A SMART+STRONG PUBLICATION JULY/AUGUST 2018 POZ.COM $3.99
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Involuntary Separation HIV discrimination at the Peace Corps
Romany Tin
What is BIKTARVY®? BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults. It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.
IMPORTANT SAFETY INFORMATION What is the most important information I should know about BIKTARVY? BIKTARVY may cause serious side effects: � Worsening of hepatitis B (HBV) infection. If you have both HIV-1 and HBV and stop taking BIKTARVY, your HBV may suddenly get worse. Do not stop taking BIKTARVY without first talking to your healthcare provider, as they will need to monitor your health.
Who should not take BIKTARVY? Do not take BIKTARVY if you take: � dofetilide � rifampin � any other medicines to treat HIV-1
What are the other possible side effects of BIKTARVY? Serious side effects of BIKTARVY may also include: � 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 BIKTARVY. � Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking BIKTARVY. � Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death.
Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. � Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. The most common side effects of BIKTARVY in clinical studies were diarrhea (6%), nausea (5%), and headache (5%). 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 BIKTARVY? � All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney or liver problems, including hepatitis virus infection. � All the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements. BIKTARVY and other medicines may affect each other. Keep a list of all your medicines and show it to your healthcare provider and pharmacist, and ask if it is safe to take BIKTARVY with all of your other medicines. � If you are pregnant or plan to become pregnant. It is not known if BIKTARVY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking BIKTARVY. � If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.
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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.
Ask your healthcare provider if BIKTARVY is right for you.
Please see Important Facts about BIKTARVY, including important warnings, on the following page.
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Get HIV support by downloading a free app at MyDailyCharge.com
KEEP SHINING. Because HIV doesn’t change who you are. BIKTARVY is a 1-pill, once-a-day complete HIV-1 treatment for adults who are either new to treatment or whose healthcare provider determines they can replace their current HIV-1 medicines with BIKTARVY.
BIKTARVY does not cure HIV-1 or AIDS.
BIKTARVY.COM
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IMPORTANT FACTS
This is only a brief summary of important information about BIKTARVY® and does not replace talking to your healthcare provider about your condition and your treatment.
(bik-TAR-vee) MOST IMPORTANT INFORMATION ABOUT BIKTARVY BIKTARVY may cause serious side effects, including: • Worsening of hepatitis B (HBV) infection. If you have both HIV-1 and HBV, your HBV may suddenly get worse if you stop taking BIKTARVY. Do not stop taking BIKTARVY without first talking to your healthcare provider, as they will need to check your health regularly for several months.
ABOUT BIKTARVY BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults. It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS. Do NOT take BIKTARVY if you also take a medicine that contains: • dofetilide • rifampin • any other medicines to treat HIV-1
BEFORE TAKING BIKTARVY Tell your healthcare provider all your medical conditions, including if you: • Have or have had any kidney or liver problems, including hepatitis infection. • Are pregnant or plan to become pregnant. • Are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Tell your healthcare provider about all the medicines you take: • Keep a list that includes all prescription and over-thecounter medicines, antacids, laxatives, vitamins, and herbal supplements, and show it to your healthcare provider and pharmacist. • Ask your healthcare provider or pharmacist about medicines that interact with BIKTARVY.
POSSIBLE SIDE EFFECTS OF BIKTARVY BIKTARVY can cause serious side effects, including: • Those in the “Most Important Information About BIKTARVY” section. • Changes in your immune system. • New or worse kidney problems, including kidney failure. • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. • The most common side effects of BIKTARVY in clinical studies were diarrhea (6%), nausea (5%), and headache (5%). These are not all the possible side effects of BIKTARVY. Tell your healthcare provider right away if you have any new symptoms while taking BIKTARVY. Your healthcare provider will need to do tests to monitor your health before and during treatment with BIKTARVY.
HOW TO TAKE BIKTARVY Take BIKTARVY 1 time each day with or without food.
GET MORE INFORMATION • This is only a brief summary of important information about BIKTARVY. Talk to your healthcare provider or pharmacist to learn more. • Go to BIKTARVY.com or call 1-800-GILEAD-5. • If you need help paying for your medicine, visit BIKTARVY.com for program information.
BIKTARVY, the BIKTARVY Logo, DAILY CHARGE, the DAILY CHARGE Logo, LOVE WHAT’S INSIDE, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. Version date: February 2018 © 2018 Gilead Sciences, Inc. All rights reserved. GILC0396 04/18
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CONTENTS
EXCLUSIVELY ON Nelson Vergel pushes for the development of new salvage therapies.
POZ.COM #ADVOCACY MAKE A DIFFERENCE Fighting against HIV/AIDS has always been a struggle. Much work remains to be done to achieve the end of the epidemic. POZ encourages you to get involved in advocacy. Go to poz.com/advocacy for the latest related news and to learn how you can make a difference in the fight.
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POZ BLOGS
COVER: ARI MICHELSON; THIS PAGE: (VERGEL) LYNN LANE; (GAVEL/BOOKS AND MEGAPHONE) ISTOCK; (SPEECH BUBBLES) THINKSTOCK
PERSONAL PERSPECTIVES Our roster of bloggers spans the diversity of the HIV/AIDS epidemic. Go to poz.com/blogs to read varying points of view from people living with the virus, as well as from HIV-negative advocates. Join the conversation in the comments section. Find hope and inspiration from others.
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POZ OPINIONS COMMENTARY ON HIV/AIDS Advocates, researchers, politicians, thought leaders and folks just like you all have ideas worth sharing. Go to poz.com/opinions to read about topics such as living with HIV, improving care and treatment, increasing prevention efforts and fighting for social justice.
30 INVOLUNTARY SEPARATIONS HIV policies at the Peace Corps come under fire. BY LUCILE SCOTT 36 COINFECTION CONNECTION Curing hepatitis C is a priority for people also living with HIV. BY BENJAMIN RYAN
4 FROM THE EDITOR
16 EVERYDAY
I Want a New Drug
Milestones in the epidemic
6 POZ Q+A
18 SPOTLIGHT The buzz on “the 7,000”
POZ DIGITAL
Carl W. Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Disease, on U=U and the latest HIV research
READ THE PRINT MAGAZINE ON YOUR COMPUTER OR TABLET
8 POZ PLANET Summer HIV-related reads include poems, memoirs and iconic artists lost to AIDS • are you #ACApositive? • how to get a free 30-day journal kit
14 VOICES
Go to poz.com/digital to view the current issue and the entire Smart + Strong digital library.
The International AIDS Society spells out its 2018 goals in advance of the 22nd International AIDS Conference. And in an excerpt from “HIV-Free Generation in Striking Distance, but Not for All,” Chad Hendry and Liz Thompson of Howard Brown Health in Chicago unpack concerns about recent statistics.
20 CARE AND TREATMENT Diabetes is on the rise • cut-price HIV meds • menopause means worse pain and fatigue • treat acute hep C earlier
25 RESEARCH NOTES How common are HIV strains that are resistant to PrEP? • Sustiva associated with higher risk of suicidal behaviors • the ethics of cure studies that stop treatment • trends in the annual HIV rate
4O POZ HEROES Long-term survivor Nelson Vergel once advocated for steroids to counter HIVrelated wasting. Today, he focuses on the importance of salvage therapies for those who develop multidrug resistance.
POZ (ISSN 1075-5705) is published monthly except for the January/February, April/May, July/August and October/November issues ($19.97 for an 8-issue subscription) by Smart + Strong, 212 West 35th Street, 8th Floor, New York, NY 10001. Periodicals postage paid at New York, NY, and additional mailing offices. Issue No. 229. POSTMASTER: Send address changes to POZ, 212 West 35th Street, 8th Floor, New York, NY 10001. Copyright © 2018 CDM Publishing, LLC. All rights reserved. No part of this publication may be reproduced, stored in any retrieval system or transmitted, in any form by any means, electronic, mechanical, photocopying, recording or otherwise without the written permission of the publisher. Smart + Strong® and POZ® are registered trademarks of CDM Publishing, LLC.
FROM THE EDITOR
I Want a New Drug
4 POZ JULY/AUGUST 2018 poz.com
ORIOL R. GUTIERREZ JR. MANAGING EDITOR
JENNIFER MORTON DEPUTY EDITOR
TRENT STRAUBE SENIOR EDITOR
KATE FERGUSON-WATSON EDITOR-AT-LARGE
BENJAMIN RYAN COPY CHIEF
JOE MEJÍA
EDITORIAL ASSISTANT
ALICIA GREEN ART DIRECTOR
DORIOT KIM
ART PRODUCTION MANAGER
MICHAEL HALLIDAY
point: “Undetectable = Untransmittable,” or “U=U.” When viral load is undetectable, there is effectively no risk of HIV transmission. The U=U message is rooted in the idea of treatment as prevention, which has been around a long time. However, the concept picked up steam in the last few years as more and more studies confirmed the message. Then, in 2016, the Prevention Access Campaign, headed by Bruce Richman, began advocating for U=U nationwide and around the world. Early U=U supporters were crucial to the success of the campaign. Carl W. Dieffenbach, PhD, is one of them. He is the director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases. Go to page 6 to read about his thoughts on U=U and to get the latest updates on HIV research. About 25 percent of Americans living with HIV also have hepatitis C virus (HCV). As a result, POZ has regularly reported on HCV through the years. The introduction of easier hep C cures in recent years has only increased reader interest for HCV coverage. Now that people living with both HIV and HCV can get cured of the latter virus, we wanted to do a deep dive on all the related effects. Go to page 36 to read more.
CONTRIBUTING WRITERS
SHAWN DECKER, OLIVIA G. FORD, AUNDARAY GUESS, CASEY HALTER, MARK S. KING, ROD MCCULLOM, TIM MURPHY CONTRIBUTING ARTISTS
JOAN LOBIS BROWN, LIZ DEFRAIN, JONATHAN TIMMES, TOKY, BILL WADMAN FOUNDER
SEAN STRUB LEGACY ADVISER
MEGAN STRUB
ADVISORY BOARD
A. CORNELIUS BAKER, GUILLERMO CHACÓN, KATHIE HIERS, TIM HORN, PAUL KAWATA, NAINA KHANNA, DAVID MUNAR, DANIEL TIETZ, MITCHELL WARREN, PHILL WILSON PRESS REQUESTS
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Want to read more from Oriol? Follow him on Twitter @oriolgutierrez and check out blogs.poz.com/oriol.
(GUTIERREZ) JOAN LOBIS BROWN; (ILLUSTRATION) ISTOCK
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OFTEN LOOK TO PAST ISSUES of POZ when I’m planning future coverage. Many of the challenges we face today in fighting HIV have been around for a long time, which means POZ has probably covered any given subject. What I’m mostly looking for is how the subjects have evolved over the years. If enough has changed, then perhaps it’s time to revisit a topic. This treatmentthemed special issue of POZ spotlights several issues that merited another look. Ten years ago, Jeremiah Johnson was featured on our cover. When he tested HIV positive during his time as a volunteer in the Peace Corps, the organization dismissed him. He fought back, and, as a result, the Peace Corps changed its policies to accommodate volunteers living with HIV. That experience led Jeremiah down the path of activism. He’s currently the community engagement coordinator for Treatment Action Group. He’s also a founding member of the direct action group Rise and Resist. And, it turns out, he’s once again advocating for change at the Peace Corps. Our current cover guy, Romany Tin, also was dismissed from his post as a Peace Corps volunteer after testing HIV positive. After an online search, Romany found media coverage of Jeremiah’s Peace Corps ordeal, including our cover story. Consequently, Romany contacted Jeremiah for help, which Jeremiah was glad to offer. Although it’s true that the Peace Corps has many programs that benefit people living with HIV, when it comes to dealing with its volunteers, another storyline unfolds. Go to page 30 to read more about how Romany and others are fighting HIV discrimination in the Peace Corps. Effective HIV treatment is a major reason why a decade ago the Peace Corps made accommodations for those living with the virus. The benefits of treatment have only increased since then. Case in
EDITOR-IN-CHIEF
Let their courage encourage you Let’s Grow Old Together Your status is part of your story, but you are much more than your diagnosis.
