Maria Khan, Matthew Epperson, Disconnetted

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MAY+JUNE 2012 TWo EPIDEMICS Incarceration and HIV How the criminal justice system can play an effective role in the treatment and prevention of HIV

The benefits of Opt-out testing risk factors for women conference Update: croi B:16.5 in T:16 in S:15 in

www.egrifta.com YOU’VE WORKED TO CONTROL YOUR HIV. NOW, TIME TO WORK ON YOUR

FILE NAME 0053_EGR_AD_SPD_ HIV-RELATED EXCESS BELLY FAT. PA_May_August_ In two separate clinical trials of HIV-infected people with lipodystrophy, each lasting 6 months, EGRIFTA® (tesamorelin M3.inddDATE 03.30.12 for injection) reduced HIV-related excess belly fat by an average of 18% in the rst trial, and 14% in the second trial. CLIENT This reduction in excess belly fat resulted in an approximate 1-inch reduction in waist size. Individual results may vary. On ® Egrifta average, patients on EGRIFTA did not lose weight. PART # Like HIV, HIV-related excess belly fat is a chronic condition. In clinical studies: 120127-102148 • People who used EGRIFTA® continuously for 1 year maintained their results over this time period DESCRIPTION • People who stopped taking EGRIFTA® after 6 months had their HIV-related excess belly fat come back

EGRIFTA® is believed to work with your own body to produce natural growth hormone to reduce your excess belly fat. Print Ad Positively Aware - Spread SPECS Indication: EGRIFTA® is a daily injectable prescription medicine to reduce the excess abdominal fat in HIV-infected patients with lipodystrophy. Trim: 16 x 10.5” Limitations of use: Bleed: 16.5 x 11” • The impact and safety of EGRIFTA® on cardiovascular health has not been studied Safety: 15 x 9.5” • EGRIFTA® is not indicated for weight-loss management Gutter: 1” • It’s not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications Colors: 4C, CMYK • EGRIFTA® is not recommended to be used in children

COLOR INFO Important Risk Information • Injection-site reactions, such as redness, itching, pain, irritation, T:10.5 in S:9.5 in Do not use EGRIFTA® if you: bleeding, rash, and swelling. Change (rotate) your injection site to help B:11 in • Have pituitary gland tumor, pituitary gland surgery, or other problems lower your risk for injection-site reactions related to your pituitary gland ® • Have active cancer (either newly diagnosed or recurrent) or are The most common side effects of EGRIFTA include: receiving treatment for cancer • joint pain • numbness and pricking MECH. BUILT TO • Are allergic to tesamorelin or any of the ingredients in EGRIFTA®, • pain in legs and arms • nausea • swelling in your legs • vomiting 100% including mannitol or sterile water • Are pregnant or become pregnant • muscle soreness • rash PRINTED AT • tingling • itching Before using EGRIFTA , ® tell your healthcare provider if you: 100% ® • Have or have had cancer EGRIFTA will NOT cure HIV or lower your chance of passing HIV to others. • Have diabetes You are encouraged to report negative side effects of prescription • Are breastfeeding or plan to breastfeed drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. • Have kidney or liver problems • Have any other medical condition Please see Consumer Brief Summary of EGRIFTA® on following page. • Take prescription or non-prescription medicines, vitamins, or Ask your healthcare provider if EGRIFTA®, the rst herbal supplements and only FDA-approved medicine for HIV-related EGRIFTA® may cause serious side effects, including: excess belly fat, may be right for you. For more • Serious allergic reaction. Stop using EGRIFTA® and get emergency information, visit www.egrifta.com or call the help right away if you have any of the following symptoms: rash over AXIS Center at 1-877-714-AXIS (2947). your body, hives, swelling of your face or throat, shortness of breath or trouble breathing, fast heartbeat, feeling of faintness or fainting • Swelling (fl uid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome) • Increase in glucose (blood sugar) intolerance and diabetes Actual patient living with HIV since 2000 120127-102148 2/12 B:16.5 in T:16 in S:15 in

www.egrifta.com YOU’VE WORKED TO CONTROL YOUR HIV. NOW, TIME TO WORK ON YOUR

Consumer Brief Summary for EGRIFTA® (tesamorelin for injection) EGRIFTA® (eh-GRIF-tuh) – hives (tesamorelin for injection) for subcutaneous use – swelling of your face or throat – shortness of breath or trouble breathing Read the Patient Information that comes with EGRIFTA® before you start to take it – fast heartbeat and each time you get a refill. There may be new information. This leaflet does not take – feeling of faintness or fainting FILE NAME the place of talking to your healthcare provider about your medical condition or • Swelling (fluid retention).EGRIFTA ® can cause swelling in some parts of your body. 0053_EGR_AD_PI_PA_ your treatment. Call your healthcare provider if you have an increase in joint pain, or pain or ® May_August_M1.indd What is EGRIFTA ? numbness in your hands or wrist (carpal tunnel syndrome) DATE • EGRIFTA® is an injectable prescription medicine to reduce the excess in abdominal 03.27.12 fat in HIV-infected patients with lipodystrophy. EGRIFTA® contains a growth • Increase in glucose (blood sugar) intolerance and diabetes. Your healthcare provider CLIENT hormone-releasing factor (GRF) will measure your blood sugar periodically ® EMD Serono • The impact and safety of EGRIFTA on cardiovascular health has not been studied • Injection-site reactions. Change (rotate) your injection site to help lower your risk for • EGRIFTA ® is not indicated for weight-loss management PART # injection-site reactions. Call your healthcare provider for medical advice if you have • I t is not known whether taking EGRIFTA® helps improve compliance with the following symptoms around the area of the injection site: antiretroviral medications – redness – bleeding ® ® DESCRIPTION • It is not known if EGRIFTA is safe and effective in children. EGRIFTA is not – itching – rash Print Ad recommended to be used in children – pain – swelling Positively Aware - Who should not use EGRIFTA®? – irritation PI Page Do not use EGRIFTA® if you: The most common side effects of EGRIFTA® include: • have pituitary gland tumor, pituitary gland surgery, or other problems related to your – joint pain – nausea SPECS pituitary gland – pain in legs and arms – vomiting • have active cancer (either newly diagnosed or recurrent) or are receiving treatment – swelling in your legs – rash for cancer – muscle soreness – itching • are allergic to tesamorelin or any of the ingredients in EGRIFTA®. See the end of this – tingling, numbness, and pricking ® leaflet for a complete list of ingredients inEGRIFTA Tell your healthcare provider if you have any side effect that bothers you or that does not ® Trim: 8 x 10.5” • are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA and go away. Safety: 7 x 9.5” talk with your healthcare provider. See “What should I tell my healthcare provider These are not all the possible side effects of EGRIFTA®. For more information, ask your ® before using EGRIFTA ?” healthcare provider or pharmacist.

