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Aging and HIV THOUGHTS ON PrEP From the first person cured of hiv ARE YOU AT RISK FOR ANAL CANCER?

POSITIVELY AWARE The HIV Treatment Journal of Test Positive Aware Network JANUARY+FEBRUARY 2015

Leong-t rm survivors are not just living longer, they’re KICKING

TEZ ANDERSON AND MATT SHARP take on AIDS ASS SURVIVOR SYNDROME This page intentionally left blank. ➤

POSITIVELY AWARE Photo: number with your story. story. your with number phone and email address, name, your include please but publication, for apseudonym or W with [email protected]. TP © 2015. P garding R TI i Con Corre INBOX the property of TP of property the articles. submitted decline or edit to right the reserve TP Positive concerned with with concerned have found H no conclusive or indis may There be pages. himself within two author contradicts haveothers not.” The in semen, while haveies found write that “there is that evidence no [ write that “there H included in andgraphs stories “ C. hepatitis of transmission sexual risk for that increases anas activity 30 anal page on box without acondom sex hepatitis C. sexual risk for transmission reduce can of sex during that acondom he knows of use anal author in indicates 31 page on the box that anal for acondom is “wear sex.” Clearly, the your hepatitis risk reduce to for C,” point 3 “ the box found in semen.” “ writes, 29page the author in semen....” that it is found evidence is no there but blood, H “ the author writes, 2014 issue: Transmitted?” in the remember the many people affected by this the manyremember affected people out acondom.out sexually transmitted n n W e a I C C e A A V.” They are valuable as they ask us to e k V is found in semen, but if “some studies V is found studies in semen, “some butif V is present in V is present N N

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- er 5 o Wo h said that? Quo tes from stories appearing in this issue

POSITIVELY AWARE O n one hand, it’s a definite privilege J OurnalISM. INTEGRITY. HOPE. that we get to worry about aging ‘There are so many lessons with HIV, given where we were even 15 years ago. That doesn’t allay our Jeff Berry to be learned from long-term edt i or-in-Chief simultaneous concerns, however, about @P Aeditor survivors, and we hope to the special challenges we’ll confront “I love highlighting the teach as well as learn.’ as adults living with HIV enter their efforts of others who are doing groundbreaking Matt Sharp, co-founder of Let’s Kick Ass. ‘golden years.’ work. I feel this issue really Kicking Ass, beginning on page 16 accomplishes that.” Ric k Loftus, MD, in Aging GRACIE-fully, beginning on page 34 Enid Vázquez associate editor @enidvazquezpa “Troubles and concerns are seen as weaknesses, so it’s sometimes difficult Both currently and soon-to-be-available HCV for survivors to talk about DAAs offer much hope for people living with their fears.” HIV and HCV. Cure rates look to be very ‘It’s something easily Rick Guasco similar to those of mono-infected persons, Creaiv t e director and the regimens appear to be safe to take transmissible. You @rickguasco with HIV medications and do not impact “It wasn’t until reading don’t need to have this issue’s stories about CD4 counts. anal sex to have long-term survivors that I realized this is what I’ve An drew Reynolds, Writer and Project Inform educator. anal cancer.’ AASLD Conference Update, beginning on page 46. been experiencing myself.” Jun sti e Almada, co-founder of the HPV and Anal Cancer Jason Lancaster Foundation. Anal Cancer: Are p roofreader You at Risk?, beginning on page 20.

contributing writers L naura Jo es Carlos A. Perez Jim Pickett ‘I don’t care about what people think Andrew Reynolds Matt Sharp about me living with HIV, my life is meaningful, and [just] because ‘There are so many chances p hotographers of [my] circumstances, you cannot when I am vulnerable Dau ne Cramer John Gress judge me. I can do anything I want to HIV. I have to protect Chris Knight to do. I can be anything I want to be, myself with those things. and I’m powerful—and that’s what people feel when I speak.’ PrEP makes me feel like adr ve tising I am in control. It makes Lo n rrai e Hayes Mar ia Davis, HIV activist and speaker. Maria L [email protected] Davis Speaks Out, beginning on page 25. me feel empowered.’

Dib stri ution and Batie hab l , a Zimbabwean sex worker, Subscription services in the HIVR4P conference update, beginning on page 31. [email protected]

SINCE 1989. PUBLISHED BY ‘People wonder, “Why have I tried this hard if my future doesn’t look that great?” ’ This article will explain why my mindset toward PrEP for Nelon s Vergel, in The cost SUITE 300 of long-term survival. sexually active individuals and 5050 N. Broadway St. Beginning on page 42. Chicago, IL 60640-3016 injection drug users has been phone: (773) 989-9400 transformed dramatically. fax: (773) 989-9494 email: [email protected] Timothy Ray Brown, known as ‘The Berlin Patient.’ Thoughts on PrEP, beginning on page 44.

6 STIV PO I ELY AWARE JAnuary+FEbruary 2015 JNE A +F B 2015 V Olume 27 NUMBER 1

‘Kic k ass’ Photo shoot: Photographer Duane cramer (center) shot the cover story, taking time for a group selfie with Matt sharp (left) and tez anderson (right).

Drepa tments F eatures

5 In Box 16 KiCKIng ASS n 31 Co feRENCE Update: n 46 Co feRENCE Update: Correcting a L ong-term survivors of HIVR4P AASLD contradiction in terms. HIV/AIDS take control of Integrating prevention News from the 2014 Support. Stigma. their destiny. strategies. Liver Meeting. Byi Dav d Duran Byc Jessi a Terlikowski By Andrew Reynolds 8 Th e Conversation readers sound off on 20 Anal cancer: 34 Aging GRACIE-fully what they feel are the Are you at risk? F acing the challenges of only on POSITIVELYAWARE.COM biggest issues facing A Pap smear that many growing older with HIV long-term survivors of men as a community. My Kind of life HIV. should get, too. By Rick Loftus, MD By Carlos A. Perez By Erin Marcus, MD D ance your ass off. 9 editor’s Note e42 Th cost of long- I’m a survivor. ria 25 Ma Davis term survival T ell it to Enid speaks out New fears evolving Byá Enid V zquez 10 Br iefly A long-term survivor and with age. D octors are long-term a new version activist opens up about Byá Enid V zquez survivors who also suffered. of Stribild. WHO life, love, HIV, and why recommends expanded we need to keep the 44 ThoUGHTS on naloxone access. conversation going. PrEP—from the Gay dating apps Inri te v ew By Jeff Berry first person team up with AIDS cured of HIV organizations. Byo Tim thy ray Brown

JAnuary+FEbruary 2015 POSITIVELY AWARE 7 TNVHE CO ERSATION

IN THE NOVEMBER+DECEMBER ISSUE, WE ASKED W hat do you think are the three biggest issues facing long-term survivors of HIV and AIDS?

W e received more responses to this question than to any other poll. The open-end- have, rather than seek treatment. ed, multiple-choice nature of our question made compilation of responses difficult. Quality of life is going to be the main Nevertheless, the usual suspects dominated responses: problems with health care, issue with a lot of people. finance, and social issues (among them stigma, shame, isolation, discrimination, addiction, depression, loneliness, survivor’s trauma, and survivor’s guilt). Some also mentioned isolation and discrimination specifically from the gay community. H ealth-related issues due to long- Following are a few of the comments from readers. term use of ARVs (I’ve already had both hips replaced at age 52 from Th is issue’s The three biggest issues facing stroke, and diabetes. Financial help Crixivan and have kidney failure from question: long-term survivors of HIV and AIDS? after years of illness-related lost Truvada—what next?). Have you ever How can anyone figure there are just employment and education. had to stop three issues at the top of a list—it’s a M y three biggest issues have been or switch an very, very long list, to be honest, and side effects of the HIV medications HIV medica- no one at this time is doing anything 1. the long-term effects of HIV causing life-threatening liver and medications. tion due to about it besides discussing it. Quality kidney problems, as well as depres- 2. Finding and sustaining mean- side effects? of life, equality, housing, health ingful long-term relationships. sion related to body-image changes care, and compassionate outreach. of severe lipodystrophy (and out-of- VOTE AT 3. dealing with survivor’s guilt— positivelyaware. Continuity of care in LGBT-oriented “Why did I live when so many pocket costs of $14,000 for plastic com. homes. Early aging, isolation... I could better people died?” surgery to slightly mitigate the buffalo go on for days. hump and turkey-waddle fat depos- its), coupled with erectile dysfunction S tigma is tops on my list, for it F or someone like me who went on issues and isolation from the gay keeps some from seeking care. LTD [long-term disability] in the early- community at large (all those “D&D- Lack of funding. Last, but not least, mid ’90s and having an LTD that free, UB2” types). HIV hasn’t been a discrimination. only goes to age 65, it is reinventing walk in the park on a sunny day for myself and finding a way to supple- me—wish I could report differently. PT SD from watching friends die. ment that LTD income once it stops. The trauma of our own loneliness. Having substantial fatigue, my energy 1. Mental health, after seeing so Planning for old age after missing is limited and I believe that my mental many close friends and loved many crucial work years to illness. acuity is somewhat diminished. ones die en masse and many of the ones left in depression Poverty; pain (neurological and D epression and social isolation. from survivor’s guilt. osteopathic); mental health (depres- Accelerated aging and frailty. Chronic 2. It’s very hard to talk about the early days when the “Oh, just sion, anxiety, and survivor guilt). conditions (such as diabetes, cardio- take a pill and things will be vascular disease, and osteoporosis) just fine” mentality is taken by A ging process. Loss of contact with caused by HIV itself, inflammation, the newly infected. friends. Lack of adequately trained and medication toxicity. 3. a feeling of being alone and health care providers. forgotten. Some deal with it by doing drugs and drinking I’ve been positive for 35 years, too much and other unhealthy Internalized stigma from long ago. and I am dealing with a lot of fatigue, activities, to try to block what Survivor syndrome. Fear of living—I neuropathy, and bowel issues, but my haunts you when you’re left thought I was dying for so long, it blood work looks fine, so my doctor with only your memories. became a habit. always thinks that the impact cannot be that much. F ew resources and support for A few single answers (some men- female longtime survivors; scarce Being a survivor of anal cancer tioned by several readers): Unresolved Read all the post-menopause support; poverty. and HIV (28 years), I have witnessed lipodystrophy. No work and no dis- responses TO the inability or the unwillingness to ability. Loneliness—a lot of our peers THIS ISSUE’S POLL QUESTION. E motional and mental health sup- continue life without a rectum and are gone. Pill fatigue. Staying relevant go to portive services, especially peer sup- the absence of anal intercourse. I in the fight against HIV. Finding joy positively aware.com. port, to heal from grief and trauma. have seen people just giving in to the and happiness again. Prevention of cancer, heart disease, outcome of the cancer or disease they

8 STIV PO I ELY AWARE JAnuary+FEbruary 2015 Pho to: CHRIS KNIGHT O A a normal, healthy and my C are the three most important issues facing long-term issues important most are the three again. Ikept thinking myself, to what we can do? expected to have. to living the Butas population people of expected during that time, which likely most my saved life defi but e question (see previous page). (see previous question and new tools weapons it. prove to Butwe need scars sinister enemy. us who of have through the Those come we as know syndrome significant problems socialin or work situations rela and survivors, and I identified andwith Iidentified manynot if survivors, allof them. order (PT order only when symptoms (which intrusive as manifest can nitely have taken their toll. me, however, and I still struggle with the effects to this to me, however, day. with and the effects Istill struggle mood, or changes in emotional reactions) start to cause orchanges cause to inmood, emotional reactions) start avoidance,memories, changes negative in thinking or up testing positive myself. The disorder was no less real to to real myself. positive up testing was disorder less no The Clinic, by a is amental health condition that’s triggered we reach them andwe let they’re them know reach alone? not our to poll last the many of some responses when Iread went into psychotherapy. PTSD,by the Mayo asdefined with words loneliness and isolation loneliness words up came over and over fight know thatfight enemy intimately, and we havebattle the it was triggered by living and endingit through was aholocaust triggered tionships, that it becomes a more serious issue. serious amore tionships, that it becomes fight to it. than simplythat is much there the to story num- more tually they’ll adjust and getbacktheir to “normal” life. It’s t terrifying event—either experiencing or witnessing it. experiencing witnessing or event—either terrifying bers and percentages. and percentages. bers hey may just have difficulty coping a heyfor may while, just havebut even difficulty veryone who experiences the event will who experiences develop PT veryone s Ip That’s whyThat’s Iwas simultaneously elated and deflated W I was first diagnosed with post-traumatic stress dis post-traumatic with stress diagnosed I was first I’ve probably been on ten different drug regimens tendifferent on been probably I’ve H h ored through the 10the ored comments, of pages so or ile my PT I V and S D D 4 T ) s A -cells and-cells C hortly after I tested positive in positive 1989 Itested and after hortly I S D D S H was related to childhood to was related sexual abuse, ages, we’re ages, beginning understand to I V-negative person my age might be V-negative person e las e r v I’ve stood in protest and marched on PCP prophylaxis, and made out living wills and medical powers of attorney. ticipated in abike ride. I’ve fallen in love, and broken hearts. and treatment, started I’ve developed strange maladies such as thrush, kidney and co-workers to sludge, and shingles. I’ve been poked, prodded and bled, and started stopped U A e I n D derneath the surface of the the of surface the derneath D S M ED O m I Jeff Berry Jeff t 4 p lies adarker lies and much more y v ’ h W ercentage are near what are near ercentage I e as iral is load undetectable, T O ked individualsked what R ’S t a 3

no 0-plus years I’ve lost hundreds of friends, acquaintances,

H te I su V and H o S w do D N - ; ot - - A - r I D S v . I A appreciate all through. that been they’ve about some of the pioneering of he’s work some about spearheading in Vergel we’re the price talksabout paying having for sur- generation—while honoring our history, and the fallen. define a generation.define to learn We have opportunity the cally our to own unique as needs L side effects, and fatigue—just to name a few—it seems seems name to afew—it and fatigue—just side effects, pay respect to our to and own soldiers, let we them know pay respect isolation, guilt, depression, of stigma, survivor’s crippling us just to friends, and expect familyour doctors, often re-assimilating, long-term survivors of of re-assimilating, survivors long-term it. worth it’s if question to reasonable who are the people of up programs and services designed and specifi tailored designed andup services programs using help to what their learned they’ve fellow warriors, vived, and the need for special services for for specialvived, for services and the need well into their golden years. They—we—deserve no less. no well They—we—deserve into their years. golden will help our veterans financially, mentally, physically,and who often feel alone and voiceless. alone feel and voiceless. who often help and let to there’s them know others, hope. S tells us in an interview how she uses her own story to to tells her own story us in how she an uses interview into their own hands. like People Tez the area of of the area be grateful to be alive. be to grateful be being Butif alive alifetime means battle andmade somehow it alive, out battle and who are now from our past, and our mentor to and an past, from teach entirely new that systems and support the structures us create to for feel out of place and useless. place and of out useless. feel o n h n the 25 years since Ifirst tested positive ftus, ftus, d long-term survivor and advocate/speaker and advocate/speaker survivor d long-term arp, amazing two individuals through the who’ve been Take yourself, of and other. care each Just as veterans as returningJust war from may have difficulty A It’s necessary to hear and share these stories, for they for stories, and hear to share these necessary It’s In this of issue i s m v W H any people pointed out in response to our to poll, in out pointed any response people a I V activist-turned-physician/researcher, and read shington, walked marathons and par- H I V and aging. r ly ly TIV Pos reaching out, and taking matters i J e A A c nuary+ tivist andtivist author W A ware e ne A I D Y ed to be sure that be to weed F o S A you’ll some meet Eb u’ll from hear H veterans. It’s time veterans. It’s n I derson and derson ruary 2015 P V/ W A e ne A I D I D M S N S ed to set set to ed can often often can a e veterans. ria lson lson M R D i a a ck vis - tt tt O S I TIV f to be alive. be to just grateful be usexpect to family often O eff l @P f riends, and and riends, o E ur doctors, LY l AED

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Pho to: Chris Knight Fol l ow Enid @ENIDVAZQUEZPA

anA APL press release, “The now “emphasizes consider- it only the second state in the three young people from around Pendleton/Goldman PrEP pro- ations for use of antiretroviral country to have a program like the world, including a college gram [began] serving patients (ARV) drugs in patients who this, the first being Washington girl from the U.S. who was born November 17, and will focus on also receive treatment for HCV state, which rolled out its PrEP with HIV. Watch the trailer at HIV-negative gay and bisexual infection. The section includes Drug Assistance Program in itsnotoverfilm.com. men, as well as transgender a new table (Table 12) that early 2014. IDPH HIV/AIDS women—a population that the provides clinicians with guid- Section Chief Mildred Williamson L egal woes unfold Centers for Disease Control and ance on the concomitant use of told the Windy City Times, for origami condom Prevention (CDC) says is statisti- HCV drugs and ARV drugs with “We’re incorporating PrEP inventor cally at higher risk for HIV. … It a focus on potential pharmaco- content into our fundamentals educates eligible HIV-negative kinetic drug interactions.” Read training for organizations that The Washington Free Beacon patients about and offers them the section at aidsinfo.nih.gov/ we fund who do HIV testing and reported that, “Origami condom access to Truvada—currently the guidelines/html/1/adult-and- counseling. We’re also sending inventor Daniel Resnic will now only drug approved for use as adolescent-arv-guidelines/26/ a ‘dear colleague’ letter to medi- have to find a third lawyer to PrEP—which is highly effective hiv-hcv. cal providers around the state take up his case against accusa- in preventing sexual transmission encouraging them to prescribe tions that he wasted millions of HIV.” To make an appoint- Chicago man arrested [Truvada] to high-risk persons of taxpayer dollars by using ment, call (323) 329-9900, or for not disclosing status they serve.” IDPH is also creat- grant money for plastic surgery, go to aplahw.org. to sex partner ing a statewide PrEP provider lavish vacations, parties at the referral list for counselors and Playboy Mansion, a Cadillac, G ay dating apps H IV activists were outraged their clients. and a condo in Provincetown, team up with AIDS after a young Chicago man was Massachusetts. The law firm organizations arrested at his job for alleg- N ew HIV documentary representing Resnic, who edly not disclosing that he had points out It’s Not Over received over $2.4 million from “ For the first time ever,” HIV to a sex partner.S The AID the National Institutes of Health reported the San Francisco AIDS Foundation of Chicago (AFC) It’s Not Over, a new feature- (NIH) to develop so-called Foundation (SFAF), “representa- charged mainstream media length documentary from origami condoms, was granted tives from seven of the largest with driving stigma instead of MTV star and award-winning a motion to be removed as gay dating and hook-up web- facts. Read the organization’s filmmaker Andrew Jenks, was his counsel on Oct. 28 in the sites and apps came together statement, along with links to released in October, and will be Superior Court of Los Angeles.” with HIV and STI prevention other reports, including an HIV distributed globally by Netflix, Read the report at freebeacon. leaders from around the coun- Plus magazine article detailing SnagFilms, and Pivot TV. Made com/issues/origami-condom- try to discuss how to create potential legal problems with possible by the MAC AIDS Fund, inventor-dropped-by-second- healthier online communities for the arrest, at aidschicago.org/ It’s Not Over follows the lives of lawyer/. gay and bisexual men.” Read inside-story/954-media-driven- about the October 2014 meeting stigma-continues-with-new-hiv- in a report at sfaf.org/hiv-info/ criminalization-case. hot-topics/from-the-experts/ hivstd-prevention-online-sur- Illinois to offer PrEP vey-results.html. drug assistance program H ep C guidelines updated In December the Illinois Department of Public Health The Department of Health and (IDPH) announced that it plans Human Services (DHHS) in to offer financial assistance for November updated the hep C/ PrEP (pre-exposure prophylaxis), HIV co-infection section of its beginning in January. Called HIV treatment guidelines, which PrEP4Illinois, this will make Sc ene from Jenks’ It’s Not Over.