Watch how others found the strength to share their HIV diagnosis at Walgreens.com/LetsGrowOldTogether.
Š2018 Walgreen Co. All rights reserved.
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POZ Q+A
BY ORIOL R. GUTIERREZ JR.
The first vaccination of HVTN 702 at the Verulam Clinic in Durban, South Africa
VIRAL BASICS
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ARL W. DIEFFENBACH, PHD, IS DIRECTOR OF THE DIVISION OF AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). He oversees a staff of more than 150 federal employees and a global HIV research portfolio of more than $1 billion. Dieffenbach is responsible for managing DAIDS programs, which include basic laboratory research and clinical trials to develop therapies to treat HIV and related infections and diseases, as well as to develop vaccines, microbicides and other HIV prevention strategies. He has restructured the DAIDS-supported clinical trials research network and has fostered collaboration across agencies and sectors. Dieffenbach became DAIDS director in 2008. Previously, he was director of the DAIDS Basic Sciences Program since 1996. He joined DAIDS in 1992 as chief of the preclinical therapeutics group.
Tell us about the role of DAIDS and its scientific programs.
Think about the unanswered questions about HIV today. What does it take to get a safe, effective and durable HIV vaccine? What does it take to cure HIV infection? What is it we don’t understand about why there is residual immune activation after effective HIV therapy? Those are the types of primary questions that DAIDS is supporting research to address domestically and internationally. The Basic Sciences Program is somewhat self-explanatory. What does HIV do, and how does it do it? How does the virus hijack the human immune system? What is happening with HIV at the atomic, macromolecular, cellular and tissue level, as well as the population level? We’re looking at what is happening at a mechanistic
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level as HIV interacts with the body. The Therapeutics Research Program, the Vaccine Research Program and the Prevention Sciences Program tackle each of those areas in a similar manner. The vaccine and prevention programs evaluate the same populations, but they differ in the types of clinical trials that get done. In the vaccine work, you’re doing a lot of immunology. In the prevention work, you’re looking at infection. Where possible, the two groups collaborate. Where they work together beautifully is on the evaluation of broadly neutralizing monoclonal antibodies. What we’re doing collectively as a field is producing these antibodies in a way that they can be used as medications, which is challenging. What are the remaining questions to be answered for a cure and, in the meantime, for improved treatments?
Let’s look at where we are now. The HIV replication cycle was delineated in the 1980s and ’90s. That led us to the key enzymes—reverse transcriptase, protease
COURTESY OF NIAID
Understanding the importance of basic HIV research and clinical trials—and the benefits of being undetectable
and integrase—and to the entry process, which uses CD4 and CCR5 receptors [to allow HIV to enter a cell]. Those are the targets for current HIV drugs, which are highly effective. Here’s the last big related unanswered question: How do we deal with a provirus [a virus that is integrated into a host cell’s DNA]? Why can we cure hepatitis C virus (HCV) today? The primary reason is that HCV does not integrate into the host genome ever. The hep C drugs are effective in stopping replication. The difference with HIV is that essentially it becomes a gene in the human genome. That is the source of all things related to latency [where the virus lies dormant] and what we still need to understand. How does HIV actually lie dormant, what does it take to reactivate it and what does it take to prevent the virus from causing disease if you stop therapy? As for treatment, it’s so much safer and easier than it was two decades ago. We’ve gone from a high pill burden to one pill a day. Now it’s a matter of improv ing adherence. Can we evolve therapy so there are long-acting formulations? Can we have combinations of drugs and monoclonal antibodies that continue to improve safety?
COURTESY OF DAIDS
In addition to keeping people healthy, an undetectable viral load means having effectively no risk of transmitting the virus. Since 2016 the “Undetectable = Untransmittable” campaign, or U=U, has promoted this message. Why were you an early supporter of U=U?
The concept of treatment as prevention has been around for a long time. However, over the first decade of this century there were studies that made an even stronger case. The HPTN 052 study sought to demonstrate the extent to which full virologic suppression could prevent HIV transmission. While there were transmissions in the 052 study, we were able to demonstrate that the HI V-positive partner who transmitted the virus in every case had a detectable viral load. This was the first strong evidence that durable suppression to the point of having an undetectable viral load could prevent infections. As more data over the years came out,
it became clear that being undetectable meant the risk of transmission was negligible to a point where it was not worth worrying about. Bruce Richman, founder of Prevention Access Campaign, which promotes the U=U message, understood the importance of these data. He believed that people could help fight HIV stigma with this information. They could live without this cloud over them that they’re putting people at risk for falling in love. To me, U=U is a strong way of helping the community to come together. It also helps us move down the road toward a point of equality for people who are HIV positive. There are people who continue to say that statistically there still could be some transmissions, but even these individuals acknowledge that the fact is
social science research so that we can attack these problems together. As a result, I feel comfortable talking about the social impacts of HIV because we approach this internally as an integrated strategy to help improve our approach to adherence, for example. That’s where the belief in supporting long-acting formulations comes from. Long-acting formulations don’t solve the adherence problem, but they do change the problem into a more manageable one. That, I think, is something people need to acknowledge. Where are we with vaccine research?
When we started with this research, we had a series of vaccines with no efficacy and even a vaccine that actually caused harm. Then the RV144 trial, which was
“What does it take to
Carl Dieffenbach
get a safe, effective and durable HIV vaccine? What does it take to cure HIV?”
that we have observed no transmissions from those who are undetectable. It’s interesting to hear you, a scientist, discuss the social impact of data.
I am a trained biomedical scientist, not a behavioral scientist, but I realize that with HIV you can’t make progress on your own on the biomedical side without understanding the behavioral and social science side of this equation. A strength of NIH is the National Institute of Mental Health (NIMH), which is highly engaged in the behavioral and social science side of HIV. To enhance our effectiveness, NIAID and NIMH have co-located our two AIDS divisions within the same space. My next door neighbor at work is the director of the NIMH Division of AIDS. We’ve put together the best biomedical research with the best behavioral and
31 percent efficacious, made us all ask if we could get to 50 percent. That rate in statistical modeling has the potential for profound impact on the epidemic when combined with things like adult medical male circumcision, plus treatment as prevention and rollout of pre-exposure prophylaxis. The result is that we now have, for the first time in the history of HIV vaccine research, two test-of-concept trials going on in sub-Saharan Africa. One is a trial called HV TN 702, which is a modified version of the RV144 trial that showed such promise. The other is called the Imbokodo trial. We’ll see if either of them hit the 50 to 70 percent efficacy that we’re seeking. If we got a vaccine that had at least 50 percent efficacy, we could then build a better mousetrap, so to speak. To me, this is an exciting time. Q
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POZ PLANET BY TRENT STRAUBE
SUMMER READS Whether you’re sunning on the beach or snuggling in bed, these books will shine through the whole season.
Heroes: A Tribute Three years ago, for a DIFFA: Design Industries Foundation Fighting AIDS fundraiser, artist and designer Doug Meyer created 19 sculptures representing creative icons lost to AIDS. He then expanded it to a series of 50 three-dimensional portraits—composed of plastic, paint, terra-cotta, papier-mâché and other materials and accompanied by text about each person’s life and legacy—that toured the country. Now comes a fabulous coffee-table book that pays homage to these amazing heroes, including Leigh Bowery (on the cover), Freddie Mercury, Tina Chow, Keith Haring, Halston, Klaus Nomi and Derek Jarman (pictured in the spread above).
I Want Your Love by Richard Renaldi Portrait photographer Richard Renaldi turned 50 this year, and lucky for us, he has been snapping images of his life for four of those decades. Spanning 1970s Illinois to 1990s New York and beyond, this collection of photos and written vignettes gives us intimate (and often erotic) glimpses of Renaldi as he discovers his sexuality, comes out to his mom, tests positive for HIV, transforms himself with steroids and bodybuilding, and meets a long-term partner. In his welldocumented life, there’s lots to love.
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(HEROES) TRA PUBLISHING; (I WANT YOUR LOVE) SUPER LABO; (SHELLS) ISTOCK
by Doug Meyer
(ONE LIFE AT A TIME) SKYHORSE PUBLISHING; (SWEET DREAMS) BELLADONNA; (DON’T CALL US DEAD) GRAYWOLF PRESS; (THE ESSENTIAL RANDY BOYD) AMAZON DIGITAL SERVICES; (PUNISHING DISEASE) UNIVERSITY OF CALIFORNIA PRESS; (EMERGE) CREATESPACE; (BE SAFE) BLACK ROSE WRITING
MEMOIR In One Life at a Time, AIDS doctor Daniel Baxter recounts his time with HIV patients in Botswana and New York, sharing life lessons and insightful comparisons on cultures and medical systems. In the slender and conversational Sweet Dreams, Pamela Sneed recalls the experiences and people (including Annie Lennox, as alluded to in the book’s title) that transformed her into a Black lesbian writer and activist. POETRY At once succinct and nimble, Danez Smith says so much about being gay, Black and HIV positive in the astonishing Don’t Call Us Dead. Also covering the AfricanAmerican queer experience but in a more expansive style, spoken-word artist Mary Bowman documents her continued journey to a better life in the aptly titled Emerge. NONFICTION Trevor Hoppe explores HIV criminalization and the impulse to blame, shame and ultimately imprison people who have an infectious illness in Punishing Disease. Journalist and long-term survivor Randy Boyd covers race, homophobia, HIV stigma and Magic Johnson in his collection The Essential Randy Boyd. FICTION If you’re jonesing for something edgier and less conventional— think William Burroughs or Charles Bukowski—then Doug Weaver’s got your fix in the darkly humorous Be Safe.
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YOU MATTER AND SO DOES YOUR HEALTH
That’s why starting and staying on HIV-1 treatment is so important.
WHAT IS DESCOVY®?
DESCOVY is a prescription medicine that is used together with other HIV-1 medicines to treat HIV-1 in people who weigh at least 77 lbs (35kg). DESCOVY is not for use to help reduce the risk of getting HIV-1 infection. DESCOVY combines 2 medicines into 1 pill taken once a day. Because DESCOVY by itself is not a complete treatment for HIV-1, it must be used together with other HIV-1 medicines.
DESCOVY does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking DESCOVY. 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 DESCOVY? DESCOVY may cause serious side effects: • Worsening of hepatitis B (HBV) infection. DESCOVY is not approved to treat HBV. If you have both HIV-1 and HBV and stop taking DESCOVY, your HBV may suddenly get worse. Do not stop taking DESCOVY without first talking to your healthcare provider, as they will need to monitor your health. What are the other possible side effects of DESCOVY? Serious side effects of DESCOVY may also include: • 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 DESCOVY. • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. Your healthcare provider may tell you to stop taking DESCOVY if you develop new or worse kidney problems. • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that
can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. The most common side effect of DESCOVY is nausea. 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 DESCOVY? • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney or liver problems, including hepatitis virus infection. • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how DESCOVY works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take DESCOVY with all of your other medicines. • If you are pregnant or plan to become pregnant. It is not known if DESCOVY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking DESCOVY. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. 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 Important Facts about DESCOVY, including important warnings, on the following page.
