NOV+DEC 2014

Four covers for A Day with HIV Four different covers were printed for the NOV+DEC 2014 issue of POSITIVELY AWARE, each one a picture selected from A Day with HIV, the magazine’s anti-stigma campaign.

POSITIVELY AWARE

C O M M E M O R A T I N G

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HIV AND SPORTS: OUT OF BOUNDS CAN HEPatitis C BE SEXUAlly TRANSMITTED?

POSITIVELY AWARE The HIV Treatment Journal of Test Positive Aware Network

NOV+DEC 2014

A DAY WITH HIV 24 hours 13 countries 4 continents 2:30 PM: San Diego

Mark Holmes: “There are few barriers folks with HIV can’t overcome. I have been living with HIV for 30 years. I am also deaf, and require hearing aids. But I also go jetpack flying three times a month!”

C O M M E M O R A T I N G

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HIV AND SPORTS: can HEPatitis C Out of Be SEXUALly bounds TRANSMItted?

POSITIVELY AWARE The HIV Treatment Journal of Test Positive Aware Network

NOV+DEC 2014

3:30 PM: Brooklyn, NEW YORK

Ken Williams (left): “I work pretty hard to eradicate HIV stigma. I write, I blog, but there’s been nothing I’ve done in the war against stigma more effective than being present and living my experience openly.

So, today, I got in the picture with my friend Charles Johnson.”

A DAY WITH HIV

24 hours in 13 countries across 4 continents

C O M M E M O R A T I N G

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HIV AND SPORTS: OUT OF BOUNDS CAN HEPatitis C BE SEXUAlly TRANSMITTED?

POSITIVELY AWARE The HIV Treatment Journal of Test Positive Aware Network

NOV+DEC 2014

A DAY WITH HIV 24 hours 13 countries 4 continents

6:44 PM: HOLLAND

Eliane Becks Nininahazwe:“I am an HIV-positive woman living in Holland, although I am originally from Burundi. I’ve been HIV-positive since 2003. I am also an artist and try to present a positive image. I openly talk about my HIV, so then people can understand that we are normal and can live normal lives like anyone else. Did I tell you that in 2006 I decided to have a kid?

Now I’ve got two boys, both HIV-free! I am very proud of myself.”

C O M M E M O R A T I N G

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Y E A R S

HIV AND SPORTS: Out of bounds

can HEPatitis C Be SEXUALly TRANSMItted?

10:00 PM: Chicago

POSITIVELY AWARE The HIV Treatment Journal of Test Positive Aware Network

NOV+DEC 2014

A DAY WITH HIV 24 hours 13 countries 4 continents

Lauren Childers (left): “This photo was taken with my partner, Bryana Wilson, and my pet iguana, Jane. I rescued Jane (the iguana) from a tree, and as an exotic pet enthusiast, I decided to take her in. The inner healing I experienced bringing her back to health was an incredibly rewarding experience—begging the question, ‘Who rescued who?’ ”

COMMEMORATING

6:44 PM: HOLLAND Eliane Becks Nininahazwe: “I am an HIV-positive woman living in Holland, although I am originally from Burundi. I’ve been HIV-positive since 2003. I am also an artist and try to present a positive image. I openly talk about my HIV, so then people can understand that we are normal and can live normal lives like anyone else. Did I tell you that in 2006 I decided to have a kid? Now I’ve got two boys, both HIV-free! I am very proud.”

25 YEARS

POSITIVELY AWARE JOURNALISM. INTEGRITY. HOPE.

Jeff Berry editor- in - C hief

@paeditor

“Working on the sports and HIV story was a great experience. It felt good to dig into a subject that I wasn’t as familiar with.”

Enid Vázquez associate editor

@enidvazquezpa

“There are three new HIV drugs, everyone, and one is quite different.”

Rick Guasco C reative director

@rickguasco

“A Day with HIV reminds us that everyone everywhere is affected by HIV. But for those of us who are HIV-positive, it’s a reminder that you are not alone.”

10:00 PM: Chicago Lauren Childers (left): “This photo was taken with my partner, Bryana Wilson, and my pet iguana, Jane. I rescued Jane (the iguana) from a tree, and as an exotic pet enthusiast, I decided to take her in. The inner healing I experienced bringing her back to health was an incredibly rewarding experience—begging the question, ‘Who rescued who?’ ”

Jason Lancaster proo freader contri b uting w riters

Laura Jones, Carlos A. Perez Jim Pickett, Andrew Reynolds Matt Sharp photographers

John Gress Chris Knight advertising

Lorraine Hayes L.Hayes@tpan.com D istri b ution and S u b scription services

3:30 PM: BROOKLYN Ken Williams (left): “I work pretty hard to eradicate HIV stigma. I write, I blog, but there’s been nothing I’ve done in the war against stigma more effective than being present and living my experience openly. So, today, I got in the picture with my friend Charles Johnson.”

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NOV+DEC 2014 V OL U ME 2 6

Department s

SPEC I AL REPORT: HI V a n d s p o rt s

16 Out of bounds

6 In Box

Sports as a vehicle for positive change.

By Jeff Berry

6 Readers Poll

Your responses to our question, “Have you ever been the target of HIV stigma or discrimination?”

7 editor’s Note

Fe atures

11 Conference Update: ICAAC 2014 Drug news from the 54th International Conference on Antimicrobial Agents and Chemotherapy.

Bully for you.

8 Briefly

By Enid Vázquez

FDA approves three new HIV drugs and a combo hep C pill. nPEP underused. Transgender partners not at increased risk. Drug pricing.

42 My Kind of life

By Carlos A. Perez

N U M B ER 7

27 Can hepatitis C be sexually transmitted?

Yes. No. Maybe. It’s complicated.

By Andrew Reynolds

35 Black, gifted, and whole

A day with a little HIV history.

The story of a fallen figure in the fight against HIV continues to affect us.

By KeitH R. Green

o nly o n POS IT IVELYAWARE .COM

37 A new triple threat against HIV The latest three-in-one pill, Triumeq, includes a newer integrase that doesn’t require boosting.

How stigma hurts prevention Social changes needed to help stop the epidemic.

By Thorner B. Harris

What does it mean to be ‘Positively Aware’?

By Enid Vázquez

peci a l s ect i o n s 43 A DAY WITH HIV On 9/9/2014, hundreds of people all over the world snapped their picture to take their best shot against HIV.

A proactive approach to living with HIV.

By Rick Guasco

ON THE COVERS This issue of POSITIVELY AWARE features four different covers, each one a picture taken on A Day with HIV and selected with the help of our judges:

2:30 PM: San diego Mark Holmes: “There are few barriers folks with HIV can’t overcome. I have been living with HIV for 30 years. I am also deaf and require hearing aids. But I also go jetpack flying three times a month!”

Eugene McCray, MD Director of the Division of HIV/AIDS Prevention at the CDC

Greg Louganis Olympic gold medalist diver, author

Mark S. King HIV blogger, advocate

Naina Khanna Positive Women’s Network-USA, advocate

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Scott Pasfield Photographer whose work has appeared in Black Book Talent and Fortune magazine

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INBOX@TPAN.COM

READERS POLL In the SEPTEMBER+OCTOBER issue, we asked

Have you ever been the target of HIV stigma or discrimination?

“I was evicted from an apartment when

Where there’s hope

I tested positive in February of 2012 and have been struggling with depression and PTSD. I am healthy, undetectable, and on a one pill, once-daily regimen.

Your September+October Editor’s Note (Musings on an epidemic) made me smile and laugh, and gave me hope that things will get better.

Thank you.

—Jim D. Boston, Massachusetts

my landlord found out I was positive. I was living with my partner and she was aware we were gay, but once she found out I was positive she said she felt misled and deceived and I had five days to move.

I was so shocked to feel such animosity that I moved out that night. We sought counsel from a lawyer but it didn’t lead to anything. There is discrimination even here in Vermont.”

“Yes, but only slightly, as in being rejected by online hookups or dates because of my status. I have never experienced outright hatred or ignorance toward my status.”

“I am an immigrant living in Brooklyn, NY and I have been discriminated upon when I was in the shelter system with my daughter. People made fun of us because we both are living with the virus, and I was denied services because I am an immigrant.”

“People make assumptions that because @posAware Let’s CONNECT. All communications (letters, email, online posts, etc.) are treated as letters to the editor unless otherwise instructed. We reserve the right to edit for length, style, or clarity. Let us if know you prefer we not use your name and city. You can also write: Positively Aware , 5050 N. Broadway St., Suite 300, Chicago, IL 60640-3016.

I have HIV I must have been a ‘slut’ or slept with a lot of guys. Only ‘sluts’ have HIV. First of all, that’s insulting to anyone with HIV and it’s inappropriate. Secondly, I had sexual intercourse with two people (both happened to be men) before I was diagnosed.”

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“I am from India. On being diagnosed (after having been tested for HIV without my permission), drinking water in a paper cup was pushed into my hospital room through a crack in the door with a stick.

And this was in a “paying” hospital just three years ago. Doctors insisted that my family dispose of everything I had touched or used (clothes, blankets, utensils, etc.) in the past two days. Unbelievable but true.

My family had to bribe the hospital to not quarantine me and send me abroad for treatment. I am thankfully alive and healthy, and I now have an undetectable viral load.”

“Unfortunately, I experience discrimination all the time. I try to live my life as open and honestly as possible with everyone, from co-workers to roommates to dates.

Once I tell someone that I’m HIV-positive, they give me the sad ‘awww, you’re gonna die’ look and every time you sniffle after that, they think it’s HIV related. I’ve been turned down for a position at my last company because I was told that it would be too stressful for ‘someone in my condition.’

I’ve opted not to tell anyone at my new job and city that I’m poz unless it’s heading down a sexual path.”

“Most men want nothing to do with a man who is HIV-positive.”

What do you think are the three biggest issues facing long-term survivors of HIV and AIDS? vote at positivelyaware.com

We accept submission of articles covering medical or personal aspects of HIV/AIDS, and reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN, Positively Aware, and its assigns. You may use your actual name or a pseudonym for publication, but please include your name, email address, and phone number with your story.

P O S I T I V E LY AWA R E

YES

78%

This issue’s question:

© 2014. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5050 N. Broadway St., Suite 300, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, send email to inbox@tpan.com. Six issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable to contribute.

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Although Positively Aware takes great care to ensure the accuracy of all the information it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician.

A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively Aware, association with TPAN, or contributions to this journal.

Editor’s note Jeff Berry

Photo: CHRIS KNIGHT

T

Bully for you he essence of sports and sportsmanship is people from different backgrounds and perspectives putting aside their differences, and coming together as a team to achieve a common goal—winning. It’s also about fairness, respect for those differences, and playing by the rules.

The increasing glorification of violence in sports is not what it’s truly about for most athletes, but is emblematic of what some spectator sports have become, and a reflection of what we as a society have grown to embrace and value.

Growing up in suburbia in the 1970s, we didn’t have a name for the abuse that was happening. Bullying is just what the “jocks” in my junior high and high school, who were popular and excelled in sports, did to kids like me. The boys who didn’t perform as well in sports, who they perceived as weak and somewhat effeminate—the fags. I was dealt an even crueler name that they would call me in class and in the halls, “fairy Berry.” It hurt, even more than the stinging dodge balls hurled at me in gym class that I was unable to escape from. More than the wet towels snapped at me in the locker room. More than being the last one who was picked when teams were chosen, while the captains argued with each other over who should have to take me this time.

I thought high school would be different than junior high, and where I would finally come into my own. I remember my first high school football game in 9th grade, I was so excited. I was walking by three guys in my class, I smiled at them, they returned the smile, when one of them suddenly reached around and punched me hard in the gut, knocking the wind out of me. Then they continued walking by, as though nothing had happened. I never went to another game, and eventually lost interest in sports altogether.

I think about today’s youth, and every time I hear about another kid who has committed suicide because he or she was bullied, another little part of me dies, just like it did on the sidelines of that football field. I always wonder, in today’s age of social media, would I have been another one of those suicide statistics? I’m not sure I would have survived the name-calling and the bullying, if it were out there for the whole world to see.

For this issue I wrote an article about how we can use sports, LGBT athletes, and their allies as an opportunity to increase HIV/AIDS awareness and provide prevention and education to our youth. While researching and interviewing for the article, I came across a study that showed that homophobia is associated with an increased risk of HIV infection among men who have

sex with men. I reached out to former rugby athlete and LGBT ally Ben Cohen, who founded his own anti-bullying organization, The StandUp Foundation, and asked him what can be done to address the issue. ​“Homophobic bullying reduces self-esteem and therefore people tend to engage in more risky behavior, which can have serious consequences,” said Cohen in an email. “Homophobic bullying is something that no one should have to tolerate, regardless of their sexual orientation. I truly believe that education is the key.”

Cohen added that, “The sporting environment has extraordinary influence on society and can be used as a mechanism for social change. Our upstanding sports stars can be role models, living by example and promoting the message of understanding and kindness into all walks of life.”

This past October 16 was Spirit Day, a day dedicated to increasing awareness about bullying. A friend on Facebook posted a comment thanking all those who bullied him as he was growing up, because they helped make him who he was today. They gave him the opportunity to learn to forgive, and for that he was grateful.

So I’ll take this opportunity now to forgive those who bullied me growing up. It doesn’t mean that I approve, or will look the other way. But it’s time to move on, and take a stand for others who may be in the same situation, and tell them that, indeed, it does get better.

The increasing glorification of violence in sports is not what it’s truly about for most athletes, but is emblematic of what some spectator sports have become, and a reflection of what we as a society have grown to embrace and value.

follow Jeff @PAEDITOR

Take care of yourself, and each other.

6:15 PM: Chicago Jeff Berry: “Unwinding by the lakefront after a busy day at the office.”

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Briefly ENID VÁzquez

FDA approves three new HIV drugs In August and September, the FDA approved a total of three new drugs for HIV treatment. Two drugs work directly on the virus, while the other one is approved for boosting blood levels of some HIV medications.

Triumeq is a single tablet regimen (STR) combining dolutegravir, an integrase strand transfer inhibitor (INSTI), with abacavir/lamivudine; see story on page 37.

Vitekta (generic name elvitegravir) is already available as part of the STR Stribild. Like dolutegravir, Vitekta is an INSTI. Vitekta is available in 85 mg and 150 mg tablets. It’s taken once a day with food in combination with a boosted protease inhibitor medication and at least one other HIV drug.

The 85 mg dose is used (once daily) if taken with Kaletra (lopinavir/ ritonavir) or boosted Reyataz (atazanavir). The 150 mg dose is used (again, once daily) if taken with boosted Aptivus (tipranavir), boosted Lexiva (fosamprenavir), or boosted Prezista (darunavir) (Aptivus is taken twice daily). The protease inhibitor taken is to be boosted with 100 mg Norvir (once daily for Reyataz and twice daily for the other drugs, except Aptivus, which uses 200 mg twice daily; Kaletra already has the Norvir booster in it).

The most common side effect seen in people taking Vitekta in clinical studies was diarrhea (5% or more of participants for adverse events Grades 1–4). It has no contraindications (drugs or other substances that can’t be taken with it).

Tybost (generic name cobicistat) is a pharmcokinetic enhancer, meaning that it affects the metabolism of other drugs, specifically to improve

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their effectiveness. It is available in 150 mg tablets, to be taken with food and used to boost blood levels of Reyataz or once-daily (but not twice-daily) Prezista. Two new fixed dose combinations of Tybost-boosted Prezista or Reyataz as one pill are expected to be available in early 2015, improving convenience.

Previously, Norvir (ritonavir) was the only drug commonly used to boost blood levels of HIV medications, improving their effectiveness.

Although Reyataz can be taken without a booster in some cases, Prezista must be boosted with either Norvir or Tybost. While Norvir and Tybost work in similar ways and have a host of interactions, those interactions may not be the same; see the Tybost drug label.

While Vitekta and Tybost are made by the same drug company, it’s not recommended that they be used together. In other words, the protease inhibitor drug taken with Vitekta should be boosted by Norvir, not Tybost. And even though elvitegravir (Vitekta) and cobisistat (Tybost) are contained in Stribild, the two have not been studied as single drugs outside of Stribild; there’s no recommendation that they not be used together, however.

In clinical study, Tybost-boosted Reyataz was found to be noninferior to Norvir-boosted Reyataz.

A patient’s estimated creatinine clearance, a marker of kidney function, must be checked before taking Tybost, because it affects this marker. If taking the drug along with tenofovir DF (brand name Viread, found in Truvada), also measure urine glucose and urine protein before starting Tybost.

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“People who report having transgender sexual partners engage in higher-risk behaviors than other HIV testers yet had a lower HIV positivity,” wrote researchers from the San Francisco Department of Public Health in the journal Sexual Health. “Potential explanations for the discrepancy between higher-risk behaviors and lower HIV positivity for PTG [partners of transgender people] may be engagement in HIVprotective behaviors like regular HIV testing and lower risk seropositioning being the insertive sexual partner.” Read the abstract (article summary) at http://bit.ly/ZZFwvF.