JAnuary+FEbruary 2015 POSITIVELY AWARE 11 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. It STRIBILD without first talking to your tell your healthcare provider if you have before. STRIBILD does not cure HIV-1 or AIDS. combines 4 medicines into 1 pill to be healthcare provider, as they will need to or had any kidney, bone, or liver problems, taken once a day with food. STRIBILD monitor your health. STRIBILD is not including hepatitis virus infection. is a complete single-tablet regimen approved for the treatment of HBV. • All the medicines you take, including and should not be used with other prescription and nonprescription HIV-1 medicines. Who should not take STRIBILD? medicines, vitamins, and herbal I started my 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 infection and decrease HIV-related • Take a medicine that contains: medicines may affect how STRIBILD personal revolution illnesses you must keep taking STRIBILD. alfuzosin, dihydroergotamine, ergotamine, works. Keep a list of all your medicines 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, sildenafil when and pharmacist. Do not start any new passing HIV-1 to others. Always practice used for lung problems (Revatio®), medicines while taking STRIBILD Talk to your healthcare provider safer sex and use condoms to lower the triazolam, oral midazolam, rifampin without first talking with your about starting treatment. chance of sexual contact with body fluids. or the herb St. John’s wort. healthcare provider. 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 fluids on them. medicines, please see the Brief control (pills, patches, rings, shots, etc). STRIBILD is a complete HIV-1 Summary on the following pages. • If you take antacids. Take antacids at treatment in 1 pill, once a day. IMPORTANT SAFETY • Take any other medicines to treat least 2 hours before or after you take INFORMATION HIV-1 infection, or the medicine STRIBILD. adefovir (Hepsera®). What is the most important • If you are pregnant or plan Ask if it’s right for you. information I should know What are the other possible side to become pregnant. It is not about STRIBILD? effects of STRIBILD? known if STRIBILD can harm 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 breastfeeding medical emergency. Symptoms of healthcare provider should do regular (nursing) or plan to breast- lactic acidosis include feeling very blood and urine tests to check your feed. Do not breastfeed. weak or tired, unusual (not normal) kidneys before and during treatment HIV-1 can be passed to muscle pain, trouble breathing, with STRIBILD. If you develop kidney the baby in breast milk. stomach pain with nausea or vomiting, problems, your healthcare provider Also, some medicines in feeling cold especially in your arms may tell you to stop taking STRIBILD. STRIBILD can pass into and legs, feeling dizzy or lightheaded, breast milk, and it is not • Bone problems, including bone pain or and/or a fast or irregular heartbeat. known if this can harm bones getting soft or thin, which may lead the baby. • Serious liver problems. The liver may to fractures. Your healthcare provider may become large (hepatomegaly) and fatty do tests to check your bones. (steatosis). Symptoms of liver problems You are encouraged include your skin or the white part of • Changes in body fat can happen in to report negative side your eyes turns yellow (jaundice), dark people taking HIV-1 medicines. effects of prescription “tea-colored” urine, light-colored bowel • Changes in your immune system. drugs to the FDA. Visit movements (stools), loss of appetite for Your immune system may get stronger www.fda.gov/medwatch, several days or longer, nausea, and/or and begin to fight infections. Tell your or call 1-800-FDA-1088. stomach pain. healthcare provider if you have any • You may be more likely to get lactic new symptoms after you start taking Please see Brief Summary of full acidosis or serious liver problems if STRIBILD. Prescribing Information with important you are female, very overweight (obese), The most common side effects of warnings on the following pages. or have been taking STRIBILD for a STRIBILD include nausea and diarrhea. long time. In some cases, these serious Tell your healthcare provider if you have 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: 9.30.14 • Client: Gilead • Product: Stribild • File Name: 23164_pgiqdp_C_Winston_PosAware_fi.indd Winston PALIO Date: 9.30.14 • Client: Gilead • Product: Stribild • File Name: 23164_pgiqdp_C_Winston_PosAware_fi.indd Winston Ad Page 1 Ad Page 2 Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.5” x 11.0” Positively Aware Mag Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.5” x 11.0” Positively Aware Mag Patient Information • Do not stop taking STRIBILD without first talking to your The most common side effects of STRIBILD include: - digoxin (Lanoxin®) STRIBILD® (STRY-bild) healthcare provider • Nausea - disopyramide (Norpace®) (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ • If you stop taking STRIBILD, your healthcare provider will need to • Diarrhea - estazolam tenofovir disoproxil fumarate 300 mg) tablets check your health often and do blood tests regularly for several ® Brief summary of full Prescribing Information. For more information, months to check your HBV infection. Tell your healthcare provider Tell your healthcare provider if you have any side effect that - ethosuximide (Zarontin ) bothers you or that does not go away. ® please see the full Prescribing Information, including Patient Information. about any new or unusual symptoms you may have after you stop - flecainide (Tambocor ) taking STRIBILD • These are not all the possible side effects of STRIBILD. For more - flurazepam information, ask your healthcare provider. What is STRIBILD? ® ® ® ® Who should not take STRIBILD? - fluticasone (Flovent , Flonase , Flovent Diskus , • Call your healthcare provider for medical advice about side effects. Flovent® HFA, Veramyst®) • STRIBILD is a prescription medicine used to treat HIV-1 in adults who You may report side effects to FDA at 1-800-FDA-1088. have never taken HIV-1 medicines before. STRIBILD is a complete Do not take STRIBILD if you also take a medicine that contains: - itraconazole (Sporanox®) regimen and should not be used with other HIV-1 medicines. • adefovir (Hepsera®) What should I tell my healthcare provider before taking STRIBILD? - ketoconazole (Nizoral®) • STRIBILD does not cure HIV-1 or AIDS. You must stay on • alfuzosin hydrochloride (Uroxatral®) - lidocaine (Xylocaine®) continuous HIV-1 therapy to control HIV-1 infection and decrease Tell your healthcare provider about all your medical conditions, • cisapride (Propulsid®, Propulsid Quicksolv®) HIV-related illnesses. including: - mexiletine ® • ergot-containing medicines, including: dihydroergotamine If you have or had any kidney, bone, or liver problems, including - oxcarbazepine (Trileptal ) • Ask your healthcare provider about how to prevent passing ® ® ® • HIV-1 to others. Do not share or reuse needles, injection mesylate (D.H.E. 45 , Migranal ), ergotamine tartrate (Cafergot , hepatitis B infection - perphenazine Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, equipment, or personal items that can have blood or body fluids ® ® ® ® • If you are pregnant or plan to become pregnant. It is not known if - phenobarbital (Luminal ) on them. Do not have sex without protection. Always practice safer Wigrettes ), and methylergonovine maleate (Ergotrate , Methergine ) STRIBILD can harm your unborn baby. Tell your healthcare provider ® ® sex by using a latex or polyurethane condom to lower the chance • lovastatin (Advicor®, Altoprev®, Mevacor®) if you become pregnant while taking STRIBILD. - phenytoin (Dilantin , Phenytek ) of sexual contact with semen, vaginal secretions, or blood. ® • oral midazolam - There is a pregnancy registry for women who take antiviral - propafenone (Rythmol ) ® ® medicines during pregnancy. The purpose of this registry is to - quinidine (Neudexta ) What is the most important information I should know • pimozide (Orap ) ® ® ® ® ® collect information about the health of you and your baby. Talk - rifabutin (Mycobutin ) about STRIBILD? • rifampin (Rifadin , Rifamate , Rifater , Rimactane ) with your healthcare provider about how you can take part in • sildenafil (Revatio®), when used for treating lung problems this registry. - rifapentine (Priftin®) STRIBILD can cause serious side effects, including: ® ® ® - risperidone (Risperdal®, Risperdal Consta®) 1. Build-up of lactic acid in your blood (lactic acidosis). Lactic • simvastatin (Simcor , Vytorin , Zocor ) • If you are breastfeeding (nursing) or plan to breastfeed. Do not acidosis can happen in some people who take STRIBILD or similar • triazolam (Halcion®) breastfeed if you take STRIBILD. - salmeterol (Serevent®) or salmeterol when taken in combination with fluticasone (Advair Diskus®, Advair HFA®) (nucleoside analogs) medicines. Lactic acidosis is a serious • the herb St. John’s wort - You should not breastfeed if you have HIV-1 because of the risk medical emergency that can lead to death. Lactic acidosis can of passing HIV-1 to your baby. - sildenafil (Viagra®), tadalafil (Cialis®) or vardenafil (Levitra®, be hard to identify early, because the symptoms could seem Do not take STRIBILD if you also take any other HIV-1 Staxyn®), for the treatment of erectile dysfunction (ED). If you get medicines, including: - Two of the medicines in STRIBILD can pass to your baby in your like symptoms of other health problems. Call your healthcare breast milk. It is not known if the other medicines in STRIBILD can dizzy or faint (low blood pressure), have vision changes or have provider right away if you get any of the following symptoms • Other medicines that contain tenofovir (Atripla®, Complera®, pass into your breast milk. an erection that last longer than 4 hours, call your healthcare which could be signs of lactic acidosis: Viread®, Truvada®) provider or get medical help right away. - Talk with your healthcare provider about the best way to feed ® • feel very weak or tired • Other medicines that contain emtricitabine, lamivudine, or ritonavir your baby. - tadalafil (Adcirca ), for the treatment of pulmonary arterial • have unusual (not normal) muscle pain (Atripla®, Combivir®, Complera®, Emtriva®, Epivir® or Epivir-HBV®, hypertension ® ® ® ® ® Tell your healthcare provider about all the medicines you take, Epzicom , Kaletra , Norvir , Trizivir , Truvada ) ® • have trouble breathing including prescription and nonprescription medicines, vitamins, - telithromycin (Ketek ) • have stomach pain with nausea or vomiting STRIBILD is not for use in people who are less than 18 years old. and herbal supplements: - thioridazine • feel cold, especially in your arms and legs • STRIBILD may affect the way other medicines work, and other - voriconazole (Vfend®) What are the possible side effects of STRIBILD? medicines may affect how STRIBILD works. • feel dizzy or lightheaded - warfarin (Coumadin®, Jantoven®) • have a fast or irregular heartbeat STRIBILD may cause the following serious side effects: • Be sure to tell your healthcare provider if you take any of the ® ® ® ® following medicines: - zolpidem (Ambien , Edlular , Intermezzo , Zolpimist ) 2. Severe liver problems. Severe liver problems can happen in • See “What is the most important information I should know - Hormone-based birth control (pills, patches, rings, shots, etc) Know the medicines you take. Keep a list of all your medicines and people who take STRIBILD. In some cases, these liver problems about STRIBILD?” show it to your healthcare provider and pharmacist when you get a can lead to death. Your liver may become large (hepatomegaly) and • New or worse kidney problems, including kidney failure. Your - Antacid medicines that contain aluminum, magnesium hydroxide, new medicine. Do not start any new medicines while you are taking you may develop fat in your liver (steatosis). Call your healthcare healthcare provider should do blood and urine tests to check your or calcium carbonate. Take antacids at least 2 hours before or STRIBILD without first talking with your healthcare provider. provider right away if you get any of the following symptoms after you take STRIBILD kidneys before you start and while you are taking STRIBILD. Your Keep STRIBILD and all medicines out of reach of children. of liver problems: healthcare provider may tell you to stop taking STRIBILD if you - Medicines to treat depression, organ transplant rejection, or high • your skin or the white part of your eyes turns yellow (jaundice) develop new or worse kidney problems. blood pressure This Brief Summary summarizes the most important information ® ® about STRIBILD. If you would like more information, talk with your • dark “tea-colored” urine • Bone problems can happen in some people who take STRIBILD. - amiodarone (Cordarone , Pacerone ) healthcare provider. You can also ask your healthcare provider or Bone problems include bone pain, softening or thinning (which may ® ® • light-colored bowel movements (stools) - atorvastatin (Lipitor , Caduet ) pharmacist for information about STRIBILD that is written for health lead to fractures). Your healthcare provider may need to do tests to ® ® professionals, or call 1-800-445-3235 or go to www.STRIBILD.com. • loss of appetite for several days or longer check your bones. - bepridil hydrochloride (Vascor , Bepadin ) ® • nausea • Changes in body fat can happen in people who take HIV-1 - bosentan (Tracleer ) Issued: October 2013 • stomach pain medicine. These changes may include increased amount of fat - buspirone in the upper back and neck (“buffalo hump”), breast, and around ® ® ® ® You may be more likely to get lactic acidosis or severe liver - carbamazepine (Carbatrol , Epitol , Equetro , Tegretol ) the middle of your body (trunk). Loss of fat from the legs, arms ® ® problems if you are female, very overweight (obese), or have and face may also happen. The exact cause and long-term health - clarithromycin (Biaxin , Prevpac ) been taking STRIBILD for a long time. effects of these conditions are not known. - clonazepam (Klonopin®) 3. Worsening of Hepatitis B infection. If you have hepatitis B virus • Changes in your immune system (Immune Reconstitution - clorazepate (Gen-xene®, Tranxene®) (HBV) infection and take STRIBILD, your HBV may get worse COMPLERA, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo, Syndrome) can happen when you start taking HIV-1 medicines. Your - colchicine (Colcrys®) TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA (flare-up) if you stop taking STRIBILD. A “flare-up” is when your immune system may get stronger and begin to fight infections that is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein HBV infection suddenly returns in a worse way than before. have been hidden in your body for a long time. Tell your healthcare - medicines that contain dexamethasone are the property of their respective owners. • Do not run out of STRIBILD. Refill your prescription or talk to provider right away if you start having any new symptoms after - diazepam (Valium®) your healthcare provider before your STRIBILD is all gone starting your HIV-1 medicine. © 2014 Gilead Sciences, Inc. All rights reserved. STBC0096 10/14

PALIO Date: 9.30.14 • Client: Gilead • Product: Stribild • File Name: 23164_pgiqdp_C_Winston_PosAware_fi.indd Winston PALIO Date: 9.30.14 • Client: Gilead • Product: Stribild • File Name: 23164_pgiqdp_C_Winston_PosAware_fi.indd Winston BS Page 1 BS Page 2 Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.5” x 11.0” Positively Aware Mag Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.5” x 11.0” Positively Aware Mag Patient Information • Do not stop taking STRIBILD without first talking to your The most common side effects of STRIBILD include: - digoxin (Lanoxin®) STRIBILD® (STRY-bild) healthcare provider • Nausea - disopyramide (Norpace®) (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ • If you stop taking STRIBILD, your healthcare provider will need to • Diarrhea - estazolam tenofovir disoproxil fumarate 300 mg) tablets check your health often and do blood tests regularly for several ® Brief summary of full Prescribing Information. For more information, months to check your HBV infection. Tell your healthcare provider Tell your healthcare provider if you have any side effect that - ethosuximide (Zarontin ) bothers you or that does not go away. ® please see the full Prescribing Information, including Patient Information. about any new or unusual symptoms you may have after you stop - flecainide (Tambocor ) taking STRIBILD • These are not all the possible side effects of STRIBILD. For more - flurazepam information, ask your healthcare provider. What is STRIBILD? ® ® ® ® Who should not take STRIBILD? - fluticasone (Flovent , Flonase , Flovent Diskus , • Call your healthcare provider for medical advice about side effects. Flovent® HFA, Veramyst®) • STRIBILD is a prescription medicine used to treat HIV-1 in adults who You may report side effects to FDA at 1-800-FDA-1088. have never taken HIV-1 medicines before. STRIBILD is a complete Do not take STRIBILD if you also take a medicine that contains: - itraconazole (Sporanox®) regimen and should not be used with other HIV-1 medicines. • adefovir (Hepsera®) What should I tell my healthcare provider before taking STRIBILD? - ketoconazole (Nizoral®) • STRIBILD does not cure HIV-1 or AIDS. You must stay on • alfuzosin hydrochloride (Uroxatral®) - lidocaine (Xylocaine®) continuous HIV-1 therapy to control HIV-1 infection and decrease Tell your healthcare provider about all your medical conditions, • cisapride (Propulsid®, Propulsid Quicksolv®) HIV-related illnesses. including: - mexiletine ® • ergot-containing medicines, including: dihydroergotamine If you have or had any kidney, bone, or liver problems, including - oxcarbazepine (Trileptal ) • Ask your healthcare provider about how to prevent passing ® ® ® • HIV-1 to others. Do not share or reuse needles, injection mesylate (D.H.E. 45 , Migranal ), ergotamine tartrate (Cafergot , hepatitis B infection - perphenazine Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, equipment, or personal items that can have blood or body fluids ® ® ® ® • If you are pregnant or plan to become pregnant. It is not known if - phenobarbital (Luminal ) on them. Do not have sex without protection. Always practice safer Wigrettes ), and methylergonovine maleate (Ergotrate , Methergine ) STRIBILD can harm your unborn baby. Tell your healthcare provider ® ® sex by using a latex or polyurethane condom to lower the chance • lovastatin (Advicor®, Altoprev®, Mevacor®) if you become pregnant while taking STRIBILD. - phenytoin (Dilantin , Phenytek ) of sexual contact with semen, vaginal secretions, or blood. ® • oral midazolam - There is a pregnancy registry for women who take antiviral - propafenone (Rythmol ) ® ® medicines during pregnancy. The purpose of this registry is to - quinidine (Neudexta ) What is the most important information I should know • pimozide (Orap ) ® ® ® ® ® collect information about the health of you and your baby. Talk - rifabutin (Mycobutin ) about STRIBILD? • rifampin (Rifadin , Rifamate , Rifater , Rimactane ) with your healthcare provider about how you can take part in • sildenafil (Revatio®), when used for treating lung problems this registry. - rifapentine (Priftin®) STRIBILD can cause serious side effects, including: ® ® ® - risperidone (Risperdal®, Risperdal Consta®) 1. Build-up of lactic acid in your blood (lactic acidosis). Lactic • simvastatin (Simcor , Vytorin , Zocor ) • If you are breastfeeding (nursing) or plan to breastfeed. Do not acidosis can happen in some people who take STRIBILD or similar • triazolam (Halcion®) breastfeed if you take STRIBILD. - salmeterol (Serevent®) or salmeterol when taken in combination with fluticasone (Advair Diskus®, Advair HFA®) (nucleoside analogs) medicines. Lactic acidosis is a serious • the herb St. John’s wort - You should not breastfeed if you have HIV-1 because of the risk medical emergency that can lead to death. Lactic acidosis can of passing HIV-1 to your baby. - sildenafil (Viagra®), tadalafil (Cialis®) or vardenafil (Levitra®, be hard to identify early, because the symptoms could seem Do not take STRIBILD if you also take any other HIV-1 Staxyn®), for the treatment of erectile dysfunction (ED). If you get medicines, including: - Two of the medicines in STRIBILD can pass to your baby in your like symptoms of other health problems. Call your healthcare breast milk. It is not known if the other medicines in STRIBILD can dizzy or faint (low blood pressure), have vision changes or have provider right away if you get any of the following symptoms • Other medicines that contain tenofovir (Atripla®, Complera®, pass into your breast milk. an erection that last longer than 4 hours, call your healthcare which could be signs of lactic acidosis: Viread®, Truvada®) provider or get medical help right away. - Talk with your healthcare provider about the best way to feed ® • feel very weak or tired • Other medicines that contain emtricitabine, lamivudine, or ritonavir your baby. - tadalafil (Adcirca ), for the treatment of pulmonary arterial • have unusual (not normal) muscle pain (Atripla®, Combivir®, Complera®, Emtriva®, Epivir® or Epivir-HBV®, hypertension ® ® ® ® ® Tell your healthcare provider about all the medicines you take, Epzicom , Kaletra , Norvir , Trizivir , Truvada ) ® • have trouble breathing including prescription and nonprescription medicines, vitamins, - telithromycin (Ketek ) • have stomach pain with nausea or vomiting STRIBILD is not for use in people who are less than 18 years old. and herbal supplements: - thioridazine • feel cold, especially in your arms and legs • STRIBILD may affect the way other medicines work, and other - voriconazole (Vfend®) What are the possible side effects of STRIBILD? medicines may affect how STRIBILD works. • feel dizzy or lightheaded - warfarin (Coumadin®, Jantoven®) • have a fast or irregular heartbeat STRIBILD may cause the following serious side effects: • Be sure to tell your healthcare provider if you take any of the ® ® ® ® following medicines: - zolpidem (Ambien , Edlular , Intermezzo , Zolpimist ) 2. Severe liver problems. Severe liver problems can happen in • See “What is the most important information I should know - Hormone-based birth control (pills, patches, rings, shots, etc) Know the medicines you take. Keep a list of all your medicines and people who take STRIBILD. In some cases, these liver problems about STRIBILD?” show it to your healthcare provider and pharmacist when you get a can lead to death. Your liver may become large (hepatomegaly) and • New or worse kidney problems, including kidney failure. Your - Antacid medicines that contain aluminum, magnesium hydroxide, new medicine. Do not start any new medicines while you are taking you may develop fat in your liver (steatosis). Call your healthcare healthcare provider should do blood and urine tests to check your or calcium carbonate. Take antacids at least 2 hours before or STRIBILD without first talking with your healthcare provider. provider right away if you get any of the following symptoms after you take STRIBILD kidneys before you start and while you are taking STRIBILD. Your Keep STRIBILD and all medicines out of reach of children. of liver problems: healthcare provider may tell you to stop taking STRIBILD if you - Medicines to treat depression, organ transplant rejection, or high • your skin or the white part of your eyes turns yellow (jaundice) develop new or worse kidney problems. blood pressure This Brief Summary summarizes the most important information ® ® about STRIBILD. If you would like more information, talk with your • dark “tea-colored” urine • Bone problems can happen in some people who take STRIBILD. - amiodarone (Cordarone , Pacerone ) healthcare provider. You can also ask your healthcare provider or Bone problems include bone pain, softening or thinning (which may ® ® • light-colored bowel movements (stools) - atorvastatin (Lipitor , Caduet ) pharmacist for information about STRIBILD that is written for health lead to fractures). Your healthcare provider may need to do tests to ® ® professionals, or call 1-800-445-3235 or go to www.STRIBILD.com. • loss of appetite for several days or longer check your bones. - bepridil hydrochloride (Vascor , Bepadin ) ® • nausea • Changes in body fat can happen in people who take HIV-1 - bosentan (Tracleer ) Issued: October 2013 • stomach pain medicine. These changes may include increased amount of fat - buspirone in the upper back and neck (“buffalo hump”), breast, and around ® ® ® ® You may be more likely to get lactic acidosis or severe liver - carbamazepine (Carbatrol , Epitol , Equetro , Tegretol ) the middle of your body (trunk). Loss of fat from the legs, arms ® ® problems if you are female, very overweight (obese), or have and face may also happen. The exact cause and long-term health - clarithromycin (Biaxin , Prevpac ) been taking STRIBILD for a long time. effects of these conditions are not known. - clonazepam (Klonopin®) 3. Worsening of Hepatitis B infection. If you have hepatitis B virus • Changes in your immune system (Immune Reconstitution - clorazepate (Gen-xene®, Tranxene®) (HBV) infection and take STRIBILD, your HBV may get worse COMPLERA, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo, Syndrome) can happen when you start taking HIV-1 medicines. Your - colchicine (Colcrys®) TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA (flare-up) if you stop taking STRIBILD. A “flare-up” is when your immune system may get stronger and begin to fight infections that is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein HBV infection suddenly returns in a worse way than before. have been hidden in your body for a long time. Tell your healthcare - medicines that contain dexamethasone are the property of their respective owners. • Do not run out of STRIBILD. Refill your prescription or talk to provider right away if you start having any new symptoms after - diazepam (Valium®) your healthcare provider before your STRIBILD is all gone starting your HIV-1 medicine. © 2014 Gilead Sciences, Inc. All rights reserved. STBC0096 10/14