Ask your healthcare provider if an HIV-1 treatment that contains DESCOVY® is right for you.
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IMPORTANT FACTS
This is only a brief summary of important information about DESCOVY and does not replace talking to your healthcare provider about your condition and your treatment. ®
(des-KOH-vee) MOST IMPORTANT INFORMATION ABOUT DESCOVY
POSSIBLE SIDE EFFECTS OF DESCOVY
DESCOVY may cause serious side effects, including: • Worsening of hepatitis B (HBV) infection. DESCOVY is not approved to treat HBV. If you have both HIV-1 and HBV, your HBV may suddenly get worse if you stop taking DESCOVY. Do not stop taking DESCOVY without first talking to your healthcare provider, as they will need to check your health regularly for several months.
DESCOVY can cause serious side effects, including: • Those in the “Most Important Information About DESCOVY” section. • Changes in your immune system. • New or worse kidney problems, including kidney failure. • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. The most common side effect of DESCOVY is nausea. These are not all the possible side effects of DESCOVY. Tell your healthcare provider right away if you have any new symptoms while taking DESCOVY. Your healthcare provider will need to do tests to monitor your health before and during treatment with DESCOVY.
ABOUT DESCOVY • DESCOVY is a prescription medicine that is used together with other HIV-1 medicines to treat HIV-1 in people who weigh at least 77 lbs (35kg). DESCOVY is not for use to help reduce the risk of getting HIV-1 infection. • DESCOVY does not cure HIV-1 or AIDS. Ask your healthcare provider about how to prevent passing HIV-1 to others.
BEFORE TAKING DESCOVY Tell your healthcare provider if you: • Have or had any kidney or liver problems, including hepatitis infection. • Have any other medical condition. • Are pregnant or plan to become pregnant. • Are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Tell your healthcare provider about all the medicines you take: • Keep a list that includes all prescription and over-the-counter medicines, vitamins, and herbal supplements, and show it to your healthcare provider and pharmacist. • Ask your healthcare provider or pharmacist about medicines that should not be taken with DESCOVY.
GET MORE INFORMATION • This is only a brief summary of important information about DESCOVY. Talk to your healthcare provider or pharmacist to learn more. • Go to DESCOVY.com or call 1-800-GILEAD-5 • If you need help paying for your medicine, visit DESCOVY.com for program information.
HOW TO TAKE DESCOVY • DESCOVY is a one pill, once a day HIV-1 medicine that is taken with other HIV-1 medicines. • Take DESCOVY with or without food.
DESCOVY, the DESCOVY Logo, LOVE WHAT’S INSIDE, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks referenced herein are the property of their respective owners. Version date: September 2017 © 2017 Gilead Sciences, Inc. All rights reserved. DVYC0085 11/17
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POZ PLANET
BY TRENT STRAUBE
ARE YOU #ACAPOSITIVE? The fight to protect trans health care from discrimination
(ACAPOSITIVE) POSITIVELY TRANS; (HAND AND PEN) ISTOCK
In the spring, the Trump administration announced it would roll back Obama-era rules that protected the health care of transgender people—the original rules prohibit discrimination under the Affordable Care Act (ACA, or Obamacare). The Positively Trans project, part of the Transgender Law Center, responded with a digital campaign called “ACApositive.” “By undermining the Affordable Care Act, the Trump administration is undermining the survival of transgender people of color living with HIV,” says Positively Trans founder Cecilia Chung. “Yet so few advocates, policymakers or media outlets covering these attacks on health care are talking about the
stakes for my community. By saying we are #ACApositive, transgender people living with HIV are demanding that our voices and experiences be heard and respected.” What are the stakes for the transgender community? The Centers for Disease Control and Prevention estimates that about 1 million adults in the United States identify as transgender and about 25 percent of trans women are living with HIV. What’s more, 44 percent of transgender people with HIV surveyed by Positively Trans said they faced discrimination in a health care setting because of their identity.
The new Positively Trans project campaign
UNWRITTEN
Record your HIV story with a free 30-day journal. It’s important that the day-to-day experiences of people with HIV are not forgotten like the calendar pages of yesteryear. That’s why the unique story preservation group called Project and Connect has launched the Journal Initiative. The way it works is simple: If you are living with HIV and want to participate, sign up online at ProjectAndConnect.org to receive a free 30-day journal kit in a discreet envelope by snail mail (including a welcome letter, a pen, journal and prepaid return envelope). Over 30 days, you fill the journal with writings, essays, diary entries, thoughts, short stories, drawings, poetry— just about anything to document your life. Next, you send it back to Project and Connect, where it will be preserved indefinitely. And yes, you can remain anonymous. “The journal doesn’t have to be about HIV or AIDS, it only has to be written by someone living with HIV or AIDS,” notes project director Daniel DeLoma. “With the journals, we are building a global community and a virtual support system, as well as giving participants the opportunity to let out feelings and say things that they may have felt the need to keep bottled up.” DeLoma says participants find the project to be revealing and therapeutic. One journal keeper said it helped “restore my faith in humanity.”
poz.com JULY/AUGUST 2018 POZ 13
VOICES
BLOGS AND OPINIONS FROM POZ.COM
2018 GOALS POZ.com excerpted the annual letter from the International AIDS Society (IAS) as an opinion piece in advance of the 22nd International AIDS Conference, held July 23 to 27 in Amsterdam. Below is an edited version.
1. Linking to a broader global agenda The IAS—Lancet Commission on the Future of Global Health and the HIV Response was convened to examine how to integrate HIV with global health and to identify the unique attributes of the HIV response that must be preserved and mainstreamed across the health field. It will launch this year. 2. Pushing science to drive policy This year, IAS will join with partners to launch the “Expert Consensus Statement on the Science of HIV in the Context of the Criminal Law,” authored by leading scientists around the world. The document outlines how the broad use of criminal law, often grounded in an exaggerated appreciation of risk, contributes to misinformation about HIV and undermines public health. It is our hope that the expert statement will become the gold standard reference. 3. Uniting scientists, advocates and health care workers at AIDS 2018 Many groups experiencing high HIV burdens also lack sexual and repro-
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ductive health services. These include men who have sex with men, transgender people, sex workers, people who inject drugs and young women and adolescent girls. IAS will embrace the interconnectedness that advances the conversation on how efforts to bring an end to AIDS will directly contribute to realizing the full Sustainable Development Agenda. This includes our new partnership with Women Deliver, Generation Now. 4. Investing in prevention prioritization IAS will now host the Global HIV Vaccine Enterprise, combining organizational efforts to increase support for researchers, scientists and advocates working to develop an effective preventive HIV vaccine. A vaccine, like other innovative prevention approaches in development, will not be a substitute for other forms of prevention but will provide a powerful new tool that can hasten reaching a genuine tipping point in the global epidemic. This commitment expands upon our ongoing work focused on developing and delivering an HIV cure. 5. Making research available We will continue to freely disseminate, through the Journal of the Interna-
tional AIDS Society, groundbreaking and important research findings. The focus is on operational and implementation science, which provides valuable information on algorithms for monitoring and delivering comprehensive yet affordable and sustainable treatment, prevention and care programs in different contexts. Similarly, the IAS Educational Fund will continue operating for the third year. Through these efforts, we are translating the most recent research from a global level to a local context. 6. Making people-centered care IAS is committed to garnering political will and increasing the scale-up of differentiated service delivery to improve access to and quality of services for people living with and most vulnerable to HIV. Differentiated service delivery is fundamentally client-centered, aiming to better serve the needs of people living with HIV while reducing unnecessary burdens on the health system. If this client-centered approach leads to cost-saving efficiency gains, then all stakeholders stand to benefit. Conversely, if investment requires additional resources, IAS remains resolute on ensuring that these resources are available. Q
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W
e look forward to working with IAS members this year to achieve these commitments together.
NOT FOR ALL In an opinion piece titled “HIV-Free Generation in Striking Distance, but Not For All,” Chad Hendry and Liz Thompson of Chicago-based Howard Brown Health shared their concerns about recent statistics. Below is an edited excerpt.
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espite big strides in education, prevention and treatment, communities of color and transgender people are still left behind in the fight against HIV. The Centers for Disease Control and Prevention (CDC) released its HIV Surveillance Supplemental Report, which highlights recent progress: The rate of new HIV cases decreased by 7.9 percent between 2010 and 2015. This trend can be attributed to advocacy and access to pre-exposure prophylaxis (PrEP) and to health insurance through the Affordable Care Act. Despite these advances, the report highlights notable disparities among demographics where new HIV cases are still occurring, which include gay, bisexual and queer-identified men between ages 25 and 34 who identify as Latino or Black. Young Black men who identify as gay, bisexual or queer make up roughly 42 percent of new HIV cases in the United States. The report does not track new HIV cases or prevalence among trans and gendernon-conforming communities. Even though there is good news, the fight against HIV is not won until gains are made in every community. As HIV advocates embark on the mission of zero new HIV cases, it’s important to
remember that an individual living with HIV who has an undetectable viral load cannot transmit the virus. Easily accessible health care that’s communitydriven and stigma-free is critical to achieve undetectable viral loads. Empowered health care also means increasing access to PrEP as well as to effective treatment and compassionate health care for those living with HIV and other chronic illnesses. At the beginning of this year, Howard Brown Health launched a same-day start program, empowering patients to begin HIV treatment the same day they test positive for HIV. Since the program’s launch, many of our patients have reached HIV viral load suppression within the first month of treatment. Key findings in the CDC report reinforce the importance of addressing the socioeconomic barriers that prevent health equity, such as lack of stable housing, transportation, job security, food security and mental health. It is not a coincidence that communities most affected by poverty share the highest rates of new cases. Strategies that focus on treating the whole person by providing safety net programs are vital because they remove barriers impairing well-being and help access life essentials, such as housing,
employment and food. Last year, Howard Brown Health’s programs handed out 2,640 transportation vouchers for medical appointments. Our weekly food trucks at our Englewood clinic provide access to healthy food, an essential element of most HIV regimens. While communities around the country have the interventions necessary to eliminate new HIV cases, for health care providers to make progress, they must be able to focus on the communities that have been left behind. Gay, bisexual and queer men of color and trans people need our collective support. Groups like Howard Brown Health need readily available quality data on all affected communities, which is why tracking incidence and prevalence in trans and gender-nonconforming communities is critical. It’s important that providers stand with their patients, not just as practitioners but also as neighbors, coworkers, family members and friends who remain resolved to prioritize the health and well-being of marginalized individuals. If nothing else, the release of the CDC report reminds advocates around the country that while Americans are so close to achieving a generation free of HIV, in some communities the work is just beginning. Q
poz.com JULY/AUGUST 2018 POZ 15
EVERYDAY
BY JENNIFER MORTON
3
The New York Times publishes the first major news story about HIV, “Rare Cancer Seen in 41 Homosexuals,” by Lawrence K. Altman. (1981)
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Elizabeth Glaser and Bob Hattoy are the first people living with HIV to speak at the Democratic National Convention. (1992)
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The U.S. Public Health Service recommends that pregnant women be given AZT to reduce the risk of perinatal transmission of HIV. (1994)
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Bobbi Campbell,, a nurse living with HIV, and his partner, Bobby Hilliard, appear on the cover of Newsweek. (1983)
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Artist and activist David Wojnarowicz dies at age 37. (1992)
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AIDS Project Los Angeles holds the world’s first AIDS Walk. (1985)
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David Wojnarowicz’s political funeral procession takes place in New York City. (1992)
The XV International AIDS Conference begins in Bangkok, Thailand. (2004)
AUGUST
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The Food and Drug Administration announces the approval of Truvada as pre-exposure prophylaxis (PrEP). (2012)
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Self-proclaimed “AIDS Poster Boy” Bobbi Campbell dies of AIDSrelated complications. (1984)
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Congress enacts the Ryan White CARE Act, providing $220.5 million in funds for HIV care in its first year. (1990)
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Activist Mary Fisher delivers her “A Whisper of AIDS” speech at the Republican National Convention. (1992)
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The U.S. Postal Service issues a commemorative stamp to honor tennis star Arthur Ashe, who died of AIDS-related complications in 1993. (2005)
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The Elizabeth Taylor AIDS Foundation is created. (1991)
AIDS is an everyday experience. These dates represent milestones in the AIDS epidemic. Some dates are known globally; others commemorate individual experiences. AIDS Is Everyday is an ongoing art project produced in conjunction with Visual AIDS to help break down the silence, shame and stigma surrounding HIV. Add a date about your history with HIV to our online calendar at poz.com/AIDSIsEveryday.