T:10.5 in S:9.5 in What should I tell my healthcare provider before using EGRIFTA®? Call your healthcare provider for medical advice about side effects. To report side effects, COLOR INFO Before using EGRIFTA ®, tell your healthcare provider if you: contact EMD Serono toll-free at 1-800-283-8088, ext. 5563. You may report side effects • have or have had cancer to the FDA at 1-800-FDA-1088. • have diabetes Keep EGRIFTA® and all medicines out of the reach of children. CMYK • are breastfeeding or plan to breastfeed. It is not known if EGRIFTA® passes into your ®: breast milk. The Centers for Disease Control and Prevention (CDC) recommends that General information about the safe and effective use of EGRIFTA HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not useEGRIFTA ® for a condition for which it was not prescribed. MECH. BUILT TO baby. Talk with your healthcare provider about the best way to feed your baby if you are taking EGRIFTA® Do not give EGRIFTA® to other people, even if they have the same symptoms you have. It 100% • have kidney or liver problems may harm them. PRINTED AT • have any other medical condition Do not share your EGRIFTA® syringe with another person, even if the needle is changed. Tell your healthcare provider about all the medicines you take, including prescription Do not share your EGRIFTA® needles with another person. 100% ® and nonprescription medicines, vitamins, and herbal supplements. EGRIFTA may affect This Patient Information leaflet summarizes the most important information about ® the way other medicines work, and other medicines may affect how EGRIFTA works. EGRIFTA®. If you would like more information, talk with your healthcare provider. You can Know the medicines you take. Keep a list with you to show your healthcare provider and ask your healthcare provider or pharmacist for information about EGRIFTA® that is pharmacist when you get a new medicine. written for healthcare professionals. ® How should I use EGRIFTA ? For more information about EGRIFTA®, go to www.EGRIFTA.com or contact the • Read the detailed “Instructions for Use” that comes with EGRIFTA® before you start AXIS Center toll-free at 1-877-714-2947. using EGRIFTA®. Your healthcare provider will show you how to inject EGRIFTA® What are the ingredients in EGRIFTA®? • Use EGRIFTA® exactly as prescribed by your healthcare provider Active ingredient: tesamorelin • Inject EGRIFTA® under the skin (subcutaneously) of your stomach area (abdomen) Inactive ingredients: mannitol and Sterile Water for Injection • Change (rotate) the injection site on your stomach area (abdomen) with each dose. Do not inject EGRIFTA® into scar tissue, bruises, or your navel • Do not share needles or syringes with other people. Sharing of needles can result in the transmission of infectious diseases, such as HIV What are the possible side effects of EGRIFTA®? EGRIFTA® may cause serious side effects including: • Serious allergic reaction. Some people taking EGRIFTA® may have an allergic reaction. ® Stop using EGRIFTA and get emergency help right away if you have any of the © 2012 EMD Serono, Inc. 120120-161843 2/12 All rights reserved. following symptoms: EGRIFTA® is a registered trademark of Theratechnologies Inc. – a rash over your body Distributed by EMD Serono, Inc., Rockland, MA 02370 MAY+JUNE 2012 VOLUME 24 NUMBER 3

Conference update: Mount Rainier looms over Seattle’s skyline as the city hosted the 19th Conference on Retroviruses and Opportunistic Infections in March. Page 44

Departments c o v e r F e at u r e s

Editor’s Note Two epidemics Female trouble A prison of our own making. How the criminal justice system has Studies look at the factors that lead 5 played a role in the HIV epidemic. some women to HIV and incarceration. 17 34 In Box 6 Money well spent Disconnected Opt-out testing in prisons can catch STD Incarceration cuts you off from your PA ReaderS’ poll cases—and save tax dollars. social network—and HIV thrives on that. 7 23 36

Briefly Positive progress Prosecuting HIV Victrelis not recommended with some Improvements in testing, technology, Take the test—and risk arrest? HIV meds. Dolutegravir non-inferior to and continuity of care. 38 Isentress. Viread and kidney risk. 27 8

Ask the HIV specialist F e at u r e s C o n f e r e n c e U p d at e You have the right to treatment while incarcerated. Return of ‘The Normal Heart’ 19th Conference on Retroviruses 43 Larry Kramer’s iconic play will coincide and Opportunistic Infections with the International AIDS Conference. Cure research, PrEP news, and more. The Buzz 11 44 Hep C news from CROI. 49 Seen in Seattle Taking in the sights while at CROI. Wholistic picture 48 Law vs. injustice. 53

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 3 Read the print version of version print the e Read l ta i g i D www.positivelyaware.com/2012/12_03/arick.shtml continues. advocate HIV of an journey The Buckles Arick Activist www.positivelyaware.com/2012/12_03/croi.shtml therapy. pediatric in Advances transmission. and contraceptives hormonal on Update thought? previously as bad with HIV—notAging as CROI news from More www. EXCLUSIVELY http://issuu.com/positivelyaware 4

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our Y e Po ou may use may ou l a y Aw sitiv rti .COM a e c re l y les Joel Gallant, MD Gallant, Joel Jim Pickett, Matt Sharp Matt Pickett, Jim IS PUBLISHED BY PUBLISHED IS associate editor POSI adv W C contri C Ed copy 5537 N 5537 www.positivelyaware.com [email protected] e photographers proofrea Gary Bucher, MD Bucher, Gary C [email protected] [email protected] fax phone M l a i r o t i d E distribution coordinator distribution Swarup Mehta, PharmD Mehta, Swarup Sal Iacopelli, Laura Jones, Laura Iacopelli, Sal Bradley PMazzie Bradley Hayes Lorraine PA Cristofano, Michael MD Berger, S. Daniel Green, R. Keith d d reative hris Knight, Joshua Thorne Joshua Knight, hris 60640 IL hicago, e e itor-in- : b M (773) 989–9494 (773) s r o s i v d a l a c i d T e : I (773) 989–9400 (773) VELY A rtising inquiri rtising aste . Broa b itor itor uting writers uting d C irector r lyAw e v i t i s o P W e hief Joshua Thorne Joshua r Sue Saltmarsh Sue d A Liz Highleyman, Liz R way S Jason Lancaster Jason E Jeff Berry Jeff Enid Vázquez Rick Guasco Rick t. e s a m o c . e r