Drug pricing The National Coalition on Health Care (NCHC) is spearheading an effort to get drug makers to disclose how much they spend inventing drugs and their rationale for drug prices. It also formed the Campaign for Sustainable Rx Pricing to fight the high cost of medication. NCHC consists of several different patient groups, including HIV.

Sex apps and STIs A study by the L.A. Gay & Lesbian Center and University of California, Los Angeles (UCLA) found that gay men using location-based social apps to meet other men were more likely to have gonorrhea or chlamydia than those who met elsewhere on the Internet or in person in venues such as a bar. They did not, however, have a higher rate of syphilis or HIV. “Future interventions should explore the use of these novel technologies for testing promotion, prevention, and education,” wrote Matthew R. Beymer and colleagues. See the abstract at http://bit.ly/1px59c6.

Hornet, one of the locations-based social apps through which gay men can meet, now also shows where the nearest HIV testing clinics can be found. The service uses the AIDS.gov database. Hornet also has a “Know Your Status” campaign which provides testing reminders to men who indicate they are HIV-negative.

Follow Enid @ENIDVAZQUEZPA

Hep C combo pill gets FDA’s approval

PrEP assistance program improves

On October 10, the FDA approved the first medication for hepatitis C virus (HCV) that combines two medications in one and, importantly, is also the first treatment for hep C that does not have to be taken with interferon or ribavirin, which are toxic therapies. The new single tablet regimen (STR) Harvoni consists of sofosbuvir (brand name Sovaldi) and ledipasvir (not available in the pharmacy by itself). Harvoni is approved for the treatment of HCV genotype 1. In three studies with nearly 1,600 participants, both new to HCV treatment and who have failed previous therapy, cure rates of 94% to 99% were achieved (a sustained virologic response, or SVR, at 12 weeks). Eight weeks of treatment with Harvoni can be considered for people without cirrhosis who have never been on HCV therapy before and have less than 6 million HCV viral load. Some participants were also given ribavirin, but it was not shown to improve response rates. The most common side effects were fatigue and headache, which occurred in more than 10% of people taking Harvoni. Visit mysupportpath.com for Harvoni and Sovaldi financial assistance. The Fair Pricing Coalition, formed by HIV activists, stated in a press release that Gilead Sciences should establish a uniform price per cure, regardless of the length of therapy, so that the “$63,000 wholesale acquisition cost (WAC) for eight weeks of Harvoni should be extended to 12- and 24-week curative treatment durations.” Read the release at positivelyaware.com.

Good news from the Truvada for PrEP (HIV prevention) Medication Assistance Program: as of October 15, income eligibility for patients went up from 200% to 500% of federal poverty level and co-pay assistance went up from $200 a month to $300.

Tampons against HIV Early research at the University of Washington is looking at tampon-like products that release anti-HIV medication. At this point, the medication being studied is maraviroc (brand name Selzentry). The use of HIV prevention medication, or PrEP (for pre-exposure prophylaxis), has been found to be problematic in women, with some studies showing low adherence levels to a variety of regimens. Researchers are looking for options to increase prevention success. Read the Huffington Post report at http://huff.to/1oJdKb6.

nPEP underused, analysis finds Despite U.S. guidelines being established for the use of HIV non-occupational post-exposure prophylaxis (nPEP) in 2005, the strategy is underused, researchers state in an analysis published in PLOS One (from the Public Library of Science). nPEP followed the more established use of PEP to prevent HIV in medical personnel exposed to the virus, as in an accidental needlestick.

If used as soon as possible after exposure, but no more than 72 hours later, the 28-day medication regimen can prevent infection. The chart review of a Seattle HIV clinic found that “only 31%” of the nPEP patients in the period of time examined were considered at high-risk of infection. “In order to use limited resources most efficiently, public health agencies should target messaging for this high-cost intervention to individuals with high-risk HIV exposures,” the researchers wrote. Read the article at http://bit.ly/1szUXHw.

Criminalization battle in Iowa Following the repeal of Iowa state law on HIV criminalization in May, prosecutors tried to change one man’s charge from a felony—as now repealed by the law—to a misdemeanor. The defense, however, argued that the charges cannot be changed, but should be dropped.

Read more about the case at http://bit.ly/1px0NBM.

“HIV physicians and scientists have a professional and ethical responsibility to assist those in the criminal justice system to understand and interpret the science regarding HIV,” wrote Mona Loutfy, MD, FRCPC, MPH in a Canadian medical journal. “This is critical to prevent a miscarriage of justice and to remove unnecessary barriers to evidence-based HIV prevention strategies.” Loutfy is among a team of Canadian HIV experts who have created a consensus statement on HIV transmission as it pertains to the law.

According to the statement’s abstract (summary), “Scientific and medical evidence clearly indicate that HIV is difficult to transmit during sex. For the purpose of informing the justice system, the per-act possibility of HIV transmission through sex, biting, or spitting is described along a continuum from low possibility, to negligible possibility, to no possibility of transmission...”

Writing in the NEJM Journal Watch: Infectious Diseases, Wendy S. Armstrong, MD and Carlos del Rio, MD note, “The document—or one like it—should be broadly developed and endorsed in the U.S. and other countries to promote a modern understanding of HIV transmission risks. HIV criminalization laws as currently conceived promote stigma and exceptionalism and in so doing remain a threat to our patients and prevention efforts.” Read the consensus statement at http://bit.ly/ZZqt5d.

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Briefly New musical is Mighty Real Mighty Real: A Fabulous Sylvester Musical chronicles the life and music of disco singer Sylvester, a gay diva who died due to AIDS in 1988. The show ran through October in New York City‘s Theater at St. Clement’s. According to a New York Times review, “Speaking of his growing alienation from the world he grew up in, in poor black Southern California, Mr. [actor/singer Anthony] Wayne’s Sylvester says, ‘The feelings I had for men seemed to overtake me… I felt dirty, wanted to crawl in a hole and die.’ But seconds later he’s found an inner strength and is exulting: ‘I had to get out! I had to spread my wings and fly!’ ”

According to the Positive Women’s NetworkUSA (PWN-USA), many women with HIV receive public benefits that force them to remain poor. “Because of the way many of our entitlement programs have been set up, people with HIV become incentivized to stay poor because you can’t, for example, earn over a couple of thousand dollars a month and still qualify for ADAP [the AIDS Drug Assistance Program],” said Executive Director Naina Khanna in a webinar. “In some states, that number might be as low as a thousand dollars or even less.” TheBody. com has a story on the webinar at thebody. com/content/74872/are-women-livingwith-hiv-incentivized-to-remain-p.html.

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Carol Potok with some of the women at the Tutweiler Prison for Women, during an educational event.

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Public aid keeps people with HIV poor

CONFERENCE UPDATE ICAAC 2014: WASHINGTON, D.C.

Drug news from the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), held in Washington, D.C. in September

By Enid Vázquez

Three years on Stribild Nearly three years of study data with the single tablet regimen Stribild, which was FDA approved in August 2012, were presented.

Study participants taking Stribild did as well as those taking two other more established standard-of-care HIV therapies, Atripla and Norvir-boosted Reyataz plus Truvada.

Undetectable viral load (less than 50 copies) was reached by 79% of people on Stribild vs. 75% of those on either of the other two regimens. (Stribild and Atripla are complete HIV regimens in one pill taken once daily.)

The rate of adverse events leading to drug discontinuation was similar for the three groups: 6%, 7% and 9%, respectively. Also, changes in serum creatinine remained the same as they were at 48 weeks, less than 1% change for all three groups. Serum creatinine is a measure of kidney health.

There were four cases of proximal renal tubulopathy (PRT, basically, a type of kidney disease) in the first 24 weeks of Stribild, out of 701 individuals put on the medication (0.6%) and none afterwards. There were three cases of PRT out of the 355

individuals in the Reyataz group (0.8%) before week 48. Both regimens contain a pharmakoenhancer (PKE) to boost blood levels of its primary medication. The PKE in Stribild is cobicistat (Tybost) and for Reyataz, Norvir (ritonavir, or RTV) was the booster used. The two boosters can have a negative effect on the kidneys.

Cobicistat vs. ritonavir With the PKE med Tybost (cobicistat, or COBI) just approved by the FDA in late September, how does it stack up to the only current PKE available before, ritonavir?

Researchers looked at nearly three years of data comparing COBI vs. RTV as a blood level booster for Reyataz (atazanavir, or ATV) when taken with Truvada. No surprise: the newcomer did as well as the long-established ritonavir. “Once-daily COBI is as safe and effective as RTV as a pharmacoenhancer of the protease inhibitor ATV,” the study abstract concluded.

“COBI-boosted ATV plus FTC/ TDF [Truvada] was well tolerated and maintained high rates of virologic suppression through Week 144.”

Whether taking COBI or RTV, study participants saw an 11% drug discontinuation

rate due to adverse events.

Six COBI patients (1.7%) vs. seven RTV ones (2%) of the 350 participants in each group experienced PRT (see above).

Injectable INSTI A body mass index (BMI) over 30, which is considered obese, lessens the absorption rate of a long-acting injectable medication being studied for both HIV treatment and prevention.

The absorption of cabotegravir (CAB, GSK1265744) decreased by 20% in men and 24% in women with BMIs over 30. It increased, however, by 35% in men and 43% in women whose BMI was less than 23.

The experimental integrase strand transfer inhibitor (INSTI) can be given as monthly or quarterly injections.

Results are from 4,482 observations with 346 individuals in early study (Phase 1 and 2 a/b). These are HIV-negative individuals taking the research drug to determine safety and pharmacokinetics (how the drug is processed and eliminated by the body). Several doses were studied.

Prezista/TAF STR One-year results were presented for the first protease inhibitor-based single tablet regimen (STR), still in study and not available in the pharmacy.

Darunavir (brand name Prezista) is a recommended protease inihibitor under U.S. HIV treatment guidelines. The

complete regimen-in-one-pill studied consisted of darunavir boosted by cobicistat instead of ritonavir plus tenofovir alafenamide (or TAF) and emtricitabine.

The TAF is an alternative to tenofovir DF (TDF). TDF plus emtricitabine together make up Truvada, the bestselling HIV drug backbone in this country, but there’s still concern about the potential kidney and bone damage that TDF may exert. To that end TAF, a new-and-improved version of TDF, has been in the works for years.

After one year of treatment, fewer individuals achieved undetectable viral load (less than 50) with the single-tablet regimen: 77% vs. those given darunavir/cobicistat/TDF/ emtricitabine as separate pills (84%). The small clinical trial (153 individuals), however, was not powered to determine non-inferiority and the results for both efficacy and adverse events were declared “comparable” in the study summary.

“This D/C/F/TAF STR [the “F” is short for emtricitabine, also known as FTC] offers a promising option for initial HIV treatment, with the high barrier to resistance of DRV, and the potential for improved bone and renal safety with TAF,” the summary stated.

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GO TO ICAAC.org For more information. FOR ABSTRACTS FOR DATA PRESENTED ABOVE, GO TO POSITIVELYAWARE.com.

P O S I T I V E LY AWA R E

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ABOUT PREZISTA®

PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.® Please read Important Safety Information below, and talk to your healthcare provider to learn if PREZISTA® is right for you.

IMPORTANT SAFETY INFORMATION What is the most important information I should know about PREZISTA®?

• PREZISTA can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?” ®

• PREZISTA® may cause liver problems. Some people taking PREZISTA,® together with Norvir ® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA®. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems • Tell your healthcare provider if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, palecolored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite • PREZISTA® may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.”

Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild Who should not take PREZISTA®?

• Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,® Embolex,® Migranal®), ergotamine (Cafergot,® Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam (Versed®), triazolam (Halcion®), the herbal supplement St. John’s wort (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor®), salmeterol (Advair,® Serevent®), simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,® Rifamate,® Rimactane®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis®), or telaprevir (Incivek®)

• Before taking PREZISTA®, tell your healthcare provider if you are taking sildenafil (Viagra,® Revatio®), vardenafil (Levitra,® Staxyn®), tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), pravastatin (Pravachol®), or colchicine (Colcrys,® Col-Probenecid®). Tell your healthcare provider if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogenbased contraceptives. You must take additional precautions for birth control, such as condoms Serious problems can happen if you or your child takes any of these medicines with PREZISTA®.

This is not a complete list of medicines. Be sure to tell your healthcare provider about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start any new medicines while you are taking PREZISTA® without first talking to your healthcare provider.

What should I tell my doctor before I take PREZISTA®?

• Before taking PREZISTA®, tell your healthcare provider if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia • Tell your healthcare provider if you are pregnant or planning to become pregnant, or are breastfeeding — The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare provider will need to decide if taking PREZISTA® is right for you — Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby.

Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk What are the possible side effects of PREZISTA®?

• High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA® • Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA®. The cause and long-term health effects of these conditions are not known at this time • Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden • The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting.

This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare provider. Do not stop taking PREZISTA® or any other medicines without first talking to your healthcare provider 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 refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.

Please see accompanying full Product Information for more details.

013729-140415

PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.

PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.

ily Once-Da

Once-Daily PREZISTA® (darunavir) taken with ritonavir and in combination with other HIV medications can help lower your viral load and keep your HIV under control.

The PREZISTA® Experience isn’t just an HIV treatment.

It’s an HIV treatment experience as unique as you.

Call

**PRZ (**779)

on your mobile phone to watch videos of people living the PREZISTA® Experience.

Please read the Important Safety Information and Patient Information on adjacent pages.

Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2014 05/14 014606-140430

IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) (darunavir) Oral Suspension PREZISTA (pre-ZIS-ta) (darunavir) Tablets Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Also read the Patient Information leaflet for NORVIR® (ritonavir).

What is the most important information I should know about PREZISTA? • PREZISTA can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section “Who should not take PREZISTA?” • PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIR® (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems.

• Tell your healthcare provider if you have any of the below signs and symptoms of liver problems.

• Dark (tea colored) urine • yellowing of your skin or whites of your eyes • pale colored stools (bowel movements) • nausea • vomiting • pain or tenderness on your right side below your ribs • loss of appetite PREZISTA may cause severe or life-threatening skin reactions or rash.

Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below: • fever • tiredness • muscle or joint pain • blisters or skin lesions • mouth sores or ulcers • red or inflamed eyes, like “pink eye” (conjunctivitis) Rash occurred more often in people taking PREZISTA and raltegravir together than with either drug separately, but was generally mild.

See “What are the possible side effects of PREZISTA?” for more information about side effects.

What is PREZISTA? PREZISTA is a prescription anti-HIV medicine used with ritonavir and other anti-HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called “viral load”). PREZISTA may also help to increase the number of white blood cells called CD4 (T) cell which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system.

This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).

PREZISTA does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA. Avoid doing things that can spread HIV-1 infection.

• Do not share needles or other injection equipment.

• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.

• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.

Who should not take PREZISTA? Do not take PREZISTA with any of the following medicines: • alfuzosin (Uroxatral®) • ergot-containing medicines: dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergotamine (Cafergot®, Ergomar®) methylergonovine • cisapride • pimozide (Orap®) • oral midazolam (Versed®), triazolam (Halcion®) • the herbal supplement St. John’s Wort (Hypericum perforatum) • the cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®, Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®) • rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) • sildenafil (Revatio®) only when used for the treatment of pulmonary arterial hypertension.

Serious problems can happen if you take any of these medicines with PREZISTA. What should I tell my doctor before I take PREZISTA? PREZISTA may not be right for you. Before taking PREZISTA, tell your healthcare provider if you: • have liver problems, including hepatitis B or hepatitis C • are allergic to sulfa medicines • have high blood sugar (diabetes) • have hemophilia • are pregnant or planning to become pregnant. It is not known if PREZISTA will harm your unborn baby.

Pregnancy Registry: You and your healthcare provider will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is follow the health of you and your baby.

• are breastfeeding or plan to breastfeed. Do not breastfeed. We do not know if PREZISTA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using PREZISTA and certain other medicines may affect each other causing serious side effects. PREZISTA may affect the way other medicines work and other medicines may affect how PREZISTA works.

Especially tell your healthcare provider if you take any of the medicines listed below. The generic name is provided, followed by examples of possible brand names for the drug product: • medicine to treat HIV • estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.