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(OBAMA) FILIP FUXA/DREAMSTIME.COM; (OTHER IMAGES) ISTOCK (MODEL USED FOR ILLUSTRATIVE PURPOSES ONLY)
JULY
The National HIV/AIDS Strategy for the United States is first released by the Obama administration. (2010)
In adults with HIV on ART who have diarrhea not caused by an infection
IMPORTANT PATIENT INFORMATION This is only a summary. See complete Prescribing Information at Mytesi.com or by calling 1-844-722-8256. This does not take the place of talking with your doctor about your medical condition or treatment.
What Is Mytesi? Mytesi is a prescription medicine used to improve symptoms of noninfectious diarrhea (diarrhea not caused by a bacterial, viral, or parasitic infection) in adults living with HIV/AIDS on ART. Do Not Take Mytesi if you have diarrhea caused by an infection. Before you start Mytesi, your doctor and you should make sure your diarrhea is not caused by an infection (such as bacteria, virus, or parasite).
Possible Side Effects of Mytesi Include:
Tired of planning your life around diarrhea?
Enough is Enough Get relief. Pure and simple. Ask your doctor about Mytesi. Mytesi (crofelemer): • Is the only medicine FDA-approved to relieve diarrhea in people with HIV • Treats diarrhea differently by normalizing the flow of water in the GI tract • Has the same or fewer side effects as placebo in clinical studies • Comes from a tree sustainably harvested in the Amazon Rainforest What is Mytesi? Mytesi is a prescription medicine that helps relieve symptoms of diarrhea not caused by an infection (noninfectious) in adults living with HIV/AIDS on antiretroviral therapy (ART). Important Safety Information Mytesi is not approved to treat infectious diarrhea (diarrhea caused by bacteria, a virus, or a parasite). Before starting you on Mytesi, your healthcare provider will first be sure that you do not have infectious diarrhea. Otherwise, there is a risk you would not receive the right medicine and your infection could get worse. In clinical studies, the most common side effects that occurred more often than with placebo were upper respiratory tract (sinus, nose, and throat) infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). For Copay Savings Card and Patient Assistance, see Mytesi.com
Please see complete Prescribing Information at Mytesi.com. NP-390-20
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RELIEF, PURE AND SIMPLE
• Upper respiratory tract infection (sinus, nose, and throat infection) • Bronchitis (swelling in the tubes that carry air to and from your lungs) • Cough • Flatulence (gas) • Increased bilirubin (a waste product when red blood cells break down) For a full list of side effects, please talk to your doctor. Tell your doctor if you have any side effect that bothers you or does not go away. 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.
Should I Take Mytesi If I Am:
Pregnant or Planning to Become Pregnant? • Studies in animals show that Mytesi could harm an unborn baby or affect the ability to become pregnant • There are no studies in pregnant women taking Mytesi • This drug should only be used during pregnancy if clearly needed A Nursing Mother? • It is not known whether Mytesi is passed through human breast milk • If you are nursing, you should tell your doctor before starting Mytesi • Your doctor will help you to decide whether to stop nursing or to stop taking Mytesi Under 18 or Over 65 Years of Age? • Mytesi has not been studied in children under 18 years of age • Mytesi studies did not include many people over the age of 65. So it is not clear if this age group will respond differently. Talk to your doctor to find out if Mytesi is right for you
What Should I Know About Taking Mytesi With Other Medicines? If you are taking any prescription or over-the-counter medicine, herbal supplements, or vitamins, tell your doctor before starting Mytesi.
What If I Have More Questions About Mytesi? For more information, please see the full Prescribing Information at Mytesi.com or speak to your doctor or pharmacist. To report side effects or make a product complaint or for additional information, call 1-844-722-8256.
Rx Only Manufactured by Patheon, Inc. for Napo Pharmaceuticals, Inc. San Francisco, CA 94105 Copyright © Napo Pharmaceuticals, Inc. Mytesi comes from the Croton lechleri tree harvested in South America.
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SPOTLIGHT BY JOE MEJÍA
The 7,000 As POZ contributor Mark S. King noted in “The Truth About the 7,000” in the April/May 2018 issue of the magazine, AIDS-related complications extend beyond the physical. King’s essay, inspired by the death of his friend and fellow HIV advocate Reshaud Olukayode, at age 33, from AIDS-related illness in November 2017, struck a chord. Many readers saw something of themselves in the 7,000 people who die of causes attributable to HIV every year despite living in an era of effective treatment for the virus. Citing depression and shame as barriers to adherence to meds, a majority of online readers sympathized with the emotional exhaustion they suspect might have contributed to Olukayode’s decision to stop taking his meds. But some commenters bemoaned the fact that someone with both awareness and access on his side couldn’t see his way to adherence and viral suppression. Whatever side you’re on, though, one thing remains clear: Fighting HIV globally and individually requires a holistic approach.
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Keith I’ve been poz since 2005 and recently quit taking my meds. I have other non-HIV problems that cause pain all of the time. I have tried dating, without success. I’m tired of being alone and have very few friends; they’ve either died or moved away. I no longer communicate with family. I have fought depression for 58 years and am worn out. It’s not that easy to find a therapist. It’s not easy telling someone that you don’t care if you live or die. I had to tell my HIV Dr. at my last appointment. April 11, 2018 • Portland, OR
mwarriner I am a white privileged woman of 73 who is HIV positive. I faced my diagnosis 3 years ago with no community support, only my family. I identify so much with this article. I see it as a “there but for the grace of God go I” kind of piece, and I am frightened that someday one of the disasters it describes might happen to me. The most relevant right now is the high co-pay on my meds. It’s an issue that nobody is dealing with except with rhetoric that goes nowhere. Something needs to be done! NOW! April 10, 2018 • California
HIVisNOTaCRIME What a great article. I’ve lost 3 friends in the past 4 months, all LTS [long-term survivors]; it feels like I’ve experienced a wave of deaths reminiscent of the ’90s. I was new to the gay community, had a support group of amazing men, all dying of AIDS. My 1st yrs HIV+ were helping 2 care 4 my new family while watching them die, knowing my time was coming. I feel many LTS are tired of the constant battle to get meds, many who R on disability. We need to unite and support each other bc our differences make us stronger. May 1, 2018 • Nashville
Kyle Anonymous This article suggests a false narrative that PLHIV are inherently dysfunctional. Why do we do this to ourselves? Is it because we’ve convinced ourselves that victimization is something to be proud of? We need the sort of advocacy Mark has shown on behalf of the HIV-. That means allowing those of us who are healthy and doing well to embrace that. April 16, 2018 • Denver, CO
Michael This article makes me ANGRY! Diagnosed poz in 1985, I refused to let it define me or ruin my plans for my life. Only AZT was available then, which I immediately went on. Many drugs and horrible side effects, hip replacements, hospitalizations and anemia, I am still here, drug compliant and undetectable. My partner of 28 years lied that he was taking his meds until he developed a fatal brain tumor and died 14 years ago. I worked hard until I couldn’t and enjoy a comfortable and happy life. Choices. May 1, 2018 • Washington, DC
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CARE AND TREATMENT BY BENJAMIN RYAN
DIABETES IS ON THE RISE People with HIV are increasingly developing prediabetes and diabetes—likely in part simply because the population is getting older but also possibly because of the toxicities of certain older antiretrovirals (ARVs). Researchers conducted a meta-analysis of 44 studies published between 2000 and 2017 that included data about prediabetes or diabetes diagnoses among people with HIV who were starting or already taking ARVs. Overall, the annual diagnosis rate was 125 cases of prediabetes and 14 cases of diabetes per cumulative 1,000 years that participants were monitored in these studies. The annual diagnosis rate for these conditions increased quickly over time. Major risk factors for developing either condition included aging, having a family history of diabetes, being Black or Latino, being overweight or obese, central obesity (carrying extra weight around the abdomen), having lipodystrophy or lipoatrophy (abnormal distribution of fat on the body and face, linked with some of the earliest ARVs), having abnormal blood lipids, having metabolic syndrome (a collection of factors including abnormal cholesterol, triglycerides and blood sugar, central obesity and high blood pressure), having a higher fasting glucose test result and taking any of a roster of ARVs, most of which are older and no longer commonly prescribed. On the bright side, it is possible that given the lower toxicity of today’s preferred ARV regimens, the diagnosis
rate of prediabetes and diabetes may ultimately decline among people with HIV. According to Steven Grinspoon, MD, a professor of medicine at Harvard Medical School who researches diabetes among people with HIV and who was not involved with the study, “These are important findings that suggest a number of potentially modifiable risks for diabetes among HIV patients.”
Cut-Price HIV Meds The Food and Drug Administration (FDA) has approved three new antiretroviral (ARV) combination tablets from Mylan that are not generic drugs but that the company has priced at about a 40 percent discount compared with comparable antiretroviral (ARV) treatments. First, there are the single-tablet regimens Symfi and Symfi Lo, which each contain efavirenz, lamivudine and tenofovir disoproxil fumarate; the difference between them is that the dose of efavirenz is 600 milligrams in Symfi and just 400 mg in Symfi Lo. The tablets are approved for the treatment of HIV among adults and children, who must weigh at least 40 kilograms (88 pounds) to take Symfi and 35 kg (77 lbs.) to take Symfi Lo. Recent research has indicated that treating HIV with tenofovir and emtricitabine is comparably effective regardless of whether individuals also receive 400 mg or 600 mg of efavirenz.