AWARE I P D e have seen arollercoaster of delayed responses, com- o su S H S l . O A H

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D V community, and O W H I K S v V-positive, life J GRA A I epidemic can A h V agenda have s i nuary+ at once was a at once v ide from most most ide from H the I P o V, Tez H r Y B i s r d F Y ING Eb

of DUA F ruary 2015 that our world has been affected o e r H N st E I C and there certainly wasn’t a lot of hope wasn’t hope alot of and certainly there and Ihad planned not living.” on a century, over half my of adult life, ‘dying,’ and dying, and even purchased detached anddetached withdrawn, and continued to darkergrew prolonged. and more I accepted my and fate made plansI accepted die.” to support system, including system, support a number his of take to his that wasdisease supposed life crisis”— “life a as describes what he enced thing I’dest ever and seen, didn’t into buy period, there weren’t treatments like weren’t treatments there today,period, not plannednot it,” for hesaid. “I’d given up so recalled much duped.” andmany ayoung dreamsas man hopes moving across the country from from the country moving across many years before. “I found myself terrified terrified found “I myself many before. years wasn’t actually until diagnosed 1986 after S he wasn’t prepared to grow older with grow to thishe wasn’t prepared the false version of hope she was selling, hope of the false version so that Imight old with grow bottle up his his feelings of bottle the as majority birthday, told him his doctor that hehad because I was dying, so I felt bitter and very and Iwas dying, very Ifelt bitter so because thought but it was hope, on the dumb- book the of start brutal less than two years to live. to years than two less for those diagnosed. made “I those plansfor die,” to V i a RA n n /A Time passed, and Time passed, A W F y n M he r derson seroconverted in 1983 at the seroconverted derson ancisco. I ER D n A A n S derson. “I bought books on death death on books bought “I derson. n derson hit age 45,derson heexperi- A month before his 26th month before H I V/ A A n I derson’s depression depression derson’s D S H D epidemic, yet I V and Ihad uring this time L A o H t uise lanta to e b ecame ecame H a y’s

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‘Wenh I started talking to friends and began reading reactions to [Spencer] Cox’s death, I realized I was not alone, and it all became very real.’ —Z TE ANDERSON what he described as “mental stress.” His And in March of 2012, Let’s Kick ASS friends and co-workers couldn’t relate to what (AIDS Survivor Syndrome) was realized he was going through and most wrote him by simply registering the LetsKickASS.org off as just being angry. “I remember being domain online. “When I started talking to resentful that they thought of themselves as friends and began reading reactions to Cox’s smart people but were clueless about the death, I realized I was not alone, and it all reality of my life,” he said. Anderson was became very real,” he recalled. clearly suffering and at one point seemed to be having symptoms of neurocognitive C ommunity survival disorders. He once again reached that dark place, and over the next four years A nderson was in good company as well. became obsessed with killing himself. “I was He was meeting with peers from ACT UP depressed, anxious, angry, hopeless, and Golden Gate, including Matt Sharp, who withdrawn, and spent nearly four years in sort became the co-founder of Let’s Kick ASS of purgatory,” said Anderson. “I had alienated (LKA) with him. “We eventually held a first most of my remaining long-time friends and LKA meeting with about 10 people and ‘family of choice’ because I had become so agreed to hold a town hall meeting to bring ornery and such difficult company.” together long-term survivors, listen to their It wasn’t until what seemed to be the low- needs and concerns, and begin to confront est point in his life that something sparked and address the issues,” said Sharp. The first while watching a news segment about post- planned town hall meeting brought together traumatic stress and Iraqi war vets. “They 250 people. Following is an excerpt from that ticked off all my symptoms,” said Anderson meeting held September 18, 2013: and proceeded to list them out: “depression, anxiety, anger, loss of future orientation, The Definition of Brave: “With courage and hopelessness, sleep disturbance, night- compassion we survived the darkest days mares…and I began to cry.” of the plague. Without access to effective What Anderson and many others had treatments, we were forced to rely on each lived through was a war of sorts—and this other and ourselves. As individuals and a revelation is what triggered him to prepare community, we exhibited strengths we didn’t for his next move in life, one that would not know we had. Now let’s all come together only affect him, but help countless others in again to face the conundrums of midlife and the process. aging to envision our future. As survivors we have valuable lessons to teach our com- S urviving a plague munity and the world about living and survival—it’s time to embrace our role as elders, AS ID activist Spencer Cox died in teachers, and leaders.” December 2012, after he stopped taking his medication and is said to have given The organization is dedicated to reclaim- up. His death shocked treatment advocates. ing lives, ending isolation, and helping long- Distraught, they experienced a wake-up call term survivors envision a future that they H IV-positive friends, had died. Although as they hadn’t had in years. once might not have dreamed of. It is raising Anderson had managed to overcome the Cox wasn’t the only long-term survivor awareness about the half-million people who most difficult years of HIV, it wasn’t without giving up. “I lost a lot of my comrades when came of age during the 1980s and ’90s a struggle. “While I looked fine, I had few they turned to drugs and alcohol to try and when HIV was considered a death sentence. T-cells and painful neuropathy, and along cope,” Anderson recalled. It’s their goal to address the psychosocial, the way I had PCP. I lived with 13 T-cells for Wanting to name the thing that was caus- mental, and behavioral determinants of eight years, I had viral meningitis in 2006, ing long-term survivors to kill themselves, health and illness among long-term survivors and there were the lesser signs of illness rather than live with the trauma of the loss, everywhere. Their focus is to help heal the that in my mind signaled impending death— grief, and survivor guilt, Anderson and his trauma of those who survived the AIDS epi- thrush, weight loss, fatigue, etc.,” he recalled. husband Mark Ruiz came up with AIDS demic by bringing people together, building a Feeling helpless without anyone who could Survivor Syndrome, and freely admits to the community, and ultimately making their lives understand what he was going through, awkward acronym. “What we needed was a little better, emulating the same together- Anderson continued to keep his struggles a way to defeat it,” he said. “I was slightly ness that brought people together at the with HIV a secret. obsessing over this idea one morning and height of the epidemic. In 2007, Anderson lost his job due to thought to myself, ‘We need to kick its ass!’” LKA is now run by Anderson and Sharp

18 STIV PO I ELY AWARE JAnuary+FEbruary 2015 ‘We knew we had touched a nerve when so many people showed up to the initial town hall meeting, and people all over the country started contacting us.’ —Matt Sharp

in a small office in the heart of the Castro in their first year they have held six town and organization for many people living in neighborhood of San Francisco, one block hall forums. They also organized the first San Francisco and across the country. “We from where ACT UP Golden Gate once met National HIV/AIDS Long-Term Survivors hope to begin a national network, reach- on a weekly basis. LKA collaborated with the Awareness Day (June 5, 2014), and a coin- ing out to other cities and jurisdictions that Shanti Project, a 40-year-old peer support ciding day-long summit. Additionally, they hope to begin their own LKA groups,” said organization for those living with HIV or other have helped establish a working group in Sharp. And to help with that goal, they plan life-threatening illness, to secure funding for San Francisco’s city council that addresses on traveling to several cities to help mentor the new organization. Sharp is LKA’s only the needs of aging HIV-positive seniors, and those long-term survivors who are seeking employee, working part-time. Anderson is collaborated to create support groups for organization. “There are so many lessons to a volunteer, due to his disability status. In people age 50 and older in existing non- be learned from long-term survivors, and we addition to the two co-founders there are profit organizations. hope to teach as well as learn,” said Sharp. other core members who help run the group and organize and plan for the larger town hall A cross the country T he long road meetings. Additional volunteers help with other projects and office duties. LKA does “Because of the work we have done over U nless you have personally lived and not have a membership process; therefore the first year, we have started a movement experienced it, it’s hard to describe or under- there are no official members. that has begun to mobilize new chapters stand what life was really like before the Let’s Kick ASS is primarily focused on in Portland [Oregon] and other cities,” said advancements in HIV treatments emerged. mobilizing the community of long-term sur- Sharp. “We began to make a place in histo- “We were simultaneously patients, caretak- vivors, both HIV-positive and HIV-negative, ry; we became part of the HIV/AIDS agenda ers, and warriors when we were young,” who survived the initial years of the HIV/AIDS that had previously been hijacked by the Anderson said. epidemic. Coming together to address the focus on at-risk HIV-negative populations.” He and many other long-term survivors many issues of long-term survivors is their Although AIDS survivor syndrome has not have felt marginalized in the most recent top priority. yet been officially studied, LKA is working to years of the HIV agenda, so many of them “Tez and I both experienced and felt many help change that, especially with regard to living in silence, confusion, depression, and of these issues, but as LKA started mobiliz- the resilience of survivors. “We have ample loneliness. What Anderson and Sharp have ing the community in San Francisco and all anecdotal information to let us not delay created together has already changed lives, over the country, the recognition of these helping folks restore a sense of meaning and and will continue to do so as their message and similar issues has been seen all over,” well-being,” said Anderson. “People need of community building and support contin- said Sharp. “We knew we had touched a help now and research is slow…we know ues to spread. nerve when so many people showed up to it’s real as we get letters from people all over the initial town hall meeting, and people the globe, thanking us for validating their all over the country started contacting us experiences.” In the meantime, LKA wants D avid Duran is an LGBT-focused freelance once they saw our website and joined our to continue to raise awareness of the lives of journalist who frequently contributes to such Facebook page.” survivors. “We are a diverse lot—there are publications as the Advocate, OUT magazine, Together with their team, Anderson and a lot of women and transgender survivors— Instinct, and the Huffington Post. Sharp have accomplished a tremendous every gender, race, and sexual orientation,” amount in a short time. Beyond providing Anderson said. F or more information on LKA, go to community support and outreach with their In a short time, Let’s Kick ASS has letskickass.org. gatherings, meditation groups, and outings, established itself as a much-needed resource

JAnuary+FEbruary 2015 POSITIVELY AWARE 19 Anal CANCER: ARE YOU AT RISK? Apa Pa sme r that many men should get, too Byn Eri N. Marcus, MD, MPH, FACP

O ne recent morning, a group of men and women telling their doctor about their sex practices. sat in a clinic reception room, waiting for their Pap Women with a history of cervical Pap smear abnormalities may not realize that they are smear appointments. at risk even if they haven’t had anal intercourse, since the virus can spread between Y ou read that correctly. The Pap smear— about 1,000 individuals die of the disease the genitals and the anus. a screening test for cervical cancer and long- annually. Even though a majority of those “A huge challenge for us is the stigma that time fixture of the women’s health exam—is diagnosed—about two out of three—survive surrounds (anal cancer) and that part of the now used to detect and prevent cancer of for five years or more, the disease and its body,” said Justine Almada, who co-founded the anus in both men and women. Experts treatment can be debilitating. Those who the HPV and Anal Cancer Foundation with her believe that routine Pap testing could play survive may have long-term problems with brother and sister after her mother, who had an important role in curbing a doubling of urination, defecation, and sexual relations. been treated years earlier for precancerous cer- new anal cancer cases that have occurred Contributing to the increase in anal cancer vical changes, died of anal cancer at age 53. over the past three decades. are the HIV epidemic and the longer lifespan “It’s something easily transmissible. You don’t of people with HIV due to highly active anti- need to have anal sex to have anal cancer.” A common virus retroviral therapy, or HAART; an increase in the number of people with organ transplants T he rub W hile anal Paps are not indicated for most may also have contributed. people, there is an increasing consensus that One study of men with HIV found that E ven if a primary care physician wants to routine screening is important for people at anal cancer tended to be diagnosed about perform an anal Pap on a patient, he or she high risk, specifically people whose immune 13 years after they were found to be infected is placed in a conundrum. If the screening systems are weakened due to HIV infection with HIV. Among men who have sex with Pap is abnormal, then the next step in the or medications taken after an organ trans- men, anal cancer is now as common as cer- work-up for cancer or pre-cancer is a proce- plant; men who have sex with men; and vical cancer was among women before the dure called a high-resolution anoscopy. But women who have cancerous or precancerous Pap smear was developed. in many parts of the U.S., specialists trained abnormalities on their cervical Pap smear. “All you’ve got to do is see one young to perform this procedure are scarce or Yet screening for anal cancer is unavail- guy with anal cancer” to realize the value of non-existent. able in many parts of the U.S., and many screening, said Dr. Elie Schochet, a colorec- “It’s an ethical dilemma for doctors if they people at high risk are unaware it exists. tal surgeon in Fort Lauderdale. “I’ve had diagnose” an abnormality and can’t send a “The awareness is remarkably low,” said patients come to me with cancer and when patient for anoscopy, said Jeff Taylor, 52, Dr. Joel Palefsky, an infectious disease I look back through the record, there was an an HIV treatment educator and community specialist and professor of medicine at the opportunity to take care of this sooner.” member of the National Cancer Institute University of California, San Francisco. “Even (NCI)’s AIDS Malignancy Consortium. in San Francisco it’s limited, though we have W ith or without anal sex “There’s a lot of frustration because access to been doing [screening] a long time. The [anoscopy] is so sporadic.” awareness is even lower elsewhere.” Compared to screening for other cancers, Mark Hubbard, who was diagnosed with Unlike colon and rectal cancer, most anal screening for anal cancer is a relatively new HIV 27 years ago, learned about anal Pap cancers are caused by a handful of strains of phenomenon. Many primary care doctors smears in the late 1990’s through his work human papilloma virus, or HPV, a common are unaware of anal cancer screening, and as a health educator and advocate. He was virus (estimated to infect the majority of peo- don’t routinely ask patients about whether concerned that he was at increased risk of ple in the U.S.) that has hundreds of different they engage in anal sex, have a history anal cancer because of his HIV and because subtypes. Cervical cancer is caused by the of sexually transmitted infections, or are he had experienced outbreaks of anal warts, same HPV strains. Most people clear HPV experiencing anal discomfort. Many doctors which are caused by different strains of HPV. infections over time. But some are vulnerable don’t even feel comfortable performing rectal Until recently, however, he was unable to to long-term infections that can eventually exams. (Even though a doctor’s rectal exam find anyone in his home state of Tennessee transform affected cells into invasive cancer. may miss very early disease, some experts who performed anal cancer screening, and More than 7,000 new cases of anal can- believe it is better than nothing in people had to travel to Pittsburgh—at a cost of cer are diagnosed in the U.S. each year, and at risk). Patients may not feel comfortable about $500 per trip—to be tested.

20 STIV PO I ELY AWARE JAnuary+FEbruary 2015 Anal CANCER: ARE YOU AT RISK? Mnore tha 7,000 new cases of Among men who have anal cancer sex with men, anal are diagnosed cancer is now as each year common as cervical cancer was among “A lot of providers were completely colonoscope passes women before the Pap biomarkers, clueless and would say crazy things,” he through the anus, the smear was developed. or laboratory said. “Once I decided I really wanted to be purpose of colonoscopy findings, predict screened, I couldn’t find anybody.” procedures is to examine the who is at highest As with the cervical Pap test, the anal large intestine and rectum for cancer. Most risk of developing anal cancer, and find Pap is simple and inexpensive. It involves colonoscopies don’t carefully examine the new treatments. swabbing the anus with a Dacron swab and anus; for them to do so, the colonoscope then placing the swab in a liquid-filled jar would have to be turned backward in an C hanging the HIV field that is the same type used for Pap smear unusual position. “Colonoscopy can be mis- samples. High resolution anoscopy—the leading,” Berry said. “People end up with a Perhaps most important, the study will next step if an anal Pap is abnormal—isn’t false sense of security—they say, ‘someone provide the “gold standard” clinical trial complex either, but it requires specialized examined my butt and it was fine, so why do evidence that the U.S. Preventive Services training for the doctor or nurse. It uses a you want to look again?’” Task Force and U.S. Centers for Disease special microscope that is already widely Control require in order to decide whether to available in many gynecologists’ offices, C hanging the medical field recommend cancer screening tests. These where it is used for colposcopy, the standard recommendations significantly sway whether procedure to examine the cervix after an A wareness of anal Pap screening has been doctors perform the test and influence insur- abnormal Pap smear. growing among health workers. Palefsky ance companies that are considering wheth- estimates that he, Berry, and other HPV er they will pay for the test (at present, many The exam specialists have trained more than 500 companies will pay for treatment of an anal health workers in high-resolution anoscopy. abnormality but not for screening to look E arly last year, I spent a morning watching The International Anal Neoplasia Society, the for that abnormality). While it may seem Dr. J. Michael Berry, a cancer specialist at world’s first professional group focused on intuitive that early treatment of precancerous the University of California, San Francisco, preventing and treating anal cancer, held its anal lesions reduces a person’s likelihood of coach a gynecologist and an HIV specialist inaugural meeting last year. The New York developing cancer, proof is needed that the on how to perform anal Paps and high- State Department of Health now recom- benefits of such therapy outweigh the harms, resolution anoscopy. The first patient was mends that HIV-infected men who have sex when performed on a massive scale. a middle-aged taxi driver who had recently with men, as well as anyone with a history The need for such a large study is frustrat- had a normal colonoscopy. As the patient of anal or genital warts and women with a ing for some advocates, who point out that lay on his side on an exam table, the HIV history of pre-cancerous Pap smear findings, the cervical Pap smear, which has been cred- specialist placed the tip of the scope in his undergo anal Pap testing each year. ited with saving millions of women’s lives, anus and then looked through a connected “When we first started, it was like, ‘I’ve was introduced into routine practice without set of magnifying binoculars, swabbing with never seen anal cancer, what kind of non- such rigorous, population-based evidence. an acetic acid-soaked cotton swab and sense are you talking about?’” Dr. Stephen But Hubbard said he hopes the study’s searching for irregular areas. (The rest of us Goldstone, a New York-based surgeon, said. findings will lead to the widespread use of watched on a computer screen that showed “But we’re developing a critical mass. As guideline-based, standardized treatments. what she was viewing.) The affected area the scientific body of evidence has grown, “Cervical dysplasia was treated for years turned pale. She took a small sample of the people have started to take notice.” without that evidence,” he said, but added, area and then rubbed it with a swab soaked An 8-year, $89 million National Cancer “people tend to overtreat when they don’t know in trichloracetic acid to destroy the abnormal Institute-funded study is now examining what they’re doing. There are a lot of horror tissue. After 20 minutes, she had finished whether treating the precancerous anal stories in the community about bad treatment. her examination. abnormalities caused by HPV reduces anal This is a really important study.” “To be good at this procedure, you have cancer in people with HIV. The study plans to do it a lot,” Berry said. “It’s very gentle— to enroll more than 5,000 people in 15 Enri N. Marcus, MD, MPH, FACP, is a gen- most people barely notice.” sites around the U.S. Scientists hope the eral internist at the University of Miami Miller The patient wondered why the abnormali- study will improve their understanding of the School of Medicine and writes about public ties hadn’t been spotted on his colonoscopy. molecular changes that occur as anal cancer health. The reporting of this article was sup- Berry explained that even though the develops, help them ascertain whether some ported by a grant from the Ford Foundation.

