medicines out of the reach of children. Lamivudine is manufactured under agreement from General information about the safe and effective use of TRIUMEQ Shire Pharmaceuticals Group plc Medicines are sometimes prescribed for purposes other than those listed Basingstoke, UK T:4.5” in a Medication Guide. Do not use TRIUMEQ for a condition for which it COMBIVIR, EPIVIR, EPZICOM, TIVICAY, TRIUMEQ, TRIZIVIR, and ZIAGEN was not prescribed. Do not give TRIUMEQ to other people, even if they have are registered trademarks of the ViiV Healthcare group of companies. the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about EPIVIR-HBV is a registered trademark of the GSK group of companies. TRIUMEQ. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information The other brands listed are trademarks of their respective owners and are about TRIUMEQ that is written for health professionals. not trademarks of the ViiV Healthcare group of companies. The makers of these brands are not affiliated with and do not endorse the ViiV Healthcare For more information go to www.TRIUMEQ.com or call 1-877-844-8872. group of companies or its products. What are the ingredients in TRIUMEQ? Active ingredients: abacavir, dolutegravir, and lamivudine ©2014, the ViiV Healthcare group of companies. All rights reserved. Inactive ingredients: D-mannitol, magnesium stearate, microcrystalline Issued: August 2014 cellulose, povidone, and sodium starch glycolate. The tablet film-coating TRM:1MG contains iron oxide black, iron oxide red, macrogol/PEG, polyvinyl alcohol– part hydrolyzed, talc, and titanium oxide. POSITIVELY AWARE MAY+JUNE 2015 | VOLUME 27 NUMBER 3

E MERALD CITY Seattle was the center of HIV news as Researchers gathered for the annual CROI meeting.

Dpartmentse REI TH NK NG HIV Cno ference update o 7 edit r’s Note 17 New Approaches 28 THE CROI REPORT R einvention. to treatment Better-than-expected PrEP results. TAF The biggest changes in 20 years found non-inferior to TDF. Curing HCV IEFLY8 BR are coming. in patients co-infected with HIV. U pdated HIV treatment guidelines. B y Melanie Thompson, MD rers po t By jeff berry, Andrew Reynolds, Drug interactions found with Sovaldi, and Enid Vázquez Harvoni. Viekira Pak approved for hep C. S20 CHA ING The Cure Bdy Eni Vázquez The state of the search. B y Richard Jefferys only on POSITIVELYAWARE.COM 11 THE CONVERSATION L ong-term survivors. HIV Drug Guide. w23 A ne Look at hiv Tell it to Enid Hep C in prison. Cell biologist-turned-animator Janet Iwasa Damon L. Jacobs on the psychology offers a 3D view of how HIV works. of PrEP. FeatureS Inri te v ew By Rick Guasco

40 What About condoms? A heartfelt message from a PrEP educator. By Damon L. Jacobs ON THE COVER Rethinking HIV 42 WHY I RIDE PHOTOGRAPH bY CHRIS KNIGHT. The Ride for AIDS Chicago addresses Assistance: WYLL MARTINEZ. Makeup: Michelle Mink. stigma while helping HIV-positive youth. models: Austin Kairis Bry Robe t Garofalo, MD and Adam Andrew.

PITIVLOS E Y AWARE MAY+JUNE 2015 5 SAVE THE DATE: POSITIVELY AWARE June 19, 2015 JSOURNALI M. INTEGRITY. HOPE.

Jeff Berry eit d or-in-Chief chicago @P Aeditor “‘ Rethinking HIV’ is about how HIV research and treatment is evolving, and how radical shifts in our perspective are necessary for us to continue POSITIVELY AWARE AND to make progress.” TEST POSITIVE AWARE NETWORK PRESENT Enid Vázquez ass ociate editor @enidvazquezpa “ More good news on PrEP— spread the word.” THE Rick Guasco Creaiv t e director @rickguasco “ For many of us living with HIV, the long-term strategy REUNION has been to stay alive for the next advance in treatment. It’s pretty heady to think we’re on the brink of the next revolution.” PROJECT

Jason Lancaster A one-day summit for long-term survivors of HIV/AIDS p roofreader to share their stories and identify strategies for successful living—today and into the future. contributing writers Cra los A. Perez Jim Pickett Go to tpan.com and positivelyaware.com for details. Andrew Reynolds Matt Sharp

pahotogr phers D uane Cramer John Gress Chris Knight T hIS program is supported by an unrestricted educational grant from Bristol-Myers Squibb. avr d e tiSIng Lorraine Hayes L [email protected]

D biSTri ution and © 2015 Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5050 Subscription services N. Broadway St., Suite 300, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support [email protected] 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, send email to [email protected]. Six issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable to contribute.

SINCE 1989. PUBLISHED BY We accept submission of articles covering medical or personal aspects of HIV/AIDS, and reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN, Positively Aware, and its assigns. You may use your actual name or a pseudonym for publication, but please include your name, email address, and phone number with your story. Although Positively Aware takes great care to ensure the accuracy of all the information it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct STUI E 300 or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are 5050 N. Broadway St. 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 Chicago, IL 60640-3016 all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, phone: (773) 989-9400 preferably a personal physician. fax: (773) 989-9494 A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively Aware, email: [email protected] association with TPAN, or contributions to this journal. positivelyaware.com @PosAware

6 MAY+JUNE 2015 POSITIVELY AWARE ERDITO ’S NOTE JEFF BERRY Retneinv n io Hwo do you reinvent yourself?

adonna has done it numerous times over the years. Her Re-Invention World Tour in 2004 was the highest grossing U.S. tour that year. IBM, Apple, and National Geographic have all reinvented themselves by adapting to the changing times, and embracing new technology. Stagnation and resistance to change can spell trouble for businesses and brands that get too comfortable with their own success, if they don’t take the time to reassess and reevaluate what got them there in the first place.

MIt can also often stand in the way of our own personal More baby steps are also being taken in the effort The good development and growth. to eradicate HIV once and for all, or at least put it into news is, there This issue of Poitivl s e y Aware, “Rethinking HIV,” is remission. Treatment Action Group’s Richard Jefferys are those out about how HIV research and treatment is evolving, and gives a fantastic overview of the current data, some of the there who are how radical shifts in our perspective are necessary for us obstacles ahead, and the exciting work that’s ongoing in developing to continue to make progress. Researchers and physicians the field. innovative are building upon the successes of the past while tackling Also in this issue, leading PrEP advocate and educa- and improved new approaches in how we treat HIV, recognizing the pos- tor Damon Jacobs challenges us to take another look at treatment options sibilities and challenges that lie ahead not only for treat- the reasons behind why people may choose not to use that will help ment, but even perhaps a lifelong remission of HIV without condoms. Our report back from the 19th Conference on us live longer, antiretroviral therapy. Retroviruses and Opportunistic Infections (CROI) looks at healthier lives. It’s these kinds of profound new ways of conducting different ways of using PrEP that may be more in line with But it’s up to us research and business that are shaking up the field of “real-world” use; an investigational drug in a new class that as individuals to HIV. It was only a few years ago when we were still seeing will be useful for those with multi-drug resistance; and a continue to work companies bringing to market “me-too” drugs. Today com- newer version of an older drug that could have the poten- on ourselves, panies and researchers have become much more focused tial to alter the landscape of HIV treatment. perhaps on only developing drugs that will provide a distinct advan- So what does all this mean for you and me? The good reinventing tage to patients, or that bring some added benefit on top news is, there are those out there who are developing our own lives. of what’s currently available, because the old model and innovative and improved treatment options that will help way of thinking are no longer feasible. us live longer, healthier lives. But it’s up to us as individu- fffollow Je In her article “Rethinking HIV Treatment,” Melanie als to continue to work on ourselves, perhaps reinvent our @PAEDITOR Thompson talks about some of the transformations in treat- own lives, or change our perspectives and shift our priori- ment that we can expect to see in the next 10–15 years. ties. For me that’s meant another change in my regimen Dr. Thompson looks at not only the kinds of drugs that due to side effects, but I’m undetectable as of yesterday! we’ll see, but also how they are administered and delivered. I’ve also gone back into therapy, and rediscovered yoga Long-acting injectables have garnered quite a bit of inter- (which has been amazing). If we don’t take care of our- est in the last few years, and are gaining momentum as selves, no treatment is going to save us. Sometimes we research moves forward. But we’ll have to make sure we are our own worst enemy. have working systems in place, to ensure these new tech- Whether you’re newly diagnosed or a long-term sur- nologies actually get to those who need them. vivor, positive or negative, a healthcare provider or case- As someone who takes a lot of pills in addition to my worker, we all definitely have one thing in common. We HIV meds (such as vitamins, blood pressure medication, always have a choice. And when it comes to life with or etc.), I’ve often said that an injectable wouldn’t make without HIV, we can choose to stay in our comfort zone, or much difference to someone like me. But as I’ve given it maybe try to think outside the box. Challenge yourself to more thought, I’m not so sure. Just as going from twice look forward, instead of holding back. a day to once a day made a big difference to me in my

T quality of life, once a week or once a month might actually Take care of yourself, and each other. H G

I be quite nice! Of course the shots will have to be given in

KN a provider setting, as they can’t be self-administered. New S I

R delivery systems will need to created to help keep down H

: C costs (such as office co-pays) and support adherence, t which will become even more critical if and when therapy

PhoO is dosed at less than once daily.

PITIVLOS E Y AWARE MAY+JUNE 2015 7 Briefly by ENID VÁzquez

Viekira Pak for hep C According to the FDA, anyone combining DHHS updates these medications should seek immediate HIV treatment guidelines The FDA in December 2014 approved Viekira medical attention if they experience fainting or Pak for the treatment of hepatitis C virus near fainting; dizziness or light-headedness; O n April 8, the Department of Health and (HCV), genotype 1, including patients who malaise (general ill feeling); weakness; exces- Human Services (DHHS) updated its HIV have cirrhosis. Viekira Pak consists of three sive tiredness; shortness of breath; chest treatment guidelines. Atripla is no longer new hep C drugs (ombitasvir, paritaprevir, pains; or confusion or memory problems. on the “recommended” list, but considered and dasabuvir) along with the older medica- “The U.S. Food and Drug Administration an “alternative” drug, based on a high rate tion ritonavir, used to boost blood levels of the (FDA) is warning that serious slowing of of central nervous system (CNS) side effects paritaprevir. The treatment can be taken with the heart rate can occur when the antiar- and a possible association with suicidality. or without ribavirin, but is not recommended rhythmic drug amiodarone [Cordarone] is Reyataz, with a Norvir booster dose plus for those whose liver doesn’t function prop- taken together with either the hepatitis C Truvada, is also no longer recommended but erly (decompensated cirrhosis). In studies, drug Harvoni (ledipasvir/sofosbuvir) or with alternative, based on a higher discontinu- 91% of the participants taking it were cured Sovaldi (sofosbuvir) taken in combination ation rate due to side effects in one large at week 12 (experienced a sustained virologic with another direct-acting antiviral for the study comparing it to two other recom- response, or SVR). The dose is one dasabuvir treatment of hepatitis C infection [such as mended regimens. The Reyataz side effect tablet twice daily plus two tablets once daily Olysio or daclatasvir],” the agency reported was not harmful to health, but cosmetic that contain the three other meds in them. in March. “We are adding information about (yellowing of the eyes and skin). The most common side effects in research serious slowing of the heart rate, known as Three other regimens were downgraded were itching, nausea, trouble sleeping, lack of symptomatic bradycardia, to the Harvoni from “recommended” to “alternative”: energy, and feeling tired or weak. and Sovaldi labels.” Complera; Sustiva plus Epzicom; and The FDA also reported that, “Health care boosted Reyataz plus Epzicom. A caveat T ruvada 2.0 closer to approval professionals should not prescribe either remains—that they be used only in people Harvoni or Sovaldi combined with another with less than 100,000 viral load and more O n April 7, Gilead Sciences applied for a direct-acting antiviral drug with amioda- than 200 T-cells. New Drug Application from the FDA for rone. However, in cases where alternative For patients who cannot take either a new version of its bestselling Truvada. treatment options are unavailable, we abacavir (Ziagen, found in Epzicom) or teno- Instead of using the tenofovir DF (TDF) recommend heart monitoring in an inpa- fovir DF (Viread, found in Truvada, Atripla, found in Truvada, the new fixed-dose pill tient hospital setting for the first 48 hours. Stribild, and Complera), there are now two combines tenofovir alafenamide (TAF) with Subsequently, monitoring in a doctor’s office regimens listed as “other”: Kaletra plus Epivir the other medication in Truvada, emtric- or self-monitoring of the heart rate should be and Prezista boosted by Norvir or Tybost itabine. The new drug will come in two done every day through at least the first 2 (Prezista/Tybost is also available in the fixed- doses: 200 mg of emtricitabine with either weeks of treatment.” dose tablet Prezcobix) plus Isentress. 10 mg TAF or 25 mg TAF. TAF has shown y high efficacy at a smaller dose than TDF, k s and with less bone and renal toxicity. The “ How effective are condoms for gay men?” Read the informative report on a

smaller 10 mg dose is for use with protease recently published CDC study at thebodypro.com. While condoms used consistently dur- Brof h t inhibitors or regimens containing ritonavir ing anal sex can reduce the risk of HIV by 70%, “Notably, the study observed low rates i e K

(Norvir, also found in Kaletra) or cobicistat of consistent condom use. Only 16% of participants reported ‘always’ using condoms / O T

(Tybost, also found in EvoTaz, Prexcobix, and during anal sex with male partners (of any HIV status) throughout the entire study period, O H

Stribild). Read more about TAF on page 30. despite having received sustained behavioral interventions.” Go to thebodypro.com/con- P K C

tent/75349/cdc-analysis-puts-numbers-on-condom-effectiveness-.html?ic=700100. O T S S ovaldi, Harvoni i : :

drug interaction found om d on c

The hepatitis C medication sofosbuvir T appears to have a negative interaction with H the heart medication amiodarone (brand IG KN S S name Cordarone). Some patients developed I R abnormally slow heartbeats and one died H of cardiac arrest. Three patients needed to have a pacemaker inserted. The others z Á recovered after discontinuing medication. V C quez:

8 MAY+JUNE 2015 POSITIVELY AWARE flol ow ENID @ENIDVAZQUEZPA

F ive regimens remain recommended for people taking HIV meds for the first time: U pdate on HCV sexual transmission the protease inhibitor drug Prezista boosted by Norvir plus Truvada and four integrase N ew data on the sexual transmission of the hepatitis C virus (HCV) have emerged inhibitors (INIs)-based regimens—Stribild, since our article on the topic (“Can hepatitis C be sexually transmitted?” in the Triumeq, Isentress/Truvada, and Tivicay/ November+December 2014 issue). In the March 1st issue of the Journal of Infectious Epzicom. Diseases (JID), researchers reported finding HCV in the semen of gay males and There is also new information and clini- other men who have sex with men (MSM) whether they were HIV-positive or -nega- cian guidance on such topics as HIV-2, drug tive, or had acute (recent) or chronic HCV. They reported that this could affect sexual interactions, treatment of people with hepa- transmission of HCV, “but other factors, including high-risk behaviors, may be the titis C virus, persistently low T-cells, and main drivers for HCV transmission in HIV-infected individuals.” In the February 18 initial therapy in various clinical scenarios. online edition of Clinical Infectious Diseases, Kaiser Permanente reported on two PrEP Go to aidsinfo.nih.gov. patients who remained HIV-negative, but had acquired HCV. Neither of the two men reported any injection drug use, tattoos or occupational exposures to blood while tak- Updated kidney disease ing PrEP, but both were diagnosed and treated with multiple rectal STIs and condom- guidelines in HIV less receptive anal sex with partners whose HCV status they did not know. This is a small sample—two out of 485 PrEP patients—but still significant enough to monitor. The 2005 version of “Clinical Practice And at this year’s CROI (see page 28), there was a poster presentation from MOSAIC, Guideline for the Management of Chronic the largest case-control study focusing on transmission of HCV in HIV-positive MSM. Kidney Disease in Patients Infected with Risk factors associated with HCV transmission in HIV-positive MSM included receptive HIV” has been updated. “These guidelines anal sex without a condom, ulcerative STIs, unprotected (no gloves) fisting, and shared recommend ART for all HIV-infected patients sex toys. Additional non-sexual factors include sharing of straws for snorting drugs and with kidney disease—a group that is fre- having a lower CD4 cell count. In contrast to past results, there was no relationship quently undertreated because of uncertain- with the number of sex partners, group sex participation, or rectal bleeding. These are ties regarding appropriate drug selection still worth considering as potential risk factors going forward. Additionally the authors and dosing,” according to Meghan E. Sise, called for further research on the role of CD4 count as a potential driver for HCV infec- MD, MS, and Rajesh T. Gandhi, MD, writ- tion. These results further support the recommendation that sexually active MSM and ing for the NEJM Journal Watch/Infectious those who do not use injection drugs should be routinely screened for HCV as a com- Diseases. The HIV Medicine Association ponent of their sexual health and wellness. —Ad n rew Reynolds, Project Inform (HIVMA) and Infectious Diseases Society of America (IDSA) produce the guidance. a screening visit, you will be screened for pre- at risk of infection, age 18 and up. People HI V-positive people needed cancerous anal lesions. If lesions are found, can be seen whether or not they have insur- for ANCHOR anal cancer study you will be enrolled and randomized to either ance, and the clinic will help patients obtain have the lesions treated or monitored every benefits such as co-pay assistance or free A nal cancer is more prevalent in HIV-positive six months. Both groups will be followed for medicine. Research opportunities are also people whether gay or straight, male or a minimum of five years. You will be compen- available (free medicine and care). Clinic female, with or without having anal sex. Yet sated $100 for the screening visit.” hours are currently being held on the first doctors still don’t know the best way to Screening consists of an anal Pap smear, and third Friday afternoon of the month; screen, prevent, or treat problems that can a swipe with a medical cotton swab. Despite appointments must be made. Call (312) progress to cancer. An important new study the growing risk of anal cancer, the procedure 572-4500. Walk-ins, however, can be seen is set to help change that. is not yet widely practiced in medical care. for screening and preliminary labs Mondays “No one knew that cervical cancer was For more details, go to anchorstudy.org. through Thursdays; ask for a Health preventable before the use of Pap smears There are 12 sites throughout the country, Educator. Adolescents younger than 18 will became widespread in the 1960s and cut including Chicago, at the Anal Dysplasia be referred to a different clinic nearby. Read the incidence of disease by 80%,” said Joel Clinic Midwest, headed by Gary Bucher, MD, more about PrEP on page 28. Palefsky, MD, principal investigator of the a longtime specialist in the disease. ANCHOR study. HI V-related heart attack According to the study’s website, “Anal Chicago PrEP clinic opens risk reversible cancer rates are rising among people living with HIV. The goal of the ANCHOR study is The Core Center (2020 W. Harrison St., in K aiser Permanente has found a decline in to find the best way to prevent anal cancer the Medical District) has opened a PrEP heart attacks in its HIV-positive patients. among HIV-positive men and women. During clinic for the prevention of HIV in anyone “Our findings lend support to the concept