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Sold under the brand name Sustiva, efavirenz is associated with various troubling side effects, including nightmares. A recent study backed up previous findings that the drug is associated with an increased risk of suicidal behaviors. Symfi and Symfi Lo have the same components as Atripla (efavirenz 600 mg/tenofovir disoproxil fumarate/ emtricitabine) but swap lamivudine for emtricitabine; both of those drugs are in the nucleoside/nucleotide reverse transcriptase inhibitor class of ARVs. The FDA has also approved Mylan’s Cimduo (lamivudine/tenofovir disoproxil fumarate), which is similar to Truvada (tenofovir disoproxil fumarate/emtricitabine) and also swaps lamivudine for emtricitabine. (Cimduo was not yet available as of press time.) The tablet is approved for use in combination with other ARVs for
the same population as Symfi Lo. It is not approved for use as pre-exposure prophylaxis. Tim Horn, MS, deputy executive director of HIV and HCV programs at Treatment Action Group, says the introduction of these cut-price tablets is “a step in the right direction” that should save some insurers money. But for considerable cost savings, he says, true generic competition “is a must— and is encouraged.”
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Treat Acute Hep C Earlier
MENOPAUSE MEANS WORSE PAIN, FATIGUE Postmenopausal women living with HIV have worse fatigue, muscle aches and insomnia compared with those who are still menstruating. Researchers conducted a survey of 222 HIV-positive women; about half had undergone menopause either naturally or as a result of a hysterectomy, and half were still having their periods. Compared with the menstruating women, the postmenopausal women were more likely to experience muscle aches and pains, fatigue and difficulty falling asleep. These findings held after the researchers controlled their data for differences in the women’s age, how long they had been living with HIV and any HIV-associated non-AIDS health conditions they had. “These preliminary findings suggest the need for further study of the physiological processes that may be contributing to exacerbated fatigue and muscle aches in older women living with HIV,” says Rebecca Schnall, RN, PhD, MPH, an associate professor at Columbia University’s School of Nursing and the study’s first and corresponding author. According to Schnall, “Postmenopausal women living with HIV can consider a number of non-estrogen therapies that may improve the inflammation that is likely contributing to worse fatigue and muscle aches, such as: diet modification, hydrotherapy, exercise, massage and reflexology.”
HIV-positive people who contract hepatitis C virus (HCV) rarely spontaneously clear the latter virus without treatment. Consequently, researchers behind the recent study that reached this finding advocate changing direct-acting antiviral (DAA) labels to specify that they should be prescribed during the acute, or very early, phase of hep C infection among those coinfected with HIV. “The challenge at the moment is that none of the DAAs are licensed for acute infection,” says the study’s lead author, Christoph Boesecke, MD, who researches hep C at the University of Bonn in Germany, “so they’re always used off label” among this population. Between 2007 and 2016, investigators documented 465 people living with HIV in various European nations who were newly infected with hep C and were monitored for at least 12 months. Virtually all of them were men who had contracted hep C through sex with men. Acute hep C infection resolved spontaneously in just 12 percent of the cohort members. Seventy percent of the men in the study began treatment for hep C within 48 weeks of being diagnosed with acute HCV. Seventy-six percent of those treated for HCV were cured of the virus. Eleven percent of the overall cohort were cured and then reinfected. The researchers found that those who saw their HCV viral load fall by more than 100-fold (a 2-log decline) during the first four weeks after receiving a diagnosis of acute hep C were more than 1,000 times more likely to spontaneously clear that virus than those who did not see such a decline.
poz.com JULY/AUGUST 2018 POZ 21
CALL FOR NOMINATIONS! 9TH ANNUAL POZ 100
The 2018 POZ 100 will celebrate people living with HIV from across the country who are 50 and older and making a difference in the fight against HIV/AIDS. Established in 2010, the POZ 100 recognizes individuals and organizations committed to ending the HIV/AIDS epidemic. For more information and to submit a nomination (self-nominations are welcome), go to POZ.com/nominate.
Early Deadline: August 24
Don’t delay! Submit your nomination for the 2018 POZ 100 today!
RESEARCH NOTES
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BY BENJAMIN RYAN
PREVENTION
TREATMENT
CURE
CONCERNS
PrEP Resistance
Sustiva & Suicide
Research Ethics
HIV Rate Trends
People living with diagnosed HIV who have a strain of the virus that is resistant to both of the meds included in Truvada (tenofovir disoproxil fumarate/emtricitabine) and also have a viral load high enough to be significantly transmissible are rarities. This finding, from an analysis of the HIV population in King County, Washington, which includes Seattle, is reassuring in the face of worries about how commonly people who stick to the daily Truvada as pre-exposure prophylaxis (PrEP) regimen might contract drug-resistant virus. Researchers estimate that about 35 people living with diagnosed HIV in King County, or 0.9 percent of the local HIV population, have a viral load above 1,000 and at least some resistance to the drugs in PrEP. Since 2008, only 0.17 percent of county residents who received resistance testing at the time of their HIV diagnosis have contracted a viral strain resistant to both drugs in Truvada.
Starting HIV treatment with a regimen that includes Sustiva (efavirenz), a component of Atripla (efavirenz/tenofovir disoproxil fumarate/ emtricitabine), is associated with an increased risk of suicidal behaviors. That’s according to a new analysis of the major randomized controlled START trial that included 4,684 participants and compared starting HIV treatment immediately with delaying until the immune system declined somewhat. Investigators looked at the 75 percent of participants prespecified to receive Sustiva and compared the rate of reports of suicidal behaviors among those randomized to start treatment immediately to the rate of such reports among those randomized to receive treatment on a deferred basis (for the latter group, this analysis considered only the period before they started treatment). Sustiva was associated with a 3.3-fold greater risk of suicidal behaviors overall and a 12.5-fold greater risk among those with a prior psychiatric diagnosis.
People participating in HIV cure studies who stop antiretroviral (ARV) treatment for a period during which they are closely monitored do not experience drug resistance, permanent damage to their immune function or a sustained increase in the size of their viral reservoir. This is according to a substudy of 10 people with HIV who were taken off ARVs for a stretch of time during a clinical trial evaluating whether infusions of an antibody could control the virus for an extended span in the absence of daily ARVs. Such a finding provides important reassurance for the ethics of enrolling participants in similar cure studies. To develop treatments that would allow people with HIV to go off ARVs without a viral rebound for sustained periods, researchers must currently put participants through these interruptions of their HIV medications. This allows scientists to observe how the virus behaves when not suppressed by ARVs.
According to new estimates from the Centers for Disease Control and Prevention that are based on mathematical modeling, the national annual HIV infection rate dropped by 15 percent between 2008 and 2015, from 45,200 to 38,500 new transmissions. The annual infection rate declined by 6.3 percent among heterosexuals and 11 percent among people who inject drugs (PWID). However, the 15-year decline seen among PWID appears to be leveling off, possibly because of the expanding opioid epidemic. The annual infection rate held steady among men who have sex with men (MSM) overall, at about 26,200 to 26,700 annual infections. Among MSM, the annual rate rose by 45 percent among 25- to 34-year-olds, rose by 25 percent among Latinos, held steady among African Americans and declined 19 percent among whites. MSM had an annual infection rate 16 times that of PWID and 135 times that of heterosexuals.
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Romany Tin stands his ground in Long Beach, California.
HIV POLICIES AT THE PEACE CORPS COME UNDER FIRE. BY LUCILE SCOTT
ITTING ON A HARD HOTEL
However, Tin says that after he completed his compulsory 30-day medical stay in DC, thousands of miles from his family and friends in Long Beach, California, the Peace Corps medically “separated” him, in effect terminating him. Such a “separation” is Peace Corps policy for any volunteer who leaves his or her post for medical reasons that are not “resolved” after 45 days. However, Tin reports that after starting antiretroviral (ARV) therapy, his CD4s doubled, his viral load plummeted toward undetectable and he felt in excellent health—and was eager to return to his rural village in Cambodia. There, in his father’s native province of Battambang, he had students, a relationship with his host family and a nascent project to improve trash collection. “There is no real reason someone with HIV couldn’t be stationed in [most] countries, as long as they are able to maintain a supply of drugs and occasionally get to a doctor,” says William McColl, vice president for policy and advocacy at DC–based AIDS United. According to a 2017 report from the Joint United Nations Programme on HIV/AIDS, services in Cambodia are more than up to this standard. Nationally, 80 percent of people living with HIV are on ARVs—the highest rate in AsiaPacific—and HIV services are available in remote rural areas throughout the country, including Battambang province. Back home in Long Beach, rage mounting the more he read about the reality of living with HIV today, Tin learned one of the most important facts he has discovered about himself since joining the Peace Corps: He’s not the type to take injustice lying down.
bed in Washington, DC, Romany Tin stares at an untouched carton of take-out food. He doesn’t want to be here—in DC, staying in this sterile hotel, spending his days alternating between a litany of doctor visits and aimlessly wandering the streets of the nation’s capital, where he knows nobody and has nowhere to be.
AFTER HIS DIAGNOSIS, TIN SAYS, HIS PEACE
Corps medical officer told him he would be immediately evacuated to DC, where he could receive top-of-the-line treatment. But he says he was given little other information about the virus—or anything resembling a choice about these next steps, despite the fact that since 2008, Peace Corps policy has been to accommodate volunteers who wish to remain in-country whenever possible. “I was very unaware and misunderstood the illness. I didn’t know of the advances in medicine and that people just live normally,” he says. “And they didn’t tell me. I had to do my own research.” Still, notwithstanding his fear, his mind quickly turned to his service. “When they told me the news, I started crying and had tears running down my face, but at the same time, my main concern was with my work,” he says. “I just always had the mindset that I was going back.”
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ONE LATE-WINTER DAY IN 2018, JEREMIAH
Johnson signed on to his LinkedIn page and noticed he had a message from someone he didn’t know named Romany Tin. “I never actually pay attention to my [LinkedIn] inbox, so I’m very happy I did this one time,” he says. In 2008, Johnson had been medically separated from his Peace Corps service in Ukraine after receiving an HIV diagnosis. While Googling, Tin had come across media coverage of Johnson’s ordeal (including a POZ cover story). Johnson, who now works as a community engagement coordinator at the Treatment Action Group (TAG), an HIV advocacy organization in New York City, immediately agreed to help Tin fight back. For two decades before Johnson’s diagnosis, official Peace Corps policy had been to immediately evacuate to the United States any volunteers who tested positive for the virus and permanently remove them from service. But by 2008, it was obvious that this policy was based on antiquated medical knowledge. So Johnson began reaching
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Blankly watching his dinner grow cold, he ponders what, after more than a week in what feels like forced quarantine, he has just been told—the last thing he wanted to hear. He can’t go back. A few months earlier, Tin, age 23, had taken a selfie overlooking a verdant, picturesque vista in Cambodia, the country that his parents fled in the 1970s amid a brutal civil war and where he was serving in the Peace Corps. He refers to Cambodia as “the motherland.” Although he’d never visited before his Peace Corps assignment, his time there gave him the chance to learn firsthand of roots that had seemed alien during his California youth. In the picture, his floppy black hair cuts off sharply, just above earnest eyes and rolling beads of sweat. He has the intent look of a young man on a journey to better understand himself and the world. And it would seem he has achieved both—though not quite in the way he anticipated. In January 2018, only six months into his two-year stint as a Peace Corps high school English teacher, Tin, who is gay, was diagnosed with HIV. He had been tested before beginning his service and believes he contracted the virus through a sexual encounter he had while in Cambodia.
out to advocates, including at the American Civil Liberties Union (ACLU), which accepted the case and threatened to sue the Peace Corps for violating The Rehabilitation Act, which prohibits discrimination on the basis of disability in programs conducted by federal agencies. The Peace Corps soon relented, sending the ACLU a written guarantee that going forward, the organization would be “committed to extending individualized assessments in cases involving HIV to include whether a newly infected volunteer could be reasonably accommodated and either kept at post or sent to another post in lieu of medical separation.” “It doesn’t seem like they did any of that for me,” says Tin, who not only was told he could not return to Cambodia but also wasn’t offered a post in another country. He was informed he could reapply via the normal, lengthy application process after six months. According to the Peace Corps’ The Health of the Volunteer 2016 report, 54 volunteers have been diagnosed with HIV while in service since 1989; 19 of those were diagnosed between 2008—when the new policy was implemented—and 2016. However, none of the lawyers or advocates POZ talked to had heard anything to indicate the policy hadn’t been enacted as promised between 2008 and 2018.