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A prison of our own making

There are times in our life when we may feel doors, I found myself standing in trapped and caught up in circumstances or situations a glass control room which was stationed in the center of a large over which we have absolutely no control. Whether it’s gymnasium-like room, with bunk an unhappy or unhealthy relationship, an addiction, a beds all around, and no privacy boring job or a career that’s going nowhere, we find whatsoever. The inmates who were in for murder or violent crimes were ourselves looking for an escape, but somehow can’t sectioned off from the rest of the seem to find a way out, or a path forward. unit, and it was all quite dehuman- It was izing. It makes one wonder what obvious An individual who is in jail or prison would seem to living with the rest of the general population of the jail that they be the prime example of a person who is powerless and must be like, to choose to live in K-11. had made doesn’t have the ability to make any choices or deci- I did learn a very valuable lesson that day, in that the a choice sions to improve their current situation. It’s no surprise experience shattered any preconceived notions I had to exert that there is gang activity, rape, and drug abuse behind held up until then about individuals who are behind bars. some power bars—undoubtedly, for some, these seem to be the only As I spoke to a group of about 50–60 men, I realized that over their choices they have to exert any kind of power or control. these guys were bright, articulate, and eager to learn own set of When a person tests positive for HIV, they may often about HIV, and they blew me away with their knowledge circumstances, feel a similar sense of loss of power or control, and for and their questions. It was obvious that they had made a and take those who find out they’re positive when they enter a choice to exert some power over their own set of circum- control of correctional facility, that powerlessness is multiplied. stances, and take control of their future. It gave me hope, their future. This is a crucial point in their viral life cycle, if you will. and it was an experience I will never forget. It gave me The support systems they could have had in place, such Just like those men in the K-11 unit had taken control hope, and as family, friends, other people living with HIV who they of their lives and the situations they found themselves it was an can trust, a good doctor who is knowledgeable about in, so can we all. If you’re in an unhealthy relationship, experience HIV and AIDS, and access to quality health care and get out. If you are suffering from an addiction, seek I will never treatment, can make all the difference in how well a help. And if you don’t like your job, well, at least you forget. person manages their diagnosis and their health going have one. Deal with that situation at work that makes forward. But there are often times when even more basic you miserable. Or maybe it’s time to think about going needs, such as food, housing, substance abuse and/or back to school so that you can get a job that’s more mental health treatment, and employment, must first be fulfilling. Stand up for yourself, believe in yourself, and addressed before someone can even consider treatment. make that change, because believe me, no one is going In March of 2007 I was invited to give a talk on AIDS to do it for you. You may just be in a prison of your own activism at the Los Angeles County Jail, the largest making, or you may be behind bars, but remember that county jail in the U.S., which has 20,000 inmates at any you have the power to tear down those internal bars given time. Housed in the men’s tower of the immense and start building a better life, one in which you are twin tower jail is the K-11 unit, where inmates who are empowered to make healthy and positive choices that gay, bisexual, or transgender can choose to live in a are good for you, and good for those you care about. segregated facility (see “The K-11 Unit” in the May/June The limits and challenges of living in any kind of prison, 2007 issue). be it in our minds, our bodies, or the real thing, are ight The experience for me was scary, exhilarating, and never more powerful than our will to survive. n illuminating, all at once. It certainly quashed any gay prison sex fantasies I may have had, and it was noth- Take care of yourself, and each other. hris K

: C ing like the homoerotic scenes from the HBO series “Oz.” After going through security and walking down HOTO

P what seemed liked endless hallways and locked, barred

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 5 In Box join the conversation: [email protected] and on Twitter @posaware ‘Positively impressed’

I was very positively impressed with what you presented in the March+April issue on HIV drugs. We are primary and secondary providers of HIV care within a huge academic environment and are always looking for ways to ensure patients understand the importance of cred- ibility and good sources of reliable information to help them engage in and manage their own care.

As pharmacy team case managers, we But when your focus have contact with every patient who starts shifted to attempt to or changes an antiretroviral treatment regi- keep (or move) HIV/AIDS men in order to assess their readiness and patients to a more God- understanding of treatment, so all of what based mind-set? I found you presented in this issue is of tremendous this to be most definitively relevance and importance. We pull infor- inappropriate and unsuccessful. Your There are many, many Christian allies mation from several sources to assist our articles made no new convert of me, and, in the fight. We are gay, straight, black, patients, but this is the first time I’ve seen in fact, much of the information you pro- white, Methodist, Catholic, Church of something so concise in one publication vided (such as Ms. Patterson’s confusing Christ, Presbyterian (you get the picture), that is not only useful to the patients but article on faith-based-organizations which and even Baptist. We are followers of to those of us who have to refer back often are admittedly not fully rooted in religious Christ and we come in all stripes. to this information as well. I’ve also book- principles, or in the wholly unhelpful What I want Sal Iacopelli to know is marked your website for future reference. advice by Father Kovach) showed the that we fight for him, too. We use our Thanks for offering such great informa- effort would—and should—be futile. Christian values, that he derides, to push tion in your publication! I have expressed my full thoughts in for love, compassion, and social justice. —Robert B. Blackwell, MSN, RN, ACRN a three-part series on my Atheist blog. We get in trouble. We “act up” and we Vanderbilt Comprehensive Care Clinic These can be found at http://bit.ly/ stand up for him. It’s what Jesus would do. Nashville, TN FaithandHIV, http://bit.ly/FaithandHIV2, Please don’t paint us all with the same and at http://bit.ly/FaithandHIV3, and at brush. Beyond belief Facebook.com/thehonestatheist. —Wayne Smith, Director As an openly HIV-positive person Again, thank you for the work that you Samaritan Ministry and a proud Atheist, I was glad to see do. I will continue reading your important Central Baptist Church of Bearden that your recent “Living on a Prayer” journal! Knoxville, TN [January+February] issue did not forgo —Mark Panzarino any of the truly necessary items for some- via the internet Book of love body living with HIV—particularly the The “church” never has been and never medical journal summaries and clinical trial Article of faith will be perfect. One cringes at all the harm information. My life is not sustained on any I just love PA. Your magazine has been my that the church has caused in the name prayers, but on advanced medical science. guide and teacher since 2004 and I always of Christ. And, unfortunately, the present I found the most fascinating and suc- appreciate the insights and the info. We day church in many cases is no better. cessful aspects of your issue were those order multiple copies for our support The problem, to me, has always been, and that focused on the topic of keeping HIV/ groups, and I think PA has been a lifesaver probably will always be, when we try to AIDS patients healthy, tested, medicated, for some of our clients. Can’t wait for the use the Bible as a “proof text” to support a informed, and educated. These articles did next issue. preconceived set of beliefs or behavior. an excellent job, even while approaching I run a faith-based HIV/AIDS service The Bible is not a science text, or phi- their religious topics (for example, the organization and we have worked tire- losophy, or even an accurate history. Every article about gay Muslims with HIV by lessly for 16 years against fundamentalist time in history that the church has tried Ms. Saltmarsh, or while addressing the ideology and stigma, and, dare I say, hate to make the Bible something it isn’t, the church’s restraint of scientific research in the Christian community. It is there for church has run into problems. The Bible over the past 1,000 years by Mr. Iacopelli). sure, but it’s not all of us, by any means. cannot be used as a proof text for science,