• medicines to prevent organ transplant rejection such as cyclosporine (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®) • amiodarone (Pacerone®, Cardarone®) • artemether/lumefantrine (Coartem®) • atorvastatin (Lipitor®) • bepridil (Bepadin®, Vascor®) • boceprevir (VictrelisTM) • bosentan (Tracleer®) • buprenorphine (Butrans®, Buprenex®, Subutex®) • buprenorphine/naloxone (Suboxone®, Zubsolv®) • carbamazepine (Carbatrol®, Equetro®, Tegretol®, Epitol®) • clarithromycin (Prevpac®, Biaxin®) • colchicine (Colcrys®, Col-Probenecid®) • desipramine (Norpramin®) • dexamethasone (Ozurdex®) • digoxin (Lanoxin®) • felodipine (Plendil®) • flecainide (Tambocor®) • fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®) • itraconazole (Sporanox®, Onmel®) • ketoconazole (Nizoral®) • lidocaine (Xylocaine Viscous®) • methadone (Methadose®) • metoprolol (Lopressor®, Toprol-XL®) • nicardipine (Cardene®) • nifedipine (Procardia®, Adalat CC®, Afeditab CR®) • paroxetine (Paxil®, Pexeva®) • phenobarbital

IMPORTANT PATIENT INFORMATION • phenytoin (Dilantin®, Phenytek®) • pravastatin (Pravachol®) • propafenone (Rythmol®) • quinidine (Nuedexta®) • rifabutin (Mycobutin®) • risperidone (Risperdal®) • rosuvastatin (Crestor®) • salmeterol (Advair®, Serevent®) • sertraline (Zoloft®) • sildenafil ( Viagra®, Revatio®) • tadalafil (Cialis®, Adcirca®) • telaprevir (IncivekTM) • thioridazine (Mellaril®) • timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Combigan®) • trazodone (Oleptro®, Desyrel®) • warfarin (Coumadin®, Jantoven®) • vardenafil (Levitra®, Staxyn®) • voriconazole (VFend®) This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider.

How should I take PREZISTA? • Take PREZISTA every day exactly as prescribed by your healthcare provider.

• You must take ritonavir (NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first.

• Take PREZISTA and ritonavir (NORVIR®) with food.

• Swallow PREZISTA tablets whole with a drink. If you have difficulty swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your health care provider will help decide whether PREZISTA tablets or oral suspension is right for you.

• PREZISTA oral suspension should be given with the supplied oral dosing syringe. Shake the suspension well before each use. See the Instructions for Use that come with PREZISTA oral suspension for information about the right way to prepare and take a dose.

• If your prescribed dose of PREZISTA oral suspension is more than 6 mL, you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to divide the dose. Ask your healthcare provider or pharmacist if you are not sure.

• If you take too much PREZISTA, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I do if I miss a dose?

People who take PREZISTA one time a day: • If you miss a dose of PREZISTA by less than 12 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.

• If you miss a dose of PREZISTA by more than 12 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time.

People who take PREZISTA two times a day • If you miss a dose of PREZISTA by less than 6 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.

• If you miss a dose of PREZISTA by more than 6 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time.

If a dose of PREZISTA is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA at any one time.

What are the possible side effects of PREZISTA? PREZISTA can cause side effects including: • See “What is the most important information I should know about PREZISTA?” • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA. • Changes in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and longterm health effects of these conditions are not known.

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine.

• Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA. The most common side effects of PREZISTA include: • diarrhea • headache • nausea • abdominal pain • rash • vomiting Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of PREZISTA. For more information, ask your health care provider.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store PREZISTA? • Store PREZISTA oral suspension and tablets at room temperature [77°F (25°C)].

• Do not refrigerate or freeze PREZISTA oral suspension.

• Keep PREZISTA away from high heat.

• PREZISTA oral suspension should be stored in the original container.

Keep PREZISTA and all medicines out of the reach of children.

General information about PREZISTA Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a condition for which it was not prescribed. Do not give PREZISTA to other people even if they have the same condition you have. It may harm them.

This leaflet summarizes the most important information about PREZISTA. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZISTA that is written for health professionals.

For more information, call 1-800-526-7736.

What are the ingredients in PREZISTA? Active ingredient: darunavir Inactive ingredients: PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment), purified water.

PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

PREZISTA 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

PREZISTA 800 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, hypromellose. The film coating contains: OPADRY® Dark Red (iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

This Patient Information has been approved by the U.S Food and Drug Administration.

Product of Ireland Manufactured by: PREZISTA Oral Suspension PREZISTA Tablets Janssen Pharmaceutica, N.V. Janssen Ortho LLC, Beerse, Belgium Gurabo, PR 00778 Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 Revised: April 2014 NORVIR® is a registered trademark of its respective owner.

PREZISTA® is a registered trademark of Janssen Pharmaceuticals © Janssen Pharmaceuticals, Inc. 2006 014859-140506

SPORTS AND HIV

OUT OF Using sports as a vehicle for positive change

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By Jeff Berry

uring the 1988 Summer Olympics in Seoul, South Korea, Greg Louganis made history when he became the first and only male diver to ever win two individual gold medals in consecutive Olympic Games.

What no one knew at the time was that he had tested HIV-positive just six months earlier.

“When I was competing in the 1988 Summer Olympics, I was competing in a country that I wouldn’t have been allowed in, had they known my HIV status,” he says.

To the horror of those watching in the stands and viewers back home, Louganis struck his head on the springboard during preliminaries, requiring five stitches.

He returned minutes later to perform the best dive in the competition, and went on to seize the gold the next day.

When he came out publicly as HIV-positive seven years later with the release of his autobiography, Breaking the Surface, some questioned whether he should have disclosed his status to the Olympics’ chief physician Dr. James Puffer, who had treated Louganis’ wounds without latex gloves.

“I knew what the situation was, and I wanted to scream out to everybody, ‘Don’t touch me!”’ Louganis recalled in a 2013 Los Angeles Times article. “But I knew how inappropriate that would be. I didn’t know what my responsibility was. I was just scared.”

After decades in which no athlete would come out, much less admit being HIV-positive, there has been a recent acceleration in coming-out among high-profile athletes. Coming out as gay and HIV-positive, in Louganis’ case, can be even more challenging and often brings with it a dual stigma. But as public attitudes

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Photo: John Gress

BOUNDS slowly begin to shift, and with billions of dollars and young ahletes’ aspirations at stake, venerated sports institutions and youth sports programs are becoming more inclusive and raising awareness not only about being gay, but also about HIV and AIDS. Athletes, who serve as role models, as well as their allies, have the ability to help lead the way.

Glenn Burke, who left Major League Baseball in 1980, carried his own burden.

Widely credited as the person who invented the high five, Burke struggled with being a professional athlete and gay, at a time when the gay rights movement was just gaining traction. When the Los Angeles Dodgers traded him to the Oakland A’s after four seasons, the A’s manager Billy Martin introduced the new players to the team and reportedly said, “Oh yeah, and this is Glenn Burke—he’s a faggot.”

“Glenn didn’t hide it,” says Burke’s sister Paula Hunt. “He didn’t hide it from his team, he didn’t hide it from his family or his friends. But the world didn’t know. He did have a lot of difficulties, not only being gay, but being black and gay back in the ’70s.”

After walking away from baseball Burke came out publicly in a 1982 Inside Sports article titled “The Double Life of a Gay Dodger,” and appeared on NBC’s Today with Bryant Gumbel. He was finally able to enjoy his time as an openly gay athlete in San Francisco for several more years, competing in the Gay Softball Leagues and the first Gay Games. His life took a sharp turn, however, when he was hit by a car in 1987 while crossing the street, suffering a broken leg and crushed foot. Unable to play sports,

he was never again the same athlete, and his life spiraled out of control with drugs, depression, crime, and ultimately homelessness. He also had contracted HIV, and died from complications due to AIDS in 1995.

“Frankly I think the reason that Glenn Burke is not given the credit he deserves is because of his HIV status,” says openly gay former NFL player Wade Davis. “There’s a lot of shame and stigma that exists around HIV, and there is, I would call it, this ‘respectability framework’ that we’re trying to improve when advocating for LGBT individuals. If you look at a Jason Collins, someone who comes from a certain type of pedigree, he’s a great and wonderful advocate. But because Glenn Burke was someone who had HIV his story wasn’t told, because people don’t think that, knowing his status, he could now become part of that conversation. I think oftentimes people are afraid to include him because they are fearful of LGBT people being looked at through the lens of HIV. I just want to make sure that people give Glenn Burke the credit that he deserves, but also that we’re transparent about why he isn’t given the credit he deserves.”

Baseball finally took a first step in the right direction by recognizing Burke and acknowledging his contributions to the sport this past summer, during the AllStar Game in Minneapolis. Burke’s sister Lutha spoke fondly of her brother at the game, with her daughter Alice Rose by her side. It’s part of a concerted effort by the League to be more tolerant and inclusive, also made evident by the recent appointment of out former baseball player Billy Bean as Ambassador of Inclusion.

“It made me feel like we allowed [Glenn Burke and his family] to come full circle,” says Bean. “It’s hard to let go of the frustration, his fall from where he was as a player, the way his life changed dramatically. He stopped way before his time, I stopped before my time—I was lucky that I did not fall into a bad situation.”

Bean’s own partner died of AIDS in 1994, but he didn’t even allow himself time to grieve, playing in a game that same evening. Bean’s doctor, who had diagnosed his partner, had no experience in HIV and no other clientele who were HIV-positive. “I lived in fear for a year because of not being educated,” he says. “The doctor said that since I had been exposed, I could seroconvert [anytime] over the next 18 months.”

The normal window period between exposure and sero-conversion is up to three months at most, although it was thought to be six months at the time.

“I went there first, and I trusted him, and I didn’t know any better, I didn’t know to question his authority… and it really led to me walking away [from baseball]. There was no Internet, I didn’t have a computer, and I didn’t know who to talk to.”

For the next year he went to get tested every four weeks, fearing the test would come back positive, and began losing weight due to the stress.

“I look back now and I think, why did I put myself in that situation? I was raised to be a soldier kind of athlete. My father was in the Marine Corps, we were raised to be strong, and tough, and keep our emotions in. It’s one of the great regrets of my life. I spent a lifetime to get to the big leagues N OV+ D E C 2 0 1 4

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and I just quit, because of fear and ignorance.”

Bean says that he was a baseball player who was hiding a secret off field. “The difference now—my dream—is to help players who may now be in that position to feel completely secure and welcomed.”

Changing image

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espite some of the recent advances, professional sports continues to have an image problem, and is viewed by some to be the last bastion of misogyny, sexism, and homophobia. The recent assault by Ray Rice on his then-fiancée and now wife Janay Palmer, added to the racist rants of former L.A. Clippers owner Donald Sterling, followed by comments that Magic Johnson had “those AIDS” and should be ashamed of himself, has certainly not helped bolster that image. While the Lakers organization includes HIV awareness and education in the training of players, they declined to be interviewed for this story.

“I hope this doesn’t set us back,” Johnson said in an interview with CNN’s Anderson Cooper at the time of Sterling’s comments. “The stigma [of HIV] is still there. We know that. We’ve been fighting it for years, and what we want to continue to do is just educate the world that it’s okay, that you can highfive a person who has HIV. It’s okay.”

Attitudes and perceptions in professional sports are slowly beginning to shift, at least as far as LGBT inclusion and awareness. Along with Bean’s appointment, and the coming out of Jason Collins

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“I look back now and I think, why did I put myself in that situation?

I was raised to be a soldier kind of athlete. My father was in the Marine Corps, we were raised to be strong, and tough, and keep our emotions in. It’s one of the great regrets of my life.

I spent a lifetime to get to the big leagues and I just quit, because of fear and ignorance.”

—BILLY BEAN

and Michael Sams, the NHL recently became the first major sports league to have a player on every team supporting LGBT athletes and fans.

“The reason it’s so important is because of what these players represent to our community,” says Bean. “When you have billions of dollars of revenue generated each year, and the hopes and dreams of every young kid, there’s a great corporate responsibility that goes with that platform. I couldn’t be prouder of baseball recognizing that responsibility… and putting me in a position to communicate that.”

Even though as a people we’ve come a long way, says Hunt, there still is the stigma. “Being in sports you’re supposed to be this macho male. When you think of athletes you may not necessarily think of gay athletes. More and more of the players are coming out now, and I’m glad, because to live your life being ashamed of who you really are, and being afraid of telling people who you are, must be very painful.”

ALL IN THE FAMILY

H

unt’s own son, Alex, came out as gay to her and her husband five years ago. Alex’s partner is currently pursuing a PhD in public health at Columbia University Health, with a focus on HIV/ AIDS prevention.

“As a mother I kind of know what my own mother went through, and the first thought that I had was, I don’t care if you’re gay, I love you more than anything, my point is that I want you to be happy—and that’s what I thought about Glenn. As a society we’ve come

Hall of famers in their own right. FROM LEFT: OLYMPIC DIVER GREG LOUGANIS; former NFL FOOTBALL PLAYER WADE DAVIS WITH FRIEND AND BUSINESS PARTNER DARNELL MOORE; BASEBALL PLAYERS GLENN BURKE AND BILLY BEAN. GREG LOUGANIS COURTESY OF GREG LOUGANIS. WADE DAVIS AND DARNELL MOORE PHOTOGRAPHED BY DARREN CALHOUN. GLENN BURKE COURTESY OF OAKLAND A’S BASEBALL CLUB. BILLY BEAN COURTESY OF BILLY BEAN.

a long way, you can get married now, and there’re benefits, [but] I think that in sports men are still made to feel very uncomfortable. Sharing a locker room, I know Glenn [experienced] some problems with that.

You look at women in sports, I don’t think the same stigma hangs over them as it does with men.”

If it’s that way for athletes who are gay, what will it take for us to get to the point where an athlete can feel comfortable coming out as HIV-positive while playing or competing—or is that even important?

“Coming out is such a process: One is an identity issue of who you are and who you love, and the other is a medical issue,” says Louganis. “There are diabetics who are athletes. There are people with asthma who are athletes. Medical conditions are generally managed; whether that needs to be made public or not, that’s a personal choice.”

“I think it’s very important,” says Davis.

“I would say that there’s a lot more work to be done.

There’s a space that’s been created for athletes like Jason Collins, Michael Sams, or Derrick Gordon, who exhibit a certain type of normative [behavior] of an athlete that doesn’t make people feel uncomfortable. But I think that we still haven’t done work to create a space for someone who doesn’t exhibit a certain type of stereotypical athlete in very heavy, male-dominated spaces. I also think we’re having a very limited conversation around homophobia—we should be having the conversation in a framework of sexism, because I believe that sexism is what creates the homophobia, that homophobia is just a byproduct of that. If we don’t tackle the way that sexism creates this gender binary where men have to act a

certain way, and women have to act a certain way, then we really haven’t done the work.”

Removing stigma

“There’s such a lack of information out there about how to contract HIV. I think back to what happened with Magic Johnson, there were players like Karl Malone and others who were afraid to be on the same court, and it was associated with [the fact that] they believed somehow they would be put at risk.”

—WADE DAVIS

O

n top of all that we need to remove the shame that exists around what it means to have HIV, says Davis. “There’s such a lack of information out there about how to contract HIV. I think back to what happened with Magic Johnson, there were players like Karl Malone and others who were afraid to be on the same court, and it was associated with [the fact that] they believed somehow they would be put at risk. I think in order for us to get to the space we [need to be] we have to not only educate [ourselves], but also live that education.” In other words, says Davis, would someone who knows how hard it is to contract HIV still put themselves in a situation where they could actually be in proximity with another player who is HIV-positive and say, “I’m still okay playing, even if there is a cut, there is an opportunity to contract HIV, and it’s very low”?

“The education is one thing,” says Davis, “but actual practice is very different.”

To an athlete who is HIV-positive, Louganis would tell him or her, “Don’t give up your dream. We’ve made so many strides in treatment. Back in the ’80s we thought it was a death sentence. We’ve come a long way from only one drug, AZT, to many treatment options today.”

The stigma of both homophobia and HIV may differ, but both can have devastating consequences in N OV+ D E C 2 0 1 4

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SPORTS AND HIV

sports, as in life. Ex-heavyweight champion Tommy Morrison tested positive in 1995, but both he and his wife Trisha became AIDS denialists and denied that Morrison had HIV or AIDS up until his death in 2013, at the age of 44.

Davis and others are now hoping to shift people’s perceptions and raise awareness by working with young gay athletes and their straight allies. Davis’ work with the Hetrick-Martin Institute from 2011–2013 was where he says he really learned that not only are there young people living with HIV, but that to do the work of an ally, he has to think about it as if he’s actually living with HIV. You Belong, an organization he co-founded with friend and business partner Darnell Moore, conducts youth camps that use sports as the entry point for young gay people to have, what Davis calls, different kinds of conversations. The first camp, held last year in Chicago, included workshops on health and wellness, antibullying, social injustice, and leadership.

“In the health and wellness piece we were intentional about having conversations around HIV and AIDS. In turn, we gave an opportunity to other young people who are actually living with HIV to share their own story. When I speak publicly I like to share a story of a young person who contracted HIV… because I think that oftentimes we think of HIV as that other person’s problem, not something that could ever impact us or our lives.”

More recently Davis created the You Can Play Project’s High Five Initiative, to remove what he calls the invisible barrier that often separates LGBT youth from athletes and athletics. It’s an effort to “humanize athletes that oftentimes we elevate to these godlike figures,” says Davis.

“How can I bring these athletes down so that they’re like, ‘Wow, I just met a young trans woman who was amazing, who I saw beyond her gender identity—I saw her as a woman, as a person, and she and I have a lot of similarities.’” If we can bring athletes to a safe space where young people exist openly and honestly and have an exchange of stories and narratives, says Davis, we’re not bringing these athletes to visit these young people so that they can view them as someone who’s “at risk,” but as people with promise.