SO WHY NOW? DID TIN’S CASE
represent a new internal directive or just a mistake? A Peace Corps spokesperson asserted the policy had not changed. “It feels to me like a bit of forgetting,” says Scott Schoettes, HIV project director at Lambda Legal, which, along with the ACLU, is advising Johnson and Tin as they fight for Tin’s immediate reinstatement (as of press time, neither organization had officially taken on the case). “I think it may be a personnel change and someone new not recognizing that the policy had changed or just not being up to speed with HIV today.” And given that the Peace Corps’ posts in 61 countries are often staffed by contracted locals and not individuals who have received uniform training at U.S. headquarters, it seemed this could well be the case— at least until Tin’s case. Like Tin, Kyle (not his real name), a 26-year-old native of the Pacific Northwest, was stationed in Southeast Asia, though not in Cambodia. Kyle reports that during his initial in-country training he requested Truvada as pre-exposure prophylaxis (PrEP) to prevent HIV but was discouraged by his medical officer, though not outright refused. “They said it was only available for people who had had
Jeremiah Johnson unprotected sex,” he says, adding that on the cover of the at the time he had not done so while July/August 2008 issue of POZ in the Peace Corps. “I just felt like it was a burden for them…like they didn’t want to give it to me, so I stopped asking.” When asked about its PrEP policy, the Peace Corps spokesperson responded, “Each volunteer is assessed for PrEP according to specific risk factors, which Peace Corps developed with input from Centers for Disease Control and Prevention experts.” Although the spokesperson did not provide further specifics, another volunteer, James Fishon, corroborated the policy as Kyle understood it, saying he was also denied PrEP last year while serving in Ukraine because he did not report having had sex in-country. “But someone wouldn’t ask for it if they didn’t need it,” he says. Indeed, though Fishon completed his service without contracting HIV, he reports that he contracted another sexually transmitted infection—which easily could have been HIV. Kyle received the news he was HIV positive in
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late March and, like Tin, was sent back to the United States. “[Volunteers] get medically evacuated all the time and go to Thailand, which was really close by. But for me that was not an option,” says Kyle, adding that he doesn’t know why. “I mean people with diabetes would have a harder time [in the Peace Corps] than people with HIV. All I need is one pill a day and to get testing every six months.” And in a somewhat ironic twist of fate, while the United Nations Development Programme recently touted Thailand’s HIV treatment program “as a model for other developing countries” and the country features any number of clinics guaranteeing same-day access to ARVs, Kyle reports that because of a snag involving his insurance, it took him two weeks to access meds once he arrived in DC.
ACCORDING TO THE PEACE CORPS SPOKES-
ARI MICHELSON
person, 18 of the countries in which it operates have medical services, such as access to “reliable specialists and trusted laboratories,” that the Peace Corps has deemed adequate to accommodate volunteers living with HIV—and the spokesperson claimed HIV-positive volunteers are currently serving in “several.” The Peace Corps did not provide a list Romany Tin of the countries or more exact criteria for is fighting to return as a determining what those countries are or Peace Corps who can serve in one of them after being volunteer.
diagnosed, instead of, in effect, losing their job. “By terminating someone’s employment over their HIV status, as a society, we’ll only continue to feed the stigma that marginalizes people living with HIV,” says Murray Penner, executive director of the National Alliance of State & Territorial AIDS Directors, which, along with the HIV Medical Association, sent a letter to the Peace Corps in May asserting there is no evidence-based medical reason for removing Tin, Kyle or any volunteer who tests HIV positive from his or her post and that doing so constitutes illegal discrimination. Kyle himself reaffirms the potentially deadly cost of this stigmatizing employment policy: “If I’d known I would be sent home, I wouldn’t have gotten tested.” The website for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the world’s largest global HIV program, declares that reducing HIV-related stigma and fighting discrimination are key to ending AIDS and that, as a result, PEPFAR-funded programs will involve “people living with HIV and their input in all aspects of its work.” Since PEPFAR’s inception in 2003, the Peace Corps has been among those programs—and integral to PEPFAR’s frontline response. In 2017, the Peace Corps received $39 million in PEPFAR funding, and 1,100 volunteers were working on HIV prevention, care and support in 47 countries. “If the United States is going to continue to be a major funder in ending the global HIV epidemic, it would really
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help us if the State Department and Peace Corps are in line with best practices and what we know to be the latest HIV knowledge,” says McColl. “Our concern is that the State Department and Peace Corps aren’t staying on top of the science.” The Peace Corps spokesperson, however, insisted that the organization was up to speed and that all medical officers “receive orientation and continuing medical education, which include sessions on PrEP and LGBTQ health practices.” However, the spokesperson declined to connect POZ to a medical officer to inquire about that training, and officers contacted directly did not respond. A PEPFAR spokesperson stated only, “As Peace Corps employed the volunteer in question, we have to defer to them on this one. As PEPFAR is a part of the Department of State, we follow its policies”—which are to reasonably accommodate employees living with the virus. The removal of both Kyle and Tin—who were stationed in different countries—strongly suggests that, as of 2018 at least, the Peace Corps has either forgotten or dismissed the 2008 policy change. But the question remains: Did the organization ever remember it?
“I ALWAYS HAD THE MINDSET THAT I WAS GOING BACK. I WANT TO FIGHT THIS.”
IN 2008, AFTER ELIZABETH TUNKLE WAS diagnosed with HIV while serving in Zambia, she was evacuated and medically separated, as had been status quo. “Then, suddenly there was a change in conversation,” she says. As Johnson’s case gathered media attention, the Peace Corps determined that Tunkle could return to her service after all, though not to Zambia. Instead, she flew to Lesotho to serve in a PEPFAR program combating HIV stigma—and this time she realized she had something new to offer, which she says turned out to be the “most impactful” thing she did in the Peace Corps. While at first, Tunkle remained silent about her HIV status, she soon began disclosing to other volunteers and then to anyone who cared to listen—in her official Peace Corps capacity. “I spoke to large groups in schools and in communities and to HIV support groups and anywhere else,” she says. Audiences often asked her how she had the courage to discuss such things publicly, but she feels the benefit wasn’t limited to combating stigma. “I had a purpose, and it felt meaningful and like it wasn’t all just for nothing.” However, despite the positive impact on everyone involved, she views her experience as something of a fluke. “I got super lucky with timing. I think all the attention because of the ACLU is the only reason the Peace Corps sent me back. They did not want to do it.” On the other hand, the story of Jessica (last name withheld) suggests that at least sometimes—or for a time—the 2008 policy functioned as promised. In 2011, Jessica was also diagnosed while serving in Zambia. “I fell extremely ill with acute HIV infection,” she says. She, too, was medically evacuated to DC. “It was all necessary and helpful in my case.”
Then, as her health improved, she says the Peace Corps began the process of reinstating her, without requiring that she reapply—though she eventually chose to remain stateside because of her own concerns about her health. “But I am confident they would have reinstated me if/when I was ready,” she says. In addition to the HIV separation policy, Tunkle raised another concern. She says a contracted Peace Corps medical officer in Zambia “wrote her up” for “breaking the rules” after she disclosed during a therapy session that she had engaged in condomless sex. “Any hope of confidentiality was off the table,” she says. Other former volunteers POZ spoke to also stressed that the Peace Corps adopts a punitive approach to encouraging safer sex—sometimes issuing disciplinarian “write-ups” to volunteers requesting PrEP, post-exposure prophylaxis (PEP) or HIV tests, which could deter others from seeking such services. On the fl ip side, one volunteer, Chris Obermeyer, reported that while stationed in Ukraine from 2016 to 2017, he was prescribed PrEP without receiving a write-up or demerit—though, unlike Kyle and Fishon, he was already taking the medication when he started his service. When asked, the Peace Corps spokesperson did not confirm or deny the write-ups, and as of press time, the organization had not assented to reinstating either Tin or Kyle.
WHILE IT REMAINS UNCLEAR WHETHER the recent rash of news about discrimination represents internal Peace Corps directives or just a failure in communication, one thing is certain. Since the inauguration of President Trump, advocates and pro–human rights government employees throughout the United States and the world are fighting on so many fronts just to ensure that the center holds that progress on certain issues will inevitably slide—if no one else steps up to stop it. “[I feel] intense anger knowing that other volunteers are experiencing the same soul-crushing discrimination I endured over a decade ago,” says Johnson about why, in addition to his duties at TAG, he continues to spearhead the campaign to restore Tin and Kyle to their posts—and ensure that the Peace Corps improve its implementation of the 2008 policy going forward. As for Tin, he’s still holding out in Long Beach, with no plans of giving up on his quest to return to his motherland. He says, “I want to fight this. There’s nothing really different about me than other volunteers, except I take one pill a day. That’s literally it.” ■
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About 25 percent of people living with HIV (in pink circles) also have hepatitis C virus (in yellow circles).
CURING HEPATITIS C IS A PRIORITY FOR PEOPLE ALSO LIVING WITH HIV. BY BENJAMIN RYAN
OT SURPRISED, YET STILL rather shocked. That was Ian Finkenbinder’s reaction to testing positive for hepatitis C virus (HCV) in 2012. The 36-year-old, who was designated male at birth and identifies as a nonbinary trans girl, had been diagnosed with HIV in 2009. During the time between these two diagnoses, the Seattle resident, who opts for they/them pronouns, had become addicted to crystal meth, which they injected. Hep C, an insidious infection of the liver for which there is no vaccine, transmits readily—much more so than HIV—through the sharing of needles, syringes and other injection-drug paraphernalia. In addition, there is a relatively small but growing epidemic of sexually transmitted HCV among men who have sex with men (MSM) in Western nations. So it’s possible that this is how Finkenbinder, who engages in sex with men, contracted the virus. Various studies that have followed groups of HIV-positive MSM over time have found that about 1 to 2 percent of the men have contracted HCV annually, apparently through condomless sex. “Finding out I had HIV was personally devastating,” Finkenbinder recalls. “So when I was diagnosed with hep C, I was naturally very upset. But I had already gotten what I thought was the worst news ever. So it was easier
to accept bad news at that point.” Fortunately for Finkenbinder and the estimated 3.5 million other U.S. residents who are living with hep C, the virus is now readily curable. In the not-so-distant past, attempting to cure hep C required tolerating up to a year of onerous treatment with the drug interferon. This injectable therapy saddled individuals with devastating flu-like side effects yet offered only a modest chance of a cure. Today, a host of highly tolerable medications known as direct-acting antivirals (DAAs) are on the market for the treatment of HCV. For most subgroups of people with the virus, just eight or 12 weeks of the daily pills—which boast cure rates in the high 90 percent range—are required to get cured. Here’s more good news for people like Finkenbinder who are coinfected with HCV and HIV: Unlike during the interferon era, having HIV is no obstacle to success with hep C treatment. Hep C cure rates for today’s various preferred DAA regimens are generally comparable between those with and those without HIV. And while some DAAs do clash with the antiretrovirals (ARVs) used to treat HIV, there are enough options for effective treatments that clinicians can assemble pairs of regimens that are safe for their coinfected patients to take concurrently. Furthermore, DAAs are also safe and effective for people with HIV who are not taking ARVs. “I just wanted to get it taken care of,” says Finkenbinder of their hep C infection. But such urgency notwithstanding,
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they had to wait a few years for better treatments to hit the market. The approval of Gilead Sciences’ fi rst two DAA tablets, Sovaldi (sofosbuvir) in late 2013 and Harvoni (ledipasvir/sofosbuvir) a year later, ushered in the current era of hep C therapy, during which interferon has fi nally fallen by the wayside. Finkenbinder wound up taking 12 weeks of Sovaldi and AbbVie’s Daklinza (daclatasvir) in 2016 and was pronounced cured that fall. “I was so excited,” Finkenbinder, who is now off meth and works nights as a dispatcher for a food delivery company, says of learning that they had kicked hep C to the curb. “It was such a weight off my chest.”