6 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m Readers’ poll for philosophy, or for history. What the I respect the right of anyone to choose What matters to you most Bible does is tell us how we are to relate to to believe in that fairytale as long as they about HIV medications: God and to our fellow man. respect my right to believe in my own and convenience, effectiveness, When we treat the Bible as a love don’t try to tell me what I can and can’t do side effects, long-term toxicity, story—God’s love for His creation and our with my body, or who I can and can’t love. or cost/access? response to His love, we can come to a Sometimes I think it would be best for Results from the March+April better understanding of what the Bible us all if those who believe in the Christian Readers’ poll actually teaches. Just as God’s love is myth were to live in one area of the all-embracing so should our love be. My country (they can have Texas and their suggestion to anyone who doubts what President Rick Santorum) and the rest of convenience: the Bible really teaches is that they read, us could be free of them and their funda- re-read, and study 1 John. John’s letter mentalist terrorism. For me, I’d want to live is filled with the teaching of love. 1 John where Sal does. side effects: 4:16 has become the one verse which, —Lynn O’Biele to me, seems to summarize the entire via the Internet Bible—“And so we know and rely on the cost/access: love God has for us. God is love. Whoever There’s an app for that lives in love lives in God, and God in them.” I saw your article regarding active inter- Long-term In spite of all the harm the church may vention on gay social apps and wanted to toxicity: have caused over the years, there is also share some thoughts on the Know Your no other organization which has brought Status campaign we use at Hornet. about as much good. And who can really Since stats show that HIV infections effectiveness: deny the results that could be realized if are on the rise and public awareness all mankind would live by the command- campaigns are muted, less present, and ments to love God and neighbor. fatigued, we built our positive intervention —Richard Servis strategy around focus groups and ways via the Internet to help remind our community about their personal choices. Your comments: Personal belief In addition, the choices an individual “It makes no difference if a medication is I just want to applaud Sal Iacopelli for tell- user makes for having a community talk convenient, effective, or has side effects ing the truth about not just the Catholic about HIV are equally important. Many if you cannot afford or have access to it.” church, but the whole “Christian” mess. social apps go to great lengths to hide this It is way too popular, even among gay, discussion and limit it. In fact, we some- “I’m most worried about long-term side HIV-positive people, to gush about “God’s times prevent users from disclosing their effects and problems caused by the love” when way too many experience any- status in profiles. However, for some users medication since the regimen is once thing but love from those who claim to be it’s hard for them to find the right time daily, for life, and I’m just 25.” devoted to a religious faith. That was clear in to disclose, and there needs to be more the article about the Muslim community too. understanding around viral loads, early “These factors have to all be taken into This country was formed from a desire detection, and STIs. consideration. However, the ultimate for religious freedom, but these days, Thank you for the article on reaching importance is how effective an ARV or that is becoming lost in the fundamental- out to young gay men through Grindr. This any medication is.” ist Christian determination to obliterate is an important conversation and I hope everyone else’s freedom and impose the you continue to explore gay social apps. this issue’s poll question: absurd, illogical, and hypocritical “teach- —Sean Howell What do you think is the best way ings” of the Bible on everyone. via the Internet to provide HIV testing in prisons? n Test if inmate requests it n Test unless inmate refuses it (opt-out) Do the write thinG. Positively Aware treats all communications (letters, e-mail, n Test whether inmate wants it or not etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for (mandatory) length, style, or clarity. Unless you tell us not to, we will use your name and city. n Don’t test at all n Not sure Positively aware We read you. 5537 N. Broadway St. SHare your comments Chicago, IL 60640 about our articles at cast your vote at [email protected] POSITIVELYAWARE.COM positivelyaware.com