JAnuary+FEbruary 2015 POSITIVELY AWARE 21 16 x 10.5 In a clinical study lasting more than May reduce viral load to undetectable 4 years (240 weeks), patients (less than 50 copies/mL) being treated with HIV medication May significantly increase CD4 cell counts for the first time demonstrated ISENTRESS may not have these effects on all patients that ISENTRESS® (raltegravir) plus Truvada®: Patients had a low rate of these moderate-to-severe common side effects (that interfered with or kept patients from performing daily activities): trouble sleeping (4%), headache (4%), nausea (3%), dizziness (2%), and tiredness (2%).

INDICATION of your eyes, dark or tea- muscle problem that can lead colored urine, pale-colored to kidney problems. ISENTRESS is a prescription stools (bowel movements), HIV-1 medicine used with other nausea or vomiting, loss These are not all the possible antiretroviral medicines to treat of appetite, pain, aching or side effects of ISENTRESS. For human immunodeficiency virus tenderness on the right side more information, ask your (HIV-1) infection in people of your stomach area. doctor or pharmacists. Tell your 4 weeks of age and older. doctor if you have any side HIV is the virus that causes Changes in your immune effect that bothers you or that AIDS (Acquired Immune system (Immune Reconstitution does not go away. Deficiency Syndrome). Syndrome) can happen when you start taking HIV-1 Tell your doctor about all It is not known if ISENTRESS medicines. Your immune your medical conditions, is safe and effective in babies system may get stronger and including if you have any under 4 weeks of age. begin to fight infections that allergies, are pregnant or have been hidden in your body plan to become pregnant, or The use of other medicines for a long time. Tell your doctor are breastfeeding or plan to active against HIV-1 in right away if you start having breastfeed. ISENTRESS is not combination with ISENTRESS new symptoms after starting recommended for use during may increase your ability to your HIV-1 medicine. pregnancy. Women with HIV fight HIV. should not breastfeed because People taking ISENTRESS may their babies could be infected ISENTRESS does not cure still develop infections or other with HIV through their HIV-1 infection or AIDS. conditions associated with breast milk. You must stay on continuous HIV infections. Tell your doctor about all the HIV therapy to control HIV-1 The most common side effects medicines you take, including: infection and decrease of ISENTRESS include: trouble prescription medicines HIV-related illnesses. sleeping, headache, dizziness, like rifampin (a medicine IMPORTANT RISK nausea, and tiredness. Less commonly used to treat INFORMATION common side effects include: tuberculosis), over-the-counter depression, hepatitis, genital medicines, vitamins, and Some people who take herpes, herpes zoster including herbal supplements. Especially ISENTRESS develop serious shingles, kidney failure, kidney tell your doctor if you take skin reactions and allergic stones, indigestion or stomach any of these medicines: reactions that can be severe, area pain, vomiting, suicidal rifampin (Rifadin, Rifamate, and may be life-threatening thoughts and actions, and Rifater, Rimactane), an antacid I was ready to learn more about my HIV treatment options. or lead to death. If you weakness. medicine that contains develop a rash with any of the aluminum or magnesium, a Tell your doctor before you take So I spoke to my healthcare professional and we chose following symptoms, stop using cholesterol lowering medicine ISENTRESS if you have a history ISENTRESS as part of my HIV regimen. He told me it could ISENTRESS and call your doctor (statin), a medicine that of a muscle disorder called right away: fever, generally contains fenofibrate (Antara, fight my HIV and may fit my needs and lifestyle. rhabdomyolysis or myopathy ill feeling, extreme tiredness, Lipofen, Tricor, Trilipix), or increased levels of creatine I can’t wait to see you next time. muscle or joint aches, blisters gemfibrozil (Lopid), a medicine kinase in your blood. or sores in mouth, blisters or that contains zidovudine peeling of skin, redness or ISENTRESS Chewable Tablets (Combivir, Retrovir, Trizivir). swelling of the eyes, swelling contain phenylalanine as part You are encouraged to report of the mouth or face, problems of the artificial sweetener, negative side effects of breathing. aspartame. The artificial prescription drugs to the FDA. sweetener may be harmful to Sometimes allergic reactions Visit www.fda.gov/medwatch, people with phenylketonuria. can affect body organs, or call FDA at 1-800-FDA-1088. such as your liver. Call your Tell your doctor right away if doctor right away if you have you get unexplained muscle Please read the Patient any of the following signs or pain, tenderness, or weakness Information on the symptoms of liver problems: while taking ISENTRESS. This adjacent page for more yellowing of your skin or whites may be signs of a rare serious detailed information.

HIV Positive Model Need help paying for ISENTRESS? Call 1-866-350-9232

Talk to your healthcare professional about ISENTRESS and visit isentress.com.

Brands mentioned are the trademarks of their respective owners. Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. INFC-1049069-0017 05/14 16 x 10.5 In a clinical study lasting more than May reduce viral load to undetectable 4 years (240 weeks), patients (less than 50 copies/mL) being treated with HIV medication May significantly increase CD4 cell counts for the first time demonstrated ISENTRESS may not have these effects on all patients that ISENTRESS® (raltegravir) plus Truvada®: Patients had a low rate of these moderate-to-severe common side effects (that interfered with or kept patients from performing daily activities): trouble sleeping (4%), headache (4%), nausea (3%), dizziness (2%), and tiredness (2%).

HIV Positive Model Need help paying for ISENTRESS? Call 1-866-350-9232

Talk to your healthcare professional about ISENTRESS and visit isentress.com.

Read this Patient Information before you start taking ISENTRESS and each time you get a refill. What are the possible side effects of ISENTRESS? There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. ISENTRESS can cause serious side effects including: • Serious skin reactions and allergic reactions. Some people who take ISENTRESS What is ISENTRESS? develop serious skin reactions and allergic reactions that can be severe, and may ISENTRESS is a prescription HIV medicine used with other antiretroviral medicines to treat be life-threatening or lead to death. If you develop a rash with any of the following Human Immunodeficiency Virus (HIV-1) infection in people 4 weeks of age and older. HIV is the symptoms, stop using ISENTRESS and contact your doctor right away: virus that causes AIDS (Acquired Immune Deficiency Syndrome). ° fever ° muscle or joint aches ° redness or swelling of the eyes It is not known if ISENTRESS is safe and effective in babies under 4 weeks of age. ° generally ill feeling ° blisters or sores in mouth ° swelling of the mouth or face extreme tiredness blisters or peeling of the skin problems breathing When used with other HIV medicines to treat HIV-1 infection, ISENTRESS may help: ° ° ° • reduce the amount of HIV in your blood. This is called “ viral load”. Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor • increase the number of white blood cells called CD4+ (T) cells in your blood, which help right away if you have any of the following signs or symptoms of liver problems: fight off other infections. ° yellowing of the skin or whites of your eyes • reduce the amount of HIV-1 and increase the CD4+ (T) cells in your blood, which may ° dark or tea colored urine help improve your immune system. This may reduce your risk of death or getting ° pale colored stools (bowel movements) infections that can happen when your immune system is weak (opportunistic infections). ° nausea or vomiting ISENTRESS does not cure HIV-1 infection or AIDS. ° loss of appetite pain, aching, or tenderness on the right side of your stomach area You must stay on continuous HIV therapy to control HIV-1 infection and decrease ° HIV-related illnesses. • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and Avoid doing things that can spread HIV-1 infection to others: begin to fight infections that have been hidden in your body for a long time. Tell your • Do not share needles or re-use needles or other injection equipment. doctor right away if you start having new symptoms after starting your HIV-1 medicine. • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. The most common side effects of ISENTRESS include: • Do not have any kind of sex without protection. Always practice safe sex by using • trouble sleeping • nausea a latex or polyurethane condom to lower the chance of sexual contact with any body • headache • tiredness fluids such as semen, vaginal secretions, or blood. • dizziness Ask your doctor if you have any questions on how to prevent passing HIV to other people. Less common side effects include: • depression • kidney stones What should I tell my doctor before taking ISENTRESS? • hepatitis • indigestion or stomach area pain Before taking ISENTRESS, tell your doctor if you: • genital herpes • vomiting • have liver problems • herpes zoster • suicidal thoughts and actions • have a history of a muscle disorder called rhabdomyolysis or myopathy including shingles • weakness • have increased levels of creatine kinase in your blood • kidney failure • have phenylketonuria (PKU). ISENTRESS chewable tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while with PKU. taking ISENTRESS. These may be signs of a rare serious muscle problem that can lead to • have any other medical conditions kidney problems. • are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your Tell your doctor if you have any side effect that bothers you or that does not go away. unborn baby. These are not all the possible side effects of ISENTRESS. For more information, ask your Pregnancy Registry: There is a pregnancy registry for women who take antiviral doctor or pharmacist. medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take Call your doctor for medical advice about side effects. You may report side effects to FDA part in this registry. at 1-800-FDA-1088. • are breastfeeding or plan to breastfeed. Do not breastfeed if you take ISENTRESS. How should I store ISENTRESS? ° You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Film-Coated Tablets: It is not known if ISENTRESS passes into your breast milk. • Store ISENTRESS Film-Coated Tablets at room temperature ° between 68°F to 77°F (20°C to 25°C). ° Talk with your doctor about the best way to feed your baby. Tell your doctor about all the medicines you take, including: prescription and over-the- Keep ISENTRESS and all medicines out of the reach of children. counter medicines, vitamins, and herbal supplements. ISENTRESS and certain other medicines General information about ISENTRESS may affect each other causing serious side effects. ISENTRESS may affect the way other medicines work and other medicines may affect how ISENTRESS works. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use ISENTRESS for a condition for which it was not prescribed. Especially tell your doctor if you take any of these medicines: Do not give ISENTRESS to other people, even if they have the same symptoms you have. • rifampin (Rifadin, Rifamate, Rifater, Rimactane) It may harm them. • an antacid medicine that contains aluminum or magnesium • a cholesterol lowering medicine (statin) You can ask your doctor or pharmacist for information about ISENTRESS that is • a medicine that contains fenofibrate (Antara, Lipofen, Tricor, Trilipix) written for health professionals. • gemfibrozil (Lopid) For more information go to www.ISENTRESS.com or call 1-800-622-4477. • a medicine that contains zidovudine (Combivir, Retrovir, Trizivir) What are the ingredients in ISENTRESS? Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. ISENTRESS film-coated tablets: Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Do not start any new medicines while you are taking ISENTRESS Active ingredient: raltegravir without first talking with your doctor. Inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% How should I take ISENTRESS? butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. • Take ISENTRESS exactly as prescribed by your doctor. The film coating contains: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red • Do not change your dose of ISENTRESS or stop your treatment without talking with your iron oxide, talc and titanium dioxide. doctor first. • Stay under the care of your doctor while taking ISENTRESS. This Patient Information has been approved by the U.S. Food and Drug Administration. • ISENTRESS film-coated tablets must be swallowed whole. • ISENTRESS chewable tablets may be chewed or swallowed whole. • ISENTRESS for oral suspension should be given to your child within 30 minutes of mixing. See the detailed Instructions for Use that comes with ISENTRESS for oral suspension, for information about the correct way to mix and give a dose of ISENTRESS for oral suspension. If you have questions about how to mix or give ISENTRESS for oral suspension, talk to your doctor or pharmacist. • Do not switch between the film-coated tablet, the chewable tablet, or the oral suspension without talking with your doctor first. • Do not run out of ISENTRESS. Get a refill of your ISENTRESS from your doctor or Distributed by: pharmacy before you run out. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. • If you miss a dose, take it as soon as you remember. If you do not remember until it is Whitehouse Station, NJ 08889, USA time for your next dose, skip the missed dose and go back to your regular schedule. Do not double your next dose or take more ISENTRESS than prescribed. Revised December 2013 • If you take too much ISENTRESS, call your doctor or go to the nearest hospital USPPI-MK0518-MF-1312R025 emergency room right away. Patient Information ON E ON ONE ISENTRESS® (eye sen tris) (raltegravir) film-coated tablets

Read this Patient Information before you start taking ISENTRESS and each time you get a refill. What are the possible side effects of ISENTRESS? There may be new information. This information does not take the place of talking with your A e long-t rm survivor and doctor about your medical condition or your treatment. ISENTRESS can cause serious side effects including: • Serious skin reactions and allergic reactions. Some people who take ISENTRESS activist opens up about What is ISENTRESS? develop serious skin reactions and allergic reactions that can be severe, and may ISENTRESS is a prescription HIV medicine used with other antiretroviral medicines to treat be life-threatening or lead to death. If you develop a rash with any of the following life, love, and HIV—and Human Immunodeficiency Virus (HIV-1) infection in people 4 weeks of age and older. HIV is the symptoms, stop using ISENTRESS and contact your doctor right away: MARIA virus that causes AIDS (Acquired Immune Deficiency Syndrome). ° fever ° muscle or joint aches ° redness or swelling of the eyes why we need to keep the It is not known if ISENTRESS is safe and effective in babies under 4 weeks of age. ° generally ill feeling ° blisters or sores in mouth ° swelling of the mouth or face extreme tiredness blisters or peeling of the skin problems breathing When used with other HIV medicines to treat HIV-1 infection, ISENTRESS may help: ° ° ° conversation going Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor • reduce the amount of HIV in your blood. This is called “ viral load”. Inri te v ew by Jeff Berry • increase the number of white blood cells called CD4+ (T) cells in your blood, which help right away if you have any of the following signs or symptoms of liver problems: photography by Duane Cramer fight off other infections. ° yellowing of the skin or whites of your eyes • reduce the amount of HIV-1 and increase the CD4+ (T) cells in your blood, which may dark or tea colored urine DAVIS ° help improve your immune system. This may reduce your risk of death or getting ° pale colored stools (bowel movements) infections that can happen when your immune system is weak (opportunistic infections). ° nausea or vomiting ISENTRESS does not cure HIV-1 infection or AIDS. ° loss of appetite pain, aching, or tenderness on the right side of your stomach area You must stay on continuous HIV therapy to control HIV-1 infection and decrease ° HIV-related illnesses. • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and Avoid doing things that can spread HIV-1 infection to others: SPEAKS begin to fight infections that have been hidden in your body for a long time. Tell your At the U.S. Conference on AIDS in • Do not share needles or re-use needles or other injection equipment. doctor right away if you start having new symptoms after starting your HIV-1 medicine. • Do not share personal items that can have blood or body fluids on them, October, Maria Davis spoke candidly about like toothbrushes and razor blades. The most common side effects of ISENTRESS include: her experiences with HIV/AIDS to an audi- • Do not have any kind of sex without protection. Always practice safe sex by using • trouble sleeping • nausea a latex or polyurethane condom to lower the chance of sexual contact with any body • headache • tiredness ence of her peers. Many were hearing • dizziness fluids such as semen, vaginal secretions, or blood. OUT her speak for the first time, but Davis has Ask your doctor if you have any questions on how to prevent passing HIV to other people. Less common side effects include: • depression • kidney stones been speaking out about HIV for years. What should I tell my doctor before taking ISENTRESS? • hepatitis • indigestion or stomach area pain Before taking ISENTRESS, tell your doctor if you: • genital herpes • vomiting Postiv i ely Aware caught up with her • have liver problems • herpes zoster • suicidal thoughts and actions recently to talk about the work she’s been • have a history of a muscle disorder called rhabdomyolysis or myopathy including shingles • weakness • have increased levels of creatine kinase in your blood • kidney failure doing, and why she is so passionate about • have phenylketonuria (PKU). ISENTRESS chewable tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while helping others navigate their own journey. with PKU. taking ISENTRESS. These may be signs of a rare serious muscle problem that can lead to • have any other medical conditions kidney problems. • are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your Tell your doctor if you have any side effect that bothers you or that does not go away. Jeff Berry: When you first walked out on unborn baby. These are not all the possible side effects of ISENTRESS. For more information, ask your Pregnancy Registry: There is a pregnancy registry for women who take antiviral stage at the U.S. Conference on AIDS in doctor or pharmacist. medicines during pregnancy. The purpose of this registry is to collect information San Diego, it was very emotional, not only about the health of you and your baby. Talk to your doctor about how you can take Call your doctor for medical advice about side effects. You may report side effects to FDA part in this registry. at 1-800-FDA-1088. for you but for many in the audience. Can • are breastfeeding or plan to breastfeed. Do not breastfeed if you take ISENTRESS. How should I store ISENTRESS? you tell us what you were thinking in that ° You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Film-Coated Tablets: moment, and why that experience was so It is not known if ISENTRESS passes into your breast milk. • Store ISENTRESS Film-Coated Tablets at room temperature ° between 68°F to 77°F (20°C to 25°C). ° Talk with your doctor about the best way to feed your baby. emotional for you? Tell your doctor about all the medicines you take, including: prescription and over-the- Keep ISENTRESS and all medicines out of the reach of children. counter medicines, vitamins, and herbal supplements. ISENTRESS and certain other medicines General information about ISENTRESS may affect each other causing serious side effects. ISENTRESS may affect the way other Mar ia Davis: I was just thinking about medicines work and other medicines may affect how ISENTRESS works. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use ISENTRESS for a condition for which it was not prescribed. my life and when I was first diagnosed, not Especially tell your doctor if you take any of these medicines: Do not give ISENTRESS to other people, even if they have the same symptoms you have. • rifampin (Rifadin, Rifamate, Rifater, Rimactane) It may harm them. thinking I would be living all that I’ve lived. • an antacid medicine that contains aluminum or magnesium Being in front of people that believed in • a cholesterol lowering medicine (statin) You can ask your doctor or pharmacist for information about ISENTRESS that is • a medicine that contains fenofibrate (Antara, Lipofen, Tricor, Trilipix) written for health professionals. the same thing I believe in … they’re there • gemfibrozil (Lopid) For more information go to www.ISENTRESS.com or call 1-800-622-4477. • a medicine that contains zidovudine (Combivir, Retrovir, Trizivir) because they care. In the beginning when I What are the ingredients in ISENTRESS? Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. first got diagnosed I was afraid to tell any- ISENTRESS film-coated tablets: Know the medicines you take. Keep a list of them to show your doctor and pharmacist when body and I didn’t think anybody cared. So you get a new medicine. Do not start any new medicines while you are taking ISENTRESS Active ingredient: raltegravir without first talking with your doctor. Inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose just to be in front of so many people and the monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% love that I received from the room—I felt it. How should I take ISENTRESS? butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. • Take ISENTRESS exactly as prescribed by your doctor. The film coating contains: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red It was so strong. • Do not change your dose of ISENTRESS or stop your treatment without talking with your iron oxide, talc and titanium dioxide. doctor first. • Stay under the care of your doctor while taking ISENTRESS. This Patient Information has been approved by the U.S. Food and Drug Administration. • ISENTRESS film-coated tablets must be swallowed whole. Backing up a little bit—can you tell us a • ISENTRESS chewable tablets may be chewed or swallowed whole. little about yourself for people who may not • ISENTRESS for oral suspension should be given to your child within 30 minutes of mixing. See the detailed Instructions for Use that comes with ISENTRESS for oral know you? suspension, for information about the correct way to mix and give a dose of ISENTRESS for oral suspension. If you have questions about how to mix or give ISENTRESS for oral Class: ACT suspension, talk to your doctor or pharmacist. Mai r a Davis Well, I’m now what they call a promoter • Do not switch between the film-coated tablet, the chewable tablet, or the oral addresses suspension without talking with your doctor first. [laughs]. I started out modeling, which led Distributed by: students AT • Do not run out of ISENTRESS. Get a refill of your ISENTRESS from your doctor or Dillard High me into being a promoter because I love pharmacy before you run out. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. • If you miss a dose, take it as soon as you remember. If you do not remember until it is Whitehouse Station, NJ 08889, USA School in Fort music. My family, my mother, always had time for your next dose, skip the missed dose and go back to your regular schedule. Do Lauderdale for not double your next dose or take more ISENTRESS than prescribed. Revised December 2013 music in the home. I grew up on music, USPPI-MK0518-MF-1312R025 a world AIDS DAY • If you take too much ISENTRESS, call your doctor or go to the nearest hospital 2014 event. thinking I was an artist, every day sing- emergency room right away. ing, microphone in my hand, trying to do

JAnuary+FEbruary 2015 POSITIVELY AWARE 25 We’ve all been traumatized in our lives, and how does that trauma affect our decision-making?