synergistically destructive impact on the body. Considerable research has indicated that when HIV remains untreated by ARVs, it accelerates HCV-related liver damage in particular. Whether HIV hastens such harm to the liver among those on successful ARV treatment has lately become a rather controversial topic, according to Daniel Fierer, MD, an infectious disease specialist at Mount Sinai Hospital in New York City. After all, controlling HIV is associated with a reduced risk of liver disease. For living proof of just how complex health problems can become for those with HIV/HCV coinfection, especially among those who engage in various high-risk behaviors associated with contracting the viruses, just ask Ed Barron. A gay man with a history of injection drug use dating back decades, Barron believes he likely contracted HIV in the late 1970s or early 1980s and was diagnosed with HCV in 2000. The 62-year-old Morristown, New Jersey, resident has endured devastating complications related to anal cancer and its treatment as well as a near-fatal severe bacterial infection he contracted from a dirty needle shortly before quitting drugs in 2012. “I’m a long-term survivor by the skin of my teeth,” Barron says wryly, noting the many years during which his injection drug use kept him from properly engaging in medical care for his HIV. “I think I have nine lives, and seven of them have been used.” Then there’s the social burden of living with yet another chronic virus. “It was actually harder to disclose about hep C than HIV for me,” says Finkenbinder. “Even though there is stigma with HIV, there is a level of acceptance that is more prevalent and a lot more information out there than there is about hepatitis C. I would disclose to someone that I have hep C, and they wouldn’t know anything about it. So when you face this lack of education, there’s a level of mistrust there.” Hayden, an HIV-positive gay New Yorker in his mid-30s who contracted HCV through sex and prefers to use a pseudonym with POZ, also faced an overall lack of awareness about the virus when he disclosed his hep C status to sex partners.
THE CENTERS for Disease Control and Prevention (CDC) estimates that one in four of the approximately 1.1 million people living with HIV in the United States are coinfected with HCV, as are perhaps 50 to 90 percent of HIV-positive people who inject drugs (PWID). The expanding opioid epidemic has apparently contributed to a more than threefold rise in the annual rate of new hep C infections since 2000—there were an estimated 41,000 transmissions in 2016—and has possibly set the stage for a reversal of the 15-year decline in annual HIV transmissions through injection drug use. While HIV targets the immune system, HCV sets its sights on liver cells. Hep C’s negative health effects tend to progress sight unseen over the course of decades as it gradually damages this vital organ. The virus is associated with the progression of fibrosis, or scarring, of the liver and can eventually lead to cirrhosis, liver cancer, liver failure and the need for a liver transplant, or death. What’s more, just as with HIV, HCV is associated with many health complications that are not directly related to the virus’s main target. Research indicates that the two viruses are each independently linked to an increased risk of diabetes, kidney disease, cardiovascular disease and numerous cancers. According to Oluwaseun Falade-Nwulia, MBBS, MPH, an infectious disease specialist at Johns Hopkins University School of Medicine in Baltimore, HIV and HCV have a
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“I CAN TELL PEOPLE THAT I’VE BEEN CURED OF HEPATITIS C. I CAN’T TELL THEM I’VE BEEN CURED OF HIV.”
Additionally, he wrestled internally with his personal policies about using condoms, which he has always disliked; he says they greatly curb his sexual enjoyment. He had long felt condomless sex was OK since he had an undetectable HIV viral load and therefore, as characterized by the CDC, had effectively no risk of transmitting that virus. But after he got his hep C cured—he upped his condom use until then—engaging in further condomless sex only made him vulnerable to that virus once again. The risk for people in Hayden’s shoes is substantial. In some European studies of HIV-positive MSM who are cured of hep C, more than 10 percent are reinfected with HCV per subsequent year. CURING HEPATITIS C OFFERS A HOST OF benefits that go beyond the health of the liver. “Once the virus is gone, then the progression of liver disease is gone,” says Falade-Nwulia of Johns Hopkins. “As long as there aren’t other things like alcohol use that could damage the liver, then your liver actually has a chance to heal.” One study of 1,625 people with HIV and HCV who were treated with interferon between 2000 and 2008 (about 600 were cured of hep C) and were followed for a median five years through 2014 found that curing hep C reduced their risk of: death by 64 percent, liver-related death by 87 percent, AIDS-defining diagnoses by 63 percent, advanced cirrhosis by 90 percent, liver cancer by 87 percent, liver transplant by 88 percent and diabetes by 43 percent. The need for hep C treatment is particularly urgent among those with advanced fibrosis or cirrhosis of the liver, since they stand the highest chance of progressing to end-stage liver disease. And delaying taking DAAs until fibrosis progresses apparently increases the risk of liver-related sickness and death among people with HIV. For those who are HIV positive, contracting HCV (as opposed to acquiring the viruses in the reverse order) can lead to rapid progression of fibrosis—in only a matter of months. That’s according to Fierer’s research; he’s one of the leading experts of acute, or very recent, hep C infection as well as sexual transmission of the virus among MSM. Fierer has long called for clinicians to make it standard practice to treat hep C during acute infection to help prevent this kind of damage to the organ. Immediately treating hep C among MSM who have contracted the virus sexually is an important component of the overall effort to slow the rate of new transmission of the virus. Clinicians such as Fierer also advocate for contacts tracing, whereby newly HCV-diagnosed MSM and PWID help recruit those in their sexual or drug-using networks for hep C testing and speedy treatment if necessary. “I think we have to be careful about finding everybody [with HCV] quickly, getting them diagnosed and cured to save their livers and to prevent ongoing transmission,” says Fierer. Hepatitis C treatment is notoriously expensive. And while increased competition among pharmaceutical companies
that manufacture DAAs has drawn prices down in recent years, a complete course of treatment still typically costs tens of thousands of dollars. Consequently, getting approval for insurance coverage for DAAs can be difficult for those who have less damaged livers, since people with worse liver disease tend to get moved toward the front of the line. However, HIV-positive indiv iduals may have an easier time getting DA As covered because HIV/HCV coinfection is considered a reason for prioritized treatment according to U.S. treatment guidelines. Hayden, who is an HIV activist, advises people with hep C who are struggling to get DAAs covered by insurance “to remember that it is not their fault that they don’t have access to the cure. It is the responsibility of coverage entities, our government and pharmaceutical manufacturers to ensure that these medications are accessible. And when those systems fail us, it is not our individual fault. We should seek help; we should find advocates and be as persistent and loud and noisy as we have to be until we get what we need.” Tom Eskridge, a 65-year-old retiree living with HIV in the Denver area who, to his surprise, tested positive for hep C in 2015—he says he probably contracted the virus sexually— received approval for coverage of DAA treatment from his insurer but still faced $1,500 in co-pays. “Which, considering the cost of the medication, is not that bad,” he says. “Still, that’s a terrible check to write.” His doctor’s office at Kaiser Permanente went to bat for him and was able to defray that extra cost thanks to money from the AIDS Drug Assistance Program as well as the manufacturer of his hep C regimen. MANY WHO GET THEIR HEP C CURED REPORT a near-immediate boost of energy and vitality. “I love the cure visits,” says Falade-Nwulia of the appointments when she delivers the good news to her hep C patients. “The patients are so happy. I’m happy. It’s like this huge burden has been taken off of them. They feel lighter, they feel happier, they feel more energetic. It’s amazing.” “As soon as I got cured, I put on 20 pounds,” says the 5-foot-11 Finkenbinder, who currently weighs 160 pounds. Hep C, Finkenbinder says “was literally wasting my body, and I didn’t even realize it.” Similarly, Barron was unaware of how much hep C had been contributing to his feeling of fatigue—a common effect of HCV—until the virus was eradicated from his body. “As a result of the cure, my energy level, my stamina has increased exponentially,” he says. “I’m 62 years old. I’m supposed to be slowing down with age, and I have people asking me all the time, ‘How can you do so much?’” “I can tell people that I’ve been cured of hepatitis C,” Barron continues. “I can’t tell them I’ve been cured of HIV. So the relief that I don’t have to disclose, or if I disclose that I had hep C, I can disclose that I’m cured of it. That’s peace of mind.’” Q
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HEROES ALICIA GREEN
“There’s wisdom with age, but there’s a lot more wisdom with age and HIV,” says Nelson Vergel. Like many long-term survivors, he initially considered his HIV diagnosis a death sentence. But despite the odds, the Venezuelan immigrant refused to give up. Vergel tested positive for the virus in 1987, three years after moving to the United States. “I arrived to this country and had a lot of dreams and plans,” says the Houston resident. His diagnosis compelled him to become a certified HIV counselor. A chemical engineer during the day, Vergel volunteered at Houston’s main HIV clinic at night. The virus ultimately caused him to experience HIV-associated wasting. But he bulked up with the help of anabolic steroids. “I not only felt better but also started to look like I didn’t have HIV,” Vergel says. Heartened by his results, he decided to raise awareness among doctors about the positive effects of these drugs on people living with HIV. He did extensive research on the synthetic hormones and created detailed fact sheets that he sent to physicians. “We were able to reverse wasting in the early ’90s,” he explains. “That brought us a few years to get to 1996, when the protease era came in.” He delivered lectures across the country and in 1994 cowrote Built to Survive, a guide to anabolic therapies, nutrition and exercise. That same year, he founded the Program for Wellness Restoration (PoWer) to help improve the quality of life of people living with HIV. Vergel is also an important advocate for salvage therapy. These treatments are the last resort for individuals like him who develop multidrug resistance. Although Vergel has been undetectable for five years, he still has a low CD4 count. He is known as an immunologic nonresponder (INR), a person with limited or no recovery of T cells despite viral suppression. Vergel is currently one of the driving forces behind an activist coalition pushing for the development of immune-boosting therapies in an effort to reduce the health risks of INRs. And he practices what he preaches. Case in point: He takes Trogarzo, a cloned antibody intravenously infused every two weeks, which was approved earlier this year by the Food and Drug Administration for the treatment of multidrug-resistant HIV among people whose current regimen is failing. “Long-term survivors have a lot of knowledge as a community,” Vergel says. “Somebody could tap into the power we have. We really are useful and still relevant.”
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LYNN LANE
Built to Survive
Nelson Vergel is a long-term survivor and HIV activist.