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 7 BRIEFLY Enid Vázquez

FDA to consider Victrelis ‘not recommended’ Truvada for PrEP with some HIV meds The HIV medication Truvada (Viread plus The new hepatitis C drug Victrelis (boceprevir) is “not recommended” to be taken Emtriva in one pill) has been accepted by with some HIV medications, according to a “Dear Doctor” letter issued in February the FDA for a six-month Priority Review by Merck & Co. Merck reported drug interaction data showing that Victrelis and for use in preventing HIV infection. Such some HIV medications reduce each other’s effectiveness when taken together. use by HIV-negative individuals is called As a result, the company does not recommend that Victrelis be taken with any PrEP, for pre-exposure prophylaxis (pre- Norvir-boosted HIV protease inhibitor (Aptivus, Crixivan, Invirase, Kaletra, Lexiva, vention). Gilead Sciences’ supplemental Prezista, or Reyataz). New Drug Application (sNDA) for Truvada The Food and Drug Administration (FDA) reported that patients already taking PrEP is set to go before the FDA on June 15. Victrelis along with a boosted HIV protease inhibitor should not stop any of their medications, but consult with their doctor. The FDA also suggested that providers closely monitor these patients for their antiviral response to both treatments. Along with Victrelis, Incivek (telaprevir), the other new hepatitis C protease Dolutegravir aces inhibitor medication that was FDA approved in May of last year, also interacts with some HIV medications. Of the HIV protease inhibitors, it can only be taken with SPRING-2 study, boosted Reyataz. It can also be taken with Sustiva and Isentress, with an increased now available via EAP dose of Incivek if taken with Sustiva. But the company behind Incivek, Vertex Pharmaceuticals (with development originally by Tibotec Pharmaceuticals), made Initial results of a large Phase 3 study of these interactions known at the time of FDA approval. dolutegravir, an investigational second- In his outstanding blog HIV and ID Observations, Dr. Paul Sax wrote, “For now, generation integrase inhibitor, showed it to the bottom line is that there really is no optimal HCV protease inhibitor for HIV/HCV be non-inferior to Isentress. “Non-inferior” co-infected patients, especially for those on a boosted PI. And why careful assess- is a scientific designation applied to study ment of those with HIV/HCV is critical [since] many patients are stable enough to results meaning that the drug studied is not wait for the next wave of HCV drugs.” less effective than the one it is compared to. If approved, dolutegravir may be at an advantage because it is given once a day, New edition of HIV Intelence now for kids while Isentress is given twice daily. The SPRING-2 study looked at about Q&A book available ages six and older 800 individuals taking HIV therapy for the The second edition of 100 Questions The HIV drug Intelence (etravirine) first time, half of them on a regimen with & Answers About HIV and AIDS by Dr. received approval from the Food and 50 mg dolutegravir once daily and half on Joel Gallant is now available. Dr. Gallant Drug Administration (FDA) for use by a regimen with Isentress (400 mg twice is a frequent contributor to PA and the children ages six to 18 weighing at least daily). ViiV Healthcare and Shionogi & Co. doctor for the Positively Aware 35 pounds, who have previous anti-HIV reported that through 48 weeks, both HIV Drug Guide for the last two years. treatment experience. This includes groups achieved undetectable viral load This handy book children whose virus has developed (less than 50 copies per mL): 88% of the provides answers to drug resistance to the same class of study participants given dolutegravir vs. the most common medications as Intelence (non-nucleoside 85% of those given Isentress. questions asked by reverse transcriptase inhibitors, or Dolutegravir is now available through people living with NNRTIs). Sustiva and Viramune are the an expanded access program (EAP), HIV and AIDS, their NNRTIs previously available for pediat- which allows for drugs not yet approved partners, and their ric use. A new scored 25 mg tablet of by the FDA to be provided free of charge families. Order your Intelence is now available for pediatrics. to those in great need. copy today from For more information about the Go to www.positivelyaware.com/ Amazon.com and drug, go to www.positivelyaware.com/ dolutegravir and www.dolutegravir-eap. jblearning.com. intelence. com for details.

8 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m Read more in-depth versions GET BRIEFED | at positivelyaware.com/briefly

New guidelines recommend ART for all

Treatment guidelines from the U.S. For people with less than 350 CD4+ T-cells, n People over age 50 Department of Health and Human Services the recommendation is “strong” based on n Anyone with a history of an AIDS- now recommend that all people with HIV data from randomized controlled studies defining illness be put on antiviral therapy. According to (the gold standard of research). For people n People with HIV-associated the panel of experts (including advocates with CD4 counts between 350 and 500, the nephropathy (HIVAN)—kidney damage living with HIV) that updated the guidelines recommendation is also “strong,” but based or disease, and on March 27, this and other changes “are on data from “well-designed nonrandom- n People who also have hepatitis B primarily based on increasing evidence ized trials or observational cohort studies showing the harmful impact of ongoing with long-term clinical outcomes.” And for Other changes to the guidelines include HIV replication on AIDS and non-AIDS dis- people with CD4 counts greater than 500, new sections on older patients with ease progression. In addition, the updated the recommendation is “moderate” and HIV, the use of hormonal contraception recommendations reflect emerging data based on expert opinion. (there is conflicting data on whether they showing the benefit of effective ART [anti- As always, there are certain groups of increase the possibility of transmission), retroviral therapy] in preventing secondary individuals for whom the panel recom- hepatitis C and tuberculosis information, transmission of HIV.” mends treatment no matter what their CD4 new drug interactions, and updates on The panel divides the strength of their counts are: transmission. See the guidelines at www. recommendations into three categories. n Pregnant women aidsinfo.nih.gov.

Viread and kidney risk

Despite new data from the Veterans’ Administration (VA), the The observational study conducted by the San Francisco Viread (tenofovir) story remains the same: patients taking VA Medical Center and the University of California, San Viread should be monitored for kidney toxicity, especially if Francisco looked at the electronic health records of nearly they have risk factors such as hepatitis C, high blood pressure, 11,000 VA patients with HIV (the majority of them male). or diabetes. The study was published in February’s issue of The study looked at three types of renal problems and after AIDS and is available at www.natap.org. controlling for other risk factors, they found that each year of Dr. Joel Gallant of Johns Hopkins University explains that, tenofovir use was associated with a 34% increased risk of pro- “The VA study essentially confirms what we already know: that teinuria, 11% increased risk of rapid decline in kidney function, tenofovir can cause kidney damage in some people who take and 11% increased risk of chronic kidney disease (CKD). These it. It isn’t surprising that the risk increases with longer time risks were found after weighing other risk factors such as older on the drug; that’s true of most drug toxicities. Tenofovir has age, non-white race, and smoking. been included in the vast majority of clinical trials involving ini- The researchers wrote that based on this data, “If you were tial antiretroviral regimens. These trials have universally shown to follow 1,000 HIV-infected patients for a year, you would excellent long-term safety, including minimal development of expect to see 50 extra cases of significant protein in urine, 38 kidney toxicity.” extra cases of rapid decline, and 11 extra cases of chronic kid- The risk of kidney damage may be higher when Viread is ney disease in users of tenofovir versus non-users.” combined with protease inhibitors, used by older people or Said Dr. Gallant in an email message, “Remember that those with pre-existing kidney disease, or in people who are while an increased risk of ‘11% to 34%’ sounds scary, an 11% taking other kidney-toxic drugs, such as non-steroidal anti- to 34% increase in a very low risk is still a very low risk. As an inflammatory drugs (e.g., ibuprofen). example, if your risk of developing kidney disease without However, Dr. Gallant added, “We know how to monitor for tenofovir is 1% per year, and tenofovir increases your risk kidney toxicity, which generally happens gradually. We can by 11% to 34%, then your risk of kidney disease on tenofovir always change drugs if it occurs.” becomes 1.11% to 1.34% per year.”