M ichael Jackson steps. So I always loved to the health department. We got tested and music and I loved to talk and meet people. they said, “Which one of you wants to come So being a promoter was so perfect for me. in and get your results first?” He went in and And then meeting so many industry people, came out—“Ahhh! I’m negative!” I was like, [such as] Puffy, and being in the offices of “Yes! That was a lie! I’m not HIV-positive. I powerful people, sometimes seeing the art- don’t have HIV.” When I went in the office ist’s information not being handled properly, the woman said, “Miss Davis, we’re sorry to caused me to be a promoter and say, “You tell you that you are HIV-positive.” My whole know what? I have influential friends in the … I can’t even … I mean, my heart dropped business. I can get them to my club and I to the floor. That was crazy, because that can get some of these unsigned artists to was one of my first lessons—that you can come in and showcase their music in front be in a relationship with someone and you of them.” That went into teaching artists could be positive, or they could be positive about publishing and always having to be and you could be negative, and that was onstage, in front of the stage, but most very confusing to me. important, about speaking up. Reading So fast forwarding, [I didn’t get] into care those little fine lines in contracts, and that immediately. A concerned friend told me went into also getting signed artists to be on about an organization called Friends in Deed, my show—I had people from Jay Z to 50 and I started going to their groups for people Cent. A good friend of mine was at a club who were HIV-positive and living with called Sweetwater and she kept begging me, AIDS. I kept going to the group and going “Maria, Maria … you need to do your own to the group and you know, not connecting, show,” and I said, “Ohhh … okay, okay.” I because I was trying to figure out why I had kept putting it off and then one day I just this. They felt because I wasn’t responding, decided to do it, and that started in March just sitting there, that I needed to be in crisis 1994. I’ll never forget it. counseling, because they knew that I wasn’t [With] the success of Mad Wednesdays taking any medication and I was losing a lot and [having] three children while being a of weight. model, I just decided if anything happens I remember Scott was the gentleman I to me, I want them to be taken care of, so I came to see, and he looked at me and said, decided to apply for a life insurance policy— “I’m going to talk to you just like you were my and it was a very large life insurance policy. sister.” He said, “If you don’t find a doctor, if There was a requirement that you take an you don’t get into care, and start on treat- HIV test. Of course, I took the test in 1995 ment, you’re not going to be here to see your with no problem. I had heard about HIV, children.” I had never thought about that. but it was all about AIDS at that time, and Wow. See my children? I’m not going to see there wasn’t much information. I didn’t think my children? That day I promised myself that that I was a person who was at risk. I don’t I would find a doctor and they helped me have HIV. I don’t have AIDS. So I took the find one. I was scared. I didn’t know what I test and days later it came back in the mail was going to ask the doctor when I got into saying, “Dear Miss Davis, We’re sorry to the office. That’s why Merck’s IDesign cam- inform you … first, we reject you. We can’t paign is so perfect, and I love working with offer you a policy. We also want to let you it. Because I remember how I felt walking their doctor about how they’re doing and know you tested positive for HIV antibodies. into that doctor’s office for the first time, not feeling on their treatment plan, and if their Please seek help. Here’s a …” I think it was knowing what questions to ask, not knowing treatment is individualized for them. What an 800 number. But I was so shocked and anything. The campaign has a desktop and are you going through? surprised. Standing in the post office by mobile app, a medication checklist, and con- I’m aging right now. I’m over 50. I feel myself, nobody to talk to around me. What versation worksheets that you can download good. But menopause is one of the first am I going to do with this? How am I going and take into the doctor’s office with you. things on my mind, and how is that going to tell my children? What am I going to do? You don’t have to be afraid. The doctors can to affect my treatment? I have to talk to And so I sat on that letter for a while. I was download it. The social workers can encour- my doctor about that. All of the things, the in a relationship with someone and I had age their clients to do it. I think it’s just such concerns, that come with aging, are so to tell them that they had to be tested. And an important piece for people who are living important to talk to your doctor about. I’m the crazy part about it was that because we with HIV to empower them to have open, a woman, and I have unique needs that are didn’t have any information, we both went honest, and meaningful conversations with different than a man’s needs. Some women

26 STIV PO I ELY AWARE JAnuary+FEbruary 2015 We’ve all been traumatized in our lives, and how does that trauma affect our decision-making?

That’s a great message. You could have remained silent about your status, but you chose not to. What prompted that decision?

[Chuckles.] It was so funny. One day I was in a hospital and I don’t know why … I was watching television this particular day and they had something on about HIV. I don’t recall what it was and I thought to myself, “They need to hear my story. They need to hear from someone who’s HIV-positive.” There weren’t a lot of people talking about having HIV except for Magic Johnson. Very few. I didn’t know any women. Magic Johnson was the only man that I knew. I felt it was important for me to tell my story to help other people that were living with HIV, especially women. You don’t have to be afraid. Your circumstances do not determine your destination in life. So I felt that if I lift my voice, if I spoke up, that that would encourage other people to speak up. There would be a domino effect. I do a lot of work in my community—I live in Harlem. When I first joined First Corinthian Baptist Church in Harlem, there might have been 600 members and I remember going up to my pastor, Michael A. Walrond, Jr., and saying, “Listen, y’all have an HIV ministry here? We ought to do something about that. What you doing in church about HIV?” [Laughs.] And he was like, “No, what y’all doing about HIV?” So he let me do whatever I wanted to do. I brought in my doctor at the time, Dr. Theresa Mack. We brought in programs and talked about prevention, and testing. After that, people would come in and say, “I’m HIV-positive [whisper- ing]. What can I do to help? I don’t want anyone to know.” So we had to meet people where they were. We didn’t force people to share their story about being HIV-positive. become pregnant, and maybe need to be on women who are living with HIV. Why do a different treatment plan. It’s important for you think others can so readily relate to Y ou’ve talked very publicly and candidly in African American women, who are dispro- your story? the past about the conversations that we portionately impacted by HIV. So that’s my need to have with today’s youth. How does reason for being part of IDesign, but not my Because I’m honest, I’m truthful, and I that work out when, for example, you’re only reason. I want to talk to people living don’t hold back. I’m not afraid and I don’t working with a religious or faith-based orga- with HIV. You mean something. Your life is care about stigma. I don’t care about what nization—are they receptive? It sounds like worthy, so take care of yourself. Make sure people think about me living with HIV—my they are, but have there been any instances that your unique needs reflect your treatment life is meaningful, and [just] because of [my] where that’s been a challenge for you? and talk to your doctor, and don’t be afraid. circumstances, you cannot judge me. I can do anything I want to do. I can be anything U h-huh. Because sexuality is a hard con- Y our story is very inspiring and strikes a I want to be, and I’m powerful—and that’s versation. People don’t want to let people chord with so many people, especially what people feel when I speak. know what they do behind closed doors. My

JAnuary+FEbruary 2015 POSITIVELY AWARE 27 Mai r a Davis (far left) and photographer Duane Cramer (third from right) with Dillard High School students following their World AIDS Day program.

point is, I’m not here to judge you. I’m here not gonna let you use me. I’m not gonna let same work that I’m doing, in different parts to try to help you make better choices that you use my body. I don’t have to use sex to of the country. Their mission is to empower don’t hurt your future. HIV is a preventable pay my rent and my bills and to eat. There’s women who are living with HIV to be leaders disease. You have to protect yourself—but help for me.” in our community, and I’m a leader in my first of all, more importantly, to love yourself It’s so important for us to share this infor- community, and they’re just doing great work. enough to want to protect yourself. There are mation and to just love each other. That’s World AIDS Day is coming up and that’s so many other things in our community that the most important thing to me, that we so important. Other than my birthday, that’s cause people to make choices that might show each other love and compassion. We one of my biggest days of the year that I not be positive. So, I try to get people to talk don’t judge people, whatever their circum- really love. To honor my friends who are no about that, because we might need help in stance may be. Everybody is a human being longer here, and to honor those living with different areas. There are a lot of different and they deserve the right to live. HIV and AIDS who are still here, and to issues in our community, especially in the empower our community—and to keep HIV African American community. One of the big- W hat is the most important message in our conversations. I think people are talk- gest issue is mental health. We’ve all been that you would like other women to know ing less and less about HIV. They say now traumatized in our lives, and how does that or to hear? that it’s just a chronic illness, but it’s not. trauma affect our decision-making? That’s There’s a stigma. The stigma is still there. very important. Being diagnosed in 1995— That love is very important, and that we that was trauma to me. So what kind of help treat each other with love, and we’re care- G ood point. did I need to get to make sure I was back on ful about what we say and how we say it the right track? That doesn’t affect my choic- to people. If your words are negative, think People are still in hiding. I still get people es? Being afraid doesn’t mean that I have about it before they come out of your mouth. telling me every day, “[Whispers] I’m HIV- to bow down to what somebody asks me to Support people who are living with HIV, and positive. I’m still not ready to talk about it.” ane Cramer ane

do. So how I felt is what I talk to my young support people who are living with AIDS. We shouldn’t even have that anymore. People u people about. You don’t have to be afraid to shouldn’t be afraid to talk about their status. D speak up. Let someone know that you need Can you describe the work that you’re doing Knowledge is power, and knowledge is of y es t

help. This way, they feel comfortable, and now, such as with the Positive Women’s life—and that’s so important. Love is life. r ou

let somebody know, “You know what? You Network-USA? So let’s get knowledge, let’s love, and let’s c o want to have sex with me without a condom. live. t

That’s a no-no. I love me. I wanna live. I’m Positive Women’s Network is doing the Pho

28 STIV PO I ELY AWARE JAnuary+FEbruary 2015 If you’re on HIV meds, Fulyzaq may help you...

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.

Snap a picture of our logo and show your doctor to ‘Start the Conversation’

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

CROF14CDNY4413_POZ_Patient_Journal_BS_Ad_r19.indd 1 7/14/14 3:37 PM Photo:Pho to: Rodger Bosch 1,300 scientists, policymakers, policymakers, 1,300 scientists, Town, This combined conference is This combined conference October marked the first time Previously the microbicide and vaccine communities communities vaccine and microbicide the Previously an important first step to real to step first an important answer our prevention prayers. the fact approach underscores HIV evolving prevention landscape. Instead, we must examine the collaboration. collaboration. tiple facets of the biomedical T r I range of optionsrange of in the ever- one for the overall field of new prevention technologies. prevention new technologies. overall the of field for one operated in separate spheres with separate confer field came together under asingle banner, called the izing the potential increased for that single no will intervention defined, this new integrated approach is an important ences. latest in prevention technology in prevention technology latest SIC Je b funders, and advocates to Cape Cape to and advocates funders, y n H ere CON of W r This new collaborative collaborative This new H o o I

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s O k a P i WN D - ATE , ing SOU H able delivery mechanismsable delivery are W drug formulations and accept diverse, common to many to common diverse, of standing all of the factors of successful successful of research and implementation. research related to the to social,related cul- effective producteffective just pieces of the larger of puzzle just pieces requires more than just an an just than more requires tural, political, economic, and that that them was the understanding biomedical prevention were were prevention biomedical I h V prevention research W ile related to the topics effective HIV prevention effective T e ne H

ed aclear under-ed AFR p H ( I I V prevention. H C fective fective . r IV A E f R mul e 4P - ). ). ve - - n access PrEP in the first place. place. PrEP in the first access environments and regulatory and community members, a person’s a person’s gel and tablet for prevention of gel and prevention tabletfor of directly into community’s each determined individuals’ ability to decision-making when choos when decision-making cultural factors shaped women’scultural factors son’s chances of becoming becoming son’s of chances provided, and whom. to the to epidemic, response that influence physical contexts Pr H H users to their friends, colleagues, colleagues, their to friends, users while the political, economic, while economic, political, the S ing the vaginal whether use to preven- including of the types individuals would as out come how,informed if, and when in nature, together butwork tion and care services that are tion services and care to reduce or increase aper- increase or reduce to u I I E V as instructed. They also They also instructed. V as V-positive. They also play ch factors are singular not ch factors F P ( o t r instance, socialr instance, and pre-exposure prophylaxis) pre-exposure i H o I V vulnerability. J A n nuary+

st F Eb - ruary 2015 P r Trial in early released results Truvada, tenofovir-based a or rstan U women’s women’s ated the safety and efficacy of of and efficacy the safety ated ltiple sessions M V ( daily tenofovir, oral of use oral did not use the test products products did the test use not dedicated to analyses of the the of analyses to dedicated enced the behaviors of study study of the behaviors enced of the discussions atof M that while reporting provided participants, and ultimately participants, regarding how some of the regarding of how some O vaginal prevention gel for of the they did. by the Conducted the varied reasons why women the variedreasons trial outcomes. trial factors mentioned above mentioned influ factors M O r a n icr u al Interventions to Control Control to al Interventions T I W C E N d obicides Trialsobicides E p h ) e te , the V study and light shed study on idemic) evalu study at follows is a snapshot O S I TIV O d g E I C LY ec d E

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- s 4 P H 31 I - V. CON FereNCE UPDATE HIVR4P: CAPE TOWN, SOUTH AFRICA

2013 revealed that the majority intriguing. Researchers inter- understand women’s decision- made the PrEP findings pos- of study participants did not viewed women to learn more making regarding communicat- sible, are unable to access take the pills or use the gels about any anal intercourse that ing product use. Researchers it. Instead, these individuals as instructed, but self-reported took place during the study. asked the participants of the can only (potentially) access high levels of adherence all The interviews revealed that CAPRISA trial to whom and PrEP through off-label prescrip- the same. To try to understand terms used in earlier questions when they disclosed product tions, demonstration projects, this discrepancy, study staff to assess anal sex activity were use. (CAPRISA found that and open-label studies. In the conducted in-depth interviews not understood by all of the using a tenofovir microbicide case of PrEP studies TDF2 as well as focus groups with a study participants. For example, gel before and after vaginal sex and iPrEx, study participants subset of VOICE participants. many women interpreted anal reduced women’s risk of HIV by who previously accessed PrEP A number of women noted sex to mean “vaginal sex from 39%. Stay tuned for FACTS trial through the clinical trial faced that participant conversations behind,” which appeared data due out this year, seeking access gaps between the end in site waiting rooms included to cause higher reporting of to confirm the CAPRISA effi- of the first study and the start rumors that the study drug anal intercourse than actu- cacy data.) of the next. Such access gaps caused serious side effects and ally occurred. And because Researchers also conducted put the health of those very even HIV. Some women also language used to describe sex focus groups and in-depth individuals who made PrEP feared that the gel could cause is, as the presenting researcher interviews with partners of possible at risk. uterine cancer or negatively noted, “frequently ambiguous, women enrolled in the study, as Bridget Haire of the impact their ability to conceive. indirect, and euphemistic,” well as men in the community University of New South Distrust of clinic staff and nega- collecting accurate data who were not partners of study Wales Australia and the tive perspectives of women’s through non-conversational participants. Outcomes indi- Australian Federation of AIDS partners, family, and friends self-reports can result in misin- cated that women were more Organisations noted during her also influenced their product terpretation of questions asked likely to share that they were plenary session that such inter- use. One woman whose partner and answers given. using the product with partners ruptions to access must and did not like the product shared Another study sought to they felt positively towards. In can be prevented. She called that her economic dependence understand women’s decisions other words, the more negative for ensuring that clinical trial on her partner required her to to stop taking PrEP. Reasons the feelings toward a partner, designs include plans to ensure stop using it. She stated that given included a partner’s the less likely a woman was continuous drug delivery fol- she “had to be more obedient to absence, or lack of a partner. to share that she was using a lowing a trial’s end. Identifying him than to the clinic.” Others stated they would stop microbicide. Disclosure was the steps and systems that are Women who were more taking PrEP if a partner asked a process for the women and necessary for ongoing access adherent to the gel and tablets them to stop, raising the issue contingent upon the relation- during the trial’s front end will said they valued the information again of how a myriad of fac- ship with partners and other make it possible for those par- and guidance given by clinic tors, particularly relationship circumstances. Similarly, their ticipants who want continued staff. Having the ability to regu- dynamics, influence a woman’s male partners’ acceptance product access to obtain it. The larly access health care and dis- decision to use any prevention of women’s product use also need for such intentionality in cuss their sexual health, receive option, even one that can be took time. When asked their trial design is not unique to risk reduction counseling, and taken without her partner’s thoughts about disclosing prod- PrEP. It is necessary for any obtain condoms, HIV tests, and knowledge. Pregnancy, side uct use, men who did not have and all of the new preven- STI screenings was also impor- effects, and disruption of partners on the gel reported tion technologies that are in tant to them. Strategies used to routine due to travel were also that communicating product development. overcome challenges included named as reasons why they use indicated a relationship’s combatting disapproval of prod- might choose to press pause stability and respect for autono- S o what do uct use by those close to them. on PrEP use. And again, issues mous decision-making. we do now? These conversations are that are determined by political critical to understanding and economic realities also PrEP access Well, the Mapping Pathways women’s concerns and con- loomed large in deciding to project housed at the AIDS texts. Such understanding can PrEP or not to PrEP. Women The United States is Foundation of Chicago (AFC) help inform the development of stated that if accessibility, avail- the only country where has a few ideas. (Full disclosure, products and programming that ability, and affordability prohib- Truvada is approved for PrEP. I work on this project and had meet diverse prevention needs. ited use, then they should stop Consequently, communities a poster on it at HIVR4P.) The A session discussing VOICE their PrEP use. vulnerable to HIV, including project is all about the need to participants’ understanding Also presented at HIVR4P thousands of study partici- identify and consider commu- of anal sex was particularly was another effort to pants outside the U.S. who nity-specific factors beyond

32 STIV PO I ELY AWARE JAnuary+FEbruary 2015 PrEP: TALK ao dv caTES shared their experiences on a panel moderated by Anna Forbes (right). clinical data that determine successful implementation of antiretroviral-based prevention options including PrEP, PEP (post-exposure prophylaxis), treatment, and microbicides. These factors are political, economic, social, and cultural. And they must be examined and understood in the clinical trial context if we are to understand what must be done to ensure that the people who need new prevention options can both access and use them. Understanding these factors and integrating that understanding into the design of clinical trials, behavioral research, and implementation programs is essential for the success of Pers pectives ON PrEP any prevention technology. It simply is not enough to know The most compelling part experience because his anxiety PrEP makes me feel like I am that a product is safe, accept- of the HIVR4P conference was related to HIV risk is so sig- in control. It makes me feel able, and effective. We must a session at the Advocates nificantly reduced. His honesty empowered.” While noting that also know what type of policy Pre-Conference that provided and emotion underscored what her friends understood her and economic environment will a platform for PrEP users from is too frequently understated in decision to go on PrEP because foster its availability. We must four different countries to share PrEP discussions. PrEP gives they are in the same industry, engage diverse stakeholders to their experiences and perspec- people peace of mind. Since she stated that she is stigma- enable uptake. We must listen tives. The panelists included going on PrEP, Marc-André has tized, as is sex work, by those to the community that these three gay men from South used his personal story in his who should be on her side and products are being designed Africa, Canada, and France and writing and advocacy to reduce lending her support. She cited for and authentically involve one young female sex worker PrEP stigma. His candor has being discriminated against by them in every aspect from from Zimbabwe. Each person proven effective. Upon learning other women. But she is unde- development to implementa- shared their very personal rea- he is on PrEP, his PrEP-averse terred. “I do it [PrEP] for myself tion to evaluation—so the field sons for choosing to use PrEP friends are re-examining this and my health.” develops things that people and what that decision means option and their views about it. As advocates for HIV want. We must honor their for them. They eloquently Emanuel of France spoke to prevention, social justice, and contributions and not discount articulated why HIV research- his concerns of being judged sexual health, it is incumbent their experiences. ers, prevention advocates, by his friends, “When I started upon us to advance an agenda Chicago will host the next program implementers, and two years ago I didn’t tell that respects individuals’ ability HIVR4P in October 2016. Stay funders must understand the anybody. I knew I would be to take control of their health. tuned. complex factors that determine shamed because it means that One Advocates Pre- successful implementation of I didn’t use condoms all of Conference participant sum- Je sSICa Terlikowski these new strategies, as well the time.” However, when he marized the power of these is Director of Prevention as continue to provide “more finally decided to share with personal stories by saying, Technology Education at the mechanisms for prevention.” his friends that he was on PrEP, “Once it is personal, it makes AIDS Foundation of Chicago. Marc-André of Canada, a he did not experience any sense.” Another issued a h c Go to aidschicago.org. long-time HIV prevention advo- condemnation. call to action by saying that, cate, gave a moving account Bathabile, the Zimbabwean “Community has a responsibility of just how powerful PrEP is sex worker, said, “There are so dger Bos dger FORe w bcasts, presenta- to get policymakers to make o

R tions, and posters from on a person’s psyche. Visibly many chances when I am vul- the right decisions to get

o the conference. go to t HIVR4P.org. emotional, he shared that he nerable to HIV. I have to pro- people what they need.”