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H I V
Antiretroviral (ARV) options abound for both those who are new to HIV treatment and those who are experienced. This quick-reference chart compares medication options, including adult dosing and dietary restrictions. *Generic version available in the U.S.
CIMDUO
ATRIPLA
(lamivudine + tenofovir disoproxil)
(efavirenz + tenofovir disoproxil + emtricitabine)
One tablet once a day. Each tablet contains 600 mg efavirenz + 300 mg tenofovir disoproxil + 200 mg emtricitabine. Take on an empty stomach. Dose should be taken at bedtime to minimize dizziness, drowsiness and impaired concentration.
APTIVUS
EDURANT
Two 250 mg capsules plus two 100 mg Norvir tablets (or capsules) twice a day. Aptivus plus Norvir should be taken with food. Aptivus plus Norvir should not be taken with other protease inhibitors.
One 25 mg tablet once a day. Take with food.
(rilpivirine)
(tipranavir)
One tablet once a day. Each tablet contains 300 mg lamivudine + 300 mg tenofovir disoproxil. Take with or without food. Photo unavailable at press time.
Pills not shown actual size
COMBIVIR *
CRIXIVAN
(zidovudine + lamivudine)
COMPLERA
(rilpivirine + tenofovir disoproxil + emtricitabine)
One tablet once a day. Each tablet contains 25 mg rilpivirine + 300 mg tenofovir disoproxil + 200 mg emtricitabine. Take with a meal.
GENVOYA
(elvitegravir + cobicistat + tenofovir alafenamide + emtricitabine)
Single-Tablet Regimens
One tablet once a day. Each tablet contains 150 mg elvitegravir + 150 mg cobicistat + 10 mg tenofovir alafenamide + 200 mg emtricitabine. Take with food.
JULUCA
(dolutegravir + rilpivirine)
One tablet once a day. Each tablet contains 50 mg dolutegravir + 25 mg rilpivirine. Take with a meal.
DESCOVY
(tenofovir alafenamide + emtricitabine)
One tablet once a day. Each tablet contains 25 mg tenofovir alafenamide + 200 mg emtricitabine. Take with or without food.
EVOTAZ
(atazanavir + cobicistat)
One tablet once a day. Each tablet contains 25 mg rilpivirine + 25 mg tenofovir alafenamide + 200 mg emtricitabine. Take with a meal.
One tablet once a day. Each tablet contains 300 mg atazanavir + 150 mg cobicistat. Take with food.
EMTRIVA
(emtricitabine)
One 200 mg capsule once a day. Take with or without food.
INVIRASE EPIVIR *
(lamivudine)
One 300 mg tablet once a day, or one 150 mg tablet twice a day. Take with or without food. Also approved for the treatment of hepatitis B virus (HBV) but at a lower dose. People living with both viruses should use the HIV dose.
EPZICOM *
(abacavir + lamivudine)
(saquinavir)
Two 500 mg tablets plus one 100 mg Norvir tablet (or capsule) twice a day. Take with food or within two hours after a meal.
KALETRA
(etravirine)
One 200 mg tablet twice a day. Take with food.
RESCRIPTOR (delavirdine)
Two 200 mg tablets three times a day, or four 100 mg tablets three times a day. Take with or without food. Discontinued by manufacturer; phaseout to be completed by 2020.
SUSTIVA * (efavirenz)
One 600 mg tablet once a day, or three 200 mg capsules once a day. Take on an empty stomach or with a low-fat snack. Dose should be taken at bedtime to minimize dizziness, drowsiness and impaired concentration.
VIRAMUNE * (nevirapine)
(lopinavir + ritonavir)
Two tablets twice a day, or four tablets once a day, depending on HIV drug resistance. Each tablet contains 200 mg lopinavir + 50 mg ritonavir. Take with or without food.
One 200 mg Viramune immediate release (IR) tablet once a day for the first 14 days, then one 400 mg Viramune extended release (XR) tablet once a day. Take with or without food.
LEXIVA
(doravirine)
One tablet once a day. Each tablet contains 600 mg abacavir + 300 mg lamivudine. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.
ODEFSEY
(rilpivirine + tenofovir alafenamide + emtricitabine)
Two 400 mg capsules every eight hours, or two 400 mg capsules with either one or two 100 mg Norvir tablets (or capsules) twice a day. Drink at least 48 ounces of water daily to prevent kidney stones. Without Norvir: Take on an empty stomach (no food two hours before or one hour after dosing) or with a low-fat snack. With Norvir: Take with or without food.
Protease Inhibitors (PIs)
One tablet once a day. Each tablet contains 50 mg bictegravir + 200 mg emtricitabine + 25 mg tenofovir alafenamide. Take with or without food.
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs, or nukes)
BIKTARVY
(bictegravir + emtricitabine + tenofovir alafenamide)
(indinavir)
One tablet twice a day. Each tablet contains 300 mg zidovudine + 150 mg lamivudine. Take with or without food.
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs, or non-nukes)
INTELENCE
(fosamprenavir)
RETROVIR * (zidovudine)
One 300 mg tablet twice a day. Take with or without food.
Two 700 mg tablets twice a day, or two 700 mg tablets plus one or two Norvir tablets once a day, or one 700 mg tablet plus one Norvir tablet twice a day (recommended for individuals who have used other PIs in the past). Take with or without food.
One 100 mg tablet once a day. Take with or without food. Approval pending at press time. Photo unavailable.
One tablet of either Symfi or Symfi Lo (above) once a day. Each tablet of Symfi contains 600 mg efavirenz + 300 mg lamivudine + 300 mg tenofovir disoproxil. Each tablet of Symfi Lo contains 400 mg efavirenz + 300 mg lamivudine + 300 mg tenofovir disoproxil. Take on an empty stomach. Dose should be taken at bedtime to minimize dizziness, drowsiness and impaired concentration.
TRIUMEQ
(dolutegravir + abacavir + lamivudine)
One tablet once a day. Each tablet contains 50 mg dolutegravir + 600 mg abacavir + 300 mg lamivudine. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.
TRUVADA
(tenofovir disoproxil + emtricitabine)
One tablet once a day. Each tablet contains 300 mg tenofovir disoproxil + 200 mg emtricitabine. Take with or without food.
(didanosine)
One 400 mg capsule once a day. (One 250 mg capsule once a day for those weighing less than 133 lbs.) Take on an empty stomach (two hours after or one hour before a meal). Videx EC should be taken with water. It should not be taken with acidic juices, soda or milk. Videx EC should be taken at least two hours after or two hours before Aptivus or Reyataz. Avoid alcohol. Brand-name product discontinued; phaseout to be completed by 2020.
One tablet once a day. Each tablet contains 800 mg darunavir + 150 mg cobicistat. Take with food.
(doravirine + lamivudine + tenofovir disoproxil)
One tablet once a day. Each tablet contains 100 mg doravirine + 300 mg lamivudine + 300 mg tenofovir disoproxil. Take with or without food. Approval pending at press time. Photo unavailable.
SELZENTRY (maraviroc)
One 150 mg, 300 mg or 600 mg tablet twice a day, depending on other meds used. Take with or without food.
PREZISTA (darunavir)
ISENTRESS (raltegravir)
REYATAZ * (atazanavir)
Two 200 mg capsules once a day, or one 300 mg capsule plus one 100 mg Norvir tablet, or one 150 mg Tybost tablet once a day. Take with food.
(tenofovir disoproxil)
One tablet once a day. Each tablet contains 800 mg darunavir + 150 mg cobicistat + 200 mg emtricitabine + 10 mg tenofovir alafenamide. Take with food. Approval pending at press time. Photo unavailable.
One 300 mg tablet once a day. Take with or without food.
Two 625 mg tablets twice a day, or five 250 mg tablets twice a day, or three 250 mg tablets three times a day. Take with food.
ZERIT *
(stavudine)
(abacavir)
One 300 mg tablet twice a day, or two 300 mg tablets once a day. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.
TIVICAY
One 50 mg tablet once a day for those first starting ARV therapy or for those who have not used an integrase inhibitor in the past. One 50 mg tablet twice a day for treatment-experienced individuals who have HIV that is resistant to other integrase inhibitors and when taken with certain ARVs. Take with or without food.
(nelfinavir)
ZIAGEN *
Two 600 mg Isentress HD tablets (above) once a day for those who are treatment naive or whose virus has been suppressed on an initial regimen. One 400 mg Isentress tablet twice daily for people with HIV treatment experience. Take with or without food.
(dolutegravir)
VIRACEPT
One 40 mg capsule twice a day. (One 30 mg capsule twice a day for those weighing less than 133 lbs.) Take with or without food. Brand-name product discontinued; phaseout to be completed by 2020.
One 90 mg (1 ml solution) subcutaneous injection twice a day. Take with or without food. Fuzeon comes as a white powder that must be mixed with sterile water in a vial each day.
(darunavir + cobicistat)
One 800 mg tablet (or two 400 mg tablets) plus one 100 mg Norvir tablet, or one 150 mg Tybost tablet once a day, or one 600 mg tablet plus one 100 mg Norvir tablet twice a day, depending on drug resistance. Take with food.
VIDEX EC *
(enfuvirtide)
PREZCOBIX
VIREAD * (darunavir + cobicistat + emtricitabine + tenofovir alafenamide)
FUZEON Entry Inhibitors
Six 100 mg tablets twice a day. The full dose of Norvir is rarely used. It is most often used at lower doses to boost the levels of other ARVs in the blood. Take with food.
Monoclonal Antibodies
Single-Tablet Regimens
(efavirenz + lamivudine + tenofovir disoproxil)
(ritonavir)
One tablet twice a day. Each tablet contains 300 mg abacavir + 300 mg zidovudine + 150 mg lamivudine. Take with or without food. Should be used only by individuals who are HLA-B*5701 negative.
Integrase Inhibitors
SYMFI AND SYMFI LO
NORVIR *
(abacavir + zidovudine + lamivudine)
TROGARZO (ibalizumab)
Administered intravenously as a single loading (or initial) dose of 2,000 mg followed by a maintenance dose of 800 mg every two weeks.
PK Enhancer
One tablet once a day. Each tablet contains 150 mg elvitegravir + 150 mg cobicistat + 300 mg tenofovir disoproxil + 200 mg emtricitabine. Take with food.
TRIZIVIR *
Protease Inhibitors (PIs)
(elvitegravir + cobicistat + tenofovir disoproxil + emtricitabine)
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs, or nukes)
STRIBILD
TYBOST
(cobicistat)
One 150 mg tablet once a day in combination with ARVs that require boosting. Used only to boost other drugs. Take with food.
A HEALTHIER LIFE CAN START WITH HIV TREATMENT. Starting HIV treatment right after diagnosis can help stop the virus in your body. Because treatment helps lower the damage HIV causes to your immune system. Plus, doctors and scientists have found that it can help lower the risk of heart disease and certain cancers.
TREATMENT ALSO HELPS YOU PROTECT OTHERS. HIV treatment can help lower the amount of virus in your body. It can get so low, it can’t be measured by a test. It’s called being undetectable. And it helps lower the chance of passing HIV on to others by more than 90%.
STOPPING T CAN START
Here are two resour
Watch videos, share see how we can all h
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TALK TO YOUR HEALTHCARE PROVIDER.
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Have an open conversation. When you work together it helps your healthcare provider find the treatment that’s right for you.
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Watch HIV: “Treat 2 Prevent”
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