PITIVLOS E Y AWARE MAY+JUNE 2015 9 Briefly

that increased heart attack risk for HIV event “spotlights the present-day intrica- along with other drugs not specifically for patients is largely reversible with continued cies of survival while aging with HIV. It also HIV but frequently used by people living with emphasis on primary prevention in combina- stresses the importance of keeping those the virus, including testosterone. tion with early initiation of anti-retroviral older adults without HIV from acquiring it. therapy to preserve immune function,” “This year’s theme is ‘Every Survivor NASTAD leadership changes said lead study author Daniel B. Klein, Counts,’ because many long-term survivors MD, in a press release. Read the press feel forgotten and invisible,” the release con- Julie Scofield, executive director of release at prnewswire.com/news-releases/ tinued. To learn more, go to LetsKickASS.org the National Alliance of State and Territorial dramatic-decline-in-risk-for-heart-attacks- and NHALTSAD.org. AIDS Directors (NASTAD), has stepped down among-hiv-positive-members-of-kaiser- after 22 years. In a blog Scofield noted that, permanente-in-california-300021887.html. I llinois ADAP drugs list “The decision to step down feels right for the sees significant expansion organization at this time and for me. ...The A nnual long-term survivors day good news is that I am passing the baton The Illinois ADAP (AIDS Drugs Assistance to an extraordinary leader who is eager to The second annual National HIV/AIDS Long- Program) list of drugs issued on February lead the organization into the future and the Term Survivors Awareness Day (NHALTSAD) 3rd shows an astounding growth in coverage. challenges we all know are ahead.” Deputy is Friday, June 5th. The organization Let’s The formulary not only includes a new HIV executive director Murray Penner, an expert Kick ASS (AIDS Survival Syndrome) created medication approved by the FDA in January, in the treatment of both HIV and hepatitis the awareness day last year to recognize Prezcobix, but for the first time also includes C who joined NASTAD in 2001, stepped up and honor those living longest with HIV. psychotropic medications, such as the anti- into the executive director’s job in April. According to a press release, this year’s depressants Cymbalta, Paxil, and Wellbutrin,

CUT HERE Carol Potok with some of theG womenET at theAN TutweilerD PrisonGIV for EWomen, P OduringS ITIVan educationalEL event.Y AWARE. ❑ 1-year subscription: $30 donation ❑ Order bulk copies I wish to donate: Six bi-monthly issues. Subscriptions are mailed U .S. only; no overseas bulk orders. Available ❑ $25 ❑ $50 ❑ $100 free of charge within the U.S. to those who are free of charge; however, we ask for a donation ❑ $250 ❑ $500 ❑ $______HIV-positive. to cover shipping. Minimum order 10 copies; shipped via UPS. (No P.O. Box addresses): Y our contribution helps ❑ Sign me up for PA Weekly ______copies provide subscriptions to people who can’t afford Poitivl s e y Aware’s free email news digest: them. Donations are tax-deductible. ❑ Order back issues: $3 per copy ______enclosed is my payment. Select issues below: emaIL ADDRESS

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started me on Combivir and Sustiva. REDR A E S POLL Since I started on medications, I’ve LE T’s In r the Ma ch+April issue we asked remained undetectable and my CD4 CONNECT D oes news of HIV medical developments count has remained within normal make you feel more fearful or more hopeful? ranges. With protease, integrase, All com- and entry inhibitors still available munications (letters, to me for future use, my answer to email, online the March+April poll question is I posts, etc.) definitely feel more hopeful! The only are treated as issue about HIV/AIDS that still sad- letters to the editor unless M ore hopeful dens me is the secrecy of HIV status otherwise 89% disclosure. instructed. —Shawn A. Simmons We reserve M ore fearful originally from Kansas City, MO the right to edit for 11% length, style, Hpe C in prison or clarity. Let us know if Ths i issue’s question A s a subscriber to Poitivl s e y Aware, you prefer we H ow often do you use condoms? and an individual who is co-infected not use your name and VOTE AT positivelyaware.com. with HIV and hepatitis C, I read city. with great interest Andrew Reynolds’ article (HIV/HCV Co-Infection W rite to: Lng o -tERM survival virus. I go to support groups and face News from the 2014 Liver Meeting, Posi y tivel my fears, I forgive and stop asking January+February 2015). I am a Aware, 5050 N. I just finished reading the why. Today I am 47 years old. My last 49-year-old male who is confined in Broadway St., January+February issue. Thank you CD4 count was 1,034 and viral load an Illinois Department of Corrections Suite 300, [Jeff Berry] for educating me. Thank was undetectable. I am a survivor, a facility. I was diagnosed with HIV in Chicago, IL you for reducing stigma. Thank you strong, healthy person living with HIV. 1992, came into the system in 1995, 60640-3016 EAM IL: for saying uncomfortable things and The why was to tell my story. and diagnosed with HCV 15 years ago. inbox@tpan. asking uncomfortable questions. —Le a Fiorini The treatment I have been receiving com. Thank you for your advocacy. Delray Beach, FL for HIV has been quite adequate; I Tweet: — Kristin Freeman, have an undetectable viral load and @PosAware. health educator Dugr guide Interaction between 700 and 900 T-cells. This Planned Parenthood has been my average for several years Dayton, OH I just got through reading the and I have no complaints with the March+April issue. Your drug guide is treatment. In 2009, I was treated I am also a longtime survivor and I always improving. Kudos! for the hep C with interferon. I was am still kicking ass (January+February —duaE rdo Perez advised that this drug has a 30% 2015, Let’s Kick ASS). I tested posi- via the Internet chance of success, but after 40 tive in 1990 when I was 22. Three weeks it was determined that it had weeks after donating blood, the Palm I’m 45 years old and I was diag- failed. Since then, a new class of Beach County Blood Bank called nosed in January of 1994. I was drugs have been released (Sovaldi and me to come and see them. Driving prescribed AZT because it was the Harvoni), and they apparently have up there my thoughts were: Why do only medication available. After taking a 90% success rate. I discussed the these people want to see me? What is it for two or three months, I tossed possibility of being prescribed either wrong with my blood? My first stage the bottle of AZT into the of these medications and was shock. I could not believe I was trash and was informed that I was being handed a death sentence (back refused to a good candidate, but then). I was so young. I did not know go back to that due to their expense, what to say to my family and friends. my doctor. it was unlikely that I I began a suicide mission. My second In 2003 I would be approved for stage was denial. I went to many came down either. I find it difficult to places to get tested again, just hoping with pneu- understand how I can be one test would come back negative. monia and denied the opportunity That never happened. I became angry. my T-cells to possibly secure a It took me a long time, many years, to dropped to cure for my hepatitis C, come to acceptance. I’m able to tell 168 and I simply because I am people, to talk about HIV, to not feel was officially incarcerated. ashamed anymore, and to take in as diagnosed with —amn e withheld much knowledge as I could about this AIDS. A doctor Galesburg, IL

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POSITIVELY AWARE REI TH NK NG HIV NE W APPROACHES TO Treatment THe biggest changes in 20 years are COMING By Melanie Thompson, MD

head dec e of the 2020s will see the biggest by guidelines from the Department of Health change in HIV treatment paradigms since the birth and Human Services (DHHS). Others have of HAART two decades ago. Newer regimens will simply stepped aside as alternatives to more potent, forgiving, and tolerable therapies. As emphasize tolerability and adherence, without sacri- cross-resistance rapidly eliminates entire ficing potency, and long-acting injectables will debut. classes and limits treatment options, we still Yet while we contemplate the exciting new drugs find ourselves at the end of the line all too that may emerge, there must be equal emphasis quickly. Today’s pipeline however is robust, on how we deliver care. Even the most stunning and licensure for its drugs will take us well advances in treatment will disappoint if we do not into the Roaring ’20s. A n entire group of drugs likely to win solve the harder challenges around care linkage, FDA approval* over the next two to three continuous care engagement, and uninterrupted years is the tenofovir alafenamide (TAF) access to ART for both prevention and therapy. family of fixed-dose compounds:

A ntIRETROVIRAL therapy a few extended release formulations. Yet our n elvitegravir/cobicistat/FTC/TAF (expected armamentarium is less robust than the num- November 2015), TSince March 1987, FDA has approved over bers suggest, as three are no longer mar- n C/TFT AF (expected 2016), 40 drugs for the treatment of HIV, including keted, and 11 are no longer recommended n rilpivirine/FTC/TAF (expected 2017), and n darunavir/cobicistat/FTC/TAF (2016–17). * po ap r val dates are based on educated guesses about when studies are projected to end, or on assumptions that could change. These will cannibalize Stribild, Truvada,

PITIVLOS E Y AWARE MAY+JUNE 2015 17 REI TH NK NG HIV

Complera, and Atripla, and provide the first Lng o -aCTING meds patients, as twice-daily dosing complicates single-tablet regimen (STR) containing a use in initial therapy. Meanwhile, BMS- boosted protease inhibitor (PI). The tenofovir The promise of long-acting nanoformulation 955176, a maturation inhibitor (MI), disrupts prodrug TAF concentrates in cells rather than injectables for both treatment and preven- a late stage in viral replication and is enter- plasma, causing less renal and bone toxicity tion is the most riveting story to emerge in ing Phase 2 for both treatment-naïve and compared to tenofovir DF (TDF; Viread), and decades. Dolutegravir’s longer acting cousin, experienced patients. If successful, FDA may have an advantage in potency and resis- cabotegravir (GSK12657744, or 744, CAB), approval for the AI could come in late 2017– tance. The decrease in total and LDL choles- and long-acting rilpivirine are being studied early 2018, and for the MI in 2020–21. terol associated with TDF (Randell, 2010), together as monthly maintenance injec- Other AIs and MIs will surely emerge in the however, appears to be lost with TAF. tions for treatment (and cabotegravir as a late teens and early ’20s and could provide Following TAF, NRTIs will be expected to quarterly injection for PrEP). Meanwhile, an options for treatment of multidrug-resistant have high potency, exceptionally low toxic- oral dolutegravir/rilpivirine co-formulation is virus as well as displace the NRTI class as ity, daily or less frequent dosing potential, planned for use as two-drug maintenance first-line therapy. and high resistance barriers in order to play. (as a switch for those who have achieved Gene therapies, including the Sangamo Only time will tell whether EFdA, one of the viral suppression on an initial three-drug zinc-finger nuclease approach, continue to few current NRTI candidates, will live up regimen and have no history of viral resis- make slow progress (Wang, 2015). While to its promise of potency and resistance tance), based on LATTE results (Margolis, therapeutic vaccines have missed the sweet advantage in the hands of Merck. If so, FDA 2015). Oral cabotegravir will be developed spot to date, newer vector-based gene approval might occur in the mid-20s. as well, but used only as part of an initial immunotherapy raises hope of spanning the The current NNRTI pipeline is thin, but regimen in persons who are transitioning to treatment and prevention realms (Gardner, Merck’s doravirine (MK-1439) is in Phase 3, maintenance with injectable CAB/RPV. 2010). having exhibited potency and low central ner- If the nanos are safe and effective for Finally, chronic inflammation contributes vous system (CNS) toxicity (Gatell, 2014) and maintenance, FDA approval could come by to excess non-AIDS morbidity and mortality could reach pharmacy shelves in 2017–18. the turn of the decade. But success is not in spite of viral suppression. Two potential On a similar course is fixed-dose doravirine/ a slam-dunk. There are potential pitfalls to approaches to controlling inflammation are in TDF/3TC, a compound that could potentially long-acting injectables such as the risk of clinical trials, and this line of research is sure take advantage of generic 3TC (available incremental toxicity that cannot be halted by to expand in the next decade. Cenicriviroc now) and generic TDF (expected 2018). stopping drug, and resistance due to a long blocks CCR2 and affects surrogate markers Protease inhibitor development has “pharmacologic tail” that could expose the of inflammation, in addition to its CCR5- slowed as companies have focused instead virus to lengthy intervals of suboptimal dos- mediated antiviral effect. It is now under on incorporating cobicistat into FDCs, or ing if repeated injections are not delivered on study for fatty liver (non-alcoholic hepatic fixed-dose combinations (EvoTaz, Prezcobix). time. Barriers to safety monitoring and drug steatosis; NASH). The NIH REPRIEVE trial TaiMed, though, is chasing the holy grail delivery must be identified and addressed, will look at the impact of pitavastatin on car- of a potent unboosted PI with TMB-607 including exploration of new distribution sys- diac outcomes over five years, with results in (formerly from Ambrilla). This nanoformula- tems such as designated pharmacy partners the ’20s (reprievetrial.org). tion is active in the lab against PI resistance and home health options. Clearly, the 744/ mutations and aims for monthly or quarterly rilpivirine adventure is being closely watched W hAT about generics? dosing. This is the kind of innovation that by biopharmas itching to embrace nano- will be required of future PIs. We may technology and explore the acceptability of Generic ARVs have had little impact on indeed see the boosted PIs find a new niche non-oral therapies. overall treatment cost, as most drugs have as tertiary therapy in the ’20s. Fusion inhibitors could get new life if been rendered obsolete prior to becoming Integrase inhibitors (INIs) have stolen albuvirtide, a better-looking cousin of enfu- generic. This is due to the rapid pace of HIV the spotlight lately, largely due to the high virtide (T-20), can capitalize on its 11-day drug development combined with a 20-year potency and tolerability and favorable resis- half-life, potentially allowing weekly dosing patent life plus additional years of market- tance profile of dolutegravir, the first INI for by injection. PRO-140, a monoclonal CCR5 ing protections (called “exclusivity”). Of the daily dosing without a booster. Reformulated antagonist (administered weekly or biweekly), seven generic ARVs, only lamivudine (3TC) once-daily raltegravir is in trials and, if suc- and the monthly anti-CD4 monoclonal and abacavir are still recommended for use cessful, headed toward possible approval antibody TMB-360 (second generation ibali- by DHHS and IAS-USA guidelines. Eclipsed in 2016. Of newer INIs in development, zumab) are moving (slowly) in clinical trials. by INIs, efavirenz and atazanavir are no lon- the most advanced is once-daily GS-9883, The anti-HIV neutralizing antibody 3BNC117 ger recommended as first-line therapy, but which also doesn’t require boosting. Now in showed promise in an early human trial. This they are due to become generic in 2017–18. Phase 2, successful trials could lead toward new direction toward injectables could make By the time TDF becomes generic in 2018, FDA approval by the end of the decade. the ’20s very interesting indeed. it will be seen as the ugly stepmother of TAF, Earlier in development are the LEDGINs Bristol-Myers Squibb (BMS) is attacking although it is likely to be incorporated into whose mechanism of action differs from the two new targets that could also change the multiple generic formulations and continued currently licensed strand transfer inhibitors, treatment paradigm. An attachment inhibitor to be used in prevention until TAF is further opening the possibility of combination INI (AI), fostemsavir (BMS-663068), is in Phase studied for use in PrEP. strategies in the mid ’20s. 3, but only for highly treatment-experienced It is through the coupling of generics in

18 MAY+JUNE 2015 POSITIVELY AWARE S ome of our biggest challenges in the late teens and 2020s will be those of implementing strategies to help patients stay consistently engaged in care, with continuous access to therapy.

steer patients toward outdated generics and access to these so-called “wrap-around” ser- A rose by any other name limit access to the best new drugs. There is vices, assistance with care engagement, and Below are some of the drug abbreviations likely to be increased attention to cost impli- support for high out-of-pocket costs. Yet clin- and acronyms used in this article. Names cations as incremental benefits influence the ics in non-expansion states now are strain- for the FDA-approved drugs are listed in ranking of preferred therapies by guidelines. ing to care for newly diagnosed uninsured alphabetical order by the generic name. Some fear that inequality in standards of patients. Over time, without substantially abacavir (ABC) Ziagen; also found in care could emerge as a trade-off for treating increased funding, waiting lists will emerge Epzicom and Triumeq larger volumes of patients, mirroring the use both for clinical care and drug access atazanavir (ATV) Reyataz; also found in EvoTaz of obsolete drugs in low-resource countries through the AIDS Drug Assistance Program cobicistat (COBI) Tybost; also found for the sake of cost. We will need to sys- (ADAP). Medicaid expansion and preserva- in EvoTaz, Prezcobix, tematically evaluate treatment outcomes to tion (perhaps re-invention) of Ryan White and Stribild assure that cost pressure does not compro- must be priorities in the coming decade. darunavir (DRV) Prezista, also found mise health. Other priorities entail exploring novel in Prezcobix dolutegravir (DTG) Tivicay; also found options for care delivery, including telemedi- in Triumeq Improving the Care Continuum cine visits, use of non-traditional venues efavirenz (EFV) Sustiva; also found for delivery of injectables and PrEP, and in Atripla Inventing drugs is just the beginning. It is judicious use of non-clinicians (especially elvitegravir (EVG) Vitekta, also found in Stribild equally, if not more, challenging to reinvent pharmacists) to supplement the waning clini- emtricitabine (FTC) Emtriva our healthcare system to increase care cal workforce. enfuvirtide (T-20) Fuzeon access, provide better support for care Finally, we must push for structural lamivudine (3TC) Epivir, also found linkage and retention, and improve services changes to better integrate prevention and in Combivir, Epzicom, for mental health, substance use, housing care, as biomedical prevention through both and Triumeq lopinavir (LPV) Kaletra (lopinavir/ assistance, incarceration transition, and treatment and PrEP stretches the boundar- ritonavir) other essential needs. The care continuum ies of traditional systems. Federal funding raltegravir (RAL) Isentress consistently shows our failings in care reten- streams across agencies (HRSA, CDC, rilpivirine (RPV) Edurant; also found tion and viral suppression. SAMHSA) must be aggressively reevaluated in Complera ritonavir (r) Norvir (booster dose); Some of our biggest challenges in the and harmonized. And while each of the Bad also found in Kaletra late teens and ’20s will be those of imple- Bugs (HIV, STIs, viral hepatitis, and TB) DRUG CLASSES menting strategies to help patients stay con- brings its own science and epidemiology to sistently engaged in care, with continuous the table, and deserves to have separate NRTI nucleoside/nucleotide reverse transcriptase access to therapy. One structural interven- attention and strategies, successful transla- inhibitor tion, the Health Information Exchange (HIE), tion of science amid increasing economic NNRTI non-nucleoside has proven effective in identifying persons constraints require us to eliminate artificial reverse transcriptase who are out of HIV care as they seek non- silos of funding that create duplicative infra- inhibitor PI protease inhibitor HIV medical services at clinics and hospitals, structures and waste. Program Coordination INI integrase inhibitor and achieving high rates of reengagement and Service Integration (PCSI) has been a in care (Herwehe, 2012). Building HIEs for CDC buzzword for a decade, yet not enough HIV and other medical purposes should be a has been done at the federal level to make it FDCs with branded drugs that a cost-benefit national priority over the next decade. a reality in the field. could first be realized. Lopinavir/ritonavir/ The Affordable Care Act has the potential The 2020s may be an exuberant time for lamivudine is approved in Europe and twice- to greatly improve the care of people with treatment paradigms, and a roller-coaster daily raltegravir/lamivudine could be an HIV, but early implementation has been time for treatment provision. Ever mindful incremental advance. ViiV Healthcare has hampered by lack of Medicaid expansion, of the progress we have made, we will be the opportunity to pair generic abacavir/lami- especially in states with the highest HIV further challenged to extend those successes vudine with dolutegravir to bring down the rates. Among the insured, drug affordability to the largest number of people possible. high price of Triumeq. One study projects is compromised by plans that place HIV Time to get to work—the Roaring ’20s are first-year cost savings nearing a billion dol- meds on unaffordable tiers in apparent on the way! lars using a partially generic efavirenz-based violation of anti-discrimination provisions of regimen (Walensky, 2013). the ACA. High cost sharing puts patients at Concerns about the potential adherence risk for inconsistent drug access and viral D r. Melanie Thompson is Principal consequences of decoupling FDCs deserve resistance. Additionally, traditional insurance Investigator of the AIDS Research study to ensure that outcomes are preserved plans generally do not offer adequate cover- Consortium of Atlanta (ARCA) where she has while money is saved. The fear that insur- age for mental health and substance use conducted over 400 studies of HIV, STDs, ance companies could mandate use of obso- services, transportation, or case manage- and viral hepatitis. She is a member of the lete generics has not yet materialized, but ment to assist with housing and other critical DHHS Panel on Antiretroviral Guidelines for this must be closely watched into the next social needs of people with HIV. Adults and Adolescents and provided the decade as prior authorizations and drug tier- Ryan White programs have been called doctor’s comments for the Poitivl s e y Aware ing with high cost sharing are other ways to upon to supplement the ACA in providing 2015 HIV Drug Guide.