Pho : has undergone a transformative tect myself with those things. c—Jessi a Terlikowski

JAnuary+FEbruary 2015 POSITIVELY AWARE 33 Aging w 34 ing F G By a i TIV s c Ric t h P k H O R Lo I I V the f tu E as LY s c

, M A AWARE

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C m J A nuary+ m ng u I e n s i F E t

Eb of y ruary 2015 gr - o f w ing ully ol d e r

“golden years.” adults as livingconfront with however, the special about challenges we’ll allaydoesn’t our simultaneous concerns, wewhere even were 15 ago. That years E time of amounts talking this about subject. increasing have spent patients our and us working of inthose them and giving them. few years, In the past A ahundred about of audienceThe consisted chronic chronic adults with of also burdened the special case double for it. That goes understand to begun activestudy,a topic of and we’ve barely aging function of adults— good aging about with we worry getto anymore.else wethe point hardly Ifeel talk anything about webinar or another lecture it, about almost to on lectures managers and patienttion case to educators. and in pharmacists, addi practitioners, nurse back. back. sible with acommunity at your when faced pos aloneimpossible becomes when faced unsolvableor is problems that what seems overwhelming seemingly facing when ence r with the year, by sponsored takes avillage to support an elder. raise a child. Iwould also say: It reach of age 70 of reach and beyond. within gets generation ahand’sBoomer tsunami”the “grey approaching, asthe Baby over the horizon adults of already see can ers tory seems in hindsight seems quitetory remarkable. has accomplished in year his our 30-plus A catastrophe. wellpatients enoughtopreventmedical our ability anticipate to these for problems about and we worry themselves, for care to the decliningabout ability our of patients They say They Those of us together rking W and aging that Igave in esearcher and esearcher v C I D ery time you turn around, there’sery it seems, o T On one hand, one On adefinite it’s privilege that that Isomewhat dread I have confess to I would say, however, that aformer as I made this on remark at alecture S U care professionals, mostly physicians, mostly professionals, care M P ’er an who later became H u U ch of whatch of the I V infection. V n ited ited H working provid- ashealth care I V and aging—both hearing V and aging—both H M S I t V physician, my experi a ates Conference on Conference ates it takes avillage to intaining the health and M e rck, inrck, conjunction H N A I V care and research and research V care e I D w S O community community W H r I leans last leans last all e w V enter their A H I adults—is adults—is D orry orry I V, given S

H A I I D - V V - S - .

Pho to: Thinkstockcom A ctivists dispatched problems of medicine, and high cholesterol. Nearly 20% will have have. One of the most striking studies speak- science, and policy again and again, working documented coronary artery disease, the ing to this was conducted by Kris Ann Oursler, together. I remain optimistic that this same condition that gives rise to heart attacks; a gerontologist at the University of Maryland approach will pay off in meeting the latest over 25% will have kidney disease and a with an interest in HIV-positive adults. Her set of challenges of aging HIV-positive adults, similar number will have confirmed diabetes. project, analyzing health outcomes in vet- and this is the message I have strived to There are some special issues with HIV- erans, found that patients’ function in daily bring to audiences when I speak on the topic. positive adults dealing with other chronic activities, as assessed by patients them- The generalities of the issue of HIV and medical conditions. For one, compared to selves, declined three times faster in HIV- aging came into sharp personal focus for their HIV-negative peers, adults living with positive adults compared to their HIV-negative me in the past five years, as I now live in HIV seem to be more likely to be dealing with peers living with the same conditions. the retirement community of the Coachella more than one chronic medical condition at For example, for a person who had Valley, in Southern California. I work in a time. In one study in veterans, for example, chronic obstructive lung disease (COPD, a large medical group practice in Palm people living with HIV who were 50 years of sometimes known to laypersons as “smok- Springs, and my particular office caters age or older were much more likely to have er’s lungs”), his or her ability to manage daily mainly to the aging LGBT patient population, multiple other chronic illnesses compared tasks affected by that condition, such as lim- many of whom are also living with HIV. with their age-matched HIV-negative peers. ited walking due to shortness of breath, got I came to the valley almost five years ago For adults with HIV age 60 or older, the worse over time at a faster rate if the person to take a job helping create a new internal vast majority—70%—had at least one other also had HIV infection. medicine residency at Eisenhower Medical chronic medical problem. Coronary artery Center. Eisenhower is one of the two largest disease, at least until people reach their C auses hospitals in the region and the first to have 70s, seems to be roughly three times more any kind of academic medicine program. prevalent in HIV-positive adults compared to W hat drives the higher number and sever- That, too, has brought with it its own set of HIV-negative people of the same age, even ity of chronic medical conditions in HIV- challenges. But it did not take long for me to when corrected for the presence of other risk positive adults? It has been hypothesized realize the special opportunities such a place factors such as smoking or obesity. that HIV may hyper-stimulate the immune offers to medical researchers interested in Besides the high rate of kidney disease system, producing chronic inflammation. the problems of “successful aging”—again, previously mentioned, patients also have “Inflammation” is familiar to anyone who’s both in the general adult population and in a high rate of liver disease—often due to had a splinter. The area around the splinter those living with HIV. co-infection with hepatitis B or hepatitis may get red, hot, and swollen; all of these In the article below, I will outline the C. Rates of bone density loss—osteopenia are physical signs of an active immune nature of the problem posed by aging suc- and osteoporosis—are much higher in HIV- system “fighting” the foreign invader—in cessfully with HIV, and then talk about how positive adults when compared to HIV nega- this case, the piece of wood. I and my research collaborators here in the tive adults, and unsurprisingly, the rate of These immune activities in the short Coachella Valley are taking advantage of the bone fractures is 50% higher. term may help fight off a challenge to the increasing numbers of HIV-positive adults liv- Perhaps most worrisome to my audiences body, such as an infection. But, if inflam- ing in the area to launch a project aimed at of HIV-positive adults is the higher rate of mation persists for days, months, or years, gaining insight into their special needs. Our memory impairment and development of it can take a toll on the body. Imagine you hope, of course, is that the lessons we learn early dementia we are seeing. Even HIV- are cooking at home, and the food in the will assist service agencies and policy mak- positive adults with no other HIV-related frying pan starts to burn. The smoke alarm ers worldwide in better addressing the needs symptoms will more commonly experience goes off, you pull the pan off the stove, and of our patient community. a decline in brain function. One study found a fire is prevented. On the other hand, if the that the rate is nearly twice as high, with at smoke alarm never shuts off, it would really HIVn a d aging: least mild cognitive impairment—problems start to make the cook feel frazzled. Like a The scope of the problem with thinking or memory—being found in smoke alarm that won’t shut up, inflamma- 36% of HIV-positive adults, compared with tion that never shuts off can turn from the “I have to deal with the reality.” 16% in HIV-negative people of the same age. body’s friend into its foe. –Project GRACIE focus group participant The neurocognitive issues of HIV-infected One important study that gave us adults is a special research interest of our insight into the chronic inflammation of In the developed world, the face of HIV collaborators from UC San Diego, Drs. HIV-infection was the SMART study, which infection is growing older. Most of us have Ronald Ellis and David Moore, and we have looked at HIV-positive adults using HIV med- heard the statistic that by 2015, 50% of all been assisting them in reaching more elderly ications. The study compared patients who HIV-positive adults in the U.S. will be over HIV-positive adults living in the valley for stayed on their medicines consistently to the age of 50. Going along with this trend, their important work in this area. those who took breaks from their medicines HIV patients today are not only living with Not only do people with HIV contend with from time to time (what we call “drug holi- HIV, but with the “diseases of aging.” As more medical problems compared to their days” or “treatment interruptions”). The big people with HIV enter their 60s, more than HIV-negative peers, they also seem to have lesson of the study was that taking breaks half of them will demonstrate hypertension a rougher time with the conditions they do from medication actually produced much

JAnuary+FEbruary 2015 POSITIVELY AWARE 35 worse outcomes for the patients than staying As noted above, these patients struggle with some of the specific challenges posed by our on medicines consistently from day to day. the insidious effects of chronic HIV infection situation in the valley—and I think our roots In the SMART study, patients with HIV and co-morbid diseases of aging, as well as in the activism of the AIDS movement will infection who were treated using a CD4 from the side effects of long-term multi-drug help us. For starters, aside from our relation- count-guided “drug conservation” approach antiretroviral therapy. ship with our colleagues at UCSD, we have no had significantly greater all-cause mortal- In the past year, I and my research major medical university program as a base; ity than those treated for maximal viral team, including Drs. Gerry Bocian and rather, we will be doing this research work suppression. The role of inflammatory and Carlos Martinez, and research assistant Erik “in the community.” Fortunately, the AIDS coagulation biomarkers in mortality in this Hernandez, have been meeting monthly with movement practically invented “community- population has subsequently been studied. clinician-scientists working at other HIV care based research,” starting with the Community Older adults participating in the SMART centers around the valley. Our colleagues Research Initiative on AIDS (now known study, compared with adults from two large include Dr. Clayton Barbour, nurse practi- as ACRIA) in New York, co-founded by my general population studies, had significant tioner Joseph Dahman, and nurse Chuck former mentor, Dr. Joseph Sonnabend, and elevations in markers of inflammatory Marbley, all from Borrego Community Health its San Francisco counterpart, the Community (hsCRP and IL-6), coagulation, and fibrinoly- Foundation; Dr. Shubha Kerkar, a founding Consortium, led by another of my mentors, sis activity (D-dimer), as well as renal func- physician of the Desert AIDS Project (DAP) Dr. Donald Abrams. Both organizations pio- tion impairment (cystatin-C). and main HIV provider at Desert Oasis HMO; neered the implementation of cutting-edge Besides the medical issues, there are and Dr. Steven Scheibel, the medical director basic and clinical research conducted in the social factors that distinguish HIV-positive of DAP. The purpose of our meetings was to office of AIDS primary care providers, outside adults that concern me as a primary care discuss common concerns regarding our care a university setting, in the early 1990s. provider who takes care of them. I consider and research work here. Community-based research doesn’t social isolation—living alone, and/or hav- At one of our meetings in early 2014, our simply mean doing research work outside ing fewer family or friends around to offer aforementioned UCSD colleagues Drs. Ron a university. It also connotes a partnership help when needed—to be a dangerous risk Ellis and David Moore presented a summary with the patients, informed by feedback on factor for poor medical outcomes in my of recent cohort studies of HIV-positive their needs and concerns. patients, and when I see that, I try to get adults. They noted that the number of adults I am hoping, along with my Coachella these patients enrolled in programs that bring age 65 or older, in total, across about a Valley colleagues, to instill in our future work volunteers or other help into the home. While dozen studies combined, numbered no more the same kind of partnering with patient it varies from person to person, the literature than about two dozen individuals. In my own volunteers in our research that I witnessed in shows that on average, older HIV-positive panel, it is the group of adults under the age many UCSF projects in San Francisco. I had adults tend to be more socially isolated than of 50 that I can count on two hands—most the good fortune in the mid-1990s to work their younger counterparts. Older people with of my HIV patients are significantly older. with Dr. Mike McCune’s lab at the Gladstone HIV are also more likely to live alone. This The pattern is the same for the other local Institute of Virology and Immunology (GIVI) may also contribute to their challenges in HIV providers. at UCSF. There, I watched his team of successfully meeting the challenges of aging. After discussion, we agreed that we scientists benefit “at the bench side” from had a unique opportunity here—indeed, an ongoing dialogue with patients and activ- Meet GRACIE a responsibility—to take advantage of this ists who contributed to the development of concentration of adults aging with HIV to bet- their studies and supported their success. “We are an open book.” ter understand their health and care needs. I also helped Dr. Steven Deeks create the –Project GRACIE focus group participant Thus, we created plans for Project GRACIE SCOPE cohort—now a large, NIH-supported (Geriatric Research of AIDS Comorbidities prospective study based at San Francisco S outhern California’s Coachella Valley and in the Inland Empire), a prospective cohort General Hospital—and watched the develop- Inland Empire are home to one of the largest study of HIV-positive adults aged 50 or older, ment of the OPTIONS early HIV infection groups of long-term survivors of HIV infec- as well as HIV-negative, aged-matched peers. cohort study there. Both projects exemplified tion to be found anywhere in the world. As The purpose of Project GRACIE is to similar active partnership with the patient a retirement community, Palm Springs has rectify the absence of information on HIV- volunteers. It was part of the work culture been a traditional magnet for LGBT vacation- positive elders and their specific aging-related of the clinician-scientists at our labs to see ers, and often as these adults approach challenges by enrolling up to 300 individuals, patients as active members of the research retirement age, they make their stays here all over age 50, in a decade-long, prospective team, contributing in the most personal way longer and longer until they become year- study that will provide the scientific, pharma- possible—with their bodies. But patients round residents. Many of these people are ceutical, and medical communities with an also helped by giving us their ideas, observa- living with HIV. accurate, detailed, data-rich portrait of aging tion, and feedback, and their willingness In the past five years, the number of AIDS patients—and provide clear guidelines to let their primary care providers and the doctors and nurses trained in HIV care living for the optimal medical management of older, larger patient community know about our here has greatly increased in order to meet seropositive individuals. work. We hope to establish a similar culture the special needs of this group of individuals. Project GRACIE’s approach is informed by of partnership with Project GRACIE.

36 STIV PO I ELY AWARE JAnuary+FEbruary 2015 GRACIEn u der pressure the established medical literature. This part 70% was formally announced December 1, 2014, of s HIV-po itive adults age 60 “Take what you need and what you or older had at least one other World AIDS Day. The nice part about a chart want, because essentially you need this chronic medical problem. review project is that its financial burdens information from us.” are quite modest. –Project GRACIE focus group participant The next phase would include, in addition to surveys of the patient-participants, col- To get GRACIE off on the right foot, we lecting and storing blood and tissue samples have been conducting focus groups with taken from volunteers. The objective of this HIV-positive adults age 55 or older, to get phase of Project GRACIE will be to monitor, their direct feedback about what their con- Rates of bone density loss quantify, and compare the comorbidities seen cerns would be in participating in such a are much higher. the rate of in older individuals living with HIV to those in bone fractures is project. This will allow us to anticipate the age-matched sero-negative controls. A num- concerns of our volunteers and address them ber of clinical markers of disease, including right from the start of the project. I think we 50% higher some of the inflammatory markers mentioned will have the support of the community. above, will be monitored in this work. And, we will need it. Establishing a pro- It has been interesting to me that the spective cohort study in a community setting focus group members have commented that is no mean feat. It will require significant getting support for coping with the challenges organizational support, which translates of aging doesn’t simply mean studying the into a need for expertise and finances. We problems. While they recognize the need to attempt it at a time when NIH funding for all involve the pharmaceutical industry as part- medical research has been declining steadily 36% ners in supporting this work, they also want- every year for the past decade. It feels like of s HIV-po itive older adults ed to make sure the investigators think about climbing a mountain. were found to have some level of complementary therapies, including nutrition Fortunately, when one climbs Mount cognitive impairment—problems and modalities like acupuncture, in the thera- with thinking or memory— Everest, one goes up the icy slopes with compared to 16% in HIV-negative peutic studies that will likely unfold out of the a band of fellow mountaineers. And, with people of the same age. GRACIE project. Likewise, I anticipate that Project GRACIE, so far, every time I thought GRACIE will partner with some of our local we were licked and couldn’t surmount the care agencies to make sure our participants next challenge, people came out of the fashion. Likewise, so far our GRACIE focus will take advantage of the existing support woodwork to help us. We have been helped group participants have commented that resources in the valley, even as our research by our local activists, including Jeff Taylor they do not have a problem with us getting helps shape and mold those resources for and Jonathan Goldman, who’ve been run- financial support from pharmaceutical indus- even better support in the future. ning our focus groups; Marlene Estevez, try sources, so long as the GRACIE team— So, it takes a village. In surmounting a local pre-medical student and the main researchers and participants—controls the the challenges of AIDS, it always has, and administrator of the nascent project; Edwin research agenda. And, as I mentioned, all of probably always will. Project GRACIE will “Ned” Bayrd, formerly of the UCLA AIDS what we’ve accomplished to date has hap- move forward thanks to the support of many Institute, whose operational savvy has been pened thanks to volunteers. scientists, care providers, and advocates, but hugely helpful; and many others. It is the most importantly, the community of aging contributions of these additional people that GRACIE : Next Steps HIV-positive adults living here in the valley. have allowed our science team to continue to I hope what we learn will benefit the larger push forward, step by step. “It would be nice to be asked if I need world community of people living with HIV/ Funding for GRACIE will be a creative to talk to someone. A lot of these trials AIDS and care providers. challenge. As I mentioned, NIH funding bring up emotional history.” continues to drop for projects like this. We’ve –Project GRACIE focus group participant Ric k Loftus, MD, is an Associate been in touch with Dr. Kenneth Lichtenstein Program Director of the Internal Medicine of the HOPS HIV cohort study—a famous The next step in our work—what we’ve Residency Program at Eisenhower Medical study somewhat similar in nature to what we dubbed “Phase 0”—will be a planned chart Center in Rancho Mirage, California, and envision for GRACIE—who has given us some review project, which will be handled by a an Adjunct Clinical Assistant Professor of ideas of ways to add to our infrastructure four-person team of resident doctors, work- Medicine at the Keck School of Medicine without adding to our explicit expenses. Many ing under each of our principal investigators of the University of Southern California. He of the AIDS-care and medical organizations in at their individual clinic locations. The would like to acknowledge Project GRACIE our region—including my own hospital—have purpose of this phase will be to character- volunteers Edwin “Ned” Baird and Marlene supported their operations with private dona- ize the comorbid medical problems of older Estevez for assistance in creating this article. tions, and we will likely proceed in a similar HIV patients, and compare those findings to He can be reached at [email protected].

JAnuary+FEbruary 2015 POSITIVELY AWARE 37 COMPLERA does not cure HIV-1 infection or AIDS. • Changes in liver enzymes: People who have had hepatitis B or C, To control HIV-1 infection and decrease HIV-related illnesses you must keep or who have had changes in their liver function tests in the past may taking COMPLERA. Ask your healthcare provider if you have questions about have an increased risk for liver problems while taking COMPLERA. COMPLERA is a prescription medicine for adults who how to reduce the risk of passing HIV-1 to others. Always practice safer sex Some people without prior liver disease may also be at risk. Your have never taken HIV-1 medicines before and who and use condoms to lower the chance of sexual contact with body fluids. healthcare provider may do tests to check your liver enzymes before and during treatment with COMPLERA. have no more than 100,000 copies/mL of virus in Never reuse or share needles or other items that have body fluids on them. • Bone problems, including bone pain or bones getting soft or thin, their blood. COMPLERA can also replace current HIV-1 It is not known if COMPLERA is safe and effective in children under which may lead to fractures. Your healthcare provider may do tests medicines for some adults who have an undetectable 18 years old. to check your bones. • Changes in body fat can happen in people taking HIV-1 medicines. viral load (less than 50 copies/mL) and whose IMPORTANT SAFETY INFORMATION • Changes in your immune system. Your immune system may get healthcare provider determines that they meet certain stronger and begin to fight infections. Tell your healthcare provider What is the most important information I should know if you have any new symptoms after you start taking COMPLERA. other requirements. COMPLERA combines 3 medicines about COMPLERA? into 1 pill to be taken once a day with food. COMPLERA COMPLERA can cause serious side effects: The most common side effects of COMPLERA include trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, should not be used with other HIV-1 medicines. • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak rash, tiredness, and depression. Other common side effects include or tired, unusual (not normal) muscle pain, trouble breathing, stomach vomiting, stomach pain or discomfort, skin discoloration (small spots pain with nausea or vomiting, feeling cold especially in your arms and or freckles), and pain. Tell your healthcare provider if you have any side legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat. effects that bother you or do not go away. one • Serious liver problems. The liver may become large (hepatomegaly) What should I tell my healthcare provider before and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” taking COMPLERA? Just the for me urine, light-colored bowel movements (stools), loss of appetite for • All your health problems. Be sure to tell your healthcare provider if several days or longer, nausea, and/or stomach pain. you have or had any kidney, mental health, bone, or liver problems, • You may be more likely to get lactic acidosis or serious liver problems including hepatitis virus infection. if you are female, very overweight (obese), or have been taking • All the medicines you take, including prescription and nonprescription COMPLERA for a long time. In some cases, these serious conditions medicines, vitamins, and herbal supplements. COMPLERA may affect have led to death. Call your healthcare provider right away if you have the way other medicines work, and other medicines may affect how any symptoms of these conditions. COMPLERA works. Keep a list of all your medicines and show it to • Worsening of hepatitis B (HBV) infection. If you also have HBV and your healthcare provider and pharmacist. Do not start any new stop taking COMPLERA, your hepatitis may suddenly get worse. Do not medicines while taking COMPLERA without first talking with your stop taking COMPLERA without first talking to your healthcare provider, healthcare provider. as they will need to monitor your health. COMPLERA is not approved for • If you take rifabutin (Mycobutin). Talk to your healthcare provider the treatment of HBV. about the right amount of rilpivirine (Edurant) you should take. • If you take antacids. Take antacids at least 2 hours before or at least Who should not take COMPLERA? 4 hours after you take COMPLERA. Do not take COMPLERA if you: • If you take stomach acid blockers. Take acid blockers at least • Take a medicine that contains: adefovir (Hepsera), lamivudine (Epivir- 12 hours before or at least 4 hours after you take COMPLERA. Ask HBV), carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, your healthcare provider if your acid blocker is okay to take, as Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin some acid blockers should never be taken with COMPLERA. (Dilantin, Dilantin-125, Phenytek), rifampin (Rifater, Rifamate, Rimactane, • If you are pregnant or plan to become pregnant. It is not known if Rifadin), rifapentine (Priftin), dexlansoprazole (Dexilant), esomeprazole COMPLERA can harm your unborn baby. Tell your healthcare provider COMPLERA is a complete (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), if you become pregnant while taking COMPLERA. pantoprazole sodium (Protonix), rabeprazole (Aciphex), more than 1 dose of • If you are breastfeeding (nursing) or plan to breastfeed. Do not HIV-1 treatment in only the steroid medicine dexamethasone or dexamethasone sodium phosphate, breastfeed. HIV-1 can be passed to the baby in breast milk. Also, some or the herbal supplement St. John’s wort. medicines in COMPLERA can pass into breast milk, and it is not known 1 pill a day. • Take any other medicines to treat HIV-1 infection, unless recommended if this can harm the baby. by your healthcare provider. You are encouraged to report negative side effects of prescription What are the other possible side effects of COMPLERA? drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Ask your healthcare Serious side effects of COMPLERA may also include: Please see Brief Summary of full Prescribing Information with • New or worse kidney problems, including kidney failure. Your important warnings on the following pages. provider if COMPLERA healthcare provider should do blood tests to check your kidneys before may be the one for you. starting treatment with COMPLERA. If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider may also check your kidneys during treatment with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself.