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 9 Sign up for the weekly email newsletter of BRIEFLY E-NEWS | positively aware. go to positivelyaware.com

Doing what Fred Says

Dr. Rob Garofalo is a physician who has treated HIV-positive children and adolescents for more than two decades. He was diagnosed with cancer in 2006 and at a particularly low point in his life, he searched the Internet for “puppy Chicago” and an image of Fred popped up. Although he had never previously had a pet, Garofalo credits the Yorkshire terrier with bringing both peace and joy to his life again. Fred’s healing properties have now led to a creative project Video readies inmates for return to society aimed at helping teens who are HIV- The video “Outside the Walls: Life Beyond HIV,” from the AIDS Foundation of Chicago positive and uninsured. (AFC), will be shown inside Illinois Department of Corrections (IDOC) facilities starting this By selling “Fred Says” year. The four-minute video features two former inmates who are living with HIV along greeting cards online, Garofalo is raising with AFC Director of Correctional Health and Community Affairs Rev. Doris J. Green. money to help this vulnerable population. Angela McLaurin describes that moment in 1995 when she tested positive for HIV while According to their website, doc and dog in prison as “the wake-up call.” Upon her release, Angela used an HIV services directory have four goals: to link herself to resources, but she knows that a booklet of information is no substitute for individual assistance. That’s why she and Tawon Dale, both members of the AFC n to raise as much money as possible Community Advisory Board, agreed to appear in the educational video, to encourage for HIV-positive teens without health inmates to know their HIV status and connect to HIV/AIDS services upon release. insurance, “I’m a testament to the fact that there is life beyond HIV,” says Angela, a motivational n to be as popular as ”Boo” on Facebook speaker and educator. “Early detection is key because what I’m seeing is that people don’t (he’s Fred’s idol), get tested until it’s way too late. And it’s sad because the help is out here.” n to have their efforts noticed by Ellen Rev. Green talks about the services Degeneres, and to go on her show available, including housing, and says, (Fred just loves her), and “When you return to the community, know n to sell enough cards that they can make people care.” Rev. Green has worked for a beneficial impact on teens with HIV. years to bring HIV education into prisons and jails and it was through her work as Garofalo is an attending physician at liaison between AFC and IDOC that pro- Children’s Memorial Hospital in Chicago, duction of the video was possible. 1.5% and Director of both the hospital’s The video is available as a free down- percentage of the 2.2 million Adolescent/Young Adult HIV Program and load at http://bit.ly/outsidethewalls and is inmates incarcerated in U.S. the Gender, Sexuality, and HIV Prevention also being distributed in Chicago neigh- prisons and jails who have Center. Garofalo is a strong advocate for borhoods as a DVD through Men & Women HIV or AIDS, roughly four HIV-positive adolescents through primary in Prison Ministries, a non-profit organiza- times the rate of the general patient care and innovative HIV prevention tion that provides support to incarcerated population. research projects. To help him and Fred populations, their families, and the com- Source: U.S. Bureau of Justice reach their goals, go to www.fredsays.org. munity at large. It can also be viewed at Statistics (2008) A $1 e-card can help teens living with HIV. www.aidschicago.org/corrections.

10 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m initially slated to run suddenly dropped Jim Parsons and Luke out, there was an opportunity to bring The Macfarlane in the 2011 Normal Heart to Arena Stage. Broadway production This production of the play has been of The Normal Heart. sanctioned as an official event of AIDS 2012, which is the first international AIDS conference being held in the U.S. since President Obama lifted the 22-year travel ban against HIV-positive individuals entering the U.S. More than 20,000 delegates will descend upon the nation’s capital for the conference, as well as national and international press, during the final week of the play’s run. But even beyond that, says Obie, it was seen as an opportunity to engage with the community for the entire seven-week run on what is still a very important story. When asked about the play’s sig- nificance some 25 years after it was first written, Obie simply states, “It’s timeless.” There was definitely a tide that turned at some point during the course of the epidemic, continues Obie, “but it’s only because of the work of advocates and activists like Larry Kramer, who were ‘The Normal Heart’ passionate and managed to sustain that passion in their work and in their activism over the last several decades.” goes to Washington The production is a replica of the original Broadway show, says Obie, including Larry Kramer’s Tony Award-winning play director George C. Wolfe and design- to coincide with the International AIDS Conference ers David Rockwell (sets), and Martin Pakledinaz (costumes). “Obviously it’s by Jeff Berry moving from city to city, so it’s something that had to be made ‘troupe-able’ as they say.” At press time, the show was being The national tour of the Broadway production cast from New York City, and the casting of Larry Kramer’s Tony Award-winning play The Normal Heart director had reached out to original cast launches in Washington, D.C. in June, with the end of the play’s members, some of whom had expressed interest, though maybe in different roles. run coinciding with AIDS 2012, the biennial international AIDS However, Obie says that as a regional the- conference, this year held in D.C. July 22-27. ater, they felt it important to try to include some regional actors in the play as well. The winner of three Tony Awards in 2011, regional production of The Normal Heart “It feels good to know that the Arena including Best Revival of a Play, The Normal at the prestigious Kreeger Theater. In an Stage has the capacity, and has the Heart follows the sexual politics of New York interview with Positively Aware, Edgar relationships with the artists, to deliver during the initial AIDS crisis as a tight-knit Obie, Arena Stage’s Executive Producer, something as important as this to our group of friends refuse to bury the truth of admits that there was a lot of serendipity community.” an unspoken epidemic. Larry Kramer, the involved with the timing of the play. s co-founder of both ACT UP (AIDS Coalition “When we got it all sorted out,” says u

rc to Unleash Power) and Gay Men’s Health Obie, “Daryl Roth, who is the commercial The Normal Heart runs June 8–July 29, Crisis in New York City, wrote the play while producer, said ‘it’s as if it was always 2012, at the Kreeger Theater, 1101 Sixth St.,

an Ma he was in Washington, D.C. following the meant to be.’ ” Molly Smith, the theater’s SW, Washington, D.C. For tickets call (202) devastating experience of watching many of artistic director, saw the play on Broadway 488-3300 or go to www.arenastage.org. his friends succumb to AIDS. and was deeply affected by it, according For information about AIDS 2012 or

Photo: Jo Arena Stage will produce the first to Obie. When a play which had been to register, go to www.AIDS2012.org.