PITIVLOS E Y AWARE MAY+JUNE 2015 19 REI TH NK NG HIV CAI H S NG THE CURE The state of the search in 2015 By Richard Jefferys

ver the past decade, the pursuit of a cure for HIV infection has gained significant momentum. At one time, the word cure was used rarely and cautiously, for fear of raising Ofalse hopes. The immediate focus after the discovery of HIV in 1983 was on treatments capable of suppressing the virus, which arrived in the form of combination antiretroviral therapy (ART) in the mid-1990s, transforming a fatal viral infection into one that now, for many people, is likely to have little or no impact on life expectancy.

But ART is imperfect, with potential toxicities and regular dosing that can negatively impact quality of life. Scientific advances and the availability of new technolo- gies have conspired to create optimism that another step forward is possible. A major research effort, not just in the U.S. but internationally, is now working toward that goal. To anyone who reads the news, the high profile of cure research has been evident in relatively frequent headlines—not always accurate, unfortunately—about various aspects of the science and newly presented or published studies. A great deal of attention has focused on the inspiring case of Timothy Ray Brown, who has lacked any sign of active HIV for eight years now and is the first individual considered cured of the infection. Amidst all the media coverage, it can be difficult to ascertain exactly where the research stands and whether or not a broadly effective cure is on the horizon. This article will attempt to offer a brief guide to the state of the field in the spring of 2015, and some of the challenges that lie ahead.

The lone cured man EL X PI

The circumstances that led to a cure in Timothy Brown D L

have been extensively documented. Brown had been WI / K

living with HIV for many years when the occurrence of a C O T

life-threatening cancer—acute myelogenous leukeumia S NK (AML)—necessitated not one but two stem cell trans- I plants as part of a complex series of treatments. The H o purpose of the stem cell transplant procedure is to create t Pho T :

20 MAY+JUNE 2015 POSITIVELY AWARE a new immune system in the recipient, gen- methods for depleting the body of the HIV The infant remained off ART for 27 erated by stem cells received from a geneti- that persists despite ART, so that there’ll months and there were hopes that she was cally matched donor. be less virus for the immune system to deal cured, but then in mid-2014 HIV viral load Brown’s cancer doctor, Gero Hütter, suc- with when ART is withdrawn. Or, even bet- became detectable again and ART was cessfully searched for a donor homozygous ter, no intact HIV left at all. restarted. for the CCR5-Delta32 mutation, which To delve into the depletion approaches The two other cases are known as the causes immune cells to lack the CCR5 co- first, the population of HIV-infected cells that “Boston patients”: these are two HIV-positive receptor that most HIV variants use to infect persists on ART is called the “HIV reservoir.” men who underwent stem cell transplants cells. When Brown ultimately interrupted The vast majority are long-lived “resting to treat cancers. Unlike Timothy Brown, ART after receiving the transplants, his viral memory” CD4 T-cells that contain HIV they received stem cells from normal donors load did not rebound. DNA that has integrated into the genome lacking the CCR5-Delta32 mutation. But With extraordinary altruism, Brown has of the cell but not completed the remainder they remained on ART throughout the proce- volunteered samples from just about every of the viral life cycle. HIV in this form is dure and it was thought this might prevent possible tissue and while a few times a trace described as latent, because virus produc- HIV from infecting the newly transplanted amount of HIV genetic material has been tion can begin at a later time—even many, immune system cells. detected, no sign of virus capable of replicat- many years later—if the latently infected After the procedures, an HIV reservoir ing has emerged. He remains off ART today. CD4 T-cell receives signals that cause it to was not detectable and both ultimately Brown’s experience suggests that it is become activated. underwent an ART interruption. The virus not impossible to cure HIV. But it can’t be The job of memory CD4 T-cells is to coor- remained undetectable for three and eight applied to most HIV-positive people, because dinate the immune response to a particular months, respectively, but then viral load stem cell transplantation is extremely risky, pathogen that your body has encountered returned and ART was restarted. and can lead to death in around one fifth of sometime in the past (for example, if you Although the lack of a cure in these cases. Part of the risk is attributable to the were vaccinated against measles as a child, individuals was disappointing, their experi- cell-killing drugs that are typically given to you will still have some memory CD4 T-cells ence is in line with mathematical modeling wipe out the existing immune system and specific for the measles virus antigens con- indicating that significant reductions in the make room for the transplanted cells. There tained in the vaccine), so they are designed HIV reservoir can equate to extended periods is also a potentially fatal complication called to be able to survive in a resting state and of “remission” from viral replication. These graft-versus-host disease (GVHD), in which only become active if they see the antigen models predict that diminishing the reservoir donated cells are recognized as foreign and that triggered their development. even further could lead to a lifelong absence attacked by the recipient’s body. Importantly, most latently infected CD4 of viral load rebound in a majority of HIV- Researchers are investigating whether T-cells do not show any outward signs of positive people. it might be possible to repeat the HIV cure containing HIV because no viral proteins are But the magnitude of the task is daunt- achieved in Brown in other HIV-positive being made, and this prevents the immune ing: it’s estimated the amount of latent HIV individuals who require stem cell transplants system from recognizing and targeting declined around 3 logs (1,000-fold) in the to treat life-threatening cancers, but to date them for elimination. Estimates suggest Boston patients, but that reductions of 5–6 there have been no reported successes. that the average number of latently infected logs (100,000–1 million-fold) would be Gero Hütter recently wrote a letter to the memory CD4 T-cells in an individual on ART needed for lifelong remission. New England Journal of Medicine review- is around a million, although recently it has Nevertheless, the correlation between ing the results of all six known cases where been reported that this could be an underes- smaller reservoir size and longer time off HIV-positive individuals received stem cell timate and that the true number could be as ART provides a starting point for one route transplants from donors homozygous for much as 60-fold higher. toward a cure. CCR5-Delta32, and sadly the news was not good: all have died either due to the Nt o so faST E TarLY AR underlying cancer or complications from the procedure. One of the individuals displayed A large amount of evidence points to the The Mississippi baby case highlights the a rebound of viral load due to the presence potential benefits of limiting or reducing the potential for starting ART soon after infec- of an HIV variant capable of using an alter- size of the HIV reservoir. The most widely tion to greatly limit the size of the reservoir, native receptor to CCR5 (named CXCR4), publicized involves three individuals who, and a trial testing whether similar—or lon- indicating that even if the cancer had been for a brief and tantalizing period, were ger—periods of remission can be obtained cured, HIV would not have been. thought to have possibly joined Timothy in other perinatally infected newborns began Brown as examples of HIV cures. One is the recently. The closest adult equivalent is M oRE practical approaches “Mississippi baby,” who acquired HIV infec- individuals identified very soon after HIV tion from her mother and was started on acquisition, and rapid initiation of ART in this A number of alternative approaches are aggressive ART extremely early after being setting is also associated with very small or being developed and tested, including gene born. An interruption in ART occurred at even undetectable HIV reservoirs. A number therapies and a therapeutic vaccine or around 18 months of age and very unusually, of studies are investigating whether early vaccine-like strategies. viral load did not rebound; furthermore no ART, with or without additional interven- Scientists are also attempting to find HIV reservoir was detectable. tions, can lead to remission in adults. Some

PITIVLOS E Y AWARE MAY+JUNE 2015 21 REI TH NK NG HIV

P rogress is certainly being made, encouragement comes from an unusual but most scientists suspect it will likely be decades before a group of 20 early-treated individuals in widely applicable curative intervention might come to light. France—known as the VISCONTI cohort—in whom a degree of remission may have occurred; they have maintained extremely low or undetectable viral loads for an aver- Cpingo strategies A n innovative alternative to vaccination age of over nine years after an ART inter- made headlines recently and is worthy of ruption, in the presence of very modest but Uncertainty about the degree to which the mention: it comprises a highly potent inhibi- detectable HIV reservoirs. HIV reservoir can be drained is not so much tor of HIV named eCD4-Ig delivered using of an issue for approaches that aim to pre- an adeno-associated virus (AAV) vector. The L aTENCY reversal pare the body to be able to deal with what- AAV takes up residence in muscle tissue and ever virus is present when ART is interrupted. acts as a factory for churning out eCD4-Ig, E fforts to deplete the HIV reservoir cur- Gene therapies that modify vulnerable cells which could theoretically equip a person with rently center on compounds referred to as are at the forefront of this aspect of cure a means of lifelong HIV suppression. The latency-reversing agents (LRAs). As the name research, and several are in clinical trials. idea has shown promise as a preventive in implies, they aim to awaken latent HIV, thus It is early days however, and only hints of macaques exposed to SIV, and therapeutic either flagging the infected CD4 T-cell for progress have been seen. studies in this animal model are now planned. elimination by the immune system or provok- The most extensively studied is ing its destruction by HIV’s cell-killing effects. Sangamo’s SB728-T, which involves extract- C oLLABORATION A class of anticancer agents called HDAC ing CD4 T-cells from HIV-positive individuals, inhibitors have emerged as lead LRA candi- genetically modifying them so they no longer There is so much activity in the cure dates, and three—vorinostat, panobinostat, express the CCR5 receptor, and then reinfus- research realm that this brief review has only and romidepsin—have demonstrated the ing them in large numbers. In clinical trials, skimmed the surface, focusing on ideas that capacity to cause HIV production by latently a few isolated examples of prolonged control are in human trials or may soon get there. infected CD4 T-cells in clinical trials. of viral load after an ART interruption have Progress is certainly being made, but most At least six different LRAs are now been reported, suggesting modified CD4 scientists suspect it will likely be decades in human testing, from multiple different T-cells may be able to coordinate a more before a widely applicable curative interven- classes (HDAC inhibitors, PKC agonists, and effective immune response against HIV. tion might come to light. toll-like receptor agonists); this represents The challenge is to attain more robust viral Solving the many challenges on the hori- significant progress given that it was only a load control in greater numbers of people, zon will require collaboration, and encour- few years ago that the first trial of an LRA and ways of modifying greater numbers of agingly many collaborative endeavors are got underway. CD4 T-cells are being tested. A new trial that underway or being formed. These include the The not so good news is that no decline will use the technique on stem cells—which International AIDS Society’s Towards an HIV in the HIV reservoir has yet been observed could potentially give rise to HIV-resistant Cure initiative which is currently updating its with any of these agents, meaning additional CD4 T-cells in the body—has recently been global strategy recommendations; amfAR’s interventions are likely needed to prompt given the green light by the FDA. Research Consortium for HIV Eradication the killing of infected CD4 T-cells after viral A company called Calimmune is also test- (ARCHE); the National Institutes of Health’s latency is reversed. But the first tentative ing a gene therapy that seeks to generate HIV- Martin Delaney Collaboratories (named after steps in this direction are occurring: a trial resistant CD4 T-cells by altering and infusing the activist and founder of Project Inform) combining romidepsin with a therapeutic HIV stem cells (results from this trial are pending). which are soon to be expanded; the Forum vaccine in people on ART is ongoing. Over the past two decades, an array of for Collaborative HIV Research’s cure project Several other therapeutic HIV vaccine different therapeutic HIV vaccines have been focused on the pathways toward regulatory candidates are also being evaluated with a tested with the goal of promoting control of approval; and a growing number of consortia view to being paired with LRAs; the hope is viral load when ART is stopped. But per- globally such as CHERUB (Collaborative HIV that vaccination will boost or create immune haps because CD4 T-cells—HIV’s primary Eradication of viral Reservoirs: UK BRC) in responses capable of delivering the coup de target—play such a crucial role in sustaining the United Kingdom. grace to latently-infected cells after the LRA vaccine-induced immune responses, signifi- Advocacy continues to be key in support- has done its work. cant success has proven elusive. ing and guiding this work, so that one day Infusions of neutralizing antibodies are Hence the recent shift in focus to com- HIV can be conquered once and for all. being eyed as another means to achieving bining therapeutic vaccines with LRAs to this end, as the antibodies can potentially reduce the viral reservoir in people on ART, bind to infected cells and mark them for which may be a more modest task than L ongtime activist R ichard Jefferys is destruction via a mechanism called antibody- controlling viral replication after ART with- the Michael Palm Basic Science, Vaccines mediated cellular cytotoxity (ADCC). An drawal. There is a seemingly uniquely potent & Cure Project Director for the Treatment antibody/LRA combination is being tested in therapeutic vaccine candidate derived from Action Group (TAG), in New York City. Go macaques infected with SIV (simian immuno- a cytomegalovirus (CMV) vector that has to treatmentactiongroup.org for additional deficiency virus, a virus similar to HIV that is shown success in macaques, but it has yet cure research resources, including a listing found in certain monkeys). to be tested in humans. of research studies.

22 MAY+JUNE 2015 POSITIVELY AWARE Through decades of research, struc- A New tural biologists have figured out the three- dimensional shapes of nearly all of the viral Look at proteins, as well as many of the proteins in our cells that interact with HIV. Through HOW HIV biochemical and cell biological studies, we’re gaining an increasingly clear picture of how the virus enters cells and co-opts the WORKS cellular machinery while evading detection by the immune system. I take this data and A Biologist work with researchers to create a movie turned that depicts what they think is happening animator inside of cells. One of the things that makes it ‘unprecedented’ is that I’m creating anima- offers new tions of events that are too small to be seen insight by the naked eye. The animation is really I nterview BY RICK GUASCO a hypothesis—a video of what researchers think the virus is doing, based upon multiple sources of experimental evidence.

What goes into creating your animations? anet Iwasa, PhD, is a cellular biologist who has become a computer animator. She believes animation can not only help people visualize The animations are created in close col- how HIV works, but allow researchers to try out their theories and laboration with HIV researchers, and are a come up with new ideas about how to treat the virus. direct reflection of their ideas. The length of J time for different segments varies quite a bit, “ Animations aren’t just useful for com- decided to learn 3D animation so that I but generally, it can take weeks to months municating an idea, they’re also really useful could learn to create these visualizations. to finish even a short segment. A lot of this for exploring a hypothesis,” said Iwasa in The software I use is from the entertainment time is spent building a model, sharing it her March 2014 presentation at a TED Talk industry; it’s the same software used in mak- with the research collaborators, discussing lecture series. “Biologists, for the most part, ing animated movies and Hollywood-style it, and making changes to better reflect their are still using paper and pencil to visualize visual effects. ideas and experimental results. The Science the processes they study.” Although my path has diverged a bit from of HIV project is funded by a grant from the Iwasa attended the University of the typical research scientist, I still consider National Institutes of Health. California-San Francisco, where her mentor myself to be a biologist first, with a very encouraged her to pursue her interest in deep interest in scientific communication, Your animations are cutting edge biology, animation. She created videos on the chemi- education, and visualization. but the narration is so conversational. Who cal origins of life for her postdoctoral work are your videos for? at Massachusetts General Hospital and the Is HIV your main area of scientific interest? Museum of Science in Boston. What made you focus on HIV? ScienceofHIV.org is targeted at the public. While she’s passionate about how anima- One of the things that I think that animations tion can change our understanding, Iwasa is I currently spend about half of my time are great at is being able to convey ideas especially focused on the fight against HIV. working on visualizations with HIV research- without getting bogged down in jargon and She recently took a moment from a trip to ers. One of the reasons I focused on this terminology. This is especially important Toronto to discuss her work. topic was that I felt that there is decades of when trying to communicate molecular-level research about how HIV works, but much biology, which can be really intimidating to R ick Guasco: You’re a cellular biologist; of it would be difficult for non-scientists to most people. how did you get into animation? understand. From these studies, however, The process of creating an animation can we know in great detail how HIV is able help researchers, too. Most molecular biolo- Janet IWASA: I was trained as a cell biolo- to infect our bodies at a molecular scale. gists, including HIV researchers, are trying to gist, and got into animation during graduate Using animation, I hope to make this body understand processes that involve numerous school. I was studying the process by which of research more accessible to the general molecules moving over time and space, but a s cells (such as some immune cells) can move, public. I want people to see how the virus lack the ability to visualize these processes. a w and was interested in trying to create visual- works, and how drugs are able to stop the Animation software allows us to do that, and I t izations of what we thought was happening virus at various stages of its life cycle. And that can help researchers wrap their heads on a molecular scale. These are events that I hope that these 3D animations will give around problems, and give them ideas of

of Jane are too small to be seen even using the best researchers a better visual model of the virus where to go next. y s e light microscopes, so we can’t directly see to help push their research forward. t what’s happening. But from different sources o tco wat h Janet Iwasa’s Ted Talk c of data, we know quite a bit about what they What advances have come about that have

o and her HIV animations, go to t might look like. These molecular processes allowed you to create what one NIH blog positivelyaware.com.