Getting back to our roots

T

—WADE DAVIS

yler Spencer was a student athlete working as an undergrad when he traveled to South Africa for the first time at the age of 19, and where he says he got his first exposure to people living with HIV

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“When I speak publicly I like to share a story of a young person who contracted HIV… because I think that oftentimes we think of HIV as that other person’s problem, not something that could ever impact us or our lives.”

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and AIDS. Spencer was working closely with a friend whose ex-girlfriend had recently tested HIV-positive.

He began working with an organization that used sports as a way to break the ice and start a conversation about HIV, gender-based violence, and other issues related to the epidemic in South Africa.

“Everyone wanted to talk about soccer,” says Spencer, “but no one wanted to talk about HIV.” Upon returning to Washington, D.C. he was considering graduate school when someone asked him to put together an HIV/AIDS fact sheet. Spencer assumed that the epidemic wasn’t as big an issue in D.C., but while researching it learned that one in 20 people in the D.C. Metro area are infected, ten times the national average. That’s a rate on par with or even worse than in some countries in Africa.

He soon founded The Grassroots Project, modeled after the program he worked with in South Africa, which provides peer education and HIV/AIDS prevention to local middle school-aged students by using high school and college athletes to serve as role models. “I thought that college athletes could benefit a lot in terms of personal growth and development,” says Spencer. “Sports for the most part of my life up to that point had been a mostly selfish endeavor—being

“Athletes,

by virtue of who they are and what they’ve accomplished, have the ability to be tremendously positive role models.”

—TYLER SPENCER

Photo: JOHN GRESS

good at sports and playing sports could be something that could make a much bigger impact.

“Athletes, by virtue of who they are and what they’ve accomplished, have the ability to be tremendously positive role models.”

The eight-week curriculum creates a safe space for youth to share their feelings and beliefs, increase their knowledge, and develop healthy attitudes and behaviors through the use of interactive games and activities.

“Honestly, the most impactful thing that happens is when a student, usually about five or six weeks into the program, gets comfortable enough to share that they have someone in their immediate family or who’s close to them who is HIV-positive or has died of AIDS. It’s incredibly powerful when a kid can share it with peers. It happens in [almost] every program,” says Spencer.

A New generation

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side from Magic, Louganis, and Burke, other athletes have demonstrated great courage in the face of HIV and gone on to advocate for others, such as tennis champion Arthur Ashe who died of AIDS

“Coming out is such a process: One is an identity issue of who you are and who you love, and the other is a medical issue. Medical conditions are generally managed, whether they need to be made public or not, that’s a personal choice.”

—GREG LOUGANIS

in 1993, and college football star Larry Bryant who tested positive in 1986, and now serves as Director of National Organizing for Housing Works in New York City.

Thankfully some of these stories are now being relayed to an entirely new generation. Bryant shares his own personal journey with young athletes as part of The Grassroots Project. A documentary on Louganis’ life, Back on Board, is currently appearing on the film festival circuit and is receiving critical acclaim. OUT: The Glenn Burke Story, a documentary produced by Doug Harris for Comcast Sports, recounts Burke’s tale as told by his friends and former teammates (licensing agreements have hindered a wider release of the film, but segments of the video are available on YouTube). Actress Jamie Lee Curtis recently purchased the rights to Burke’s autobiography Out at Home, published shortly before his death, and a movie based on the book is now in the works at HBO. Burke’s sister Hunt says she’s heard that they’re struggling with how to bring some happiness to a film about her brother’s life, because ultimately it is such a sad story.

“I remember at his funeral, my sisters and I stood around his casket and sang, ‘He Ain’t Heavy, He’s My Brother’ in a capella. Then we all high-fived each other, and I thought that was just a wonderful memorial to him. When I tell people that my brother was the first person in sports to do the high-five they’re like, ‘No way!’ But he did, it was in the 1977 World Series with Dusty Baker, if I’m not mistaken, and my mother was at the game.”

Hunt hopes her brother will be remembered as a great athlete, for caring about people, making people laugh, and always making people happy to be around him. She would love for the world to remember him in a more positive light, and to focus on the beginning of his career, rather than the end.

“It’s my belief that he was up against so much… that it probably led to the drug abuse, because it helped him to escape from his reality. So I can’t stress enough that people should be who they are, no matter what.

“He was a great protector, he was my protector—he always looked out for his sisters and his little brother. There wasn’t always a father in the home, so he was someone that we leaned on for that. Glenn unfortunately became a drug addict and that led to risky behavior and he got ill—and it breaks my heart that that’s how he left us, with that image. But the people who really knew him knew who he was, before all of that. They knew that he was a great person, and had the biggest heart that you could ever want to know.”

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POSITIVELY AWARE

CAN HEPATITIS C BE SEXUALLY TRANSMITTED? Yes. No. Maybe. It’s complicated.

All of the above.

By Andrew Reynolds

A Photo: VSTOCK

s a hepatitis C health educator, I think it’s fair to say that the question of sexual transmission of HCV is one of the more common ones I’m asked. And unlike sexually transmitted infections like syphilis or gonorrhea, where we can say definitively that they are indeed STIs, the answer to the HCV question is most definitely complicated.

Why is it complicated? We know that HCV is transmitted from blood-to-blood contact. Hepatitis C (HCV) is the most commonly transmitted bloodborne pathogen in the U.S. Official estimates are that about 3.2 million people are chronically infected with HCV, but many experts think it’s likely much higher. It is widely accepted that certain populations, some might call them “risk groups,” are at greater risk of HCV than others: For example, people who inject drugs (PWIDs) and people born between

1945 and 1965 (the “baby-boomers”) are two such groups. We have good data to support this, so we can confidently make recommendations to test for HCV. Similarly, we have several studies that support that there is significant risk for sexual transmission of HCV among HIV-positive gay men. We have fewer studies looking at HIV-negative gay men, but studies so far have suggested a relatively low rate of HCV in this group. Similar rates of HCV among non-injecting heterosexuals have been found: HIV-positive N OV+ D E C 2 0 1 4

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HCV is a tough virus—it can live in syringes for up to 63 days, on surfaces for up to 6 days,

Who should be screened for HCV? Everyone born between 1945 and 1965—the so-called “babyboomers”—should receive a one-time screening for HCV with no need to determine risk factors.

How is hepatitis C commonly transmitted?

Persons who received a blood transfusion, blood products, or an organ transplant before 1992.

HCV is transmitted through blood-to-blood contact. It is most commonly transmitted among people who inject drugs (PWIDs) who share syringes and other injecting equipment (cotton, cookers, water, etc.). There are several risks associated with non-injection drug use, too: sharing straws for snorting drugs or pipes for smoking. HCV is a tough virus—it can live in syringes for up to 63 days, on surfaces for up to 16 days, and in water for up to 21 days. There are other risks of transmission where blood-to-blood contact can occur: unsterile tattooing, poorly sterilized medical equipment (including dialysis machines), and other procedures where contaminated blood may infect you. For a summary list of people who are at risk of being infected with HCV, see box at left, “Who should be screened for HCV?”

Persons who have been on long-term hemodialysis.

When we talk about sex, what we are referring to?

Persons who inject or have ever injected drugs (including those who may have only injected once or those who did it many years ago).

Persons born to an HCV-infected mother.

Persons who are incarcerated or have a history of incarceration (jail or prison).

Persons who use non-injectable drugs, including straws for intranasal drugs or pipes for crack and crystal meth.

Persons who received an unregulated tattoo.

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heterosexuals have higher rates of HCV than do their HIV-negative counterparts. Finally, it’s complicated because it’s challenging to tease out other risk factors for HCV transmission, including hidden injection drug use that people do not disclose due to fear of negative judgment and stigma.

There are many different sexual practices, and sex holds many different meanings for different people. For the purposes of this piece, we will be as specific as we can when talking about sex (for example, “vaginal sex” or “anal sex”), but we will focus primarily on the sexual practices where we have the most data: anal sex (insertive and receptive), fisting, and sex toys among HIV-positive gay men. One thing to consider is blood present during sex: We know HCV is present in blood, but there is no evidence that it is found in semen or vaginal fluids. If a sexual practice can lead to bleeding, there is some risk for HCV transmission. If you minimize the risk of bloodto-blood contact during sex, you minimize the risk of HCV transmission.

Persons living with HIV.

What is the risk for heterosexual men and women?

Source: Recommendations for Testing, Managing, and Treating Hepatitis C. hcvguidelines.org

Although the focus of this piece is the sexual transmission of HCV among HIV-positive gay men, we do want to address the needs of other populations as well. That said, a running theme throughout this article will be how complicated the answer to

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sexual transmission questions will be, and it’s no different here with respect to the risk in heterosexuals.

The complications arise from the wide range of relationships and types of sexual contacts: There are different degrees of risk in monogamous relationships than there are for those with multiple sex partners.

Additionally, the presence of certain risk factors can raise the risk of sexual transmission of HCV, including presence of an STD or HIV infection.

For monogamous, serodiscordant (that is, one person has HCV and the other does not) heterosexual couples, the risk is extremely low. One recent study of 500 different monogamous couples found the risk of transmission to be about 1 per 190,000 sexual contacts. Couples in this study did not necessarily use condoms or practice other risk reduction methods, nor did it appear that certain sexual practices increased the risk for transmission.

There have been several other long-term studies of this group, and they also show no increased risk for the HCV-negative partner. This is not to say that it cannot happen, and there are people in this group who have become infected with HCV through sex. Nevertheless, the odds are very much against it. Indeed, the authors of the study state that this extremely low risk of transmission means that partners who remain monogamous do not need to change their sexual practices.

Whatever the information about risk of sexual transmission of HCV in monogamous heterosexual couples may be, ultimately, you decide your comfort level around risk: You (and your partner) should decide the sexual practices and level of risk you are comfortable with, and take it from there.

While the risk for monogamous couples might be low, people with multiple sex partners appear to be at higher risk for sexual transmission of HCV. In a review article published in 2010 by two researchers from the CDC, persons with multiple sex partners were found to have more than twice the risk of sexually transmitted HCV. Presence of co-existing STDs, especially those that cause a sore, increase risk for men and women alike.

Finally, although we don’t have nearly as many studies in HIV-positive heterosexual men or women, HIV infection significantly raises the risk for sexual transmission of HCV, just as it does with gay men.

One study found that HIV-positive women were twice as likely to get HCV as were HIV-negative women, and another looking at HIV-positive men attending a Baltimore STD clinic found that their risk was four times greater than their HIV-negative counterparts.

and in water for up to 21 days.

What is the risk for HIV-negative gay men?

This is a very interesting question and one for which the answer may be changing. Until recently, we thought the risk was relatively low. Although we don’t have the number of studies or the data when compared to HIV-positive gay men, when we do have it, they do not show a relationship between sexually transmitted HCV and HIV-negative gay men.

A recent review of HCV awareness presented at ICAAC 2014 summarized the HCV prevalence (how much HCV within the community) in gay men in various countries (see box at right, “HCV rates by country”).

As the review shows, rates of HCV in HIV-negative gay men are much lower than in HIV-positive gay men. In a large review article, researchers offer further confirmation that HIV-negative gay men are at low risk of HCV, and, as with HIV-negative heterosexuals who don’t inject drugs, routine screening for HCV is not warranted.

This research flies in the face of what many people assume: Gay men have anal sex, and anal sex can lead to bleeding. Since blood can transmit HCV, it makes sense that anal sex will transmit the virus.

Again, as a health educator, I hear this all the time.

And while the data suggest little risk, the concerns and anxiety about the risk remain high.

This anxiety may be validated by results from another review, also presented at ICAAC. It’s not a conclusive, game-changing review, but it definitely serves as a warning that people need to be aware of HCV risk in HIV-negative gay men. The numbers of this review were pretty small: 44 HIV-negative gay men who were diagnosed with acute HCV (acute HCV is defined as the first six months of infection).

The study author reviewed the sex and drug-using practices that these men engaged in, and found several high-risk activities that we know have been associated with sexual transmission of HCV in HIV-positive gay men: condomless anal sex, group sex, fisting, drug use with sex, presence of an STD, and limited awareness of a partner’s status. While it is true that some of these men may have acquired HCV from drug use (either intranasal or injection), 42% of them reported no use at all, suggesting sexual transmission as the source of infection. Finally, a key point made by the author is that we don’t offer HCV screening to HIV-negative gay men, so perhaps we are missing asymptomatic HCV infections in this group.

So, what is our takeaway? The rates of HCV among HIV-negative gay men might be low, but we should remain aware of the risks. Even if sex might not be the direct mode of transmission, we know

the risk factors that may lead to HCV infection, as we know the ones that facilitate sexual transmission.

HIV-negative gay men who practice condomless anal sex with partners of unknown status, fist, and/or use drugs, particularly in combination with sex, should consider HCV screening as a part of their sexual health awareness practice.

HCV rates by country Australia

What is the risk for HIV-positive gay men?

This is the area where we have the most evidence and the area where we have the most confidence: HIV-infected gay men are at higher risk of sexually-acquired HCV than are other groups. That said, it can still be a little complicated when you start to break it down. For example, we know that HCV is transmitted from blood-to-blood contact, but what about sexual fluids? The truth is, we don’t know.

Some studies have found HCV in semen, while others have not. In the end, whether it’s in semen or not, we know it’s in blood, and sexual practices that can lead to bleeding carry risk for HCV transmission.

As we saw in the box, “HCV rates by country,” comparing HCV prevalence in HIV-negative gay men to HIV-positive gay men, there are much higher rates of HCV in people living with HIV. Within the HIV-positive group, we see similar behaviors: condomless anal sex, group sex, fisting, and so on. So what accounts for the higher rates in this population? One possible explanation is serosorting, or the practice of only having sex with someone who has the same HIV status. Many gay men have taken to this practice to prevent the transmission of HIV to negative sex partners. Gay men may be aware of their partner’s HIV status, but not their HCV status, and if they practice condomless anal sex (or fisting) their risk for HCV is higher.

What is the role of HIV itself and the risk of HCV acquisition from sex? It certainly makes sense that a weaker immune system can make you more vulnerable to HCV infection. Although the data on this are not great, we do have one excellent review that shows a relationship between lower CD4 counts and increased risk of HCV acquisition. Additionally, rates of HCV were higher in HIV-positive gay men with lower CD4 counts even when they had fewer risk factors for HCV. We do not yet know what the protective factor of taking anti-HIV medications might be against sexual transmission of HCV, but we know all of the health benefits it provides otherwise, so it can’t hurt. Regardless of CD4 count, you want to minimize your risk of blood contact to minimize the risk of HCV transmission. The following section reviews the risk factors for sexual transmission of N OV+ D E C 2 0 1 4

Among THOSe HIV-negative in a sample of 1,398:

1.07%

Among those HIV-positive in a sample of 245:

9.39%

Canada Among those HIV-negative In a sample of 1,095:

2.9%

England Among those HIV-negativE in a sample of 953:

1.2%

Among those HIV-positive in a sample of 168:

7.7%

Switzerland Among those HIV-negative in a sample of 821:

0.38%

Among those HIV-positive in a sample of 19:

21.1%

United States Among those HIV-negative non-PWID in a sample of1,699:

1.5%

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You need two HCV tests to confirm that you are infected; 20–25% of people who get infected HCV that have been identified in a variety of studies looking at HIV-positive gay men.

HCV TEST ResultS and what they mean There are two tests for HCV: The HCV antibody test and the HCV viral load test. The antibody test tell you if you’ve ever been exposed to the virus and the viral load test tells you if you actually have it in your system.

About 20–25% of people exposed to HCV clear the virus from their body within six months, but will always test antibody positive. The viral load test is needed to determine if someone actually has active infection.

Negative and Undetectable (negative):

You do not have HCV.

Positive and Undetectable (negative):

You do not have HCV; you cleared the virus.

Positive and Detectable (positive):

You have chronic HCV.

Negative and Detectable (positive):

You either have early (acute) HCV or your immune system cannot produce enough HCV antibodies (may occur in people with low CD4 counts).

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What risk factors increase the risk of sexual transmission for HIV-positive gay men?

As briefly stated above in the previous section, there are several activities and behaviors that increase the risk of sexual transmission of HCV. Check out the box at the bottom of this page, “What activities increase the risk of sexually transmitted HCV?” for a review of risk factors that are associated with sexual transmission of HCV.

How do I test for hepatitis C? Testing for HCV can be a little confusing, especially if you are used to testing for HIV. In HIV testing, a positive antibody test means you have been infected with HIV. In HCV testing, you need two tests to confirm that you are infected, because 20–25% of people who get infected with HCV will clear the virus naturally in the first six months. These people will always test antibody positive, but not have actual virus damaging the liver. So, it’s possible to get a positive HCV antibody test, but not be infected with HCV. Because of this, positive HCV antibody tests must be followed with a confirmatory viral load test.