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

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

To order, go to www.adaywithhiv.com/book Two Epidemics: Incarceration and HIV

How the criminal justice system has played a role in the HIV epidemic

by David Alain Wohl, MD

How did HIV and our criminal justice system become Here in the U.S. during the infancy of so well acquainted? The answer involves Darwinian evolution, the HIV epidemic, it was the bathhouses and bars that urban gay men favored 1980s era AIDS activists, the science of viral transmission, and where the virus was to be found. Within Richard Nixon—a confluence of seemingly unrelated events, a few years, thousands of infected gay crossed with the laws of unintended consequences, that led the men died and an anguished community responded with a strong push for safer, virus that infected Rock Hudson to now be concentrated among less risky sex. those who find themselves doing time. HIV then found an opportunity among

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 17 The U.S. has 5% of the world’s population but 25% of its prisoners. We incarcerate more people 2,500,000 per capita than any nation—A total of 2.5 million.

injection drug users and heterosexuals most, including the federal prison system, whether this is mostly sexual or via tattoo- living in poverty—people who were no offer HIV testing on a voluntary or opt-out ing and needle sharing. In almost all states, strangers to the U.S. criminal justice sys- basis. Therefore, not everyone, including condoms are not permitted in prisons and tem. Before long places like the Bronx and those at high risk, is tested. jails. Similarly, clean needles, bleach, and central Philadelphia had rates of HIV that According to government estimates safe tattooing equipment are typically rivaled those found in some African coun- there are about 22,000 people with HIV unavailable. Data from Canada and Europe tries. Cut to our nation’s prisons and jails. in prison, but the prevalence rates vary suggest that such interventions, proven considerably (0.2% in Montana and 5.8% effective in other settings, can be imple- An Epidemic of Incarceration in New York).2 The number of HIV-positive mented safely in prisons. However, there The U.S. is a superpower when it comes inmates in jails, where people are housed has been little interest in uptake of these to locking people up. We have 5% of the before conviction and transfer to prison, is measures in the U.S. This reflects a long- world’s population but 25% of its prison- a mystery, but if the prevalence is close to standing philosophical tension between the ers.1 We incarcerate more people per that seen in prison, we are talking about mores of the correctional culture in the U.S. capita than any nation on the planet— another 11,000 HIV-positive detainees. and public health’s reliance on evidence- about 2.5 million—and have another five based prevention methods. million under parole or other form of The Effects of Incarceration Of even greater importance than the supervision in their communities.2 This on the Spread of HIV spread of HIV within prisons and jails are massive incarceration has been brought With the entrenchment of HIV in our the broader socially disruptive effects of to us by the ”war on drugs.” Launched in correctional populations, there has been incarceration. The impact of imprisonment the early 1970s by President Nixon, the considerable thought given to the ways in extends well beyond the individual placed campaign to stamp out drug use through which incarceration facilitates the spread in a cell and reaches his relationships and arrest and imprisonment led to a strato- of HIV. It is a common perception that HIV his community. Stable, protective, intimate spheric increase in the number of people, is spread within correctional settings, as partnerships are disrupted, if not ended, especially people of color, sent to prisons predatory and consensual sex is known especially with prolonged incarceration.6, 7 and jails. Further swelling our correctional to occur in prisons and jails, places where This can lead the partner left in the com- facilities were the Sentencing Reform Act condoms are contraband. munity vulnerable to infection via new of 1984, curtailing alternative sentencing, While there are clearly documented relationships formed in the absence of the “three strikes” laws of the 1990s, and cases of HIV transmission in correctional the incarcerated partner. In communities harsher sentencing guidelines for crack settings, most data point to the lion’s where HIV and other sexually transmit- cocaine than for powdered coke. share of the HIV–positive individuals in ted infections are more endemic, this can The number of people incarcerated prisons and jails having acquired the virus greatly increase the risk of infection. each year has started to level out, and while free. Testing of inmates entering As the vast majority of prisoners are the population that is incarcerated has prison and jails finds high rates of infec- released, those returning to their com- declined—a consequence of an aging tion, as described above—likely reflecting munities may now face an even greater risk population, fairer sentencing laws, and a the incarceration of those with or at high of HIV transmission. For the HIV-negative move away from conditional release, such risk of HIV rather than the locking up of former inmate, reconnecting with a partner as parole, that can make re-incarceration uninfected people who are then placed in who had sex with other partners during the more likely. Still, one in 32 Americans is a high-risk environment. One study that incarceration, or who finds new partners involved in the criminal justice system in actually tested inmates in Rhode Island post-release can result in exposure to HIV. one way or another.1 both on prison entry and then again on The risk behavior of HIV-negative released release found no cases of HIV acquisition men is well described and demonstrates When Epidemics Collide during incarceration.4 that the potential for acquisition of HIV At the same time that the nation went on On the other hand, an attention- after, rather than during, incarceration is its incarceration spree, HIV was jumping grabbing report a few years ago did real.8 Much less is known about the behav- from gay men to substance abusers. It describe the detection of a number of ior of HIV-positive men and women after did not take long for HIV (and hepatitis inmates who tested HIV-negative when prison release. Work conducted in North C or HCV) to find its way into our cor- entering the state prison in Georgia and Carolina suggests that re-engagement in rectional facilities. The exact number of then were found to be HIV-positive during sex after release is a slow process, but that, people with HIV in our prisons and jails their incarceration.5 This demonstrates that as is the case with HIV-positive people in can only be estimated. A few state prisons transmission during incarceration does general, some do practice behaviors that mandate HIV testing of all inmates, but occur, but we remain unsure how often, and can risk transmission of the virus.9

18 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m HIV mortality rates in prisons have plummeted, mirroring survival trends seen in the free world, attributed to Trend partnerships with academic centers and health Departments.