Pho are dynamicur and three-dimensional, so I called ‘unprecedented views of HIV’?

PITIVLOS E Y AWARE MAY+JUNE 2015 23 What is STRIBILD? • Worsening of hepatitis B (HBV) What should I tell my healthcare STRIBILD is a prescription medicine used as infection. If you also have HBV and stop provider before taking STRIBILD? a complete single-tablet regimen to treat HIV-1 in STRIBILD is a prescription medicine taking STRIBILD, your hepatitis may used to treat HIV-1 in adults who have suddenly get worse. Do not stop taking • All your health problems. Be sure to adults who have never taken HIV-1 medicines never taken HIV-1 medicines before. STRIBILD without fi rst talking to your tell your healthcare provider if you have before. STRIBILD does not cure HIV-1 or AIDS. STRIBILD combines 4 medicines into healthcare provider, as they will need to or had any kidney, bone, or liver problems, 1 pill to be taken once a day with food. monitor your health. STRIBILD is not including hepatitis virus infection. STRIBILD is a complete single-tablet approved for the treatment of HBV. • All the medicines you take, including regimen and should not be used with prescription and nonprescription other HIV-1 medicines. Who should not take STRIBILD? medicines, vitamins, and herbal STRIBILD does not cure HIV-1 Do not take STRIBILD if you: supplements. STRIBILD may affect the infection or AIDS. To control HIV-1 way other medicines work, and other I started my infection and decrease HIV-related • Take a medicine that contains: medicines may affect how STRIBILD illnesses you must keep taking STRIBILD. alfuzosin, dihydroergotamine, ergotamine, works. Keep a list of all your medicines personal revolution Ask your healthcare provider if you have methylergonovine, cisapride, lovastatin, and show it to your healthcare provider questions about how to reduce the risk of simvastatin, pimozide, sildenafi l when and pharmacist. Do not start any new passing HIV-1 to others. Always practice used for lung problems (Revatio®), medicines while taking STRIBILD safer sex and use condoms to lower the triazolam, oral midazolam, rifampin without fi rst talking with your Talk to your healthcare provider chance of sexual contact with body fl uids. or the herb St. John’s wort. healthcare provider. about starting treatment. Never reuse or share needles or other • For a list of brand names for these • If you take hormone-based birth items that have body fl uids on them. medicines, please see the Brief control (pills, patches, rings, shots, etc). Summary on the following pages. • If you take antacids. Take antacids at STRIBILD is a complete HIV-1 IMPORTANT SAFETY • Take any other medicines to treat least 2 hours before or after you take treatment in 1 pill, once a day. INFORMATION HIV-1 infection, or the medicine STRIBILD. adefovir (Hepsera®). What is the most important • If you are pregnant or plan to information I should know What are the other possible side become pregnant. It is not about STRIBILD? effects of STRIBILD? known if STRIBILD can harm Ask if it’s right for you. your unborn baby. Tell your STRIBILD can cause serious Serious side effects of STRIBILD healthcare provider if you side effects: may also include: become pregnant while taking STRIBILD. • Build-up of an acid in your blood • New or worse kidney problems, (lactic acidosis), which is a serious including kidney failure. Your • If you are medical emergency. Symptoms of healthcare provider should do regular breastfeeding lactic acidosis include feeling very blood and urine tests to check your (nursing) or plan weak or tired, unusual (not normal) kidneys before and during treatment to breast-feed. muscle pain, trouble breathing, with STRIBILD. If you develop kidney Do not breastfeed. stomach pain with nausea or vomiting, problems, your healthcare provider HIV-1 can be feeling cold especially in your arms may tell you to stop taking STRIBILD. passed to the baby in and legs, feeling dizzy or lightheaded, breast milk. Also, some • Bone problems, including bone pain or and/or a fast or irregular heartbeat. medicines in STRIBILD bones getting soft or thin, which may lead can pass into breast milk, • Serious liver problems. The liver may to fractures. Your healthcare provider may and it is not known if this become large (hepatomegaly) and fatty do tests to check your bones. (steatosis). Symptoms of liver problems can harm the baby. include your skin or the white part of • Changes in body fat can happen in your eyes turns yellow (jaundice), dark people taking HIV-1 medicines. You are encouraged “tea-colored” urine, light-colored bowel • Changes in your immune system. to report negative side movements (stools), loss of appetite for Your immune system may get stronger effects of prescription several days or longer, nausea, and/or and begin to fi ght infections. Tell your drugs to the FDA. Visit stomach pain. healthcare provider if you have any www.fda.gov/medwatch, or call 1-800-FDA-1088. • You may be more likely to get lactic new symptoms after you start taking acidosis or serious liver problems if STRIBILD. you are female, very overweight (obese), The most common side effects of Please see Brief Summary of full or have been taking STRIBILD for a STRIBILD include nausea and diarrhea. Prescribing Information with important long time. In some cases, these serious Tell your healthcare provider if you have warnings on the following pages. conditions have led to death. Call your any side effects that bother you or don’t healthcare provider right away if you go away. have any symptoms of these conditions.

PALIO Date: 03.23.15 • Client: Gilead • Product: Stribild • File Name: 28277_pgiqdp_8.125_10.5_Master_C_Del_wh_lo6 Del PALIO Date: 03.23.15 • Client: Gilead • Product: Stribild • File Name: 28277_pgiqdp_8.125_10.5_Master_C_Del_wh_lo6 Del Ad Page 1 Ad Page 2 Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.25” x 10.75” Positively Aware Mag Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.25” x 10.75” Positively Aware Mag Patient Information 3. Worsening of Hepatitis B infection. If you have hepatitis B virus • Changes in your immune system (Immune Reconstitution Syndrome) - colchicine (Colcrys®) STRIBILD® (STRY-bild) (HBV) infection and take STRIBILD, your HBV may get worse can happen when you start taking HIV-1 medicines. Your immune system - medicines that contain dexamethasone (fl are-up) if you stop taking STRIBILD. A “fl are-up” is when your may get stronger and begin to fi ght infections that have been hidden in (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ - diazepam (Valium®) tenofovir disoproxil fumarate 300 mg) tablets HBV infection suddenly returns in a worse way than before. your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine. - digoxin (Lanoxin®) Brief summary of full Prescribing Information. For more information, • Do not run out of STRIBILD. Refi ll your prescription or talk to please see the full Prescribing Information, including Patient Information. your healthcare provider before your STRIBILD is all gone The most common side effects of STRIBILD include: - disopyramide (Norpace®) • Do not stop taking STRIBILD without fi rst talking to your • Nausea - estazolam healthcare provider What is STRIBILD? • Diarrhea - ethosuximide (Zarontin®) • If you stop taking STRIBILD, your healthcare provider will need to check Tell your healthcare provider if you have any side effect that - ecainide (Tambocor®) • STRIBILD is a prescription medicine used to treat HIV-1 in adults your health often and do blood tests regularly for several months to bothers you or that does not go away. who have never taken HIV-1 medicines before. STRIBILD can also be check your HBV infection. Tell your healthcare provider about any new - fl urazepam used to replace current HIV-1 medicines for some adults who have an • These are not all the possible side effects of STRIBILD. For more or unusual symptoms you may have after you stop taking STRIBILD ® ® ® undetectable viral load (less than 50 copies/mL of virus in their blood), information, ask your healthcare provider. - uticasone (Flovent , Flonase , Flovent Diskus , Flovent HFA®, Veramyst®) and have been on the same HIV-1 medicines for at least 6 months Who should not take STRIBILD? • Call your doctor for medical advice about side effects. You may and have never failed past HIV-1 treatment, and whose healthcare report side effects to FDA at 1-800-FDA-1088. - itraconazole (Sporanox®) provider determines that they meet certain other requirements. Do not take STRIBILD if you also take a medicine that contains: - ketoconazole (Nizoral®) • STRIBILD is a complete HIV-1 medicine and should not be used • adefovir (Hepsera®) What should I tell my healthcare provider before taking STRIBILD? ® with any other HIV-1 medicines. - lidocaine (Xylocaine ) • alfuzosin hydrochloride (Uroxatral®) • STRIBILD does not cure HIV-1 or AIDS. You must stay on Tell your healthcare provider about all your medical conditions, - mexiletine continuous HIV-1 therapy to control HIV-1 infection and decrease • cisapride (Propulsid®, Propulsid Quicksolv®) including: - oxcarbazepine (Trileptal®) HIV-related illnesses. • ergot-containing medicines, including: dihydroergotamine • If you have or had any kidney, bone, or liver problems, including - perphenazine ® ® ® hepatitis B infection • Ask your healthcare provider about how to prevent passing mesylate (D.H.E. 45 , Migranal ), ergotamine tartrate (Cafergot , - phenobarbital (Luminal®) HIV-1 to others. Do not share or reuse needles, injection Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, • If you are pregnant or plan to become pregnant. It is not known if ® ® equipment, or personal items that can have blood or body uids Wigrettes®), and methylergonovine maleate (Ergotrate®, Methergine®) STRIBILD can harm your unborn baby. Tell your healthcare provider - phenytoin (Dilantin , Phenytek ) on them. Do not have sex without protection. Always practice safer • lovastatin (Advicor®, Altoprev®, Mevacor®) if you become pregnant while taking STRIBILD. - propafenone (Rythmol®) sex by using a latex or polyurethane condom to lower the chance ® of sexual contact with semen, vaginal secretions, or blood. • midazolam, when taken by mouth - There is a pregnancy registry for women who take antiviral - quinidine (Neudexta ) medicines during pregnancy. The purpose of this registry is to collect ® • pimozide (Orap®) information about the health of you and your baby. Talk with your - rifabutin (Mycobutin ) What is the most important information I should know ® ® ® ® ® healthcare provider about how you can take part in this registry. - rifapentine (Priftin ) about STRIBILD? • rifampin (Rifadin , Rifamate , Rifater , Rimactane ) ® ® • sildenafi l (Revatio®), when used for treating lung problems • If you are breastfeeding (nursing) or plan to breastfeed. Do not - risperidone (Risperdal , Risperdal Consta ) STRIBILD can cause serious side effects, including: breastfeed if you take STRIBILD. ® • simvastatin (Simcor®, Vytorin®, Zocor®) - salmeterol (Serevent ) or salmeterol when taken in combination 1. Build-up of lactic acid in your blood (lactic acidosis). Lactic - You should not breastfeed if you have HIV-1 because of the risk with uticasone (Advair Diskus®, Advair HFA®) acidosis can happen in some people who take STRIBILD or similar • triazolam (Halcion®) of passing HIV-1 to your baby. - sildenafi l (Viagra®), tadalafi l (Cialis®) or vardenafi l (Levitra®, (nucleoside analogs) medicines. Lactic acidosis is a serious ® medical emergency that can lead to death. Lactic acidosis can • the herb St. John’s wort - Two of the medicines in STRIBILD can pass to your baby in your Staxyn ), for the treatment of erectile dysfunction (ED). If you get be hard to identify early, because the symptoms could seem Do not take STRIBILD if you also take any other HIV-1 breast milk. It is not known if the other medicines in STRIBILD can dizzy or faint (low blood pressure), have vision changes or have like symptoms of other health problems. Call your healthcare medicines, including: pass into your breast milk. an erection that last longer than 4 hours, call your healthcare provider right away if you get any of the following symptoms - Talk with your healthcare provider about the best way to feed provider or get medical help right away. • Other medicines that contain elvitegravir, cobicistat, emtricitabine, ® which could be signs of lactic acidosis: or tenofovir (Atripla®, Complera®, Emtriva®, Truvada®, Tybost®, your baby. - tadalafi l (Adcirca ), for the treatment of pulmonary arterial • feel very weak or tired Viread®, Vitekta®) Tell your healthcare provider about all the medicines you take, hypertension • have unusual (not normal) muscle pain • Other medicines that contain lamivudine or ritonavir (Combivir®, Epivir® including prescription and over-the-counter medicines, vitamins, - thioridazine ® ® ® ® ® ® and herbal supplements: ® • have trouble breathing or Epivir-HBV , Epzicom , Kaletra , Norvir , Triumeq , Trizivir ) - voriconazole (Vfend ) STRIBILD is not for use in people who are less than 18 years old. • STRIBILD may affect the way other medicines work, and other - warfarin (Coumadin®, Jantoven®) • have stomach pain with nausea or vomiting medicines may affect how STRIBILD works. - zolpidem (Ambien®, Edlular®, Intermezzo®, Zolpimist®) • feel cold, especially in your arms and legs What are the possible side effects of STRIBILD? • Be sure to tell your healthcare provider if you take any of the • feel dizzy or lightheaded following medicines: Know the medicines you take. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a STRIBILD may cause the following serious side effects: - Hormone-based birth control (pills, patches, rings, shots, etc) • have a fast or irregular heartbeat new medicine. Do not start any new medicines while you are taking 2. Severe liver problems. Severe liver problems can happen in • See “What is the most important information I should know - Antacid medicines that contain aluminum, magnesium hydroxide, STRIBILD without fi rst talking with your healthcare provider. about STRIBILD?” or calcium carbonate. Take antacids at least 2 hours before or people who take STRIBILD. In some cases, these liver problems Keep STRIBILD and all medicines out of reach of children. can lead to death. Your liver may become large (hepatomegaly) and • New or worse kidney problems, including kidney failure. Your after you take STRIBILD you may develop fat in your liver (steatosis). Call your healthcare healthcare provider should do blood and urine tests to check your - Medicines to treat depression, organ transplant rejection, or high This Brief Summary summarizes the most important information provider right away if you get any of the following symptoms kidneys before you start and while you are taking STRIBILD. Your blood pressure about STRIBILD. If you would like more information, talk with your of liver problems: healthcare provider may tell you to stop taking STRIBILD if you healthcare provider. You can also ask your healthcare provider or - amiodarone (Cordarone®, Pacerone®) • your skin or the white part of your eyes turns yellow (jaundice) develop new or worse kidney problems. pharmacist for information about STRIBILD that is written for health - atorvastatin (Lipitor®, Caduet®) professionals, or call 1-800-445-3235 or go to www.STRIBILD.com. • dark “tea-colored” urine • Bone problems can happen in some people who take STRIBILD. Bone problems include bone pain, softening or thinning (which may - bepridil hydrochloride (Vascor®, Bepadin®) Issued: December 2014 • light-colored bowel movements (stools) lead to fractures). Your healthcare provider may need to do tests to - bosentan (Tracleer®) check your bones. • loss of appetite for several days or longer - buspirone • nausea • Changes in body fat can happen in people who take HIV-1 ® ® ® ® medicine. These changes may include increased amount of fat - carbamazepine (Carbatrol , Epitol , Equetro , Tegretol ) • stomach pain COMPLERA, EMTRIVA, GILEAD, the GILEAD 7Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo, in the upper back and neck (“buffalo hump”), breast, and around - clarithromycin (Biaxin®, Prevpac®) TRUVADA, TYBOST, VIREAD, and VITEKTA are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks You may be more likely to get lactic acidosis or severe liver the middle of your body (trunk). Loss of fat from the legs, arms - clonazepam (Klonopin®) problems if you are female, very overweight (obese), or have and face may also happen. The exact cause and long-term health referenced herein are the property of their respective owners. been taking STRIBILD for a long time. effects of these conditions are not known. - clorazepate (Gen-xene®, Tranxene®) © 2015 Gilead Sciences, Inc. All rights reserved. STBC0171 03/15