Pill shown is not actual size.

PALIO Date: 9.15.14 • Client: Gilead • Product: Complera • File Name: 24057_pgitvd_8.125_10.5_C_Lawryn_POS_Aware_fi.indd PALIO Date: 9.15.14 • Client: Gilead • Product: Complera • File Name: 24057_pgitvd_8.125_10.5_C_Lawryn_POS_Aware_fi.indd Ad Page 1 Positively Aware Mag Ad Page 2 Positively Aware Mag Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.5” x 11.0” Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.5” x 11.0” Brief Summary of full Prescribing Information • You may be more likely to get lactic acidosis or severe liver problems increased risk of developing new or worsening liver problems during • Be sure to tell your healthcare provider if you take any of the following COMPLERA® (kom-PLEH-rah) if you are female, very overweight (obese), or have been taking treatment with COMPLERA. Liver problems can also happen during medicines: COMPLERA for a long time. treatment with COMPLERA in people without a history of liver disease. (emtricitabine 200 mg, rilpivirine 25 mg, tenofovir disoproxil – Rifabutin (Mycobutin), a medicine to treat some bacterial infections. • Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) Your healthcare provider may need to do tests to check your liver Talk to your healthcare provider about the right amount of rilpivirine fumarate 300 mg) tablets infection and take COMPLERA, your HBV may get worse (flare-up) if enzymes before and during treatment with COMPLERA. (Edurant) you should take. Brief summary of full Prescribing Information. For more information, you stop taking COMPLERA. A “flare-up” is when your HBV infection • Bone problems can happen in some people who take COMPLERA. Bone – Antacid medicines that contain aluminum, magnesium hydroxide, or please see the full Prescribing Information, including Patient Information. suddenly returns in a worse way than before. COMPLERA is not approved problems include bone pain, softening or thinning (which may lead to calcium carbonate. Take antacids at least 2 hours before or at least for the treatment of HBV, so you must discuss your HBV with your fractures). Your healthcare provider may need to do tests to check your bones. 4 hours after you take COMPLERA. What is COMPLERA? healthcare provider. • Changes in body fat can happen in people taking HIV-1 medicine. – Certain medicines to block the acid in your stomach, including • COMPLERA is a prescription medicine used as a complete HIV-1 treatment – Do not run out of COMPLERA. Refill your prescription or talk to your These changes may include increased amount of fat in the upper back cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or in one pill a day. COMPLERA is for adults who have never taken HIV-1 healthcare provider before your COMPLERA is all gone. and neck (“buffalo hump”), breast, and around the main part of your ranitidine hydrochloride (Zantac). Take the acid blocker at least medicines before and who have no more than 100,000 copies/mL of – Do not stop taking COMPLERA without first talking to your healthcare body (trunk). Loss of fat from the legs, arms and face may also happen. 12 hours before or at least 4 hours after you take COMPLERA. Some virus in their blood (this is called ‘viral load’). Complera can also replace provider. The cause and long term health effect of these conditions are not known. acid blocking medicines should never be taken with COMPLERA (see current HIV-1 medicines for some adults who have an undetectable viral – If you stop taking COMPLERA, your healthcare provider will need to “Who should not take COMPLERA?” for a list of these medicines). load (less than 50 copies/mL) and whose healthcare provider determines • Changes in your immune system (Immune Reconstitution Syndrome) check your health often and do blood tests regularly to check your can happen when you start taking HIV-1 medicines. Your immune – Medicines that can affect how your kidneys work, including acyclovir that they meet certain other requirements. HBV infection. Tell your healthcare provider about any new or unusual system may get stronger and begin to fight infections that have been (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), • COMPLERA is a complete regimen and should not be used with other symptoms you may have after you stop taking COMPLERA. hidden in your body for a long time. Tell your healthcare provider if you valacyclovir (Valtrex), and valganciclovir (Valcyte). HIV-1 medicines. HIV-1 is the virus that causes AIDS. When used start having any new symptoms after starting your HIV-1 medicine. – clarithromycin (Biaxin) properly, COMPLERA may reduce the amount of HIV-1 virus in your Who should not take COMPLERA? The most common side effects of COMPLERA include: – erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone) blood and increase the amount of CD4 T-cells, which may help improve Do not take COMPLERA if you also take any of the following medicines: – fluconazole (Diflucan) your immune system. This may reduce your risk of death or getting • Trouble sleeping (insomnia), abnormal dreams, headache, dizziness, – itraconazole (Sporanox) infections that can happen when your immune system is weak. • Medicines used for seizures: carbamazepine (Carbatrol, Equetro, diarrhea, nausea, rash, tiredness, depression Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine (Trileptal); – ketoconazole (Nizoral) • COMPLERA does not cure HIV-1 or AIDS. You must stay on continuous Additional common side effects include: phenobarbital (Luminal); phenytoin (Dilantin, Dilantin-125, Phenytek) – methadone (Dolophine) HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses. • Vomiting, stomach pain or discomfort, skin discoloration (small spots • Medicines used for tuberculosis: rifampin (Rifater, Rifamate, Rimactane, – posaconazole (Noxafil) • Ask your healthcare provider about how to prevent passing HIV-1 or freckles), pain Rifadin); rifapentine (Priftin) – telithromycin (Ketek) to others. Do not share or reuse needles, injection equipment, or Tell your healthcare provider if you have any side effect that bothers personal items that can have blood or body fluids on them. Do not have • Certain medicines used to block stomach acid called proton pump you or that does not go away. – voriconazole (Vfend) inhibitors (PPIs): dexlansoprazole (Dexilant); esomeprazole (Nexium, sex without protection. Always practice safer sex by using a latex or Know the medicines you take. Keep a list of all your medicines and Vimovo); lansoprazole (Prevacid); omeprazole (Prilosec, Zegerid); • These are not all the possible side effects of COMPLERA. For more polyurethane condom to lower the chance of sexual contact with semen, information, ask your healthcare provider. show it to your healthcare provider and pharmacist when you get a new pantoprazole sodium (Protonix); rabeprazole (Aciphex) medicine. Do not start any new medicines while you are taking COMPLERA vaginal secretions, or blood. • Call your healthcare provider for medical advice about side effects. • Certain steroid medicines: More than 1 dose of dexamethasone or without first talking with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088. What is the most important information I should know about COMPLERA? dexamethasone sodium phosphate • Certain herbal supplements: St. John’s wort How should I take COMPLERA? COMPLERA can cause serious side effects, including: What should I tell my healthcare provider before taking COMPLERA? • Certain hepatitis medicines: adefovir (Hepsera), lamivudine (Epivir-HBV) • Stay under the care of your healthcare provider during treatment with • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis Tell your healthcare provider about all your medical conditions, including: COMPLERA. can happen in some people who take COMPLERA or similar (nucleoside Do not take COMPLERA if you also take any other HIV-1 medicines, including: • If you have or had any kidney, mental health, bone, or liver problems, • Take COMPLERA exactly as your healthcare provider tells you to take it. analogs) medicines. Lactic acidosis is a serious medical emergency • Other medicines that contain tenofovir (ATRIPLA, STRIBILD, TRUVADA, VIREAD) including hepatitis B or C infection. that can lead to death. Lactic acidosis can be hard to identify early, • Always take COMPLERA with food. Taking COMPLERA with food is important • Other medicines that contain emtricitabine or lamivudine (ATRIPLA, • If you are pregnant or plan to become pregnant. It is not known if because the symptoms could seem like symptoms of other health Combivir, EMTRIVA, Epivir, Epzicom, STRIBILD, Trizivir, TRUVADA) to help get the right amount of medicine in your body. A protein drink is not COMPLERA can harm your unborn child. a substitute for food. If your healthcare provider decides to stop COMPLERA problems. Call your healthcare provider right away if you get any of • rilpivirine (Edurant), unless you are also taking rifabutin (Mycobutin) the following symptoms which could be signs of lactic acidosis: – There is a pregnancy registry for women who take antiviral and you are switched to new medicines to treat HIV-1 that includes COMPLERA is not for use in people who are less than 18 years old. medicines during pregnancy. The purpose of this registry is to collect – feel very weak or tired rilpivirine tablets, the rilpivirine tablets should be taken only with a meal. information about the health of you and your baby. Talk to your Keep COMPLERA and all medicines out of reach of children. – have unusual (not normal) muscle pain What are the possible side effects of COMPLERA? healthcare provider about how you can take part in this registry. – have trouble breathing This Brief Summary summarizes the most important information about COMPLERA may cause the following serious side effects: • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed – having stomach pain with nausea or vomiting COMPLERA. If you would like more information, talk with your healthcare • See “What is the most important information I should know if you take COMPLERA. provider. You can also ask your healthcare provider or pharmacist for – feel cold, especially in your arms and legs about COMPLERA?” – You should not breastfeed if you have HIV-1 because of the risk of information about COMPLERA that is written for health professionals, – feel dizzy or lightheaded • New or worse kidney problems, including kidney failure. Your healthcare passing HIV-1 to your baby. or call 1-800-445-3235 or go to www.COMPLERA.com. – have a fast or irregular heartbeat provider should do blood and urine tests to check your kidneys before – Two of the medicines in COMPLERA can pass to your baby in your Issued: June 2014 • Severe liver problems. Severe liver problems can happen in people you start and while you are taking COMPLERA. If you have had kidney breast milk. It is not known if this could harm your baby. who take COMPLERA. In some cases, these liver problems can lead to problems in the past or need to take another medicine that can cause – Talk to your healthcare provider about the best way to feed your baby. death. Your liver may become large (hepatomegaly) and you may develop kidney problems, your healthcare provider may need to do blood tests Tell your healthcare provider about all the medicines you take, fat in your liver (steatosis). Call your healthcare provider right away if to check your kidneys during your treatment with COMPLERA. including prescription and nonprescription medicines, vitamins, you get any of the following symptoms of liver problems: • Depression or mood changes. Tell your healthcare provider right away and herbal supplements: – your skin or the white part of your eyes turns yellow (jaundice) if you have any of the following symptoms: COMPLERA, the COMPLERA Logo, EMTRIVA, GILEAD, the GILEAD Logo, GSI, • COMPLERA may affect the way other medicines work, and other – dark “tea-colored” urine – feeling sad or hopeless medicines may affect how COMPLERA works. HEPSERA, STRIBILD, TRUVADA, VIREAD, and VISTIDE are trademarks of – light-colored bowel movements (stools) – feeling anxious or restless Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of • If you take certain medicines with COMPLERA, the amount of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced – loss of appetite for several days or longer – have thoughts of hurting yourself (suicide) or have tried to hurt yourself COMPLERA in your body may be too low and it may not work to help herein are the property of their respective owners. – nausea • Change in liver enzymes. People with a history of hepatitis B or C control your HIV-1 infection. The HIV-1 virus in your body may become – stomach pain virus infection or who have certain liver enzyme changes may have an resistant to COMPLERA or other HIV-1 medicines that are like it. ©2014 Gilead Sciences, Inc. All rights reserved. CPAC0115 08/14

PALIO Date: 9.15.14 • Client: Gilead • Product: Complera • File Name: 24057_pgitvd_8.125_10.5_C_Lawryn_POS_Aware_fi.indd PALIO Date: 9.15.14 • Client: Gilead • Product: Complera • File Name: 24057_pgitvd_8.125_10.5_C_Lawryn_POS_Aware_fi.indd BS Page 1 Positively Aware Mag BS Page 2 Positively Aware Mag Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.5” x 11.0” Trim: 8.0” x 10.5” • Live: 7.0” x 9.5”• Bleed: 8.5” x 11.0” Brief Summary of full Prescribing Information • You may be more likely to get lactic acidosis or severe liver problems increased risk of developing new or worsening liver problems during • Be sure to tell your healthcare provider if you take any of the following COMPLERA® (kom-PLEH-rah) if you are female, very overweight (obese), or have been taking treatment with COMPLERA. Liver problems can also happen during medicines: COMPLERA for a long time. treatment with COMPLERA in people without a history of liver disease. (emtricitabine 200 mg, rilpivirine 25 mg, tenofovir disoproxil – Rifabutin (Mycobutin), a medicine to treat some bacterial infections. • Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) Your healthcare provider may need to do tests to check your liver Talk to your healthcare provider about the right amount of rilpivirine fumarate 300 mg) tablets infection and take COMPLERA, your HBV may get worse (flare-up) if enzymes before and during treatment with COMPLERA. (Edurant) you should take. Brief summary of full Prescribing Information. For more information, you stop taking COMPLERA. A “flare-up” is when your HBV infection • Bone problems can happen in some people who take COMPLERA. Bone – Antacid medicines that contain aluminum, magnesium hydroxide, or please see the full Prescribing Information, including Patient Information. suddenly returns in a worse way than before. COMPLERA is not approved problems include bone pain, softening or thinning (which may lead to calcium carbonate. Take antacids at least 2 hours before or at least for the treatment of HBV, so you must discuss your HBV with your fractures). Your healthcare provider may need to do tests to check your bones. 4 hours after you take COMPLERA. What is COMPLERA? healthcare provider. • Changes in body fat can happen in people taking HIV-1 medicine. – Certain medicines to block the acid in your stomach, including • COMPLERA is a prescription medicine used as a complete HIV-1 treatment – Do not run out of COMPLERA. Refill your prescription or talk to your These changes may include increased amount of fat in the upper back cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or in one pill a day. COMPLERA is for adults who have never taken HIV-1 healthcare provider before your COMPLERA is all gone. and neck (“buffalo hump”), breast, and around the main part of your ranitidine hydrochloride (Zantac). Take the acid blocker at least medicines before and who have no more than 100,000 copies/mL of – Do not stop taking COMPLERA without first talking to your healthcare body (trunk). Loss of fat from the legs, arms and face may also happen. 12 hours before or at least 4 hours after you take COMPLERA. Some virus in their blood (this is called ‘viral load’). Complera can also replace provider. The cause and long term health effect of these conditions are not known. acid blocking medicines should never be taken with COMPLERA (see current HIV-1 medicines for some adults who have an undetectable viral – If you stop taking COMPLERA, your healthcare provider will need to “Who should not take COMPLERA?” for a list of these medicines). load (less than 50 copies/mL) and whose healthcare provider determines • Changes in your immune system (Immune Reconstitution Syndrome) check your health often and do blood tests regularly to check your can happen when you start taking HIV-1 medicines. Your immune – Medicines that can affect how your kidneys work, including acyclovir that they meet certain other requirements. HBV infection. Tell your healthcare provider about any new or unusual system may get stronger and begin to fight infections that have been (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), • COMPLERA is a complete regimen and should not be used with other symptoms you may have after you stop taking COMPLERA. hidden in your body for a long time. Tell your healthcare provider if you valacyclovir (Valtrex), and valganciclovir (Valcyte). HIV-1 medicines. HIV-1 is the virus that causes AIDS. When used start having any new symptoms after starting your HIV-1 medicine. – clarithromycin (Biaxin) properly, COMPLERA may reduce the amount of HIV-1 virus in your Who should not take COMPLERA? The most common side effects of COMPLERA include: – erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone) blood and increase the amount of CD4 T-cells, which may help improve Do not take COMPLERA if you also take any of the following medicines: – fluconazole (Diflucan) your immune system. This may reduce your risk of death or getting • Trouble sleeping (insomnia), abnormal dreams, headache, dizziness, – itraconazole (Sporanox) infections that can happen when your immune system is weak. • Medicines used for seizures: carbamazepine (Carbatrol, Equetro, diarrhea, nausea, rash, tiredness, depression Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine (Trileptal); – ketoconazole (Nizoral) • COMPLERA does not cure HIV-1 or AIDS. You must stay on continuous Additional common side effects include: phenobarbital (Luminal); phenytoin (Dilantin, Dilantin-125, Phenytek) – methadone (Dolophine) HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses. • Vomiting, stomach pain or discomfort, skin discoloration (small spots • Medicines used for tuberculosis: rifampin (Rifater, Rifamate, Rimactane, – posaconazole (Noxafil) • Ask your healthcare provider about how to prevent passing HIV-1 or freckles), pain Rifadin); rifapentine (Priftin) – telithromycin (Ketek) to others. Do not share or reuse needles, injection equipment, or Tell your healthcare provider if you have any side effect that bothers personal items that can have blood or body fluids on them. Do not have • Certain medicines used to block stomach acid called proton pump you or that does not go away. – voriconazole (Vfend) inhibitors (PPIs): dexlansoprazole (Dexilant); esomeprazole (Nexium, sex without protection. Always practice safer sex by using a latex or Know the medicines you take. Keep a list of all your medicines and Vimovo); lansoprazole (Prevacid); omeprazole (Prilosec, Zegerid); • These are not all the possible side effects of COMPLERA. For more polyurethane condom to lower the chance of sexual contact with semen, information, ask your healthcare provider. show it to your healthcare provider and pharmacist when you get a new pantoprazole sodium (Protonix); rabeprazole (Aciphex) medicine. Do not start any new medicines while you are taking COMPLERA vaginal secretions, or blood. • Call your healthcare provider for medical advice about side effects. • Certain steroid medicines: More than 1 dose of dexamethasone or without first talking with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088. What is the most important information I should know about COMPLERA? dexamethasone sodium phosphate • Certain herbal supplements: St. John’s wort How should I take COMPLERA? COMPLERA can cause serious side effects, including: What should I tell my healthcare provider before taking COMPLERA? • Certain hepatitis medicines: adefovir (Hepsera), lamivudine (Epivir-HBV) • Stay under the care of your healthcare provider during treatment with • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis Tell your healthcare provider about all your medical conditions, including: COMPLERA. can happen in some people who take COMPLERA or similar (nucleoside Do not take COMPLERA if you also take any other HIV-1 medicines, including: • If you have or had any kidney, mental health, bone, or liver problems, • Take COMPLERA exactly as your healthcare provider tells you to take it. analogs) medicines. Lactic acidosis is a serious medical emergency • Other medicines that contain tenofovir (ATRIPLA, STRIBILD, TRUVADA, VIREAD) including hepatitis B or C infection. that can lead to death. Lactic acidosis can be hard to identify early, • Always take COMPLERA with food. Taking COMPLERA with food is important • Other medicines that contain emtricitabine or lamivudine (ATRIPLA, • If you are pregnant or plan to become pregnant. It is not known if because the symptoms could seem like symptoms of other health Combivir, EMTRIVA, Epivir, Epzicom, STRIBILD, Trizivir, TRUVADA) to help get the right amount of medicine in your body. A protein drink is not COMPLERA can harm your unborn child. a substitute for food. If your healthcare provider decides to stop COMPLERA problems. Call your healthcare provider right away if you get any of • rilpivirine (Edurant), unless you are also taking rifabutin (Mycobutin) the following symptoms which could be signs of lactic acidosis: – There is a pregnancy registry for women who take antiviral and you are switched to new medicines to treat HIV-1 that includes COMPLERA is not for use in people who are less than 18 years old. medicines during pregnancy. The purpose of this registry is to collect – feel very weak or tired rilpivirine tablets, the rilpivirine tablets should be taken only with a meal. information about the health of you and your baby. Talk to your Keep COMPLERA and all medicines out of reach of children. – have unusual (not normal) muscle pain What are the possible side effects of COMPLERA? healthcare provider about how you can take part in this registry. – have trouble breathing This Brief Summary summarizes the most important information about COMPLERA may cause the following serious side effects: • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed – having stomach pain with nausea or vomiting COMPLERA. If you would like more information, talk with your healthcare • See “What is the most important information I should know if you take COMPLERA. provider. You can also ask your healthcare provider or pharmacist for – feel cold, especially in your arms and legs about COMPLERA?” – You should not breastfeed if you have HIV-1 because of the risk of information about COMPLERA that is written for health professionals, – feel dizzy or lightheaded • New or worse kidney problems, including kidney failure. Your healthcare passing HIV-1 to your baby. or call 1-800-445-3235 or go to www.COMPLERA.com. – have a fast or irregular heartbeat provider should do blood and urine tests to check your kidneys before – Two of the medicines in COMPLERA can pass to your baby in your Issued: June 2014 • Severe liver problems. Severe liver problems can happen in people you start and while you are taking COMPLERA. If you have had kidney breast milk. It is not known if this could harm your baby. who take COMPLERA. In some cases, these liver problems can lead to problems in the past or need to take another medicine that can cause – Talk to your healthcare provider about the best way to feed your baby. death. Your liver may become large (hepatomegaly) and you may develop kidney problems, your healthcare provider may need to do blood tests Tell your healthcare provider about all the medicines you take, fat in your liver (steatosis). Call your healthcare provider right away if to check your kidneys during your treatment with COMPLERA. including prescription and nonprescription medicines, vitamins, you get any of the following symptoms of liver problems: • Depression or mood changes. Tell your healthcare provider right away and herbal supplements: – your skin or the white part of your eyes turns yellow (jaundice) if you have any of the following symptoms: COMPLERA, the COMPLERA Logo, EMTRIVA, GILEAD, the GILEAD Logo, GSI, • COMPLERA may affect the way other medicines work, and other – dark “tea-colored” urine – feeling sad or hopeless medicines may affect how COMPLERA works. HEPSERA, STRIBILD, TRUVADA, VIREAD, and VISTIDE are trademarks of – light-colored bowel movements (stools) – feeling anxious or restless Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of • If you take certain medicines with COMPLERA, the amount of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced – loss of appetite for several days or longer – have thoughts of hurting yourself (suicide) or have tried to hurt yourself COMPLERA in your body may be too low and it may not work to help herein are the property of their respective owners. – nausea • Change in liver enzymes. People with a history of hepatitis B or C control your HIV-1 infection. The HIV-1 virus in your body may become – stomach pain virus infection or who have certain liver enzyme changes may have an resistant to COMPLERA or other HIV-1 medicines that are like it. ©2014 Gilead Sciences, Inc. All rights reserved. CPAC0115 08/14

“ We long-term survivors get lost in the present atmosphere received in his work with Ask the Experts at that says HIV is no longer a big deal. It is a big deal for us as we deal TheBody.com, a website devoted to people with the effects of long-term infection and the accumulated ravages of living with the virus. Earlier this year he sent taking the meds. I feel alone and forgotten; and, I envy those who died out a message to the PozHealth listserv and to Postiv i ely Aware, linking to these let- back in the ’80s and early ’90s.” ters from readers who had virtually given up or who feared for their future.