The box at left shows the range of HCV tests and their meaning.

If you are at risk for HCV infection, talk to your

medical provider about taking a test. There may also be community-based organizations or other dropin clinics where you can get an HCV antibody test (including a rapid test), but you always want to make sure there is a confirmatory viral load test available should you test positive.

How frequently should I test for hepatitis C? There are no clear guidelines for how frequently a person should test for HCV, especially for those at risk of sexual transmission. Indeed, sexual transmission of HCV is not included in either of the CDC risk-based or birth cohort guidelines. Recent recommendations from the AASLD/IDSA call for “annual HCV testing for persons who inject drugs and for HIV sero-positive men who have unprotected sex with men. Periodic testing should be offered to other persons with ongoing risk factors for exposure to HCV.” There are other recommendations and guidelines, both national and international, that we can draw from to give us a sense of how frequently a person at risk for HCV should screen for it.

How can I reduce my risk for hepatitis C? Awareness of the risk for HCV is the first step for reducing it. Hopefully this article has offered you enough information about the sexual transmission of HCV that you can make your own informed choices for reducing the risk of it. Increasing blood

What activities increase the risk of sexually transmitted HCV? Fisting Fisting can cause trauma to the surfaces of the anus and rectum that could lead to bleeding, including microscopic bleeding. Fisting someone else might also increase your risk if you have breaks in your skin, fingers, or hands.

Multiple Sex PartnerS As with group sex, multiple partners is associated with sexual transmission of HCV: More partners not only increase the possibility of having sex with someone with HCV, but it has also been shown to coincide with other risk behaviors.

Sharing Sex Toys As with fisting, sex toys can lead to anal or rectal bleeding. If a sex toy has HCV-infected blood on it, it may facilitate transmission of the virus. Note: There have not yet been any studies looking at HCV on sex toys, but we know that HCV can live on surfaces for as long as 16 days, so it’s a safe assumption that it can live this long on sex toys and you should exercise the same caution.

STDs (STIs) Sexually transmitted diseases that cause sores (ulcers) are associated with HCV due to the presence of blood.

These include herpes, chanchroid, lymphogranuloma venereum (LGV), and primary syphilis. Anal warts, specifically sex following anal wart removal, have also been found to be increase the risk of HCV.

Group Sex Engaging in group sex appears to increase the risk of sexual transmission of HCV. This may be due to longer sex sessions that might lead to more trauma and bleeding, but it could also increase the likelihood of coming into contact with someone with HCV.

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Non-Injectable Drugs with Sex HCV transmission can occur due to the sharing of intranasal straws or pipes, but using substances during sex might also decrease one’s inhibitions and lead to more risk taking than usual. Additionally, some substances, such as poppers, may increase bleeding, while others, like ketamine, might numb you to feeling any discomfort or tearing during anal sex.

with HCV will clear the virus naturally in the first six months. awareness and reducing the risk of blood-to-blood contact during sex will reduce your risk for sexual transmission of HCV. Check out the fact sheet on this page for tips and techniques for reducing your risk of sexual transmission of HCV.

Conclusions We hope this helps to clarify the confusing topic of sexual transmission of HCV. There’s a lot to it and it’s a subject that continues to evolve. If you are HIV negative, your risk of sexual transmission is relatively low. If you are living with HIV, the risk is higher,

especially among gay men who have condomless anal sex, engage in fisting, or use non-injection drugs during sex (among other risk factors). The takeaway message is to increase your awareness of HCV as a potentially sexually transmitted disease, and to engage in risk-reduction practices to minimize the risk. And of course, talk to your medical provider and screen for it at least annually, and maybe more frequently if your risk factors warrant it.

References at positivelyaware.com.

Higher risk HCV exposures suggesting more frequent screening (every 3–6 months) for MSM living with HIV Persons who share injection drug equipment (syringes, cookers, cotton, water, etc.).

How to reduce your risk for hepatitis C These tips are geared toward HIV-positive gay men, but the risk reduction tips and activities are applicable to anyone with concerns about sexual transmission of HCV.

Persons who share noninjection drug use equipment (straws and pipes), especially when used with sex.

1. Test for HCV routinely.

7. Take a break from anal play.

2. Talk to your partner(s) about hepatitis C.

8. If you use drugs during sex, don’t share anything.

Persons who report bleeding during anal sex.

9. Screen for STDs regularly.

Persons who have sexual activities that may cause tearing or breaks that lead to bleeding, including fisting, sex toys, or multiple partners.

Testing for HCV alone is not prevention, but knowing your status so you can seek treatment and prevent transmitting it to others is very important. You should test at least once per year, but may want to consider more frequent testing depending upon your level of risk.

If he is HCV-positive, or does not know his HCV status, you might consider doing things that are less risky such as oral sex, masturbation, or wearing a condom for anal sex. Communication and awareness of your sex partner’s HCV status is especially important if you are serosorting and only having sex with other HIV-positive men.

3. Wear a condom for anal sex.

Both tops and bottoms are at increased risk for sexual transmission of HCV. Condoms can provide an effective barrier to prevent blood contact during anal sex. Use water-based lube to make sex smoother and minimize the chance for microcopic tears and bleeding.

4. Practice safer fisting.

As with anal sex, both tops and bottoms are at increased risk for sexual transmission of HCV. Check your hands for any cuts or bleeding cuticles. Wear latex gloves and change into new, unused ones for each new partner. HCV is a tough virus and can live in water for up to 21 days, so although we may not know how long it can live in lube, it’s good practice to not share lube between partners, either.

5. Sequence your sex play.

Avoid receptive anal sex after fisting or vigorous sex toy play that may have caused tearing and bleeding in the rectum, or flip and become the top for anal sex.

6. Keep your sex toys clean.

Cover your dildos and vibrators with condoms and change them for new ones with each partner. Do not use toys with more than one person before fully washing them.

If you recently had anal warts removed, or had a case of hemorrhoids, take a break from bottoming to give yourself a chance to heal. The same is true following any type of receptive anal sex, especially if you see any blood or feel any discomfort or pain.

Whether you use injectable or non-injectable drugs, don’t share anything. HCV can live on surfaces for a very long time in syringes, on surfaces, and in drug using equipment, and anything with HCV-infected blood on it can transmit the virus.

Routine screenings for STDs that can cause sores—primary syphilis, herpes, anal warts, etc.—are an important part of your sexual health. If you are sexually active, aim for STD testing every 3–6 months. Give yourself self-exams, too, and check for any sores (especially if you have a history of herpes or anal warts). If you see something, check with your medical provider or go to an STD clinic to get it checked out. If you feel any rectal discomfort or see any rectal bleeding or other discharge, do the same.

Persons who test positive for an STD.

10. Stay HIV-negative.

Persons with a history of STDs that cause a sore (such as herpes, HPV, and primary syphilis).

11. Stay HCV-negative.

Persons who don’t use, or don’t consistently use, barriers during anal sex (including gloves for fisting).

Screen routinely for HIV and know your status. If you test positive, get into care, screen for HCV, and talk about HIV care and treatment. If you test HIV negative, continue to practice safer sex and safer drug use, screen for STDs regularly, and talk to your medical provider about PrEP. If you clear HCV—either naturally or through treatment—remember that you can get re-infected with the virus if you get exposed to it again. Continue to use the practices above to stay negative, and remember: If you cleared the virus, you will always test HCV antibody positive, so your follow-up testing going forward must be viral loads to look for the virus directly.

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Persons with HIV who serosort.

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ns.

V treatment optio ore about my HI m rn lea to y ad e chos I was re essional and we y healthcare prof e it could m So I spoke to m ld to en. He rt of my HIV regim .

ISENTRES S as pa s and lifest yle may fit my need fight my HIV and time. see you next I can’t wait to

HIV Positive Model

In a clinical study lasting more than 4 years (240 weeks), patients being treated with HIV medication for the first time demonstrated that ISENTRESS® (raltegravir) plus Truvada ®:

INDICATION ISENTRESS is a prescription HIV-1 medicine used with other antiretroviral medicines to treat human immunodeficiency virus (HIV-1) infection in people 4 weeks of age and older.

HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

It is not known if ISENTRESS is safe and effective in babies under 4 weeks of age.

The use of other medicines active against HIV-1 in combination with ISENTRESS may increase your ability to fight HIV. ISENTRESS does not cure HIV-1 infection or AIDS. You must stay on continuous HIV therapy to control HIV-1 infection and decrease HIV-related illnesses.

IMPORTANT RISK INFORMATION Some people who take ISENTRESS develop serious skin reactions and allergic reactions that can be severe, and may be life-threatening or lead to death. If you develop a rash with any of the following symptoms, stop using ISENTRESS and call your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing.

Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of your skin or whites

May reduce viral load to undetectable (less than 50 copies/mL) May significantly increase CD4 cell counts ISENTRESS may not have these effects on all patients 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%). of your eyes, dark or teacolored urine, pale-colored stools (bowel movements), nausea or vomiting, loss of appetite, pain, aching or tenderness on the right side of your stomach area.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine.

People taking ISENTRESS may still develop infections or other conditions associated with HIV infections.

The most common side effects of ISENTRESS include: trouble sleeping, headache, dizziness, nausea, and tiredness. Less common side effects include: depression, hepatitis, genital herpes, herpes zoster including shingles, kidney failure, kidney stones, indigestion or stomach area pain, vomiting, suicidal thoughts and actions, and weakness.

Tell your doctor before you take ISENTRESS if you have a history of a muscle disorder called rhabdomyolysis or myopathy or increased levels of creatine kinase in your blood.

muscle problem that can lead to kidney problems.

These are not all the possible side effects of ISENTRESS. For more information, ask your doctor or pharmacists. Tell your doctor if you have any side effect that bothers you or that does not go away.

Tell your doctor about all your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. ISENTRESS is not recommended for use during pregnancy. Women with HIV should not breastfeed because their babies could be infected with HIV through their breast milk.

Tell your doctor about all the medicines you take, including: prescription medicines like rifampin (a medicine commonly used to treat tuberculosis), over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take any of these medicines: rifampin (Rifadin, Rifamate, Rifater, Rimactane), an antacid medicine that contains aluminum or magnesium, a cholesterol lowering medicine (statin), a medicine that contains fenofibrate (Antara, Lipofen, Tricor, Trilipix), gemfibrozil (Lopid), a medicine that contains zidovudine (Combivir, Retrovir, Trizivir).

ISENTRESS Chewable Tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with phenylketonuria.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call FDA at 1-800-FDA-1088.

Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be signs of a rare serious

Please read the Patient Information on the adjacent page for more detailed information.

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

Patient Information ISENTRESS ® (eye sen tris) (raltegravir) film-coated tablets Read this Patient Information before you start taking ISENTRESS and each time you get a refill.

There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is ISENTRESS? ISENTRESS is a prescription HIV medicine used with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV-1) infection in people 4 weeks of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

It is not known if ISENTRESS is safe and effective in babies under 4 weeks of age.

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”.

• increase the number of white blood cells called CD4+ (T) cells in your blood, which help fight off other infections.

• reduce the amount of HIV-1 and increase the CD4+ (T) cells in your blood, which may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

ISENTRESS does not cure HIV-1 infection or AIDS. You must stay on continuous HIV therapy to control HIV-1 infection and decrease HIV-related illnesses.

Avoid doing things that can spread HIV-1 infection to others: • Do not share needles or re-use needles or other injection equipment.

• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.

• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

Ask your doctor if you have any questions on how to prevent passing HIV to other people.

What should I tell my doctor before taking ISENTRESS? Before taking ISENTRESS, tell your doctor if you: • have liver problems • have a history of a muscle disorder called rhabdomyolysis or myopathy • have increased levels of creatine kinase in your blood • have phenylketonuria (PKU). ISENTRESS chewable tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU. • have any other medical conditions • are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your unborn baby.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral 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 part in this registry.

• are breastfeeding or plan to breastfeed. Do not breastfeed if you take ISENTRESS. ° You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. ° It is not known if ISENTRESS passes into your breast milk. ° 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-thecounter medicines, vitamins, and herbal supplements. ISENTRESS and certain other medicines may affect each other causing serious side effects. ISENTRESS may affect the way other medicines work and other medicines may affect how ISENTRESS works.

Especially tell your doctor if you take any of these medicines: • rifampin (Rifadin, Rifamate, Rifater, Rimactane) • an antacid medicine that contains aluminum or magnesium • a cholesterol lowering medicine (statin) • a medicine that contains fenofibrate (Antara, Lipofen, Tricor, Trilipix) • gemfibrozil (Lopid) • a medicine that contains zidovudine (Combivir, Retrovir, Trizivir) Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

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 without first talking with your doctor.

How should I take ISENTRESS? • Take ISENTRESS exactly as prescribed by your doctor.

• Do not change your dose of ISENTRESS or stop your treatment without talking with your doctor first.

• Stay under the care of your doctor while taking ISENTRESS. • 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 pharmacy before you run out.

• If you miss a dose, take it as soon as you remember. If you do not remember until it is 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.

• If you take too much ISENTRESS, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of ISENTRESS? ISENTRESS can cause serious side effects including: • Serious skin reactions and allergic reactions. Some people who take ISENTRESS develop serious skin reactions and allergic reactions that can be severe, and may be life-threatening or lead to death. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: ° fever ° muscle or joint aches ° redness or swelling of the eyes ° generally ill feeling ° blisters or sores in mouth ° swelling of the mouth or face ° extreme tiredness ° blisters or peeling of the skin ° problems breathing Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor right away if you have any of the following signs or symptoms of liver problems: ° yellowing of the skin or whites of your eyes ° dark or tea colored urine ° pale colored stools (bowel movements) ° nausea or vomiting ° loss of appetite ° pain, aching, or tenderness on the right side of your stomach area • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine.

The most common side effects of ISENTRESS include: • trouble sleeping • nausea • headache • tiredness • dizziness Less common side effects include: • depression • kidney stones • hepatitis • indigestion or stomach area pain • genital herpes • vomiting • herpes zoster • suicidal thoughts and actions including shingles • weakness • kidney failure Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. These may be signs of a rare serious muscle problem that can lead to kidney problems.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ISENTRESS. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ISENTRESS? Film-Coated Tablets: • Store ISENTRESS Film-Coated Tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep ISENTRESS and all medicines out of the reach of children.

General information about ISENTRESS 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.

Do not give ISENTRESS to other people, even if they have the same symptoms you have.

It may harm them.

You can ask your doctor or pharmacist for information about ISENTRESS that is written for health professionals.

For more information go to www.ISENTRESS.com or call 1-800-622-4477.

What are the ingredients in ISENTRESS? ISENTRESS film-coated tablets: Active ingredient: raltegravir Inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate.

The film coating contains: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA Revised December 2013 USPPI-MK0518-MF-1312R025

Black, gifted, and whole The story of a fallen figure in the fight against HIV continues to affect us

By Keith R. Green

Former PA Associate Editor LeRoy Whitfield

At the National Minority AIDS Council’s recent United States Conference on AIDS in San Diego this past October, a powerful session entitled “Black, Gifted, and Whole,” explored the intergenerational impact of the HIV/AIDS epidemic through the lens of three gifted African American same-gender loving men. Keith Green, MSW, community advocate and doctoral student at the University of Chicago School of Social Service Administration; David Malebranche, MD, MPH, primary care physician at University of Pennsylvania Student Health Services; and Leo Moore, MD, clinical scholar with the Robert Wood Johnson Foundation shared their own personal narratives combined with song and a riveting spoken word performance. Following is an excerpt that we thought would be fitting in commemoration of Positively Aware’s 25th year.

I first met AIDS commentator LeRoy Whitfield in the early ’90s,

Photo: Jason smith

when I was just a junior in high school. His younger brother Crofton and I were crushing on one another, but neither of us knew how to express it.

So instead we just hung out, doing things that other boys our age were doing with girls.

At the time, I was working at a Subway sandwich shop that’s just around the corner from where I currently live in Chicago, in the same neighborhood where LeRoy had lived back in the day.

I remember receiving a call from Crofton one afternoon while I was at work. I could tell from the tone in his voice that something was bothering him, but he hesitated a

while before getting to the point.

Eventually, he told me that he was spending the weekend with Roy and that they had run out of money for food. I would later learn that his deeply religious mother had actually put him out when she discovered that he was gay, just as she had done with LeRoy many years before.

Me, being the broke working teenager

I was, certainly didn’t have any money to offer them. But I was standing over a trough of lunchmeat and veggies, so I invited them up to the restaurant to take advantage of my “employee” discount.

And that was the first time I met LeRoy Whitfield. I had no idea at the time how important he was to the AIDS movement.

In fact, I didn’t even know that an AIDS movement was underway.

About 10 years after our first meeting, I stumbled upon LeRoy’s writings while doing research for an article that I was working on for Positively Aware. His words drew me in immediately, and I soon found myself on a quest to get my hands on everything that he had written.