PALIO Date: 03.23.15 • Client: Gilead • Product: Stribild • File Name: 28277_pgiqdp_8.125_10.5_Master_C_Del_wh_lo6 Del PALIO Date: 03.23.15 • Client: Gilead • Product: Stribild • File Name: 28277_pgiqdp_8.125_10.5_Master_C_Del_wh_lo6 Del BS Page 1 BS Page 2 Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.25” x 10.75” Positively Aware Mag Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.25” x 10.75” Positively Aware Mag Patient Information 3. Worsening of Hepatitis B infection. If you have hepatitis B virus • Changes in your immune system (Immune Reconstitution Syndrome) - colchicine (Colcrys®) STRIBILD® (STRY-bild) (HBV) infection and take STRIBILD, your HBV may get worse can happen when you start taking HIV-1 medicines. Your immune system - medicines that contain dexamethasone (fl are-up) if you stop taking STRIBILD. A “fl are-up” is when your may get stronger and begin to fi ght infections that have been hidden in (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ - diazepam (Valium®) tenofovir disoproxil fumarate 300 mg) tablets HBV infection suddenly returns in a worse way than before. your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine. - digoxin (Lanoxin®) Brief summary of full Prescribing Information. For more information, • Do not run out of STRIBILD. Refi ll your prescription or talk to please see the full Prescribing Information, including Patient Information. your healthcare provider before your STRIBILD is all gone The most common side effects of STRIBILD include: - disopyramide (Norpace®) • Do not stop taking STRIBILD without fi rst talking to your • Nausea - estazolam healthcare provider What is STRIBILD? • Diarrhea - ethosuximide (Zarontin®) • If you stop taking STRIBILD, your healthcare provider will need to check Tell your healthcare provider if you have any side effect that - ecainide (Tambocor®) • STRIBILD is a prescription medicine used to treat HIV-1 in adults your health often and do blood tests regularly for several months to bothers you or that does not go away. who have never taken HIV-1 medicines before. STRIBILD can also be check your HBV infection. Tell your healthcare provider about any new - fl urazepam used to replace current HIV-1 medicines for some adults who have an • These are not all the possible side effects of STRIBILD. For more or unusual symptoms you may have after you stop taking STRIBILD ® ® ® undetectable viral load (less than 50 copies/mL of virus in their blood), information, ask your healthcare provider. - uticasone (Flovent , Flonase , Flovent Diskus , Flovent HFA®, Veramyst®) and have been on the same HIV-1 medicines for at least 6 months Who should not take STRIBILD? • Call your doctor for medical advice about side effects. You may and have never failed past HIV-1 treatment, and whose healthcare report side effects to FDA at 1-800-FDA-1088. - itraconazole (Sporanox®) provider determines that they meet certain other requirements. Do not take STRIBILD if you also take a medicine that contains: - ketoconazole (Nizoral®) • STRIBILD is a complete HIV-1 medicine and should not be used • adefovir (Hepsera®) What should I tell my healthcare provider before taking STRIBILD? ® with any other HIV-1 medicines. - lidocaine (Xylocaine ) • alfuzosin hydrochloride (Uroxatral®) • STRIBILD does not cure HIV-1 or AIDS. You must stay on Tell your healthcare provider about all your medical conditions, - mexiletine continuous HIV-1 therapy to control HIV-1 infection and decrease • cisapride (Propulsid®, Propulsid Quicksolv®) including: - oxcarbazepine (Trileptal®) HIV-related illnesses. • ergot-containing medicines, including: dihydroergotamine • If you have or had any kidney, bone, or liver problems, including - perphenazine ® ® ® hepatitis B infection • Ask your healthcare provider about how to prevent passing mesylate (D.H.E. 45 , Migranal ), ergotamine tartrate (Cafergot , - phenobarbital (Luminal®) HIV-1 to others. Do not share or reuse needles, injection Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, • If you are pregnant or plan to become pregnant. It is not known if ® ® equipment, or personal items that can have blood or body uids Wigrettes®), and methylergonovine maleate (Ergotrate®, Methergine®) STRIBILD can harm your unborn baby. Tell your healthcare provider - phenytoin (Dilantin , Phenytek ) on them. Do not have sex without protection. Always practice safer • lovastatin (Advicor®, Altoprev®, Mevacor®) if you become pregnant while taking STRIBILD. - propafenone (Rythmol®) sex by using a latex or polyurethane condom to lower the chance ® of sexual contact with semen, vaginal secretions, or blood. • midazolam, when taken by mouth - There is a pregnancy registry for women who take antiviral - quinidine (Neudexta ) medicines during pregnancy. The purpose of this registry is to collect ® • pimozide (Orap®) information about the health of you and your baby. Talk with your - rifabutin (Mycobutin ) What is the most important information I should know ® ® ® ® ® healthcare provider about how you can take part in this registry. - rifapentine (Priftin ) about STRIBILD? • rifampin (Rifadin , Rifamate , Rifater , Rimactane ) ® ® • sildenafi l (Revatio®), when used for treating lung problems • If you are breastfeeding (nursing) or plan to breastfeed. Do not - risperidone (Risperdal , Risperdal Consta ) STRIBILD can cause serious side effects, including: breastfeed if you take STRIBILD. ® • simvastatin (Simcor®, Vytorin®, Zocor®) - salmeterol (Serevent ) or salmeterol when taken in combination 1. Build-up of lactic acid in your blood (lactic acidosis). Lactic - You should not breastfeed if you have HIV-1 because of the risk with uticasone (Advair Diskus®, Advair HFA®) acidosis can happen in some people who take STRIBILD or similar • triazolam (Halcion®) of passing HIV-1 to your baby. - sildenafi l (Viagra®), tadalafi l (Cialis®) or vardenafi l (Levitra®, (nucleoside analogs) medicines. Lactic acidosis is a serious ® medical emergency that can lead to death. Lactic acidosis can • the herb St. John’s wort - Two of the medicines in STRIBILD can pass to your baby in your Staxyn ), for the treatment of erectile dysfunction (ED). If you get be hard to identify early, because the symptoms could seem Do not take STRIBILD if you also take any other HIV-1 breast milk. It is not known if the other medicines in STRIBILD can dizzy or faint (low blood pressure), have vision changes or have like symptoms of other health problems. Call your healthcare medicines, including: pass into your breast milk. an erection that last longer than 4 hours, call your healthcare provider right away if you get any of the following symptoms - Talk with your healthcare provider about the best way to feed provider or get medical help right away. • Other medicines that contain elvitegravir, cobicistat, emtricitabine, ® which could be signs of lactic acidosis: or tenofovir (Atripla®, Complera®, Emtriva®, Truvada®, Tybost®, your baby. - tadalafi l (Adcirca ), for the treatment of pulmonary arterial • feel very weak or tired Viread®, Vitekta®) Tell your healthcare provider about all the medicines you take, hypertension • have unusual (not normal) muscle pain • Other medicines that contain lamivudine or ritonavir (Combivir®, Epivir® including prescription and over-the-counter medicines, vitamins, - thioridazine ® ® ® ® ® ® and herbal supplements: ® • have trouble breathing or Epivir-HBV , Epzicom , Kaletra , Norvir , Triumeq , Trizivir ) - voriconazole (Vfend ) STRIBILD is not for use in people who are less than 18 years old. • STRIBILD may affect the way other medicines work, and other - warfarin (Coumadin®, Jantoven®) • have stomach pain with nausea or vomiting medicines may affect how STRIBILD works. - zolpidem (Ambien®, Edlular®, Intermezzo®, Zolpimist®) • feel cold, especially in your arms and legs What are the possible side effects of STRIBILD? • Be sure to tell your healthcare provider if you take any of the • feel dizzy or lightheaded following medicines: Know the medicines you take. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a STRIBILD may cause the following serious side effects: - Hormone-based birth control (pills, patches, rings, shots, etc) • have a fast or irregular heartbeat new medicine. Do not start any new medicines while you are taking 2. Severe liver problems. Severe liver problems can happen in • See “What is the most important information I should know - Antacid medicines that contain aluminum, magnesium hydroxide, STRIBILD without fi rst talking with your healthcare provider. about STRIBILD?” or calcium carbonate. Take antacids at least 2 hours before or people who take STRIBILD. In some cases, these liver problems Keep STRIBILD and all medicines out of reach of children. can lead to death. Your liver may become large (hepatomegaly) and • New or worse kidney problems, including kidney failure. Your after you take STRIBILD you may develop fat in your liver (steatosis). Call your healthcare healthcare provider should do blood and urine tests to check your - Medicines to treat depression, organ transplant rejection, or high This Brief Summary summarizes the most important information provider right away if you get any of the following symptoms kidneys before you start and while you are taking STRIBILD. Your blood pressure about STRIBILD. If you would like more information, talk with your of liver problems: healthcare provider may tell you to stop taking STRIBILD if you healthcare provider. You can also ask your healthcare provider or - amiodarone (Cordarone®, Pacerone®) • your skin or the white part of your eyes turns yellow (jaundice) develop new or worse kidney problems. pharmacist for information about STRIBILD that is written for health - atorvastatin (Lipitor®, Caduet®) professionals, or call 1-800-445-3235 or go to www.STRIBILD.com. • dark “tea-colored” urine • Bone problems can happen in some people who take STRIBILD. Bone problems include bone pain, softening or thinning (which may - bepridil hydrochloride (Vascor®, Bepadin®) Issued: December 2014 • light-colored bowel movements (stools) lead to fractures). Your healthcare provider may need to do tests to - bosentan (Tracleer®) check your bones. • loss of appetite for several days or longer - buspirone • nausea • Changes in body fat can happen in people who take HIV-1 ® ® ® ® medicine. These changes may include increased amount of fat - carbamazepine (Carbatrol , Epitol , Equetro , Tegretol ) • stomach pain COMPLERA, EMTRIVA, GILEAD, the GILEAD 7Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo, in the upper back and neck (“buffalo hump”), breast, and around - clarithromycin (Biaxin®, Prevpac®) TRUVADA, TYBOST, VIREAD, and VITEKTA are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks You may be more likely to get lactic acidosis or severe liver the middle of your body (trunk). Loss of fat from the legs, arms - clonazepam (Klonopin®) problems if you are female, very overweight (obese), or have and face may also happen. The exact cause and long-term health referenced herein are the property of their respective owners. been taking STRIBILD for a long time. effects of these conditions are not known. - clorazepate (Gen-xene®, Tranxene®) © 2015 Gilead Sciences, Inc. All rights reserved. STBC0171 03/15

Pano rama from the Space Needle: a nearly 360-degree view that includes (from left) Puget Sound, Magnolia, Queen Anne Hill, Lake Union, Capitol Hill, downtown Seattle, Elliott Bay, and West Seattle. G Reat EXPECTATIONS give way to greater promise IN SEATTLE

The Conference on Retroviruses and Opportunistic the results before trying this Infections, or CROI, has long been an important gather- at home. PrEP ON DEMAND ing for clinical scientists, doctors, and epidemiologists Among its conclusions, the research group reported that to discuss the latest research and study results for the on demand PrEP is an “attrac- prevention and treatment of HIV/AIDS and opportunistic tive alternative to daily PrEP infections. Here are some of the most important news [as FDA approved] in high-risk items from CROI 2015, held from February 23–26 MSM [men who have sex with in Seattle, Washington. men] who do not use condoms consistently.” The group expected to show By Enid VÁzquez at least a 50% decrease in HIV incidence and the 86% IPERGAY participants IV can be pre- The IPERGAY study design reduction they saw surprised took three doses vented with the use was based on one in macaque them. Due to the success of for prevention: of four pills taken monkeys showing “you almost the Truvada group in staying around the time of fully protect” them with Truvada HIV free, the placebo arm was discontinued early and everyone sex. CROI 2015 before and after exposure to two tablets brought this and a virus, said presenter Jean- in that group offered the oppor- taken together, 2–24 hours Hlot of other good news on using Michel Molina, MD, of the HIV tunity to take the drug. before sex, followed by the HIV medication Truvada research collaborative ANRS to prevent infection with the in Paris. R eal-world PrEP virus in HIV-negative people (an Participants used three doses British researchers decided to one tablet intervention called PrEP, for pre- totalling four tablets for preven- check on the PrEP potential in 24 hours after sex, and exposure prophylaxis). tion (see infographic). Anyone the real world following a 44% Meanwhile, researchers having sexual intercourse reduction in HIV seen in the reported zero linked infections more than once in a week was landmark iPrEx study.

in nearly 6,000 acts of con- advised to continue taking one Presenter Sheena ) ONE tablet e d domless anal sex in 152 male pill a day, followed by the two McCormack, MD, noted that 48 hours after sex. . g serodiscordant couples when the doses after the last encounter. effectiveness might be less in HIV-positive partner had unde- Altogether, most people used the real world because iPrEx par- ornun tectable viral load on therapy, sixteen tablets a month, for an ticipants were seen monthly and infections. Participants were nh i a strategy called Treatment as average of one sex act a week. had strong resources for adher- recruited from sexual health clin- arm Prevention, or TasP (Grulich, Then again, participants did ence support, and because they ics in London. .

1019LB). not always use PrEP. “Overall, received behavioral interventions These men also needed to ww w

28% of these participants did and were constantly reminded be at high risk of infection. They ( g O n demand PrEP not use PrEP during the last that PrEP may not work. reported condomless anal sex in Doctors from Montreal and intercourse, so patients were Would people take greater the past 90 days and were likely

Paris teamed up to study able to select the type of sexual risks knowing that Truvada PrEP to have condomless sex again. hornun n Truvada PrEP around the time [act] including the type of part- does work to prevent HIV? Also as with IPERGAY, the i of sexual risk, and found an ner with whom they would want As with IPERGAY, taking Truvada PrEP group did so well o 86% decrease in risk of HIV to use PrEP,” Molina said. Truvada succeeded in achieving at preventing HIV that the data t

with the strategy. Wait for confirmation of an 86% reduction in new HIV monitoring board recommended Pho arm:

28 MAY+JUNE 2015 POSITIVELY AWARE Panorama from the Space Needle: a nearly 360-degree view that includes (from left) Puget Sound, Magnolia, Queen Anne Hill, Lake Union, Capitol Hill, downtown Seattle, Elliott Bay, and West Seattle. GREAT EXPECTATIONS give way to greater promise IN SEATTLE

giving the drug to all participants as a prevention bridge in the each other’s effectiveness for seen with newer medications, in the study. And again as in HIV-negative partners of serodis- prevention, and as with the but fat gain was. IPERGAY, the research team cordant couples in four African London group, it noted that “A 30% gain in fat after two was surprised at how many countries, hoping to keep them people at highest risk for HIV years? That’s really bad,” she infections they saw in the group uninfected until the positive had the greatest uptake of PrEP. said in response to a ques- not given Truvada. It was three partners get their virus down to “Remarkably, the uptake of tion from the audience. “It’s times the number of HIV infec- undetectable through therapy. It PrEP is strongly and positively a relatively short duration of tions they expected to see. found that PrEP reduced infec- correlated with reported HIV risk, treatment.” The group concluded, among tions by 96% (from the expected such that 63% of men reporting The effects were similar no other things, that, “Our con- rate of more than 5% a year condomless anal sex in the last matter what regimen people took. cerns about PrEP being less down to a half-percent). six months reported having used It was the strong correlation effective in the real world were “Our results also speak to PrEP,” said Grant, who is now with the virus that came as an unfounded.” the potential for HIV protection Chief Medical Officer for the even greater surprise. “What is absolutely fantastic,” from integrated PrEP and ART San Francisco AIDS Foundation. “I think it’s amazing that said McCormack, “is that given in other high-risk populations, “People with lower levels of risk regardless of the regimen you [the successful] results for PrEP, we would argue, including MSM have much less uptake.” looked at, the fat gains were people who need it really came and women at risk,” said Baeten. so much more if you start with forward.” high viral load [over 100,000],” S an Francisco Wac t h webcasts of McComsey continued. “Then, these PrEP findings at ¡!Adios, HIV U sing a mathematical model, the conference website, if you adjust for inflammation N ot mincing their words, the leading medical providers from croiconference.org, markers, viral load remains by Partners Demonstration Project San Francisco showed that the and read a longer itself associated with higher version of this report at researchers called the results city can reduce its number of positivelyaware.com. gains. The research, especially of their study with Truvada “the new HIV infections by 70%. on central fat, needs to continue near elimination of HIV.” Presenter Robert M. Grant, and needs to be geared towards While high levels of adher- MD, of iPrEx study fame, said Body composition inflammation and other markers, ence to either PrEP or ART (HIV that although PrEP use was The early days of highly active rather than just the drugs.” therapy) can reduce the risk of “negligible” when it became avail- medication for HIV were known The metabolic sub-study of infection by more than 90%, able in 2011, it increased over for resulting in undesirable body A5257 looked at fat loss and said presenter Jared M. Baeten, time. In turn, increasing PrEP composition changes. Although increases along with measure- MD, PhD, of the University of use correlates with decreasing the causes of these changes are ments of inflammation in 328 Washington, there are issues to numbers of new HIV infections, not completely understood to individuals who were using consider. Delays in starting HIV he said. this day, the AIDS Clinical Trials regimens containing Isentress therapy are common, and trans- New infections went down Group (ACTG) presented data (raltegravir, an integrase inhibi- mission risk may continue for from 420 in 2012 to 359 in showing that the virus itself may tor) or Prezista (darunavir) or months after starting treatment 2013, and so far for 2014, have not only contribute to increased Reyataz (atazanavir), both prote- until a person’s virus is undetect- gone down to 320 (some of the fat, but do so more than the ase inhibitors (PIs). able. Some studies have report- cases need to be confirmed, so medications. Although the protease inhibi- ed that not everyone offered HIV the number may be even lower). Presenter Grace A. tor class of drugs was thought to therapy wishes to take it. As for As with the Partners McComsey, MD, of Case be responsible for fat gain back PrEP, not all at-risk individuals Demonstration Project, the San Western Reserve University, in the day, this study found no use it when it is offered. Francisco group expects HIV said that lipoatrophy (fat loss difference in fat gain between This study looked at PrEP treatment and PrEP to bolster in the face and limbs) wasn’t Isentress and the two PIs.

PITIVLOS E Y AWARE MAY+JUNE 2015 29 “no studies have yet assessed have“no studies yet assessed “ a I The This can cause the progressive This the progressive cause can re CR C 30 attack].” atherosclerosis in coronary of achieve regression Viramune (nevi Viramune In a small withindi- 40 study exposure exposure letra vs. Viramune vs. letra K Lipitor F of and other types deposits atherosclerosis,” coronary cal disease atherosclerosis. superiority of of superiority disease events and deterthe events disease can known statins as drugs cells that build up in arteries. noncalci statin therapy reduces strated to have to elevatedrisk strated may disease artery coronary rapine or risk plaque features inrisk plaque features researchers reported. reported. researchers of myocardial infarction [heart [heart infarction myocardial of patients, a population demon population a patients, progression of atherosclerosis, atherosclerosis, of progression cardiovascular the risk of reduce patients.” M viduals living with weeks of of weeks were put on the statin medica- the puton statin were whether reduction inwhether reduction high risk plaquefied volume and high had earlier reported short-term short-term had earlier reported for children infected patients with subclini with patients infected to to through 24 tion the ability of statin treatment to to the ability treatment statin of of population this at-risk tion cardiovascular of in events preven- translate into effective less of any of less life, regard for infants infants for u O e a “ rther studies should assess should studies assess rther NF

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V a E r now, P dy’s a rly rly TAF TD TD TD T The two studies compared a compared studies two The w and increased concentrations of of concentrations and increased with clinicallyassociated sig- and 111) in 1,733 individuals. (104 studies active-controlled 50% of the participants were were the participants of 50% 200 mg/T 200 (T (ST (lower than Stribild current the drug tenofovir diphosphate (DP). cells. cells. equal to or greater thanequal greater 1,000 or to 150 mg/emtricitabine cobicistat copies/m planned analysis two from sideresulting ineffects reduced nificant renal toxicity. and bone once-daily single-tablet regimen once-daily Phase 3 48-week datain a Phase 348-week mularrate, filtration a markerof has been a lot of interest in see- interest alot of has been Stribild, an ST identically interna designed, forward. ing move this drug kidney function) 50 at least of individuals who had aviral load in were treatment-naïveies tenofovir DP is but metabolized t waythen makesinto its the plasma, intenofovir blood the the drug within cells. there So tional, randomized, double-blind threshold of 70). 70). of threshold Jeff Berry Jeff b lower (90% lower in studies), levels plasma in the blood much largely within the cell, making T enofovir alafenamideenofovir fumarate A y A F F F F ith improved safety profile The medianThe age was 34; A David Wohl, R F ) t is converted to the to active is converted the active of is a prodrug ( new “version” of TD of new “version” ) ) o , is also a prodrug of of , is also aprodrug E o the currently available / non-inferior to f elvitegravir 150 mg/ C/ L F A Truvada and included and an eG component of of component used to treat treat to used vir e in most in most fumarate (TD / F TD n 10 mg ( o R F f which contains ) M o . Both stud . Both D H , presented , presented I V regimens V regimens F E disoproxil R / C/ F H (glo ) F I , a F V, is , / - - - 1% in the T T-cells in the T 400,000 c/m 400,000 and at week 48 there was a there and at 48 week a treatment-related discon- a treatment-related arm there was newarm no signal there average viral load of study par-average viral study of load 23% having abaseline viral load greater increase of 30 CD4+ of increase greater emergent resistance was less was less resistance emergent event ( duringcount increase the trial, comparable levels viral of sup- cant. The rate of virologic of failurecant. rate The sex. There was a “robust” CD4 CD4 was a“robust” There sex. similar all when groups across of in rates saw difference no discontinuation, but as Wohl discontinuation due renal to or studies. descent, and 19%descent, suppression through week 48 48 through week suppression pression in patients with in viral patients pression over 100,000, and 5% over stated, “importantly in the T “importantly stated, started) was 4.58 log started) or anythingor differentiate to reasons given for treatment giventreatment for reasons E CD4 count was 400. CD4 viral suppression. with CD4 count less than 200 countwith less CD4 was 4% while in groups, both signifi statistically whichwas Similarly count, those CD4 for in this combined analysis two of thanin arms, with both less the TD than percent. one in the TD tinuation. varying were There broken down byand age, race, ticipants at baseline (when they between both arms in the two arms in both the two between bone toxicity in the toxicity T bone arms, and no the two between load above and below 100,000. and above below load female, 25% black or / C/ T O Safety was “well-balanced” Safety A F TDF v / F erall 92% treated with erall 92% treated T F A and TD A group (211 group 181), vs. E A F F ) w n achieved virologic group experiencing group y serious adverse adverse y serious A F as less than 10% less as

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A W A - ARE F

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Is diarrhea holding you back? If you are on HIV Fulyzaq may help manage your diarrhea over time by making your bowel medications, Fulyzaq is a plant-based, FDA-approved movements less frequent and loose. Fulyzaq works by normalizing the ﬂ ow prescription medication that may help of water in your gut. Fulyzaq did not interfere with commonly used HIV manage your diarrhea. medications, and did not affect CD4 count or viral load in a 4-week study. It’s time to stop dealing with diarrhea and ‘Start the Conversation’ about Fulyzaq today.