“ Recently I had to add testosterone to my to look forward to but more chaos, uncer- Wrote Vergel, “I am getting so many emails m o c .

daily medication regimen and as soon as I tainty, and pain?” like these. We really need to have a discussion k c o

get myself to the doctor for an A1C screening “I recently read the question by someone about how prevalent depression while aging t

I know I’m going to be put on oral diabe- [wondering] whether he ‘deserved to live.’ with HIV is, and how we should advocate for nks i tes medication. I mean, when is enough My question is, ‘Do I want to live?’” special services for the ‘AIDS veterans.’” o

enough? What is the reason for scraping to These are some of the comments HIV The former chemical engineer and co- t

stay alive and healthy when there’s nothing treatment advocate Nelson Vergel has author of Built to Survive travels extensively Pho Th:

42 STIV PO I ELY AWARE JAnuary+FEbruary 2015 ‘My a be you have PTSD [ostup -tra matic stress disorder],’ a friend told him one day. It suddenly all began to make sense.

feel safe enough to admit any of this. Gay, In that blog entry, he wrote, “Many straight, male, female—we had this intense people with HIV on permanent disability fear of death. You’re almost afraid to release struggle by on less than $1,000 a month to it. And we are still waiting to be happy.” pay all their bills. Others who get payments Vergel said he experiences mood swings, from private disability policies from their last crying jags, numb emotions, and constant job will lose them when they reach age 65. unexplained aches and pains. But who thought we were going to live to be “Maybe you have PTSD [post-traumatic 65 anyway?!” stress disorder],” a friend told him one day. Vergel has eight friends who are set to It suddenly all began to make sense. lose their former job’s disability income, and “We don’t have a place to go for vets with it terrifies them. The City of San Francisco is HIV. That’s what we are—veterans of a war, looking at its aging HIV-positive population but we don’t have that recognition or sup- and what will happen as those who have port,” said Vergel. “I had to bury all these private disability plans reach retirement age friends and my boyfriend. I completely shut and lose that income. The activist group down that part of myself so I don’t suffer. I Let’s Kick ASS, or AIDS Survivor Syndrome don’t cry and I don’t grieve.” He didn’t even (see page 16), is reaching out to people who feel anything when his father died, making are in this position. (Contact LKA co-founder Vergel wonder what was wrong with him. Tez Anderson at [email protected].) “We have concentrated on viral load and “They feel trapped financially,” Vergel says T-cells for 30 years, and we have neglected of long-term survivors. “They can’t regain this side of us,” Vergel said. their financial health. There’s lots of fear and Although married to a psychiatrist, his depression, a lot of anxiety.” long-term partner of 20 years, Vergel finds Vergel also wonders what will happen that only others who have lived his experi- to nursing homes and other care facilities ence can understand it. “We’re a minority for those with the added layer of HIV. There within a minority. Only another person who’s might be a lack of LGBT-friendly places. gone through it really gets it. People tell “Where are we going to fit?” he asked. Then us, ‘you need new friends’ or, ‘get out of the also, there are no non-profit organizations house more.’” Many, he points out, also con- working on any of these issues, he said. tinue to live with lingering body and facial “We’re lacking creative solutions.” changes from lipodystrophy as well, creating Meanwhile, bad news about aging and yet another stressor. HIV continues to come out from medical Having talked with people all over the journals and conferences. “We don’t want to country who are living with HIV and getting hear that,” said Vergel. “We want solutions.” constant messages from many others, Vergel “We used to have retreats,” he recalls. has seen that having survived trauma and “We don’t have the social networks we used around the country giving talks on HIV nutri- perhaps not having dealt with it, long-term to have. All we have now is the Internet.” tion, exercise, and treatment, so he constantly survivors now face renewed fears about ill- One of the difficulties of long-term hears the concerns of people living with the ness, with all the added concerns of the later survivors is not wanting to appear weak or virus. He wrote a blog entry entitled “The stages of life. As the epidemic shifted to one whiney. Said Vergel, “We try to live in the Long-Term Survivor Dilemma” three years ago, with viable medications, those who have present and be happy, but there’s also this but said he’s hearing more and more about survived the earliest days live not only with ticking time bomb.” the problems he discussed then, including a leftover health issues, but with the financial sense of shame about admitting fears. constraints that go hand-in-hand with medi- A’ uthor s note: Also read, “What we owe “People wonder, ‘Why have I tried this cal care. Now there are health problems longtime survivors” by Victoria Noe at windy- hard if my future doesn’t look that great?’ The on the horizon with no foreseeable extra citymediagroup.com/lgbt/VIEWS-What-we- thing is, those people can’t say that to anyone resources for those with limited incomes. owe-longtime-survivors/49154.html. because people say you should be happy Vergel’s cancer diagnosis and chemotherapy you’re alive, but sometimes we don’t feel very last year brought out all these fears and Nelon s Vergel is starting a new website, happy to be alive,” Vergel said. “We don’t insecurities. HIVSurvivors.org.

JAnuary+FEbruary 2015 POSITIVELY AWARE 43 T hOUGHTS on PrEP—from the first person cured of HIV by Timothy Ray Brown

W hen I first heard about the introduction of the use of Truvada for PrEP (pre-exposure prophylaxis) in 2012, I did not give it much thought. I had been cured of HIV in 2007, and had been told by my doctors that I am immune to the virus. Therefore, I did not think that PrEP was something I needed for myself. Since the whole reason for all of my work is to help the HIV-positive community and their loved ones by giving hope that HIV can be cured, I eventually decided that PrEP is an important tool in preventing new infections and this is an extremely large part of my mission. This article will explain why my mindset toward PrEP for sexually active individuals and injection drug users has been transformed dramatically.

W hen asked by a leading HIV quarterly medical checkups with scientist at a conference in Marseille, HIV and STD tests. To me, his views France, in July 2012 what my seemed less hardline in that set- thoughts on PrEP were, I said that ting than his publicly broadcasted since so many HIV-infected people views. My mindset was beginning were unable to access HAART, we already to evolve at that point. Shortly needed to take care of them first rath- thereafter, in order to learn more er than using precious resources to about the subject, I joined Damon L. prevent further transmissions. Despite Jacob’s Facebook group PrEP Facts: the fact that preventing HIV through Rethinking HIV Prevention and Sex, “safer sex” did not work out so well which offers in-depth discussions for me, I thought that we already have on PrEP. prevention methods for HIV, and that Although I have been cured of those having receptive sex could just HIV, I sincerely wish that PrEP had insist that their partners use condoms been available during my early years to prevent HIV. of sexual activity. I was diagnosed in However, I have since changed my 1995; I wish that I had never had to mind. deal with the fear of thinking I only In November 2013, my partner, had about two years to live, or with Tim Hoeffgen, and I attended a PrEP the fear of judgment and stigma from debate in West Hollywood between a friends, family, and the general public. good friend of ours, Aaron Matthew I also had to take many pills daily for Laxton, and the CEO of the AIDS 11 years while being HIV-positive. Healthcare Foundation, Michael For most people it means a lifetime Weinstein. Weinstein had made public of taking daily multiple medications, inflammatory remarks against people unless they are able to “join” my cure who choose to use PrEP to prevent club. With PrEP back then, I never HIV. Aaron supported the use of would have had to go through any of PrEP. I found that in contrast to his this. I wish this for all people who are media opinion, Weinstein strangely currently at risk for HIV. admitted that PrEP does work if taken My partner and I in October daily as prescribed. He also seemed attended the U.S. Conference on convinced by the opposing argu- AIDS in San Diego. One of the ses- ment that people on PrEP may have sions we attended was the PrEPare less of a tendency to spread other for Life workshop. Its speakers STDs because of the recommended included several of NMAC’s (National

44 STIV PO I ELY AWARE JAnuary+FEbruary 2015 Thoughts on PrEP—from the first person cured of HIV by Timothy Ray Brown

M inority AIDS Council’s) Youth number of new infections, we could Scholars, all of whom were young, get closer to the objective of ending gay men of color. Their knowledge AIDS. The people who are not infect- and ability to speak about their ed obviously cannot infect others. reasons for choosing to use PrEP While my ultimate goal is to see impressed me greatly. the end of AIDS, and a cure for HIV A good example is Devin is extremely important, we also need Barrington-Ward, who was already to curb the rate of new infections. I an advocate focusing mostly on black believe that the use of PrEP is one of men and methods of HIV prevention. several methods now available to do He was looking at ways to protect that. Therefore, I have gone from feel- his clients from HIV infection. This ing ambivalent about PrEP, to becom- led him as a black HIV-negative gay ing a strong advocate for its use. man to take his own advice and begin using PrEP himself at the beginning Editor’s note: Read “He’s Not of 2014. When discussing changes Just ‘the Berlin Patient’: Timothy Ray in relationships, once he realized that Brown wants to help find a cure he could date and have sex with posi- for everyone living with HIV” at tive people without worrying about positivelyaware.com. HIV, dating had become much easier. He felt he had more freedom since he could share in the responsibility to remain HIV-negative himself. He C DC starts PrEP had a few mild side effects at first, program for clinicians which went away. He has experienced virtually no stigma and says that it The CDC has launched has even opened conversations with PrEPline, a free national people who did not know about PrEP. service for clinicians seeking For those on the fence on the subject, advice and consultation about he said that people should ignore all prescribing HIV PrEP, the of the arguments on both sides and agency announced late last seek more of the facts available on year. “When taken consistently, websites such as PrEPwatch.org or PrEP provides a safe, effective the National Minority AIDS Council’s approach to reduce the risk of PrEPare for Life education and aware- new HIV infection. However, ness program. many clinicians are unfamiliar All of these influences have led with its use. PrEPline can to a change in my thinking about the serve as a valuable resource for use of PrEP to stem the rise in new physicians, nurse practitioners, HIV infections. If taken as prescribed, and physician assistants which means one pill daily, PrEP has who provide primary care for been shown to be highly effective in uninfected patients facing high reducing the risk of HIV transmis- risk of acquiring HIV.” The sion. The World Health Organization, PrEPline number is (855) Human Rights Campaign, and HIV-PrEP (448-7737). For many leading HIV/AIDS organiza- more information on services tions strongly endorse PrEP, and the offered through the PrEPline, Centers for Disease Control (CDC) has visit the National Clinicians issued guidelines on its use. This ush- Consultation Center at nccc. ers in a new wave of HIV prevention. ucsf.edu. —Enid Vázquez I feel that if we are able to reduce the Pho to: Raymond Bordeaux Photography

JAnuary+FEbruary 2015 POSITIVELY AWARE 45 CON FereNCE UPDATE AASLD 2014: Boston HIV/HCV Co-Infection News from the 2014 Liver Meeting

By Andrew Reynolds

A pproximately 10,000 doctors, researchers, dasabuvir plus ribavirin, also known and advocates from around the world gathered in Boston in as the “3D” regimen. An additional November for the 65th Meeting of the American Association arm comprised patients who were treated for 24 weeks and achieved for the Study of Liver Diseases (AASLD), also known as an SVR12 of 90.6% (29/32). All “The Liver Meeting.” Over 400 abstracts at the conference patients taking HIV medications had focused on hepatitis C (HCV), covering a wide array of issues an average CD4 count of around and topics. This brief review will look at a select number of 625–633. Some of the participants presentations on currently available HCV direct acting antivi- had cirrhosis and the study included ral agents (DAAs) devoted to HIV/HCV co-infection. those who were both HCV treatment naïve and experienced. The Co-infection with HIV and HCV cure) results can be found in the most common side effects reported presents a number of challenges for chart on the following page. were fatigue, insomnia, nausea, and the treatment of HCV, including but These cure rates are very simi- headaches, but the regimen was not limited to the faster progression lar to the results in people living extremely well tolerated with no one of liver disease, poorer response with HCV mono-infection, and of discontinuing treatment due to side rates to treatment, and drug-drug added significance, none of the effects. Although this drug regimen interactions with HIV medications. HIV-positive patients experienced is not yet approved, it was anticipat- With few FDA-approved options a loss in CD4 T-cells (which does ed to go before the FDA for approval for the treatment of HCV in people occur in interferon-based therapies) at the end of 2014, after this issue living with HIV, new options are nor did there appear to be any drug went to press. The results of this needed. To that end, there have interactions that led to an HIV viral study offer hope for an effective been several clinical trials of current load breakthrough. The regimen new therapy for treating HIV/HCV and investigational HCV DAAs for was also very well tolerated, with co-infected people, but the numbers this population, and a brief review fatigue, insomnia, nausea, and of participants are relatively small of the results of this research headaches the commonly reported and further study (both currently follows. side effects, and only 15 partici- ongoing or planned) is needed. pants discontinuing treatment due Mark Sulkowski and colleagues W hat’s approved now: to adverse events. presented the final results of the sofosbuvir These results show that this is C-Worthy Study, a randomized, an excellent option for treating HCV open-label Phase 2 clinical trial Of currently available FDA in people who are HIV/HCV co- looking at the effectiveness of the approved treatments, an interferon- infected, particularly for people with Merck drugs grazoprevir and elbas- free option is available: sofosbuvir GT (genotype) 2 or 3, or those who vir with or without RBV (ribavirin) (SOF; brand name Sovaldi) and rib- cannot wait any longer for any of the for the treatment of HCV GT 1 in avirin (RBV). Jurgen Rockstroh pre- newer DAAs to come on the scene. HIV/HCV co-infected persons. The sented results from the Photon-1 study participants were split up into and -2 trials which looked at the N ew options two groups with 97% (28/29) in the treatment of HCV genotypes 1 to on the horizon RBV-based regimen achieving an 4 in HIV/HCV co-infected persons. SVR12 and 87% (26/30) of those There were 497 people in these In a poster presentation, D avid without RBV achieving an SVR12. trials; some were treated for 12 Wyles and colleagues reported a This regimen was very well toler- weeks, and others were treated for 93.5% (29/31) SVR12 (at week 12) ated with headaches and fatigue 24. Within this group, 96% were in HIV/HCV co-infected patients reported, and no one stopped treat- taking HIV medicines with an aver- with HCV GT 1 who were treated ment due to adverse events. These age CD4 count of 605. The SVR with 12 weeks of the AbbVie regi- promising results support the move (sustained virologic response, or men of ABT-450/r/ombitasvir and of these drugs into Phase 3 clinical

46 STIV PO I ELY AWARE JAnuary+FEbruary 2015 HIV/HCV Co-Infection News from the 2014 Liver Meeting

this is a re-infection Sovaldi + ribavirin or not. SVR (sustained virologic response, or cure) results in HIV/HCV (Photon-1 and -2) In the end, this small study shows G enotype 12 weeks 24 weeks that the LDV/SOF GT 1 NA 81% (182/226; treatment naive) combination is as Rresou ces safe and effective in A lthough this GT 2 89% (40/45; treatment naive) 90% (27/30; treatment experienced) article mentions co-infected patients 91% (52/57; treatment naïve) a select number GT 3 67% (28/42; treatment naïve) as it is for mono- of abstracts that 88% (58/66; treatment experienced) infected ones. This were focused on GT 4 NA 84% (26/31; treatment naive) HIV/HCV co-infec- is great news for tion, in all, over people living with 400 abstracts HIV/HCV who are were presented at the 2014 Liver trials, which are ongoing and will an SVR12. The side effects were looking for an interferon- and riba- Meeting. You can likely be reported this year. relatively mild, with nasal conges- virin-free HCV therapy. As it is not learn more about tion, nasopharyngitis, and teeth yet FDA approved for the treatment study results and news from the H arvoni for HIV/HCV issues most commonly reported of HCV in co-infected persons, any conference from co-infection (but even here, the numbers were doctor who prescribed this would be these sources: very few). The more commonly doing so “off label” (that is, not FDA On October 10, 2014 the FDA known side effects such as fatigue, approved, but has scientific backing Project Inform approved the Gilead drug Harvoni. nausea, and headaches were also for its use, as limited as the evi- projectinform.org Harvoni is a fixed-dose combination reported, but at very low numbers. dence may be), so it might be hard of ledipasvir/sofosbuvir (90/400 No one had any serious adverse to access it at this time. This drug HIVandHepatitis.org mg) for the treatment of HCV geno- events while on treatment, and no combination is currently under study hivandhepatitis.org type 1. This FDA approval is for the one stopped treatment due to side in co-infected individuals in a Phase treatment of mono-infected HCV, effects. Of equal importance—no 3, open-label trial. HCV Advocate but not for HIV/HCV co-infection, one experienced any changes in hcvadvocate.org although it can be prescribed off- their HIV viral loads nor did they C onclusions label for this group. have lower CD4 counts while on N AtaP In a small, open-label study HCV treatment. Both currently and soon to be natap.org of 50 patients, researchers at the The one participant with available HCV DAAs offer much National Institute of Allergy and treatment failure did not have an hope for people living with HIV and Infectious Diseases (NIAID) studied undetectable hep C viral load at the HCV. Cure rates look to be very Y ou can also call the author the safety, tolerability, and efficacy end of treatment, but experienced similar to those of mono-infected (as well as his of Harvoni in people living with HIV/ an early viral relapse two weeks persons, and the regimens appear colleagues) on HCV. All of the study patients were post-treatment. There did not to be safe to take with HIV medi- The Support Partnership’s treatment-naïve, and none had cir- appear to be any glaring reason for cations and do not impact CD4 national hepatitis rhosis. There were 13 people who the relapse, but as this can happen counts. This optimism needs to C phoneline, (877) were not on antiretrovirals, and 37 with mono-infected patients too, be tempered a bit by the relatively HELP-4-HEP, (877) 435-7443, about who were taking them. The group it is a subject that researchers will small numbers of patients in these results from this was 74% male, and the average continue to monitor and study so studies, but ongoing clinical trials conference, as age of the group was 59 years old. we can learn how to best re-treat will provide us with more informa- well as HCV prevention, care, and African Americans comprised 84% people for whom the medications tion in the year ahead. treatment. of study participants and 78% had do not work. Additionally, one par- the harder to treat genotype 1a. ticipant was recently found to have An drew Reynolds is the The results of the study were a detectable HCV viral load at 36 Hepatitis C Education Manager remarkable: 98% (49/50) achieved weeks, but it is too soon to tell if at Project Inform.

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