Diagnosed with HIV at the age of 19, LeRoy remained relatively healthy for many years and his writings chronicled his journey through life with the virus. A conspiracy theorist in every sense of the term, LeRoy was critical of the U.S. healthcare system overall and particularly skeptical of the emerging science of antiretrovirals. He wrote candidly about his personal struggles with whether or not to take them, given some of the side effects that many of his friends and readers were experiencing.

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Keith Green at the United States Conference on AIDS.

Oddly enough, I was actually living on the other side of a very similar struggle. I had been diagnosed with HIV in my senior year of high school, which was actually the year after I first met LeRoy. I was put on a very early regimen of AZT, 3TC, and DDI, and I had firsthand experience with many of the side effects that LeRoy described in his writings. Those drugs made me feel miserable, so I vowed at the time that if my chances of surviving HIV were slim anyway, I wasn’t going to spend the rest of my days feeling miserable. So I stopped taking them.

Eight years later, I found myself with 30 T-cells and almost as many options for combating the disease. The science of antiretrovirals had evolved in such a way that people were in fact beginning to live “normal, healthy lives” with HIV, with minimal side effects.

So what exactly was LeRoy’s beef, I remember asking myself as I tried to make sense of his musings.

I still get chills when I think about our last conversation. About two years after I started working for Positively Aware, in the exact same position that LeRoy once held, he walked into a support group that I was co-facilitating at TPAN, the agency that produces this magazine. He told the group that his decision to avoid antiretrovirals was beginning to catch up with him physically, but that he found himself tripped up by

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his own words. His T-cells were declining rapidly and his viral load continued to rise.

By taking meds, however, he somehow felt that he would be going against everything that his writings stood for and that he was ultimately letting his readers and community down. He struggled to separate his personal decisions from the professional personality that he had become.

In many respects, LeRoy’s struggles with antiretrovirals are reflective of an entire generation’s journey with these new developments, including my own. We were made aware of the side effects of the first generation of HIV medications from the first generation to be affected by HIV, the baby boomers. In addition to the horror stories of constant nausea and uncontrollable diarrhea, more visible effects such as facial wasting and the “buffalo hump” served to further stigmatize us men and women who were attempting to survive. And because these medications were so new, no one had any idea how the side effects would evolve over time. As a result, many of us opted out for as long as we could; a decision that resulted in death for far too many people, perhaps unnecessarily.

It is important to acknowledge then, that the decisions we make today about antiretrovirals are deeply rooted in a rather rich and complicated historical context.

Despite the mounting evidence of the

benefits of these drugs, and the remarkable scientific strides that have made them less toxic and easier to take, the ghosts of our past still haunt us. Our sometimes hostile and imbalanced relationship with healthcare in this country still haunts us.

Extended bellies and sunken cheeks still haunt us. Rejection from our loved ones still haunts us. Religious rhetoric of AIDS as God’s curse for being faggots and whoremongers still haunts us.

As Black gay men who have committed our lives to healing our communities and eradicating the horrors of HIV from them, it is nearly impossible to separate these ghosts from the practicalities of the work at hand. For us, this isn’t an anthropological expedition of a “hard to reach” population or an opportunity for academic promotion because the funding stream was right.

When we leave our offices and shut off our computers to go home, there is no magical button that turns off our blackness or sexual orientation. This is who we are.

Whether we’re HIV-positive or not, these are in fact our own lives that we are saving. Racing against time and AIDS to avoid becoming known as a group of people who once were.

Editor’s note: LeRoy Whitfield died in

New York City in 2005 at the age of 36, of AIDS-related complications.

A NEW Triple threat against the Virus The latest three-in-one pill, Triumeq, includes a newer integrase that doesn’t require boosting

T

By Enid Vázquez

he eagerly awaited single tablet HIV regimen Triumeq, formerly known as 572-Trii, or simply Trii (pronounced “try”), was approved by the Food and Drug Administration (FDA) in August. The new medication brings with it potency and convenience, with high tolerability and a high barrier to drug resistance—meaning that it can be expected to do right by patients for a long, long time.

Triumeq consists of an HIV medication that’s been beating the competition, and it brings back a by-and-large discarded backbone drug, allowing for new options. It’s the fourth HIV pill on the market that consists of a complete daily treatment combination, joining the single tablet regimens (STRs) Atripla, Complera, and Stribild. And it’s the first and only STR to not contain tenofovir and emtricitabine, the component drugs which make up Truvada.

INSTI power There are three medications in Triumeq: dolutegravir, abacavir, and lamivudine (3TC).

The primary drug in Triumeq (pronounced TRY-oo-mek) is dolutegravir, from the drug class known as integrase strand transfer inhibitor (INSTI, or “integrase inhibitor”). Since the arrival of the first INSTI, raltegravir (Isentress), in 2007, the drug class has excelled with high potency against the virus along with high tolerability.

“I think that Trii represents the continued evolution of HIV treatments which are highly effective, very well tolerated, and simple to take,” wrote HIV specialist Dr. Benjamin Young, MD, PhD, for TheBody.com, upon the FDA approval. “Integrase inhibitors, in my opinion, really are becoming the new standard of care, having shown superiority to previous standards like efavirenz

[Sustiva, found in Atripla] or boosted PIs [protease inihibitors].”

The entire INSTI class did so well that in October of last year, dolutegravir (available by itself under the brand name Tivicay) and elvitegravir (Vitekta, see page 8, available in combination with three other drugs under the brand name Stribild) were added alongside raltegravir (Isentress) to the list of “recommended” drugs for first-time HIV therapy in the U.S. Department of Health and Human Services (DHHS) guidelines, because they had shown either non-inferiority or superiority to other recommended combinations.

No other drug class has all of its available medications on the recommended list.

As a second-generation INSTI, dolutegravir works for some people whose virus has developed drug resistance to raltegravir or elvitegravir, depending on the level of resistance. Furthermore, in people taking dolutegravir for their first HIV treatment, the development of drug resistance has so far not been seen.

In the SINGLE study, which was used to win FDA approval, the drug combination contained in Triumeq was found to be superior to that in the top-selling STR Atripla.

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An important difference with Triumeq is that it is the first STR to use an abacavir/3TC backbone instead of tenofovir/FTC.

discontinuations because of side effects with Atripla. That’s not such a small consideration, as HIV therapy continues to leave behind the days when people had to put up with side effects in order to fight the virus.

Superiority continued to be shown in nearly three years of data from this study, presented in September at ICAAC (see page 11 for more from this conference). The large study had nearly 420 individuals on each of the two regimens being compared, with 71% of the dolutegravir group having undetectable viral load (less than 50 copies) vs. 63% of the efavirenz (Atripla) folks. Efficacy was about the same whether people started out with a high viral load of more than 100,000 or with less than that.

Note, however, that the study used a strict standard of double-blind and doubledummy pills, meaning that participants were not given the easier-to-take STR. In this study, everyone took three pills (either Tivicay, Epzicom, and a placebo or Sustiva, Truvada, and a placebo). They didn’t know what they were given. People can expect to do better in the real world with the convenience of an STR. Still, the study was in people taking HIV therapy for the first time, and they tend to do best on treatment.

In addition, a bioequivalence study submitted to the FDA showed that using Triumeq was equivalent to taking its three components separately.

The FLAMINGO study found dolutegravir plus a background drug of choice (abacavir/3TC or TDF/FTC) superior to Norvir-boosted Prezista plus the background drug, also due to better tolerability.

(Go to positivelyaware.com/2013/13-07/ ICAAC-2013.shtml.)

INSTI vs. INSTI Dolutegravir has also been studied head-to-head with raltegravir, along with whatever backbone drugs patients and their doctors decided to use. It again proved to be non-inferior, also in a treatment-naïve population.

In the SAILING study, however, treatment-experienced patients did better with dolutegravir than raltegravir, as long as they didn’t already have INSTI

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drug-resistant virus and used an optimized background of medications. At 48 weeks, 71% of the dolutegravir patients vs. 64% of the raltegravir ones had undetectable viral loads. There were about 350 individuals in each group in this large study.

At the international AIDS conference in Melbourne in July, researchers reported that no development of drug resistance was seen in the 32 people in SAILING taking dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs, such as abacavir, tenofovir, 3TC, and FTC).

However, for those on raltegravir plus one or two NRTIs, drug resistance developed in 7/32 individuals (22%). “In the SAILING study of patients failing therapy with at least 2-class resistance, there was no evidence of an increased risk of virologic failure for subjects receiving DTG + 2 NRTIs, even in the presence of NRTI-resistance,” the researchers said in their conclusion.

“Further studies and longer follow-up are planned to confirm these findings.”

Raltegravir is dosed twice daily and must be taken with other medications. On the other hand, it has been a popular drug to add when people need to switch their HIV treatment.

Stribild has also shown non-inferiority to Atripla. Unlike Stribild (see page 8), Triumeq doesn’t contain a booster medication. The booster cobicistat (Tybost) in Stribild, used to raise blood levels of elvitegravir, is associated with many drug interactions.

The return of abacavir An important difference with Triumeq is that it is the first STR to use an abacavair/3TC backbone instead of tenofovir/FTC. Tenofovir/FTC (Truvada) is a part of all the other STRs and used in about 80% of HIV drug regimens in the U.S. Both backbone medications have their potential problems.

Epzicom is made up of Ziagen (abacavir) and Epivir (lamivudine, or 3TC). The reason for using them in Triumeq is easy to see— ViiV Healthcare makes all three medications.

Truvada was able to outdistance Epzicom in the marketplace for several

reasons. First, there was the severe allergic reaction to abacavir that caused a few deaths when it came on the market. That all went away once and for all with a simple genetic blood test that predicts who would have the allergic reaction. It’s inexpensive—about $150, although the drug maker might pay for it if insurance doesn’t.

Today anyone planning to take an abacavircontaining regimen must first test negative for a genetic marker, the HLA-B*5701 allele.

Nevertheless, the drug labels states that anyone exhibiting signs of an allergic reaction after taking an abacavir-containing medication (Epzicom, Ziagen, Trizivir, or Triumeq) must stop taking the medication, although some experts would prefer to consult with their patient immediately.

Then a large head-to-head study by the AIDS Clinical Trials Group (ACTG) found that Epzicom was inferior to Truvada in people with viral loads above 100,000 who were taking the drugs with either efavirenz (Sustiva) or atazanavir/ritonavir (Reyataz/ Norvir). However, this problem was not seen when dolutegravir was taken with abacavir and 3TC. A ViiV-sponsored review of several studies that used abacavir and 3TC in people with high viral loads found no difference compared to the people in the studies who had less than 100,000 viral load. However, the ACTG study was larger and had a greater number of patients with high viral loads, making it a more powerful study than the company analysis.

Finally, the possibility of heart problems with abacavir is still unclear. Different observational studies have shown conflicting results about whether or not abacavir can contribute to heart problems. For now, providers pay extra attention to abacavir patients who have other contributing factors (such as a family history of heart attack or a high cholesterol level), and the guidelines recommend avoiding prescribing an abacavir-containing regimen to patients with multiple cardiac risk factors from the get go. Read more about the topic at positivelyaware.com/ziagen.

Truvada is comprised of tenofovir DF (Viread) and emtricitabine (or FTC, brand name Emtriva). Tenofovir DF may cause kidney damage and decrease bone mineral

density (BMD), making Triumeq an especially welcome option for people who have, or who develop, these problems. On the other hand, a new and improved version of tenofovir DF that has a smaller risk for these complications, tenofovir alafenamide (TAF), is in development.

The FTC in Truvada and the 3TC in Epzicom are virtual twins; they are both very tolerable drugs.

Add a pill Although all of the STRs are taken only once a day, some people who’ve already taken HIV therapy and developed drug resistance may not be able to take Triumeq by itself. The good news is that for people who don’t fall into this group, development of drug resistance with Triumeq has not been seen.

Those individuals, however, who have already been on HIV therapy and whose virus has developed drug resistance, particularly to raltegravir or elvitegravir (Isentress and Vitekta or Stribild), won’t be able to take Triumeq by itself.

For Triumeq, this means that at the least, individuals with INSTI resistance will need to have a Tivicay pill added to their daily regimen, so that they are taking a twice-daily dose of dolutegravir. An extra dose means extra cost and inconvenience.

Some HIV researchers, however, expect that people with INSTI resistance substitutions won’t be able to use Triumeq by itself even with the extra Tivicay dose, because of the likelihood of additional drug resistance in these treatment-experienced individuals. It’s likely that people with this type of resistance will need to take other HIV medications in addition, depending on their drug resistance profile.

More information Of note, both abacavir and 3TC are available as generics here in the U.S. This leads to the possibility that some insurers will make patients take the three drugs separately in order to save money. This hurts the convenience aspect of Triumeq and may increase the risk of missing doses

(Actual size)

Triumeq

(pronounced TRY-oo-mek)

It’s the fourth HIV pill that is a single tablet regimen (STR), providing a complete daily treatment combination.

Triumeq is the first and only STR that does not contain tenofovir and emtricitabine, the component drugs which make up Truvada. Triumeq is the first STR to use an abacavair/3TC backbone instead of tenofovir/FTC. The primary drug in Triumeq is dolutegravir, from the drug class known as integrase strand transfer inhibitor (INSTI, or “integrase inhibitor”). All INSTIs are recommended drugs for first-time therapy by the DHHS. As a second-generation INSTI, dolutegravir works for some people whose virus has developed drug resistance to other INSTIs. In people who take dolutegravir as their first HIV treatment, development of drug resistance has not been seen so far.

Some people who’ve already taken HIV therapy and developed drug resistance may not be able to take Triumeq by itself.

Abacavir and 3TC are available as generics here in the U.S. This leads to the possibility that some insurers will make patients take the three drugs separately in order to save money.

Average wholesale price (AWP):

$2,649 for 30 days.

(non-adherence). Cost is important: the average wholesale price (AWP) for Triumeq is $2,649 for 30 days. That’s less than Stribild ($2,949) and more than Atripla ($2,462) and Complera ($2,463).

The only known drug contraindication (do not take with) is dofetilide (Tikosyn), an antiarrhythmic medication for abnormal heart rhythm. There are other drug interactions (see the Positively Aware Annual HIV Drug Guide at positivelyaware.com/ drugguide).

Because 3TC has an anti-hep B effect, patients should be checked for the presence of hepatitis B. When stopping Triumeq, they could experience a flare-up of the hep B due to the withdrawal of the 3TC. (This is the same with the other STRs, as the tenofovir DF and the FTC in those drugs also have anti-hep B activity.) It’s not a good idea, however, for someone with hep B to take a drug like Triumeq that only has one medication treating hep B. Grade 2–4 (mild to moderate) adverse reactions occurring in 2% or more participants taking dolutegavir in the SINGLE study at 96 weeks (data for the FDA approval) were insomnia (3%), headache (2%), and fatigue (2%).

A pediatric sprinkle formulation of Tivicay is being studied. For now, Triumeq can be given to patients ages 18 and up.

All in all, Triumeq brings with it options, and that’s always a good thing.

“There’s a growing recognition, based on multiple clinical trials, that starting therapy with integrase inhibitors may be the best way to go for most people, and there are now two integrase inhibitor-based STRs to choose from: Stribild and Triumeq. Both are excellent choices,” wrote HIV specialist Joel Gallant, MD, MPH, for TheBody. com. “Stribild has the advantage of being combined with tenofovir/emtricitabine, which has been our nucleoside backbone of choice for many years based on potency and tolerability. Triumeq has fewer drug interactions, a higher barrier to resistance, and is an option for people who can’t take tenofovir. With the approval of Triumeq, an even great number of HIV-positive people will be candidates for easy single-tablet regimens.”

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“I fought for my country.

Now Iʼ m bringing the fight to my HIV.” Reggie - Atlanta, GA Living with HIV since 1985.

As a military guy, I know how to follow orders. So when my doctor told me to start and stay in treatment, I listened. Now my treatment regimen is part of my life. That means I take my pills, I keep my medical appointments, I stay connected to support groups and I keep up with the latest education.

Treatment works for me, and now I show other veterans who are HIV-positive how it can work for them.