Indication FULYZAQ® (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Important Safety Information about FULYZAQ FULYZAQ® (crofelemer) delayed-release tablets should not be used for the treatment of infectious diarrhea. It is important that your healthcare provider considers infectious causes of diarrhea before you start taking FULYZAQ. If infectious causes are not considered, and you begin taking FULYZAQ based on a probable diagnosis of noninfectious diarrhea, there is a risk that you will not receive the appropriate treatments, and your disease may worsen. • FULYZAQ tablets should be swallowed whole. FULYZAQ tablets should not be crushed or chewed. You may take FULYZAQ with or without food. You should follow the instructions of your healthcare provider. • If you are pregnant, or planning to become pregnant, talk to your healthcare provider before taking FULYZAQ. The safety and effectiveness of FULYZAQ have not been established in people younger than 18 years of age. • In clinical studies, the most common adverse reactions associated with FULYZAQ – occurring in at least 3% of patients taking FULYZAQ – were upper respiratory tract infection, bronchitis (inﬂ ammation of the lining of the tubes which carry air to and from your lungs), cough, ﬂ atulence (intestinal gas passed through your rectum), and increased bilirubin (a waste product of the breakdown of red blood cells). • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088. Please see following page for brief summary of Prescribing Information for FULYZAQ.

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CROF14CDNY4413_POZ_Patient_Journal_Ad_r19.indd 1 7/14/14 3:37 PM IMPORTANT PATIENT INFORMATION Under 18 or Over 65 Years of Age? The following is a brief summary only. See complete Prescribing • FULYZAQ has not been studied in children under Information at Fulyzaq.com or request complete Prescribing 18 years of age Information by calling 1-800-508-0024. This information does not • FULYZAQ studies did not contain a large number of patients take the place of talking with your doctor about your medical over the age of 65; therefore, it is unclear if this age group will condition or your treatment. respond differently

WHAT IS FULYZAQ? Talk to your doctor to ﬁ nd out if FULYZAQ is right for you. FULYZAQ is a prescription medication used to improve symptoms of noninfectious diarrhea (diarrhea not caused by HOW SHOULD I TAKE FULYZAQ? a bacterial, viral, or parasitic infection) in adult patients with • FULYZAQ should be taken orally, by mouth 2 times per day HIV/AIDS who take HIV medication. • FULYZAQ tablets may be taken with or without food WHO SHOULD NOT TAKE FULYZAQ? • FULYZAQ tablets should not be crushed or chewed • FULYZAQ should not be taken if you have diarrhea caused • FULYZAQ tablets should be swallowed whole by an infection WHAT SHOULD I KNOW ABOUT TAKING FULYZAQ • Your doctor and you should make sure your diarrhea is not WITH OTHER MEDICATIONS? caused by an infection (such as bacteria, virus, or parasite) before you start taking FULYZAQ • If you are taking any prescription or over-the-counter (OTC) medications, or herbal supplements or vitamins, tell your WHAT ARE THE POSSIBLE SIDE EFFECTS doctor before starting FULYZAQ OF FULYZAQ? WHAT IF I HAVE MORE QUESTIONS ABOUT FULYZAQ? • Upper respiratory tract infection (nasal or sinus infection) • For more information, please see the full Prescribing • Bronchitis (infl ammation of the lining of the tubes which Information at Fulyzaq.com or speak to your doctor carry air to and from your lungs) or pharmacist • Cough • Flatulence (intestinal gas passed through your rectum) To report side effects, a product complaint, or for additional information, call: 1-800-508-0024. • Increased bilirubin (a waste product of the breakdown of red blood cells) Rx Only For a full list of side effects, please talk to your doctor. Manufactured by Patheon, Inc. for Tell your doctor if you have any side effect that bothers you or Salix Pharmaceuticals, Inc. does not go away. 8510 Colonnade Center Drive, Raleigh, NC 27615 You are encouraged to report negative side effects of prescription drugs www.salix.com to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Copyright © Salix Pharmaceuticals, Inc. US Patent Nos. 7,341,744 and 7,323,195. SHOULD I TAKE FULYZAQ IF I AM: FUL-RALAB49-062014 Pregnant or Planning to Become Pregnant? Fulyzaq is manufactured for Salix Pharmaceuticals, Inc. by Patheon, Inc. • Studies in animals show that FULYZAQ could cause harm to and distributed under license from Napo Pharmaceuticals, Inc. an unborn baby or affect the ability to become pregnant ©2014 Salix Pharmaceuticals, Inc. All rights reserved. Printed in USA. • There are no studies in pregnant women taking FULYZAQ FUL50-0614 • This drug should only be used during pregnancy if clearly needed A Nursing Mother? • It is not known whether FULYZAQ is passed through human breast milk The botanical drug substance of FULYZAQ is extracted from Croton lechleri (the botanical raw material) that is harvested • If you are nursing, you should tell your doctor before from the wild in South America. starting FULYZAQ • Your doctor will help you to make a decision whether to stop nursing or to stop taking FULYZAQ

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M - 33 I - C ONFEreNCE UPDATE CROI 2015: SEATTLE

of 96%, offering compelling evi- research has shown high dence that co-infected persons response rates with this regimen can be treated for HCV with a in African Americans who were once-daily regimen. HCV mono-infected. This effect ION-4 is a Phase 3 study of will be monitored going forward co-infected patients with HCV to see if this regimen does not genotype (GT) 1 and 4. The perform as well in HIV/HCV co- study was open to both HCV infected African Americans as it treatment-naïve and -experi- does in other groups. enced patients, and 20% of All patients maintained participants had compensated stable CD4 counts both during cirrhosis (early liver disease). treatment and afterwards, and Patients were on a variety of HIV no patient experienced an HIV regimens, and all had HIV RNA virologic rebound. The regimen of less than 50 copies and CD4 was very well tolerated, with cell count greater than 100. 257 (77%) reporting some side R eversing the trend for those Of the 335 patients, 276 effects, but all were on the mild with HIV/HCV co-infection (82%) were male, 115 (34%) to tolerable level. Reported side were African American, 56 effects included headaches, By Andrew Reynolds (17%) were Latino/a, and the fatigue, diarrhea, nausea, Project Inform average age was 52. The vast arthralgia (joint pain), and upper majority, 327 (98%), were respiratory tract infections. No n recent years, other people, but we are also see- GT1, and 185 (55%) were HCV one discontinued HCV treatment infectious diseases besides ing nearly the same rates in treatment-experienced. due to these side effects. HIV have been featured co-infected people. Indeed, the The study results showed The results of the ION-4 prominently at CROI, most AASLD/IDSA/IAS HCV treatment high SVR rates, with no impact study are very promising especially hepatitis C guidelines recommend that HIV/ on HIV disease severity or treat- for patients with HIV/HCV (HCV). CROI 2015 was no HCV co-infected persons should ment and minimal side effects. co-infection and show that a Iexception and with more than be treated and re-treated the Overall, 321 of 335 patients, once-daily regimen of LDV/SOF 100 abstracts, HCV research same as those without HIV (once or 96%, achieved an SVR12. can cure people at very high was well represented. This brief drug-drug interactions have been A breakdown of the SVR rates rates with minimal side effects, review provides information on addressed). Several presentations by treatment experience and and no impact on their HIV the latest data from a selection at CROI provide further support sustained virologic responses care. Although LDV/SOF has of posters and presentations, for both the FDA-approved and in ION-4 are as follows: not been FDA approved for HIV/ with particular emphasis on off-label use (when there is no HCV co-infection, these results HIV/HCV co-infected persons. FDA approval but evidence of will further support patients and potential benefit exists) of DAAs I4ON- providers who wish to treat HCV SauSt ined C : uring HCV in co-infected patients. off-label. Virologic RESPONSES ION-4 and ALLY-2 The fixed-dose combination The ALLY-2 study, a Phase 3 Ov erall SVR: 96% Today, co-infected patients of ledipasvir/sofosbuvir, brand clinical trial evaluating the effec- Trean tme t-naïve 95% are more likely to experience name Harvoni, was approved by tiveness of daclatasvir (DCV) Trea tment-experienced: the same cure rates as those the FDA in October 2014 for the and sofosbuvir (SOF, brand 97% infected only with HCV. treatment of HCV in genotype 1 name Sovaldi) for 8 or 12 weeks N o cirrhosis: 96% Prior to the direct acting in mono-infected persons, but for patients living with HIV/ C isirrhos : 94% antiviral (DAA) era, treating HCV not for HIV/HCV co-infection. HCV co-infection, shows very in HIV/HCV co-infected persons Although we have seen some promising results for people with was very challenging: Pegylated very compelling evidence that There were 10 HCV viral genotypes 1–4 with 12 weeks Z

interferon and ribavirin were the this treatment is effective in co- relapses and two treatment of therapy. I RU

standard of care and the com- infected persons—an NIH study failures (both had poor adher- Daclatasvir is a pangeno- I V A

bination of length of treatment, comprising 50 non-cirrhotic HIV/ ence to the regimen), while one typic (it works against GT 1–4) J / K

severe side effects, and low suc- HCV co-infected patients had an person was lost to follow-up and NS5A inhibitor taken once per C O

cess rates stood as significant SVR rate of 98% (49 of 50)— another died of non-treatment day that is under review in the ST barriers for patients and their the numbers were too small to related causes (injection drug- United States. Sofosbuvir, also K STIC

medical providers. draw any conclusions regarding related fatality). The 10 patients pangenotypic, is an NS5B inhibi- : N

In the DAA era, we are not its efficacy in larger groups. who relapsed were all African tor that is taken once daily that O TI

only seeing high sustained viro- Results from the ION-4 dem- American. There were no clear has been FDA approved since R

logic response (SVR, or virologic onstrated an SVR12 (sustained explanations as to why their late 2013. Both drugs are safe ST L cure) rates in HCV mono-infected virologic response at 12 weeks) virus came back. Previous and well tolerated, and both I A lu

34 MAY+JUNE 2015 POSITIVELY AWARE A LLY-2 dal ir c atasv plus sofosbuvir SVR12 response rates, by genotype and patient type Pan tie t Type Genotype 1a Genotype 1b Genotype 2 Genotype 3 Genotype 4 T reatment-naïve 96% 100% 100% 100% 100% (68 out of 71) (12 out of 12) (11 out of 11) (6 out of 6) (1 out of 1) T reatment-experienced 97% 100% 100% 100% 100% (32 out of 33) (11 out of 11) (2 out of 2) (4 out of 4) (1 out of 1)

have few drug-drug interactions, T he benefits of treating for the study were hepatic Index (FI) levels (F2, F3, and making them ideally suited for and curing HCV decompensation, death, platelet F4), the results progressively use in people living with HIV. H epatitis C infection is a major count, and AST to Platelet Ratio worsened. For example, if one is ALLY-2 comprised 203 cause of suffering in people liv- Index (APRI) scores. treated at F3 rather F2, the risk patients with HIV/HCV co- ing with HIV: HCV-related liver The authors found that SVR of liver-related death is twice as infection, with genotypes 1–6. disease is the leading non-AIDS is associated with reducing the high. Wait until F4, and the risk Study participants were given cause of death, and people with risks of decompensation and is four times greater. DCV plus SOF for 8 or 12 weeks. HIV/HCV co-infection suffer from death in mono-infected patients, Additionally, the longer one There were 151 treatment-naïve higher rates of extra-hepatic and found no decompensation in waits for treatment, particularly in patients who were randomized complications such as heart the HIV/HCV co-infected group. F3 and F4, the patient’s risk for into the 8-week arm (50 par- disease and bone fractures. Additionally, all patients who developing these complications ticipants) or 12-week arm (101 Additionally, sexually active HIV- achieved an SVR had improve- remains even after achieving SVR. participants). There were 52 positive gay men are at greater ments in their platelet counts Similarly, if one is treated treatment-experienced patients risk of sexual transmission of and APRI scores, indicating an and achieves SVR earlier, their (all of whom took an interferon- HCV, or re-infection with HCV. improvement in their liver fibrosis. risk of transmitting to others is based regimen in the past) who That said, although there are In a study that further high- limited. By contrast, if you wait were all given 12 weeks of treat- both compelling individual and lights the importance of early until a patient achieves F4, their ment. Most (98%) were on HIV public health reasons to treat and treatment and achievement of period of HCV infectiousness is ARTs, with HIV under control cure HIV-positive people for HCV, SVR in HIV/HCV co-infected as long as 20 years. This model and high CD4 cell counts. access to insurance coverage for people for both the purposes provides compelling evidence The 8-week results were said treatments can be limited to of improving individual health for the early detection and treat- not promising: 76% of patients only those with more advanced and preventing transmission to ment of HCV in HIV-positive per- achieved an SVR. The patients liver disease due to cost barriers others, Cindy Zahnd and col- sons regardless of the amount of who took 12 weeks of DCV and the perception that patients leagues with the Swiss HIV and fibrosis they may have. and SOF, however, achieved can wait, as HCV disease pro- Hepatitis C Cohort Studies pre- an overall SVR12 of 97%. A gression is relatively slow. sented the “Impact of Deferring C onclusions breakdown by genotype is in the In an effort to come to a HCV Treatment on Liver-Related These select treatment results chart above. better understanding of the Events in HIV-Positive Patients” from both ION-4 and ALLY-2 The regimen was safe and benefits of SVR, Janet Tate and showed that the longer offer hope for the treatment and well tolerated, and did not and colleagues, in a poster HCV treatment is deferred, the cure of HCV in people living with impact HIV care and treatment. entitled “The Impact of SVR greater the risk of developing HIV/HCV co-infection. We also No one discontinued HCV thera- on Liver Decompensation and hepatocellular carcinoma (HCC), see the compelling evidence py due to side effects or serious Hepatic Fibrosis Markers in HIV/ end-stage liver failure, and for the benefits of cure for both adverse events. HCV,” presented data from the death. Additionally, the longer individual and public health. With liver disease the leading Veterans Aging Cohort Study one waits to be treated, the cause of non-AIDS death and (VACS) and the VA Hepatitis longer the time of infectiousness Edit or’s note: Congratulations significant morbidity in people C case registry to evaluate the that patient has and the greater to Andrew Reynolds on his co-infected with HIV/HCV, safe rates of liver decompensation the risk of HCV transmission. appointment to the guidelines and effective treatments with and death, and to compare Using a mathematical model panel of the AASLD/ISDA/ little drug-drug interaction changes in fibrosis markers over to predict the progression of liver IAS “Recommendations for and impact on HIV disease is time in these two groups. disease, the researchers found the Testing, Management, and extremely important. The com- The study authors looked that if treatment was initiated Treatment of Hepatitis C.” bination of DCV with SOF for 12 at 12,067 HCV mono-infected within one year of diagnosis weeks looks to fit those criteria, and 372 HIV/HCV co-infected the risks of developing decom- V iSIT the conference and will potentially provide patients who were treated and pensated liver disease, HCC, or website, croiconference. org, for more information patients and providers with an achieved SVR with pegylated liver-related deaths were dra- (including webcasts) on option to cure HCV without com- interferon and ribavirin-based matically reduced. As treatment all of these reports. promising their HIV care. regimens. The main outcomes was delayed to higher Fibrosis

PITIVLOS E Y AWARE MAY+JUNE 2015 35 B:8.25 in T:8 in S:7 in

WHAT IS PREZCOBIX™? • PREZCOBIX™ is a prescription HIV-1 (Human Immunodeficiency Medihaler,® Migergot,® Wigraine,® Wigrettes®), methylergonovine Virus 1) medicine used with other antiretroviral medicines to treat (Methergine®), lovastatin or a product that contains lovastatin HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired (Altoprev,® Advicor,® Mevacor®), lurasidone (Latuda®), oral Immune Deficiency Syndrome). PREZCOBIX™ contains the prescription midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), medicines PREZISTA® (darunavir) and TYBOST® (cobicistat). rifampin (Rifadin,® Rifater,® Rifamate,® Rimactane®), sildenafil ® ™ (Revatio ) when used for pulmonary arterial hypertension (PAH), • It is not known if PREZCOBIX is safe and effective in simvastatin or a product that contains simvastatin (Simcor,® children under 18 years of age. Vytorin,® Zocor®), St. John’s Wort (Hypericum perforatum) or a • When used with other antiretroviral medicines to treat product that contains St. John’s Wort, or triazolam (Halcion®). ™ HIV-1 infection, PREZCOBIX may help: • Serious problems can happen if you take any of these medicines ○ reduce the amount of HIV-1 in your blood. This is called “viral load.” with PREZCOBIX.™ ○ increase the number of CD4+ (T) cells in your blood that help What should I tell my healthcare provider before fight off other infections. taking PREZCOBIX™? • PREZCOBIX™ is always taken in combination with other HIV • About all health problems. Tell your healthcare provider if you medications for the treatment of HIV-1 infection in adults. have liver problems, including hepatitis B or hepatitis C, have kidney PREZCOBIX™ should be taken once daily with food. problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition, are pregnant, ™ • PREZCOBIX does not cure HIV-1 infection or AIDS, and you breastfeeding, or plan to become pregnant or breastfeed. Tell your may still experience illnesses associated with HIV-1 infection. healthcare provider if you become pregnant while taking PREZCOBIX.™ You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. • About all medicines you take. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter • Ask your healthcare provider if you have any questions medicines, vitamins, and herbal supplements. Some medicines interact on how to prevent passing HIV to other people. with PREZCOBIX.™ Keep a list of your medicines to show your • Please read the Important Safety Information below healthcare provider and pharmacist. Do not start taking and talk to your healthcare provider to learn a new medicine without telling your healthcare provider. if PREZCOBIX™ is right for you. Your healthcare provider can tell you if it is safe to take PREZCOBIX™ with other medicines. IMPORTANT SAFETY INFORMATION What are the possible side effects of PREZCOBIX™? B:10.75 in T:10.5 in What is the most important information I should know • The most common side effects of darunavir, one of the S:9.5 in about PREZCOBIX™? medicines in PREZCOBIX,™ include diarrhea, nausea, rash, headache, stomach area (abdominal) pain, and vomiting. • PREZCOBIX™ may cause liver problems. Some people taking PREZCOBIX™ may develop liver problems which may be • Other possible side effects include: life-threatening. Your healthcare provider should do blood tests ™ ○ High blood sugar, diabetes or worsening diabetes, and before and during your treatment with PREZCOBIX. increased bleeding in people with hemophilia have been ○ Chronic hepatitis B or C infection may increase your chance reported in patients taking protease inhibitor medicines, of developing liver problems. Your healthcare provider including PREZCOBIX.™ should check your blood tests more often. ○ Changes in body fat can happen in people who take ○ Signs and symptoms of liver problems include dark (tea-colored) HIV-1 medicines. The exact cause and long-term health urine, yellowing of your skin or whites of your eyes, pale-colored effects of these changes are not known. stools (bowel movements), nausea, vomiting, pain or tenderness ○ Changes in your immune system (Immune Reconstitution on your right side below your ribs, or loss of appetite. Tell your Syndrome) can happen when you start taking HIV medicines. healthcare provider if you develop any of these symptoms. Your immune system may get stronger and begin to fight • PREZCOBIX™ may cause severe or life-threatening skin infections that have been hidden in your body for a long time. reactions or rash. Sometimes these skin reactions and skin These are not all of the possible side effects of PREZCOBIX.™ rashes can become severe and require treatment in a hospital. For more information, ask your healthcare provider. Call your healthcare provider right away if you develop a rash.

™ Tell your healthcare provider if you have any side effect that bothers ○ Stop taking PREZCOBIX and call your healthcare provider right you or that does not go away. away if you develop any skin changes with symptoms such as fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores You are encouraged to report negative side effects of or ulcers, red or inflamed eyes like “pink eye” (conjunctivitis). prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. • PREZCOBIX,™ when taken with certain other medicines, can cause new or worse kidney problems, including kidney failure. Please see accompanying full Product Information Your healthcare provider should check your kidneys before you start for more details. and while you are taking PREZCOBIX.™ Who should not take PREZCOBIX™? Janssen Therapeutics, • Do not take PREZCOBIX™ with any of the following medicines: Division of Janssen Products, LP alfuzosin (Uroxatral®), cisapride (Propulsid,® Propulsid® Quicksolv), colchicine (Colcrys,® Mitigare,® if you have liver or kidney problems), dronedarone (Multaq®), dihydroergotamine (D.H.E.45,® Embolex,® © Janssen Therapeutics, Division of Janssen Products, LP 2015 Migranal®), ergotamine tartrate (Cafergot,® Ergomar,® Ergostat,®® 01/15 008417-140113 027409-150108

Date: 02/09/15 Customer Code: 008417-140113 Group 360 Job #: 722793 File Name: 008417-140113_722793_v1a (Left hand page 1) Brand: Prezcobix Size: 8" x 10.5" Colors: CMYK Description: DISCOVER YOUR WISDOM WITHIN Pub: Positivly Aware (March/April 2015 Issue)

K P G75 M50 K75 Y50 GN M25 B C75 M75 K25 Y C50 M G25 C Y75 K50 C25 G50 Y25 R B:8.25 in B:8.25 in T:8 in T:8 in S:7 in S:7 in

WHAT IS PREZCOBIX™? • PREZCOBIX™ is a prescription HIV-1 (Human Immunodeficiency Medihaler,® Migergot,® Wigraine,® Wigrettes®), methylergonovine Virus 1) medicine used with other antiretroviral medicines to treat (Methergine®), lovastatin or a product that contains lovastatin HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired (Altoprev,® Advicor,® Mevacor®), lurasidone (Latuda®), oral Immune Deficiency Syndrome). PREZCOBIX™ contains the prescription midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), medicines PREZISTA® (darunavir) and TYBOST® (cobicistat). rifampin (Rifadin,® Rifater,® Rifamate,® Rimactane®), sildenafil ® ™ (Revatio ) when used for pulmonary arterial hypertension (PAH), • It is not known if PREZCOBIX is safe and effective in simvastatin or a product that contains simvastatin (Simcor,® children under 18 years of age. Vytorin,® Zocor®), St. John’s Wort (Hypericum perforatum) or a • When used with other antiretroviral medicines to treat product that contains St. John’s Wort, or triazolam (Halcion®). ™ HIV-1 infection, PREZCOBIX may help: • Serious problems can happen if you take any of these medicines ○ reduce the amount of HIV-1 in your blood. This is called “viral load.” with PREZCOBIX.™ ○ increase the number of CD4+ (T) cells in your blood that help What should I tell my healthcare provider before fight off other infections. taking PREZCOBIX™? • PREZCOBIX™ is always taken in combination with other HIV • About all health problems. Tell your healthcare provider if you medications for the treatment of HIV-1 infection in adults. have liver problems, including hepatitis B or hepatitis C, have kidney PREZCOBIX™ should be taken once daily with food. problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition, are pregnant, ™ • PREZCOBIX does not cure HIV-1 infection or AIDS, and you breastfeeding, or plan to become pregnant or breastfeed. Tell your may still experience illnesses associated with HIV-1 infection. healthcare provider if you become pregnant while taking PREZCOBIX.™ You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. • About all medicines you take. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter • Ask your healthcare provider if you have any questions medicines, vitamins, and herbal supplements. Some medicines interact on how to prevent passing HIV to other people. with PREZCOBIX.™ Keep a list of your medicines to show your • Please read the Important Safety Information below healthcare provider and pharmacist. Do not start taking and talk to your healthcare provider to learn a new medicine without telling your healthcare provider. if PREZCOBIX™ is right for you. Your healthcare provider can tell you if it is safe to take PREZCOBIX™ with other medicines. Wisdom inspired { by real people IMPORTANT SAFETY INFORMATION What are the possible side effects of PREZCOBIX™? B:10.75 in B:10.75 in T:10.5 in T:10.5 in S:9.5 in What is the most important information I should know • The most common side effects of darunavir, one of the S:9.5 in about PREZCOBIX™? medicines in PREZCOBIX,™ include diarrhea, nausea, rash, headache, stomach area (abdominal) pain, and vomiting. • PREZCOBIX™ may cause liver problems. Some people taking PREZCOBIX™ may develop liver problems which may be • Other possible side effects include: life-threatening. Your healthcare provider should do blood tests ™ ○ High blood sugar, diabetes or worsening diabetes, and before and during your treatment with PREZCOBIX. increased bleeding in people with hemophilia have been ○ Chronic hepatitis B or C infection may increase your chance reported in patients taking protease inhibitor medicines, of developing liver problems. Your healthcare provider including PREZCOBIX.™ should check your blood tests more often. ○ Changes in body fat can happen in people who take ○ Signs and symptoms of liver problems include dark (tea-colored) HIV-1 medicines. The exact cause and long-term health urine, yellowing of your skin or whites of your eyes, pale-colored effects of these changes are not known. stools (bowel movements), nausea, vomiting, pain or tenderness ○ Changes in your immune system (Immune Reconstitution on your right side below your ribs, or loss of appetite. Tell your Syndrome) can happen when you start taking HIV medicines. healthcare provider if you develop any of these symptoms. Your immune system may get stronger and begin to fight • PREZCOBIX™ may cause severe or life-threatening skin infections that have been hidden in your body for a long time. reactions or rash. Sometimes these skin reactions and skin These are not all of the possible side effects of PREZCOBIX.™ rashes can become severe and require treatment in a hospital. For more information, ask your healthcare provider. Call your healthcare provider right away if you develop a rash.

™ Tell your healthcare provider if you have any side effect that bothers ○ Stop taking PREZCOBIX and call your healthcare provider right you or that does not go away. away if you develop any skin changes with symptoms such as fever, DISCOVER YOUR WISDOM WITHIN tiredness, muscle or joint pain, blisters or skin lesions, mouth sores You are encouraged to report negative side effects of or ulcers, red or inflamed eyes like “pink eye” (conjunctivitis). prescription drugs to the FDA. Visit www.fda.gov/medwatch Visit PREZCOBIX.com to hear wisdom inspired by experts and people like you living with HIV. or call 1-800-FDA-1088. * ™ • PREZCOBIX,™ when taken with certain other medicines, can Ask your provider if Once-Daily PREZCOBIX is right for you. cause new or worse kidney problems, including kidney failure. Please see accompanying full Product Information Your healthcare provider should check your kidneys before you start for more details. and while you are taking PREZCOBIX.™ Who should not take PREZCOBIX™? Janssen Therapeutics, • Do not take PREZCOBIX™ with any of the following medicines: Division of Janssen Products, LP alfuzosin (Uroxatral®), cisapride (Propulsid,® Propulsid® Quicksolv), colchicine (Colcrys,® Mitigare,® if you have liver or kidney problems), PREZCOBIX.com dronedarone (Multaq®), dihydroergotamine (D.H.E.45,® Embolex,® © Janssen Therapeutics, Division of Janssen Products, LP 2015 Migranal®), ergotamine tartrate (Cafergot,® Ergomar,® Ergostat,®® ™ 01/15 008417-140113 027409-150108 *PREZCOBIX is taken in combination with other HIV medications for the treatment of HIV-1 infection in adults.

Date: 02/09/15 Customer Code: 008417-140113 Group 360 Job #: 722793 Date: 02/09/15 Customer Code: 008417-140113 Group 360 Job #: 722793 File Name: 008417-140113_722793_v1a (Left hand page 1) Brand: Prezcobix File Name: 008417-140113_722793_v1a (Right hand page 2) Brand: Prezcobix Size: 8" x 10.5" Colors: CMYK Description: DISCOVER YOUR WISDOM WITHIN Size: 8.5" x 11" Colors: CMYK Description: DISCOVER YOUR WISDOM WITHIN Pub: Positivly Aware (March/April 2015 Issue) Pub: Positively Aware (March/April 2015 Issue)

K P G75 M50 K75 Y50 GN M25 B C75 M75 K25 Y C50 M G25 C Y75 K50 C25 G50 Y25 R K P G75 M50 K75 Y50 GN M25 B C75 M75 K25 Y C50 M G25 C Y75 K50 C25 G50 Y25 R IMPORTANT PATIENT INFORMATION PATIENT INFORMATION • increase the number of CD4+ (T) cells in your blood that PREZCOBIX (prez-koe-bix) help fight off other infections. (darunavir and cobicistat) Reducing the amount of HIV-1 and increasing the CD4+ (T) tablets cells in your blood may help improve your immune system. Please read this information before you start taking This may reduce your risk of death or getting infections that PREZCOBIX and each time you get a refill. There may be new can happen when your immune system is weak (opportunistic information. This information does not take the place of talking infections). with your healthcare provider about your medical condition PREZCOBIX does not cure HIV-1 infection or AIDS. You must or treatment. What is the most important information I should keep taking HIV-1 medicines to control HIV-1 infection and know about PREZCOBIX? decrease HIV-related illnesses. • PREZCOBIX may cause liver problems. Some people taking Avoid doing things that can spread HIV-1 infection to others. PREZCOBIX may develop liver problems which may be life- threatening. Your healthcare provider should do blood tests • Do not share or re-use needles or other injection equipment. before and during your treatment with PREZCOBIX. If you • Do not share personal items that can have blood or body have chronic hepatitis B or C infection, your healthcare fluids on them, like toothbrushes and razor blades. provider should check your blood tests more often because • Do not have any kind of sex without protection. Always you have an increased chance of developing liver problems. practice safe sex by using a latex or polyurethane condom Tell your healthcare provider if you have any of the below to lower the chance of sexual contact with semen, vaginal signs and symptoms of liver problems. secretions, or blood. • dark (tea colored) urine Ask your healthcare provider if you have any questions on • yellowing of your skin or whites of your eyes how to prevent passing HIV to other people. • pale colored stools (bowel movements) Who should not take PREZCOBIX? • nausea Do not take PREZCOBIX with any of the following medicines: • vomiting • alfuzosin (Uroxatral®) • pain or tenderness on your right side below your ribs • cisapride (Propulside®, Propulsid® Quicksolv) • loss of appetite • colchicine (Colcrys®, Mitigare®), if you have liver or kidney • PREZCOBIX may cause severe or life-threatening skin problems reactions or rash. Sometimes these skin reactions and • dronedarone (Multaq®) skin rashes can become severe and require treatment in • ergot-containing medicines: a hospital. Call your healthcare provider right away if you • dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®) develop a rash. Stop taking PREZCOBIX and call your • ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, healthcare provider right away if you develop any skin Medihaler®, Migergot®, Wigraine®, Wigrettes®) changes with symptoms below: • methylergonovine (Methergine®) • fever • lovastatin or a product that contains lovastatin (Altoprev®, • tiredness Advicor®, Mevacor®) • muscle or joint pain • lurasidone (Latuda®) • blisters or skin lesions • midazolam (Versed®), when taken by mouth • mouth sores or ulcers • pimozide (Orap®) • red or inflamed eyes, like “pink eye” (conjunctivitis) • ranolazine (Ranexa®) • PREZCOBIX when taken with certain other medicines can • rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) cause new or worse kidney problems, including kidney • sildenafil (Revatio®), when used for the treatment of failure. Your healthcare provider should check your kidneys pulmonary arterial hypertension (PAH) before you start and while you are taking PREZCOBIX. • simvastatin or a product that contains simvastatin (Simcor®, See “What are the possible side effects of PREZCOBIX?” for Vytorin®, Zocor®) more information about side effects. • St. John’s Wort (Hypericum perforatum), or a product that What is PREZCOBIX? contains St. John’s Wort ® PREZCOBIX is a prescription HIV-1 (Human Immunodeficiency • triazolam (Halcion ) Virus 1) medicine used with other antiretroviral medicines to Serious problems can happen if you take any of these treat HIV-1 infection in adults. HIV is the virus that causes medicines with PREZCOBIX. AIDS (Acquired Immune Deficiency Syndrome). What should I tell my healthcare provider before taking PREZCOBIX contains the prescription medicines PREZISTA PREZCOBIX? (darunavir) and TYBOST (cobicistat). Before taking PREZCOBIX, tell your healthcare provider if you: It is not known if PREZCOBIX is safe and effective in children • have liver problems, including hepatitis B or hepatitis C under 18 years of age. • have kidney problems When used with other antiretroviral medicines to treat HIV-1 • are allergic to sulfa (sulfonamide) infection, PREZCOBIX may help: • have diabetes • reduce the amount of HIV-1 in your blood. This is called • have hemophilia “viral load”. • have any other medical condition IMPORTANT PATIENT INFORMATION IMPORTANT PATIENT INFORMATION PATIENT INFORMATION • increase the number of CD4+ (T) cells in your blood that • are pregnant or plan to become pregnant. It is not known The exact cause and long-term health effects of these PREZCOBIX (prez-koe-bix) help fight off other infections. if PREZCOBIX will harm your unborn baby. Tell your conditions are not known. (darunavir and cobicistat) Reducing the amount of HIV-1 and increasing the CD4+ (T) healthcare provider if you become pregnant while taking • Changes in your immune system (Immune Reconstitution PREZCOBIX. tablets cells in your blood may help improve your immune system. Syndrome) can happen when you start taking HIV-1 Please read this information before you start taking This may reduce your risk of death or getting infections that • Pregnancy Registry: There is a pregnancy registry medicines. Your immune system may get stronger and for women who take antiretroviral medicines during PREZCOBIX and each time you get a refill. There may be new can happen when your immune system is weak (opportunistic begin to fight infections that have been hidden in your body pregnancy. The purpose of the registry is to collect information. This information does not take the place of talking for a long time. Tell your healthcare provider right away if infections). information about the health of you and your baby. Talk with your healthcare provider about your medical condition you start having new symptoms after starting your HIV-1 PREZCOBIX does not cure HIV-1 infection or AIDS. You must to your healthcare provider about how you can take part medicine. or treatment. What is the most important information I should keep taking HIV-1 medicines to control HIV-1 infection and in this registry. know about PREZCOBIX? • Increased bleeding for hemophiliacs. Some people decrease HIV-related illnesses. • are breastfeeding or plan to breastfeed. Do not breastfeed with hemophilia have increased bleeding with protease • PREZCOBIX may cause liver problems. Some people taking Avoid doing things that can spread HIV-1 infection to others. if you take PREZCOBIX. inhibitors including PREZCOBIX. PREZCOBIX may develop liver problems which may be life- • You should not breastfeed if you have HIV-1 because of The most common side effects of darunavir, one of the threatening. Your healthcare provider should do blood tests • Do not share or re-use needles or other injection equipment. the risk of passing HIV to your baby. medicines in PREZCOBIX, include: before and during your treatment with PREZCOBIX. If you • Do not share personal items that can have blood or body • It is not known if PREZCOBIX can pass into your breast have chronic hepatitis B or C infection, your healthcare fluids on them, like toothbrushes and razor blades. milk. • diarrhea provider should check your blood tests more often because • Do not have any kind of sex without protection. Always • Talk to your healthcare provider about the best way to • nausea you have an increased chance of developing liver problems. practice safe sex by using a latex or polyurethane condom feed your baby. • rash • headache Tell your healthcare provider if you have any of the below to lower the chance of sexual contact with semen, vaginal Tell your healthcare provider about all the medicines you secretions, or blood. • stomach area (abdominal) pain signs and symptoms of liver problems. take, including prescription and over-the-counter medicines, • vomiting Ask your healthcare provider if you have any questions on vitamins, and herbal supplements. Some medicines interact • dark (tea colored) urine Tell your healthcare provider if you have any side effect that • yellowing of your skin or whites of your eyes how to prevent passing HIV to other people. with PREZCOBIX. Keep a list of your medicines to show your healthcare provider and pharmacist. bothers you or that does not go away. • pale colored stools (bowel movements) Who should not take PREZCOBIX? • nausea • You can ask your healthcare provider or pharmacist for a These are not all of the possible side effects of PREZCOBIX. Do not take PREZCOBIX with any of the following medicines: For more information, ask your health care provider. • vomiting ® list of medicines that interact with PREZCOBIX. • alfuzosin (Uroxatral ) • Do not start taking a new medicine without telling your Call your doctor for medical advice about side effects. You • pain or tenderness on your right side below your ribs • cisapride (Propulside®, Propulsid® Quicksolv) • loss of appetite healthcare provider. Your healthcare provider can tell may report side effects to FDA at 1-800-FDA-1088. • colchicine (Colcrys®, Mitigare®), if you have liver or kidney you if it is safe to take PREZCOBIX with other medicines. • PREZCOBIX may cause severe or life-threatening skin problems How should I store PREZCOBIX? reactions or rash. Sometimes these skin reactions and • dronedarone (Multaq®) How should I take PREZCOBIX? • Store PREZCOBIX tablets at room temperature between skin rashes can become severe and require treatment in • ergot-containing medicines: • Take PREZCOBIX exactly as your healthcare provider tells 68°F to 77°F (20°C to 25°C). you. a hospital. Call your healthcare provider right away if you • dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®) Keep PREZCOBIX and all medicines out of reach of children. • Do not change your dose or stop taking PREZCOBIX without develop a rash. Stop taking PREZCOBIX and call your • ergotamine tartrate (Cafergot®, Ergomar®, Ergostat®, General information about PREZCOBIX healthcare provider right away if you develop any skin ® ® ® ® talking to your healthcare provider. Medihaler , Migergot , Wigraine , Wigrettes ) • Take PREZCOBIX 1 time a day with food. Medicines are sometimes prescribed for purposes other changes with symptoms below: ® • methylergonovine (Methergine ) • If you miss a dose of PREZCOBIX by less than 12 hours, take than those listed in a Patient Information leaflet. Do not use • fever ® • lovastatin or a product that contains lovastatin (Altoprev , your missed dose of PREZCOBIX right away. Then take your PREZCOBIX for a condition for which it was not prescribed. • tiredness ® ® Advicor , Mevacor ) next dose of PREZCOBIX at your regularly scheduled time. Do not give PREZCOBIX to other people, even if they have the • muscle or joint pain • lurasidone (Latuda®) • If you miss a dose of PREZCOBIX by more than 12 hours, same symptoms that you have. It may harm them. • blisters or skin lesions • midazolam (Versed®), when taken by mouth wait and then take the next dose of PREZCOBIX at your • mouth sores or ulcers If you would like more information, talk with your healthcare • pimozide (Orap®) regularly scheduled time. provider. You can ask your healthcare provider or pharmacist • red or inflamed eyes, like “pink eye” (conjunctivitis) • ranolazine (Ranexa®) • If a dose of PREZCOBIX is skipped, do not double the next for information about PREZCOBIX that is written for health • PREZCOBIX when taken with certain other medicines can • rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) dose. Do not take more or less than your prescribed dose professionals. cause new or worse kidney problems, including kidney • sildenafil (Revatio®), when used for the treatment of of PREZCOBIX at any one time. For more information call 1-800-526-7736. failure. Your healthcare provider should check your kidneys pulmonary arterial hypertension (PAH) • If you take too much PREZCOBIX, call your healthcare What are the ingredients in PREZCOBIX? before you start and while you are taking PREZCOBIX. • simvastatin or a product that contains simvastatin (Simcor®, provider or go to the nearest hospital emergency room Active ingredients: darunavir and cobicistat See “What are the possible side effects of PREZCOBIX?” for Vytorin®, Zocor®) right away. more information about side effects. • St. John’s Wort (Hypericum perforatum), or a product that What are the possible side effects of PREZCOBIX? Inactive ingredients: colloidal silicon dioxide, crospovidone, contains St. John’s Wort hypromellose, magnesium stearate, and silicified micro- What is PREZCOBIX? PREZCOBIX may cause serious side effects including: crystalline cellulose. The tablets are film-coated with a • triazolam (Halcion®) PREZCOBIX is a prescription HIV-1 (Human Immunodeficiency • See “What is the most important information I should coating material containing iron oxide black, iron oxide red, Virus 1) medicine used with other antiretroviral medicines to Serious problems can happen if you take any of these know about PREZCOBIX?” polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), treat HIV-1 infection in adults. HIV is the virus that causes medicines with PREZCOBIX. • Diabetes and high blood sugar (hyperglycemia). Some talc, and titanium dioxide. AIDS (Acquired Immune Deficiency Syndrome). people who take protease inhibitors including PREZCOBIX What should I tell my healthcare provider before taking can get high blood sugar, develop diabetes, or your Manufactured by: PREZCOBIX contains the prescription medicines PREZISTA PREZCOBIX? diabetes can get worse. Tell your healthcare provider if you Janssen Ortho LLC, Gurabo, PR 00778 (darunavir) and TYBOST (cobicistat). Before taking PREZCOBIX, tell your healthcare provider if you: notice an increase in thirst or urinate often while taking Manufactured for: It is not known if PREZCOBIX is safe and effective in children • have liver problems, including hepatitis B or hepatitis C PREZCOBIX. Janssen Therapeutics, Division of Janssen Products, L P, under 18 years of age. • have kidney problems • Changes in body fat can happen in people who take Titusville NJ 08560 When used with other antiretroviral medicines to treat HIV-1 • are allergic to sulfa (sulfonamide) HIV-1 medications. The changes may include an increased Issued: January 2015 • have diabetes infection, PREZCOBIX may help: amount of fat in the upper back and neck (“buffalo hump”), © Janssen Pharmaceuticals, Inc. 2015 • reduce the amount of HIV-1 in your blood. This is called • have hemophilia breast, and around the middle of your body (trunk). Loss “viral load”. • have any other medical condition of fat from the legs, arms, and face may also happen. 027415-150108 What about condoms? A heartfelt message from the “Why can’t people creator of PrEP Facts: Rethinking just use condoms?” HIV Prevention and Sex Ar s a P EP educator and psychotherapist, b y Damon L. Jacobs this is the reaction I receive most consistently when I explain the benefits of using pre-exposure prophylaxis (PrEP) to prevent HIV. There is an implicit notion that gay and bisexual men “should” use condoms to prevent HIV, to decrease disease, to take responsibility for one’s health. However, the proponents of this argument constantly ignore one tiny flaw in their logic: Skin-to-skin sex feels better for most people. Believe me, I understand the essential role condoms have played in preventing HIV. My first experience of living and working in the gay community was in 1990 at The Patio Café on Castro Street. That was during the time when knowing people with AIDS, living with people with AIDS, working with people with AIDS, serving people with AIDS, loving