HIV

TREATMENT

WORKS

Get in care. Stay in care. Live well. cdc.gov/HIVTreatmentWorks

My Kind of life Carlos A. Perez

A Day with a little HIV history

42

I now work as a Medical Case people with HIV live under the Manager in a busy clinic where I get radar, don’t get tested, stay on the the opportunity to work with my down low, or stay high all day is community, one-on-one, providing because of the bang-up job that case management services. I feel our religion, society, and governlucky to be in this position. I stay ment did to scare us into believing in touch with over 80 HIV-positive their HIV propaganda. What I find patients and it helps to keep me most interesting is that since the on top of my own health care and, Reagan days, more Republicans therefore, I’m very good at being have been busted in one way or sympathetic because I can actually another for being latent homos sympathize. themselves than Democrats, many It’s a sad shame that on this of whom have been quoted in Day with HIV we still have tragic public speeches demeaning LGBT HIV statistics. I blame this on our people and dare to say whether government and society. By 1982 we should or should not get margay men, IV drug users, and hemoried. I always wonder where they philiacs were dropping like flies get their guts. and on October 15, 1982 during a A Day with HIV tells me that press briefing White House Press we still have many hurdles to Secretary Larry Speakes had a jump. We now need funding for ball joking about AIDS, and the programs more than ever because 8:45 AM: Chicago fact that neither he nor President there’s no money left for people Carlos Perez: Off to work on a Tuesday with HIV. Reagan had any “personal experiliving with HIV and AIDS when our ence” with AIDS. Instead of requesting a full investigaeconomic interests are not really based on our citizens. tion from the CDC and every major U.S. city hospital that The fight for HIV and AIDS is far from over, and will was packed with AIDS patients, he poked fun at people continue to be as long as we as a society continue to let who were suffering. this disease be treated differently from others simply Finally on September 17, 1985 President Reagan, because of how it’s transmitted. If HIV would’ve been looking very stressed and pressured, painfully utters the discovered under a not-so-hostile and fearful administraacronym AIDS. The five or so years he and his administion, we may not have needed so many disclosure and tration let this disease continue to cause death and pain confidentiality laws and we certainly may have not needand go unnoticed by their own effort to keep it in the ed criminal transmission of HIV laws altogether, because closet speaks to the shame and stigma that we still feel perhaps people with HIV would have felt more normal by today. This is one of the toughest barriers people with simply having a disease. Every day people in this country HIV have; this shame and stigma paralyzes much of our transmit diseases such as syphilis and tuberculosis, and community. people die of these diseases every year and these peoThe religious fanatics also had a field day trying to ple, some of whom may transmit their illness knowingly, prove to the world that people with HIV were dirty, are not treated like criminals. I believe the same respect shameful, and subhuman. The reason why so many should be given to people living with HIV and AIDS.

P O S I T I V E LY AWA R E

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Photo: CHRIS KNIGHT

A Day with HIV tells me that we still have many hurdles to jump.

The fight for HIV and AIDS is far from over, and will continue to be as long as we as a society continue to let this disease be treated differently from others simply because of how it’s transmitted.

A

nother day with HIV is another day that I can wake up with my husband on a lazy Sunday morning, sit together sipping coffee and be grateful that we’re still together after 18 years. It’s also a wonderful thing because we’re still serodiscordant. On Mondays I go to work, full-time, like everyone else, after being on Social Security disability income for nearly a decade, because through my volunteering efforts I found a new career in HIV. That which made me ill has healed me!

+ SNAPSHOTS OF LIFE WITH HIV A DAY WITH HIV

By Rick Guasco

O

n 9/9/2014, people in 13 countries on four continents snapped their photos during the same 24-hour period for A Day with HIV, Positively Aware’s anti-stigma campaign.

Begun in 2010, A Day with HIV makes the point that, regardless of their status, everyone everywhere is affected by HIV. By getting people to take their picture on the same day, the campaign turns everyday snapshots into a real-time photo album of life with HIV. This year, A Day with HIV partnered with the Centers for Disease Control and Prevention, joining forces with Act Against AIDS and the CDC’s Let’s Stop HIV Together campaign. Olympic diver Greg Louganis and HIV blogger/educator Mark S. King, both featured in the CDC’s campaign, were among the judges who helped select the four covers of this issue of Positively Aware from among the photos submitted.

In this day of social media, many of the more than 300 pictures submitted were selfies, some of which were posted on Facebook, Instagram, and Twitter with the hashtag #adaywithhiv.

“Today I learned that someone near and dear to me is living with HIV,” said Mario Montalvo, who posted his picture, taken on the campus of Texas Christian University, to Instagram. “By coincidence, today happens to be #adaywithhiv, so here is my selfie.”

More a self-portrait than a selfie, Jason Daisey shared his story: “I was confirmed positive just one week ago,” his caption read. “It was a scary week, but I won’t let it change my life for the worse. My center and balance point is being in the barn with my horses. I’m a professional guy, the kind that no one ever would think would get diagnosed with HIV. Now’s my time to use my uniqueness to educate other gay men about how real this really is.”

Underscoring how HIV affects people in many ways, some pictures honored friends

and loved ones living with HIV. “I’m not HIV-positive, but my best friend is,” said Carmen Garcia. “I support her on anything and everything. I’m proud to say it has been 17 years for her. She’s still here with us—with her kids and two dogs. She lives her life pretty well.”

A number of photos confronted stigma head on, such as the picture of Reverend Andrena Ingram wearing a t-shirt that states, I’m not ‘infected’ with HIV. I’m ‘living’ with HIV! Stop the stigma! “Two persons whom I knew asked me about my shirt,” Rev. Ingram added in her caption. “Others glanced at my shirt, at my face, and then turned away. Infection can be a stigmatizing word; living is not. We are living with HIV!” A good number of organizations and groups got into the picture, too.

Many of our colleagues at the HIV news website TheBody.com took part; notably, editor Myles Helfland snapped a selfie with Warren Tong as they covered the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C. Staff members of AIDS Athens, the AIDS Clinical Trials Group (ACTG), and the San Francisco AIDS Foundation, among others, also submitted photos. BOOM! Health in Brooklyn made a day of it, submitting dozens of photos. Students at Duke University’s HIV narratives class posted their own group and individual pictures on Instagram and Twitter.

A Day with HIV has grown beyond one day out of the year. Through the

13 countries on four continents are represented this year for A Day with HIV: AUSTRALIA BRAZIL CANADA DENMARK GERMANY GUATEMALA HOLLAND ITALY SPAIN TRINIDAD UNITED KINGDOM UNITED STATES VENEZUELA

campaign’s collaboration with the CDC, an exhibit of photos from A Day with HIV 2013 has been traveling throughout the country to such events as the Chicago convention of the National Lesbian and Gay Journalists Association (NLGJA) and the Positive Women’s Network-USA Leadership Summit in Florida. A selection of this year’s photos will be added to the exhibit. Pictures will also be posted on Instagram and Twitter throughout the year ahead accompanied by the #adaywithhiv hashtag. On A Day with HIV, everyday pictures reveal that there are no ordinary lives.

A six-page special section of images begins on page 48.

View the complete gallery of pictures taken on a day with HIv AT Adaywithhiv.com.

1:31 PM: New York City

Jeffrey Newman: Always thankful. Always keeping the faith. (Taken at the exact time I was born 47 years ago this month.)

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What is STRIBILD? STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. It combines 4 medicines into 1 pill to be taken once a day with food. STRIBILD is a complete single-tablet regimen and should not be used with other HIV-1 medicines.

STRIBILD does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking STRIBILD. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids.

Never reuse or share needles or other items that have body fluids on them.

IMPORTANT SAFETY INFORMATION What is the most important information I should know about STRIBILD?

• Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking STRIBILD, your hepatitis may suddenly get worse. Do not stop taking STRIBILD without first talking to your healthcare provider, as they will need to monitor your health. STRIBILD is not approved for the treatment of HBV.

Who should not take STRIBILD? Do not take STRIBILD if you: • Take a medicine that contains: alfuzosin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil when used for lung problems (Revatio®), triazolam, oral midazolam, rifampin or the herb St. John’s wort.

• For a list of brand names for these medicines, please see the Brief Summary on the following pages.

• Take any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera®).

What are the other possible side effects of STRIBILD?

STRIBILD can cause serious side effects:

Serious side effects of STRIBILD may also include:

• Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.

• New or worse kidney problems, including kidney failure. Your healthcare provider should do regular blood and urine tests to check your kidneys before and during treatment with STRIBILD. If you develop kidney problems, your healthcare provider may tell you to stop taking STRIBILD.

• Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain.

• You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking STRIBILD for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.

• Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.

• Changes in body fat can happen in people taking HIV-1 medicines.

• Changes in your immune system.

Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking STRIBILD. The most common side effects of STRIBILD include nausea and diarrhea.

Tell your healthcare provider if you have any side effects that bother you or don’t go away.

What should I tell my healthcare provider before taking STRIBILD? • All your health problems. Be sure to tell your healthcare provider if you have or had any kidney, bone, or liver problems, including hepatitis virus infection.

• All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking STRIBILD without first talking with your healthcare provider.

• If you take hormone-based birth control (pills, patches, rings, shots, etc).

• If you take antacids. Take antacids at least 2 hours before or after you take STRIBILD. • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed.

HIV-1 can be passed to the baby in breast milk.

Also, some medicines in STRIBILD can pass into breast milk, and it is not known if this can harm the baby.

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 Brief Summary of full Prescribing Information with important warnings on the following pages.

STRIBILD is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD does not cure HIV-1 or AIDS.

I started my personal revolution Talk to your healthcare provider about starting treatment.

STRIBILD is a complete HIV-1 treatment in 1 pill, once a day.

Ask if it’s right for you.

Patient Information STRIBILD® (STRY-bild) (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) tablets Brief summary of full Prescribing Information. For more information, please see the full Prescribing Information, including Patient Information.

What is STRIBILD? • STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD is a complete regimen and should not be used with other HIV-1 medicines.

• STRIBILD does not cure HIV-1 or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses.

• Ask your healthcare provider about how to prevent passing HIV-1 to others. Do not share or reuse needles, injection equipment, or personal items that can have blood or body fluids on them. Do not have sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

What is the most important information I should know about STRIBILD? STRIBILD can cause serious side effects, including: 1. Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take STRIBILD or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis: • feel very weak or tired • have unusual (not normal) muscle pain • have trouble breathing • have stomach pain with nausea or vomiting • feel cold, especially in your arms and legs • feel dizzy or lightheaded • have a fast or irregular heartbeat 2. Severe liver problems. Severe liver problems can happen in people who take STRIBILD. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems: • your skin or the white part of your eyes turns yellow (jaundice) • dark “tea-colored” urine • light-colored bowel movements (stools) • loss of appetite for several days or longer • nausea • stomach pain You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking STRIBILD for a long time.

3. Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) infection and take STRIBILD, your HBV may get worse (flare-up) if you stop taking STRIBILD. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

• Do not run out of STRIBILD. Refill your prescription or talk to your healthcare provider before your STRIBILD is all gone

• Do not stop taking STRIBILD without first talking to your healthcare provider • If you stop taking STRIBILD, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking STRIBILD Who should not take STRIBILD? Do not take STRIBILD if you also take a medicine that contains: • adefovir (Hepsera®) • alfuzosin hydrochloride (Uroxatral®) • cisapride (Propulsid®, Propulsid Quicksolv®) • ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, Migranal®), ergotamine tartrate (Cafergot®, Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, Wigrettes®), and methylergonovine maleate (Ergotrate®, Methergine®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • oral midazolam • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil (Revatio®), when used for treating lung problems • simvastatin (Simcor®, Vytorin®, Zocor®) • triazolam (Halcion®) • the herb St. John’s wort Do not take STRIBILD if you also take any other HIV-1 medicines, including: • Other medicines that contain tenofovir (Atripla®, Complera®, Viread®, Truvada®) • Other medicines that contain emtricitabine, lamivudine, or ritonavir (Atripla®, Combivir®, Complera®, Emtriva®, Epivir® or Epivir-HBV®, Epzicom®, Kaletra®, Norvir®, Trizivir®, Truvada®) STRIBILD is not for use in people who are less than 18 years old.

What are the possible side effects of STRIBILD? STRIBILD may cause the following serious side effects: • See “What is the most important information I should know about STRIBILD?” • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking STRIBILD. Your healthcare provider may tell you to stop taking STRIBILD if you develop new or worse kidney problems.

• Bone problems can happen in some people who take STRIBILD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones.

• Changes in body fat can happen in people who take HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen. The exact cause and long-term health effects of these conditions are not known.

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.

The most common side effects of STRIBILD include: • Nausea • Diarrhea Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

• These are not all the possible side effects of STRIBILD. For more information, ask your healthcare provider.

• Call your healthcare provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my healthcare provider before taking STRIBILD? Tell your healthcare provider about all your medical conditions, including: • If you have or had any kidney, bone, or liver problems, including hepatitis B infection • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. - There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

• If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you take STRIBILD. - You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

- Two of the medicines in STRIBILD can pass to your baby in your breast milk. It is not known if the other medicines in STRIBILD can pass into your breast milk.

- Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements: • STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works.

• Be sure to tell your healthcare provider if you take any of the following medicines: - Hormone-based birth control (pills, patches, rings, shots, etc) - Antacid medicines that contain aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take STRIBILD - Medicines to treat depression, organ transplant rejection, or high blood pressure - amiodarone (Cordarone®, Pacerone®) - atorvastatin (Lipitor®, Caduet®) - bepridil hydrochloride (Vascor®, Bepadin®) - bosentan (Tracleer®) - buspirone - carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) - clarithromycin (Biaxin®, Prevpac®) - clonazepam (Klonopin®) - clorazepate (Gen-xene®, Tranxene®) - colchicine (Colcrys®) - medicines that contain dexamethasone - diazepam (Valium®)

- digoxin (Lanoxin®) - disopyramide (Norpace®) - estazolam - ethosuximide (Zarontin®) - flecainide (Tambocor®) - flurazepam - fluticasone (Flovent®, Flonase®, Flovent® Diskus®, Flovent® HFA, Veramyst®) - itraconazole (Sporanox®) - ketoconazole (Nizoral®) - lidocaine (Xylocaine®) - mexiletine - oxcarbazepine (Trileptal®) - perphenazine - phenobarbital (Luminal®) - phenytoin (Dilantin®, Phenytek®) - propafenone (Rythmol®) - quinidine (Neudexta®) - rifabutin (Mycobutin®) - rifapentine (Priftin®) - risperidone (Risperdal®, Risperdal Consta®) - salmeterol (Serevent®) or salmeterol when taken in combination with fluticasone (Advair Diskus®, Advair HFA®) - sildenafil (Viagra®), tadalafil (Cialis®) or vardenafil (Levitra®, Staxyn®), for the treatment of erectile dysfunction (ED). If you get dizzy or faint (low blood pressure), have vision changes or have an erection that last longer than 4 hours, call your healthcare provider or get medical help right away.

- tadalafil (Adcirca®), for the treatment of pulmonary arterial hypertension - telithromycin (Ketek®) - thioridazine - voriconazole (Vfend®) - warfarin (Coumadin®, Jantoven®) - zolpidem (Ambien®, Edlular®, Intermezzo®, Zolpimist®) Know the medicines you take. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Do not start any new medicines while you are taking STRIBILD without first talking with your healthcare provider.

Keep STRIBILD and all medicines out of reach of children.

This Brief Summary summarizes the most important information about STRIBILD. If you would like more information, talk with your healthcare provider. You can also ask your healthcare provider or pharmacist for information about STRIBILD that is written for health professionals, or call 1-800-445-3235 or go to www.STRIBILD.com.

Issued: October 2013

COMPLERA, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein are the property of their respective owners. © 2014 Gilead Sciences, Inc. All rights reserved. STBC0096 10/14

+ A DAY WITH HIV 7:20 AM: SAN FRANCISCO

Calvin Johnson: Walking to work after hanging out with my friends for our daily talk over coffee. I was diagnosed at the age of 56 in May 2013. I’ve heard it said that, “every day is a gift.”

For this old dog, it’s very true.

7:24 AM: UNITED STATES

Byron: I am a 36-year-old father with three beautiful, amazing kids. I’ve been HIV-positive for over 10 years, undetectable. Who knew I would be happy with my partner and having three kids? I had thought being positive was the end of my life.

11:15 AM: DURHAM, NORTH CAROLINA

Eric Evans (right): Attending the AIDS United Conference for Southern States, with Dorian Alexander, Chair of the Louisiana AIDS Advocacy Network. Together, we’re continuing to learn how to be better advocates for Louisiana.

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9:30 AM: TEXAS

Morénike Giwa Onaiwu: The course of my life changed forever when my family became affected by HIV in 2007. Rather than disclosing specifically who is positive in our family, we have chosen to identify as an HIV-affected family. We feel that it doesn’t matter if we publicly state exactly which one(s) of us are HIV-positive or HIV-negative because we’re all in this together.

1:00 PM: São Paulo, BRAZIL

Leonardo Melo: Mais um sobrevivente, tamo junto! Another survivor, we are united!

1:23 PM: San Francisco

San Francisco AIDS Foundation: A day in the life of our front desk volunteer Davin Coffey, greeting those who come in to get tested for HIV and STIs at our gay men’s health clinic in the heart of the Castro.

10:45 AM: Portland, Oregon 9:30 AM: Georgia

Michelle Turner: Children with HIV are often overlooked for adoption or fostering. Breaking the stigma so that all children can be loved, cherished, accepted, and adored!

1:32 PM: ROME, ITALY

Stephen J. Lewis (via Twitter): Supporting #hiv awareness on #adaywithhiv with a picture from the Gallery of Maps in the Vatican.

9:30 AM: DURHAM, NORTH CAROLINA

Caitlin Margaret Kelly: Learning from HIV narratives at Duke University in Global Narratives in HIV class.