40 MAY+JUNE 2015 POSITIVELY AWARE people with AIDS, fucking people with AIDS, Ds e pite the overwhelming evidence demonstrating meant losing people with AIDS. I did all of PrEP’S effectiveness in individuals who took it daily during the the above, and lost a lot during that era. groundbreaking iPrEx study (not one single infection with daily use), During this time I was also getting people were not learning about this essential new strategy. my undergraduate degree in psychology. However, nothing in academia encouraged and alienated the individuals who weren’t fol- M eanwhile, there are those who main- or rewarded using education and activism to lowing suit. It made me realize that I wasn’t tain that “condoms only” is still the best improve mental health. It seemed incongru- someone my friends could trust with these way to prevent HIV. They wish to ignore ent, if not unethical, for me to be living in one pleasurable yet terrifying experiences. It history, human nature, medical advances, of the areas hit hardest by the AIDS epidemic revealed to me the limitations of a rigid HIV pleasurable choices. They believe that if we and not be actively involved in the solution. prevention strategy that reflected a medical continue to beat the drum of “condoms, con- How could I truly serve my community’s ideal while ignoring complicated feelings of doms, condoms” that somehow people will emotional needs if I wasn’t doing something ambivalence, confusion, and hunger to share wake up and use condoms more in 2015 to resolve the source of so much trauma and another man’s body without barriers. than they did in 1992. anguish? It was time to get active. Over the next decade, new HIV rates I learned from my failures in the ’90s By 1992, we had a very clear understand- in the U.S. remained consistent, at about the most important lessons of my career: ing of how HIV was spread, and how con- 50,000 per year, with no significant rises Listen to what people are telling you with doms could prevent transmissions. The exact or decreases. So in 2011, when I began their words and their actions. People want to stats were always sketchy, but my early train- learning about a daily pill called Truvada that experience the maximal pleasure, with the ing taught they were “about 98%” effective if can prevent HIV by up to 99% when used minimal consequences. They want to have used consistently and correctly. With that in daily, I had to seriously take pause. Could more connection, with fewer barriers. They mind, I began volunteering for an organization this finally be the key to bringing down new want to feel heightened physical sensations, that was running a “100%” campaign, hand- infection rates after a decade of stagnation? with lowered medical risks. Why not support ing out condoms, lube, pins, and pamphlets, I decided that for myself this would be the individuals of all HIV statuses in discovering on street corners and in bars, that said ideal strategy for remaining HIV-negative the most proactive, responsible, empowered, “100%”. The intention of this marketing tool after 22 years of being sexually active and and healthy means of experiencing pleasure was to let people know that if everyone used constantly worrying if and when and how I as possible? condoms 100% of the time—everyone who would someday become HIV-positive. For is HIV-positive, everyone who is HIV-negative, these reasons, I began using Truvada as everyone who is having sex at all—then we PrEP on a daily basis on July 19, 2011. Damon L. Jacobs has been working in would eradicate this epidemic by the year However, despite the overwhelming HIV prevention education since 1991, and 2000. We had people wear the shirts and evidence demonstrating PrEP’s effectiveness has been a Licensed Marriage and Family pins as a sign of their commitment to 100% in individuals who took it daily during the Therapist since 2003. His “PrEParing for condom use. It made perfect sense. groundbreaking iPrEx study (not one single P.L.E.A.S.U.R.E.” presentation has now But what happened? People didn’t use infection with daily use), people were not been seen throughout the state of New condoms consistently. Even back during learning about this essential new strategy. York, as well as the 2015 Conference on the darkest day of this epidemic, when the Initially, I attributed the dearth of media Retroviruses and Opportunistic Infections consequences of not using condoms were coverage and community dialogue to the fact (CROI), and the 2015 European AIDS potentially an excruciatingly painful death, that the Food and Drug Administration (FDA) Treatment Group (EATG) conference. He has people didn’t use condoms consistently. had yet to approve its use. I figured that appeared on MSNBC, New York WPIX, Al Moreover, one by one, many of my col- on the day the FDA approved PrEP people Jazeera America, NPR, and The Huffington leagues, co-workers, lovers, roommates, and would swarm the streets of Manhattan in Post Live, as well as in The New York Times, friends became newly HIV-positive. So much jubilation, much like they did when Marriage USA Today, and Out magazine. for ending HIV by the new millennium. Equality passed in New York the year before. I had an opportunity to ask a good friend Not so much. The FDA approved Truvada Edt i or’s note: The Truvada for PrEP drug about this many years later. I wondered to as PrEP as the first, and to date only, HIV label states that it should be used in addi- him, “Was getting HIV the result of a con- prevention strategy (nope, condoms were tion to condoms, while at the same time dom breaking? Was there an accident? We never FDA approved) on July 16, 2012. I stating that one of the populations indicated always talked about condom use, so how waited for the confetti, the glitter, the tri- for PrEP use is people at high-risk who did this happen?” My friend, who is still very umphant shouts of joy, or at least someone use condoms inconsistently or not at all. healthy today, told me, “Actually, Damon, I who was happy about this. Instead, noth- Moreoever, data from the CDC indicate that wasn’t using condoms consistently. I under- ing. There were no major announcements, the effectiveness of consistent use of con- stood what the risks were, and I was embar- community events, pride parties, organiza- doms for HIV prevention is 70% among gay rassed to tell you because I knew you were tional forums, subway ads, street rallies, bar and other men who have sex with men. Also, right about that. But regardless of the facts, crawls, nor mainstream communications although iPrEx estimated a 99% efficacy I wasn’t using condoms 100% and was too that heralded this new era of hope. It wasn’t with Truvada PrEP for those who took the e ashamed to talk about how much better sex until two years later, after the Centers for drug every day, the more widely accepted yt b felt without them.” Disease Control (CDC) and the World Health figure for the high end is 96% reduction in k c

o That was a difficult conversation to have. Organization (WHO) both endorsed PrEP, HIV infections with four tablets a week. See t It forced me to understand how all my frantic that it seemed people started learning about PA Associate Editor Enid Vázquez’s blog, Tell o: S t efforts to get everyone in the community to it, talking about it, and making rational deci- It To Enid, for a one-on-one discussion with

Pho use a condom 100% inadvertently shamed sions about their own use. Damon L. Jacobs at positivelyaware.com.

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43 Y Y brunch, a BBQ, or a casual walk by the lake- that was not entirely rational. I had never front represent far less strenuous options. had nor cared for a pet and at the time However, once I drag myself out of bed, struggled to make sound decisions caring for deftly avoid Fred’s stink eye and obvious myself. What made me think a dog would be displeasure at my early arousal, and power the answer? through a shower while getting ready for But Fred brought me back to life. With an outdoor training ride, it all comes back boundless positive energy and unconditional to me. love, he was the antidote to my self-imposed Now in my fourth year, I do the Ride for isolation and he had no time or patience for AIDS Chicago for many reasons, but there my self-pity. In short order he taught me are three that I think are the most important. how to smile and laugh when I thought nei- First I ride because the Ride will forever ther might be possible ever again. However, be an integral part of the healing related to my healing was incomplete. Although Fred stigma that followed my own HIV diagnosis. was without question my guardian angel, Healing that, in part because of the Ride, my life very quickly became about my dog. has now turned into thriving. It was Fred and I (and me and Fred). I still Second, I ride because the people struggled in efforts to make new friends and associated with the Ride have become my reconnect to the community around me. family and friends. They have shown me So, one early afternoon in January 2012, and others like me unwavering support, and sitting in my parked car on the side of the demonstrate through action what it means to road with tears in my eyes following yet change the world. another intense session with my therapist, And third, I ride because whether it I got a Facebook notification on my cell means supporting the work TPAN does for phone, “Keith Stryker is at the Ride for AIDS our community or supporting the charitable Chicago Kick-Off Party.” Keith was someone work that Fred Says does for organizations I had met briefly a few weeks earlier. He is serving HIV-positive youth, I am unwaver- one of those people who draws attention ingly committed to making the world a better because he just exudes positive energy—you place for those affected by HIV/AIDS. can feel kindness and warmth when around My own journey with the Ride began in him. I had made a mental note to myself the 2012 (coincidentally the same year Fred day we met that this was someone I wanted Says became an official non-profit organiza- in my life. tion). I had had my share of challenges in Without giving it much thought—like the years leading up to my first Ride. I dealt thinking that I did not even own a bike—I with a cancer diagnosis in 2007; I spent the drove over and signed up for my first AIDS majority of 2008 and 2009 dealing with the Ride. Keith was the captain of my team, loss of a man I loved deeply and the end of Team CÜR. My first Ride was all about Team or unwilling to step forward and be open our 10-year relationship, one that I cherish to CÜR, and while it is not the kind of thing and honest about my own status. I stood this day. And in 2010 I was utterly devastat- you say at the time, I’m not sure the group paralyzed with fear, afraid of being visible, ed by my own HIV diagnosis. I felt damaged, of guys that were Team CÜR ever quite knew especially as a physician, not wanting others ashamed, and alone. Although I had always how important they were (and are) to me. to know about my struggles or about my been in my mind a silly and fun-loving guy, That first year was also about meeting HIV. I had talked freely and candidly over the each day was now a struggle. Self-pity had people from diverse segments of our com- years about overcoming cancer, but when become my reality, and it was not pretty. I munity; people too many to name, who were it came to discussing my HIV, stigma ruled. knew I needed to take back control of my it not for the Ride I would have never had I was always cleverly vague and used lan- life, I just didn’t know how. the pleasure of getting to know. Working guage such as “personal struggles” but could As a pediatrician at Lurie Children’s together with a singular fundraising focus, never utter the words “I am HIV-positive” in Hospital I had devoted my career to helping Team CÜR and the other teams and individu- public. And in that moment during the clos- adolescents and young people cope with als that formed the Ride became a family of ing ceremonies I stood silent, unable to just and manage HIV. There was irony in the sorts, and I was honored to be part of it. come out and say, “Hey! I am HIV positive, fact that I was unable to afford myself the However, there was a defining moment and I just killed it and rode 200 miles on my same compassion I had spent my career in the Ride that first year during the closing bike!” I was so disappointed in myself for giving to others. But in 2011, I took my first ceremonies, when a group of HIV-positive giving HIV and stigma that much power and healing step. I drove to Gurnee, Illinois on a riders called the Poz Pedalers walked out control. I vowed that the next year would be frigid winter day and adopted a 10-week old with a riderless bicycle symbolizing all different, and it was. Yorkie puppy I aptly named Fred. those who have lost their lives to HIV/AIDS. I now participate in the Ride each year It was an impulsive decision, and one In that moment I felt like a fraud, unable as an openly HIV-positive man. I take my

44 MAY+JUNE 2015 POSITIVELY AWARE ‘Me y secr t weapon against the stigma that used to paralyze me remains the unconditional love I receive from my dog Fred.’

place alongside other Poz Pedalers next to In 2014, my third year doing the Ride, I T he 2015 Ride for AIDS Chicago takes that riderless bike, unapologetic about my became a team captain and formed Team place July 11–12; to register or for deatils past, proud of who I am, and feeling (pardon Fred. As a community partner, it was an go to rideforaids.org. For more information the pun) positive about my future. My secret amazing opportunity to help establish the about TPAN or Fred Says go to tpan.com and weapon against the stigma that used to giving of our grassroots charity Fred Says fredsays.org. paralyze me remains the unconditional love while simultaneously supporting the work of I receive from my dog Fred, who walks by TPAN. It was an opportunity we did not take D r. Robert Garofalo, MD, MPH, is a my side at the closing ceremonies, unaware lightly. In our first year Team Fred—almost Professor of Pediatrics and Preventative of the power of his being. Honesty about 40 members strong—raised just under Medicine at Northwestern University’s my HIV has also allowed me to be open to $80,000, and had lots of fun doing it. Feinberg School of Medicine. He is a national receiving love and support from my family So, we are back for 2015! Each member authority on LGBT health issues, adolescent and friends, many of whom are fellow riders. of Team Fred may ride for different reasons, sexuality, and HIV clinical care and preven- Too many HIV-positive people still live as I but we are committed to the Ride and to tion, and has served as principal investigator once did, in the shadows, afraid to ask for each other. For some, such as myself, the on several HIV prevention grants through help or afraid of being open with family or Ride may be part of their healing process. the National institutes of Health, targeting friends for fear that they may be judged or For some, the Ride may be about the cama- young men who have sex with men and alienated. For me the Ride remains part of raderie of teammates, friends, and family. transgender women. Dr. Garofalo is a for- my own healing, and I hope that being more But without question the one unifying reason mer past-President of the Gay and Lesbian open about my diagnosis may in some small for us all, is that the Ride is our way of help- Medical Association. He received his MD way help others to find the courage to do ing those in our community affected by from NYU School of Medicine and MPH from so as well. HIV/AIDS. the Harvard School of Public Health.

PITIVLOS E Y AWARE MAY+JUNE 2015 45 The 2015 Ride for AIDS Chicago JULY 11-12

JOIN US! #200MILES

details at rideforaids.org