1:45 PM: Parkersburg, West virginia

Dustin Stollings: I just turned 24. I was diagnosed with HIV 17 months ago. I’m sitting in my doctor’s office getting refills for my antiretrovirals and getting routine lab work done. It’s a little ironic that my doctor’s appointment fell on the same day as the fifth annual A Day With HIV. It made me smile.

Rob McElroy: Diagnosed in 1990, I have spent the last 24 years making good on my decision to live. At 45 years old, I am in the best shape of my life, thanks to being active and optimistic, groundbreaking meds, informative literature, supportive friends, and good doctors.

2:00 PM: Orlando, Florida

Harry Wingfield: My work in the AIDS Clinical Trials Group from 1999–2002 helped me change careers and start working in research administration after 12 years on disability. I started off as the regulatory coordinator for the 1917 HIV research clinic at the University of Alabama at Birmingham; I work at the IRB (institutional review board) level. This photo shows me at my desk in my current job as the IRB manager for the Orlando Regional Medical Center in Florida. My AIDS diagnosis came in 1990, and I am still here.

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+ A DAY WITH HIV 2:45 PM: New York City

2:03 PM: Washington, D.C.

Beck Mason: On the steps of the Lincoln Memorial! Perfection.

3:30 PM: PLYMOUTH, ENGLAND

Kevin Kelland: At Plymouth Museum.

I feel so fortunate to still be here after living with HIV for 28 years. I am now on a combination of HIV drugs and heart medication. I feel great. I have been with my partner Steve for nearly 10 years.

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Jack R. Miller: I’m a long-term survivor of HIV, over 20 years. I’m living life to the fullest: healthy, smart, and drama free! Just like a carnival, colorful and bright!

3:30 PM: Milwaukee, Wisconsin

Patti Morchinek: My family. Connection gives purpose and meaning to our lives.

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2:51 PM: London, ENGLAND

Anthony Babajee: At Parliament Hill, one of the best views of London. I hope you like the @KeithHaring top too.

3:30 PM: Seattle, Washington

Barb Cardell: An amazing day of training on GIPA (Greater Involvement of People Living with HIV/AIDS) and the Denver Principles with @Aspield, Seattle, Washington, where we were doing a positive leadership training with Lifelong, representing the U.S. People Living with HIV caucus.

3:o0 PM: Navajo reservation

Lorne James: I’d like to introduce myself in our language: Yá’át’ééh (hello) shik’éí dóó shidine’é (my family and my people, friends). Shí éí Lorne James yinishyé (I am called Lorne James). I am ‘Áshiihí (Salt People) and born for Kinyaa’áanii (Towering House People). Ákót’éego diné nishł (I am a Navajo male). In this picture I am displaying an artist’s piece at an auction. I tested HIV-positive in December 2006 and have been undetectable as of July 2014.

3:30 PM: Harlem, New York

Angela Louis: Living my life day by day. Undetectable and healthy. No shame. Life is beautiful, and so am I.

3:00 PM: Dallas, North Carolina

@USMCDevil (via Twitter): Celebrating #adaywithhiv. Just passed my math final exam. Feeling blessed with my #HappyBuddha.

4:05 PM: Atlanta, Georgia

Jay McMinn: I took a selfie with my friend and colleague Sherri-Ann, who coordinates our company’s volunteers for AIDS Walk Atlanta & 5K Run. She uses a week of vacation time to be onsite and help set up for the Walk. Sherri and I picture a day without HIV, and continue fighting until then.

3:13 PM: West Bromwich, England

Luke Alexander: Found my column in The Gay Times while shopping at Asda!

4:22 PM: Atlanta, Georgia

David Salyer: My 21st anniversary of living with HIV came around in June of 2014. I’m hangin’ in there. Music keeps me sane, so you’ll regularly find me listening to my iPod. As the Pet Shop Boys once declared, “Music is our life’s foundation and shall succeed all the nations to come.”

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+ A DAY WITH HIV 5:30 PM: Washington, D.C.

5:20 PM: Guatemala City, Guatemala

Juan Carlos: I am HIV-positive. In Guatemala, as in many countries of Latin America, it is a huge stigma, and the risk of losing your job continues.

6:37 PM: TRinidad & TOBAGO, WEST INDIES

Tyker Pionero: Photo of my mom and me about to dance. I have learned to cherish the little things after losing people I knew and loved to this virus, so when I get the opportunity to steal a dance with her, I do. Much love from Trinidad and Tobago.

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@squinty1 (via Instagram): I felt sick today and left work early to go to an urgent care facility. I went to the gym instead (I know; you can fuss at me later, LOL). Next year will mark 10 years living with HIV. I’ve worked in the HIV prevention field since 2007. I have good days and not-so-good days. Today wasn’t the best day, but I’m stubborn and won’t let illness get me down!

I’m determined to live long, live strong, and live happily!

7:01 PM: Durham, North carolina

Quang N. Nguyen: I have been fascinated by HIV and emotionally moved by narratives of people living with HIV/AIDS. With the goal of developing a maternal and infant vaccine against HIV, I have contributed to a research study examining the protective immune factors in natural hosts of simian immunodeficiency virus (SIV) in African green monkeys.

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8:00 PM: Arizona

5:38 PM: Washington, D.C.

Noël Gordon (left): My colleague Marcos Garcia and I are committed to ending the HIV/AIDS epidemic. We represent the changing face of the epidemic, and as such, we think it is our responsibility to raise awareness of the needs of young gay and bisexual men of color wherever we go.

@larathefarmerswife (via Instagram): I asked Mary what she wants people to know about living with HIV. She says, “The most important thing for people to know is they can’t get HIV just by touching someone. I was sick from HIV, but God saved me with medicine. I still have HIV, but I’m alive and not sick.”

6:20 PM: Maryland

5:50 PM: West virginia

Barbara Lagodna: At age 60, running keeps me healthy and fit!

10:20 PM: The Bronx, New York

Jason Daisey: I was confirmed positive just one week ago. It was a scary week, but I won’t let it change my life for the worse. My center and balance point is being in the barn with my horses. I’m a professional guy, the kind that no one ever would think would get diagnosed with HIV. Now’s my time to use my uniqueness to educate other gay men about how real this really is.

Susanna Feder: After a New York Yankees win over Boston. Excited with a good friend and showing off my dress at the subway stop. You can see the lights of NYC and the Freedom Tower in the background. Being a part of life, not afraid to enjoy every minute.

6:30 PM: Connecticut

Jonathan-Joseph Ganjian: In addition to being a philanthropic consultant, I’m a painter. As a positive artist, I use painting to give voice to emotions otherwise unexplored, often related to my status. This is my Day with HIV.

10:30 PM: Santa Rosa, California

Ayrick Broin: I was diagnosed with HIV in 1999 and AIDS in late 2000. None of the medications worked for me up until recently. Thanks to my wonderful doctor and his nursing team, I’m back on the stage in California’s wine country. Life is a Cabaret!

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COMPLERA is a prescription medicine for adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood. COMPLERA can also replace current HIV-1 medicines for some adults who have an undetectable viral load (less than 50 copies/mL) and whose healthcare provider determines that they meet certain other requirements. COMPLERA combines 3 medicines into 1 pill to be taken once a day with food. COMPLERA should not be used with other HIV-1 medicines.

Just the

one

for me

COMPLERA is a complete HIV-1 treatment in only 1 pill a day.

Ask your healthcare provider if COMPLERA may be the one for you.

Pill shown is not actual size.

COMPLERA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking COMPLERA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids.

Never reuse or share needles or other items that have body fluids on them.

It is not known if COMPLERA is safe and effective in children under 18 years old.

IMPORTANT SAFETY INFORMATION What is the most important information I should know about COMPLERA? COMPLERA can cause serious side effects: • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.

• Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain.

• You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.

• Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking COMPLERA, your hepatitis may suddenly get worse. Do not stop taking COMPLERA without first talking to your healthcare provider, as they will need to monitor your health. COMPLERA is not approved for the treatment of HBV.

Who should not take COMPLERA? Do not take COMPLERA if you: • Take a medicine that contains: adefovir (Hepsera), lamivudine (EpivirHBV), carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek), rifampin (Rifater, Rifamate, Rimactane, Rifadin), rifapentine (Priftin), dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), pantoprazole sodium (Protonix), rabeprazole (Aciphex), more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate, or the herbal supplement St. John’s wort.

• Take any other medicines to treat HIV-1 infection, unless recommended by your healthcare provider.

What are the other possible side effects of COMPLERA? Serious side effects of COMPLERA may also include: • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood tests to check your kidneys before 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.

Changes in liver enzymes: People who have had hepatitis B or C, or who have had changes in their liver function tests in the past may have an increased risk for liver problems while taking COMPLERA. Some people without prior liver disease may also be at risk. Your healthcare provider may do tests to check your liver enzymes before and during treatment with COMPLERA. • Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.

• Changes in body fat can happen in people taking HIV-1 medicines.

• Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking COMPLERA. •

The most common side effects of COMPLERA include trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression. Other common side effects include vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), and pain. Tell your healthcare provider if you have any side effects that bother you or do not go away.

What should I tell my healthcare provider before taking COMPLERA? All your health problems. Be sure to tell your healthcare provider if you have or had any kidney, mental health, bone, or liver problems, including hepatitis virus infection.

• All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking COMPLERA without first talking with your healthcare provider.

• If you take rifabutin (Mycobutin). Talk to your healthcare provider about the right amount of rilpivirine (Edurant) you should take.

• If you take antacids. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA. • If you take stomach acid blockers. Take acid blockers at least 12 hours before or at least 4 hours after you take COMPLERA. Ask your healthcare provider if your acid blocker is okay to take, as some acid blockers should never be taken with COMPLERA. • If you are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking COMPLERA. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. Also, some medicines in COMPLERA can pass into breast milk, and it is not known if this can harm the baby.

•

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 Brief Summary of full Prescribing Information with important warnings on the following pages.

Brief Summary of full Prescribing Information COMPLERA® (kom-PLEH-rah) (emtricitabine 200 mg, rilpivirine 25 mg, tenofovir disoproxil fumarate 300 mg) tablets Brief summary of full Prescribing Information. For more information, please see the full Prescribing Information, including Patient Information.

What is COMPLERA? • COMPLERA is a prescription medicine used as a complete HIV-1 treatment in one pill a day. COMPLERA is for adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood (this is called ‘viral load’). Complera can also replace current HIV-1 medicines for some adults who have an undetectable viral load (less than 50 copies/mL) and whose healthcare provider determines that they meet certain other requirements.

• COMPLERA is a complete regimen and should not be used with other HIV-1 medicines. HIV-1 is the virus that causes AIDS. When used properly, COMPLERA may reduce the amount of HIV-1 virus in your blood and increase the amount of CD4 T-cells, which may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak.

• COMPLERA does not cure HIV-1 or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses.

• Ask your healthcare provider about how to prevent passing HIV-1 to others. Do not share or reuse needles, injection equipment, or personal items that can have blood or body fluids on them. Do not have sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

What is the most important information I should know about COMPLERA? COMPLERA can cause serious side effects, including: • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis: – feel very weak or tired – have unusual (not normal) muscle pain – have trouble breathing – having stomach pain with nausea or vomiting – feel cold, especially in your arms and legs – feel dizzy or lightheaded – have a fast or irregular heartbeat • Severe liver problems. Severe liver problems can happen in people who take COMPLERA. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems: – your skin or the white part of your eyes turns yellow (jaundice) – dark “tea-colored” urine – light-colored bowel movements (stools) – loss of appetite for several days or longer – nausea – stomach pain

• You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time.

• Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) infection and take COMPLERA, your HBV may get worse (flare-up) if you stop taking COMPLERA. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV with your healthcare provider.

– Do not run out of COMPLERA. Refill your prescription or talk to your healthcare provider before your COMPLERA is all gone.

– Do not stop taking COMPLERA without first talking to your healthcare provider.

– If you stop taking COMPLERA, your healthcare provider will need to check your health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking COMPLERA. Who should not take COMPLERA? Do not take COMPLERA if you also take any of the following medicines: • Medicines used for seizures: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine (Trileptal); phenobarbital (Luminal); phenytoin (Dilantin, Dilantin-125, Phenytek) • Medicines used for tuberculosis: rifampin (Rifater, Rifamate, Rimactane, Rifadin); rifapentine (Priftin) • Certain medicines used to block stomach acid called proton pump inhibitors (PPIs): dexlansoprazole (Dexilant); esomeprazole (Nexium, Vimovo); lansoprazole (Prevacid); omeprazole (Prilosec, Zegerid); pantoprazole sodium (Protonix); rabeprazole (Aciphex) • Certain steroid medicines: More than 1 dose of dexamethasone or dexamethasone sodium phosphate • Certain herbal supplements: St. John’s wort • Certain hepatitis medicines: adefovir (Hepsera), lamivudine (Epivir-HBV) Do not take COMPLERA if you also take any other HIV-1 medicines, including: • Other medicines that contain tenofovir (ATRIPLA, STRIBILD, TRUVADA, VIREAD) • Other medicines that contain emtricitabine or lamivudine (ATRIPLA, Combivir, EMTRIVA, Epivir, Epzicom, STRIBILD, Trizivir, TRUVADA) • rilpivirine (Edurant), unless you are also taking rifabutin (Mycobutin) COMPLERA is not for use in people who are less than 18 years old.

What are the possible side effects of COMPLERA? COMPLERA may cause the following serious side effects: • See “What is the most important information I should know about COMPLERA?” • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking COMPLERA. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your 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 • Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an

increased risk of developing new or worsening liver problems during treatment with COMPLERA. Liver problems can also happen during treatment with COMPLERA in people without a history of liver disease.

Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with COMPLERA. • Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones.

• Changes in body fat can happen in people taking HIV-1 medicine.

These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen.

The cause and long term health effect of these conditions are not known.

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having any new symptoms after starting your HIV-1 medicine.

The most common side effects of COMPLERA include: • Trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, depression Additional common side effects include: • Vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

• These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider.

• Call your healthcare provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my healthcare provider before taking COMPLERA? Tell your healthcare provider about all your medical conditions, including: • If you have or had any kidney, mental health, bone, or liver problems, including hepatitis B or C infection.

• If you are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child.

– There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

• If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you take COMPLERA. – You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

– Two of the medicines in COMPLERA can pass to your baby in your breast milk. It is not known if this could harm your baby.

– Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements: • COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works.

• If you take certain medicines with COMPLERA, the amount of COMPLERA in your body may be too low and it may not work to help control your HIV-1 infection. The HIV-1 virus in your body may become resistant to COMPLERA or other HIV-1 medicines that are like it.

• Be sure to tell your healthcare provider if you take any of the following medicines: – Rifabutin (Mycobutin), a medicine to treat some bacterial infections.

Talk to your healthcare provider about the right amount of rilpivirine (Edurant) you should take.

– Antacid medicines that contain aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA. – Certain medicines to block the acid in your stomach, including cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine hydrochloride (Zantac). Take the acid blocker at least 12 hours before or at least 4 hours after you take COMPLERA. Some acid blocking medicines should never be taken with COMPLERA (see “Who should not take COMPLERA?” for a list of these medicines).

– Medicines that can affect how your kidneys work, including acyclovir (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), valacyclovir (Valtrex), and valganciclovir (Valcyte).

– clarithromycin (Biaxin) – erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone) – fluconazole (Diflucan) – itraconazole (Sporanox) – ketoconazole (Nizoral) – methadone (Dolophine) – posaconazole (Noxafil) – telithromycin (Ketek) – voriconazole (Vfend) Know the medicines you take. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Do not start any new medicines while you are taking COMPLERA without first talking with your healthcare provider.

How should I take COMPLERA? • Stay under the care of your healthcare provider during treatment with COMPLERA. • Take COMPLERA exactly as your healthcare provider tells you to take it.

• Always take COMPLERA with food. Taking COMPLERA with food is important to help get the right amount of medicine in your body. A protein drink is not a substitute for food. If your healthcare provider decides to stop COMPLERA and you are switched to new medicines to treat HIV-1 that includes rilpivirine tablets, the rilpivirine tablets should be taken only with a meal.

Keep COMPLERA and all medicines out of reach of children.

This Brief Summary summarizes the most important information about COMPLERA. If you would like more information, talk with your healthcare provider. You can also ask your healthcare provider or pharmacist for information about COMPLERA that is written for health professionals, or call 1-800-445-3235 or go to www.COMPLERA.com.

Issued: June 2014

COMPLERA, the COMPLERA Logo, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, TRUVADA, VIREAD, and VISTIDE are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein are the property of their respective owners. ©2014 Gilead Sciences, Inc. All rights reserved. CPAC0115 08/14

WE KNOW

HIV/AIDS MEDICATION THERAPY

But we also know you prefer pedaling over pumping gas.

Welcome to a pharmacy that gets to know you, not just your diagnosis. We’re not just treating HIV patients, we’re getting to know individuals.

So no matter the level of support, guidance and confidentiality you prefer, we’re here for you.

©2013 Walgreen Co. All rights reserved.

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