The collateral damage of incarceration jails. Unless they are one of the mega-jails than those assigned to routine discharge extends even beyond the partner pair to like those in Chicago and Los Angeles, planning by the prison. In all, about half the community at large, where the effects budgets are typically small and there are of the former inmates in both study arms of the absence of a significant proportion usually few or no staff with HIV expertise. saw a medical provider within a month of of men alters the social landscape. Most The chaos of jails, where stays can be as release, at which time their prison-provided directly, the gender ratio (number of men short as a few hours or as long as months HIV medications would run out.13 compared to the number of women) is to even years, further challenges HIV care. Innovative approaches to linkage to shifted, influencing gender power (includ- Those entering jail without their medica- care are being explored and the National ing negotiation regarding monogamy and tions can expect a lapse in dosing. With Institutes of Health (NIH) and others have condom use), and partner parity (social an average stay of a couple of days, there been funding efforts to test these in order status, economic status, and HIV risk). is also limited time to provide screening, to identify evidence-based models that Communities are further harmed by the treatment, and linkage to community care. can be implemented. Failure to link those loss of working age men and women, under correctional supervision to ongo- leaving a vacuum that saps vitality and Transition to the Community ing HIV care would bode poorly for the stability. Therefore, incarceration has toxic In the cascade of HIV care that extends broader effort to increase the proportion societal effects that can promote the cir- from finding those who are infected to of all HIV-positive people with undetect- cumstances in which HIV thrives. establishing care, retaining patients in able viral loads from its current 28%. care, and suppressing viral load long Care for HIV term, each point in this spectrum is an Conclusions in Prisons and Jails opportunity for those in corrections. As Incarceration is one of a number of forces The confluence of HIV and incarceration described above, screening for HIV is com- that have shaped the domestic HIV epi- has forced jails and prisons to provide mon in correctional settings and quality demic. The massive imprisonment of the medical care and services to infected care is provided, especially in prisons and members of populations that bear a dispro- inmates. Prisons provide HIV therapy larger jails. The weakest link of this chain portionate burden of HIV has significantly to inmates at no cost and monitor viral has been maintenance of the benefits perpetuated the spread of the virus and it is load and CD4 cell counts. All indicators of that care following release. It is ironic unlikely we will see an overhaul of the legal suggest HIV care in prisons is good, with that incarcerated people living with HIV system any time soon. The sentencing laws the majority of HIV-positive individuals fare better, in terms of metrics of physical that feed a gluttonous criminal justice sys- behind bars achieving undetectable HIV health (weight, viral load, and CD4 cell tem with inmates are likely to remain, as will viral loads.10 Further, rates of death due to count), than those living with the virus in policing policies that lead to the arrest of HIV have plummeted in prisons over the the communities from which they came. people of color and those living in poverty. past several years, mirroring the survival With release, much of the available data Few people under correctional supervision trends seen in the free world.2 Much of this paints a bleak picture of unfilled ART pre- will receive the substance abuse and men- success can be attributed to partnerships scriptions, missed medical appointments, tal health care they need. So, behind the between corrections, academic centers, and a return to behaviors that often lead walls of our correctional facilities, the virus and departments of health, as well as the to a return to a jail or prison.11 Much work will remain. hiring of correctional health care providers has gone into identifying transitioning with HIV expertise. strategies that are effective at maintain- for references, Additionally, there is a sense among ing HIV care and service post-release. The Go to PosItivelyAware.com providers of HIV care in corrections that model of HIV transition programming was inmates may do better than free-world pioneered in Rhode Island and involves peers in terms of health outcomes due to pre- and post-release intensive case David Alain Wohl, MD, is an Associate structural factors that can lead to access management.12 Other states have adapted Professor of Infectious Diseases and to better nutrition, opportunities to exer- this approach with reported success. One Co-Director of the AIDS Clinical Trials cise, limited or no access to substances of trial conducted in North Carolina found Unit at the University of North Carolina. abuse, and close monitoring of adherence that among 89 HIV-positive inmates, Metabolic complications associated with to medication and laboratory values. those randomized to a case management HIV infection and the nexus between HIV The situation in jails may not always be program, modeled on the Rhode Island and incarceration are his major areas of so rosy. Unlike prison systems, which are program, that spanned the periods before research interest. His e-mail address is run by the Federal or state governments, and after release had no more success in [email protected]. counties, municipalities, and towns fund making doctor appointments post-release

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 19 I am active. I am devoted to family. I am inspired. I am HIV positive. You are special, unique, and different from anyone else. And so is your path to managing HIV. When you’re ready to start HIV therapy, talk to your doctor about a medication that may fit your needs and lifestyle. In clinical studies lasting 96 weeks, patients being treated with HIV medication for the first time who took ISENTRESS plus Truvada: Had a low rate of side effects — The most common side effect of moderate to severe intensity (that interfered with or kept patients from performing daily activities) was trouble sleeping — This side effect occurred more often in patients taking ISENTRESS plus Truvada (4%) versus Sustiva plus Truvada (3%) Experienced less effect on LDL cholesterol (“bad” cholesterol) — Cholesterol increased an average of 7 mg/dL with ISENTRESS plus Truvada versus 21 mg/dL with Sustiva plus Truvada — When they began the study, the average LDL cholesterol of patients on ISENTRESS plus Truvada was 96 mg/dL versus 93 mg/dL for those on Sustiva plus Truvada Ask your doctor about ISeNTReSS. Model Not sure where to start? Visit isentress.com/questions INDICATIONS When ISENTRESS has been given with other anti-HIV drugs, side effects included nausea, headache, ISENTRESS is a medicine used to treat the human immunodeficiency virus (HIV).ISENTRESS must be taken with tiredness, weakness, trouble sleeping, stomach pain, dizziness, depression, and suicidal thoughts and actions. other HIV medicines to improve your chances of fighting the virus. You must remain under your doctor’s care. People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions ISENTRESS has not been studied in children. that occur with HIV infection. ISENTRESS will not cure HIV or reduce your chance of passing it to others. Tell your doctor about all of your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breast-feeding or plan to breast-feed. ISENTRESS is not recommended for use IMPORTANT RISK INFORMATION during pregnancy. Women with HIV should not breast-feed because their babies could be infected with HIV Severe, life-threatening, and fatal skin reactions and allergic reactions have been reported in some patients taking through their breast milk. ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements. blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing. Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any You are encouraged to report negative side effects of prescription drugs to the FDA. of the following signs or symptoms of liver problems: yellowing of the skin or whites of the eyes, dark or tea colored Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. urine, pale colored stools/bowel movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on the Please read the Patient Information on the adjacent page for more detailed information. right side below the ribs. Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Need help paying for ISENTRESS? Call 1-866-350-9232 Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV medicines. Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking INFC-1032967-0000 03/12 ISENTRESS. This is because on rare occasions muscle problems can be serious and can lead to kidney damage. Sustiva is a registered trademark of Bristol-Myers Squibb Truvada is a registered trademark of Gilead Sciences, Inc. II amam active.active. II amam devoteddevoted toto family.family. II amam inspired.inspired. II amam HIVHIV positive. positive. You are special, unique, and different from anyone else. You are special, unique, and different from anyone else. And so is your path to managing HIV. When you’re ready And so is your path to managing HIV. When you’re ready to start HIV therapy, talk to your doctor about a medication to start HIV therapy, talk to your doctor about a medication that may fit your needs and lifestyle. that may fit your needs and lifestyle. In clinical studies lasting 96 weeks, patients being treated with HIV medication for the In firstclinical time studies who took lasting ISENTRESS 96 weeks, pluspatients Truvada being: treated with HIV medication for the first time who took ISENTRESS plus Truvada: Had a low rate of side effects Had— Thea low most rate common of side effects side effect of moderate to severe intensity (that interfered — Thewith most or keptcommon patients side from effect performing of moderate daily to activities) severe intensity was trouble (that interferedsleeping —with This or side kept effect patients occurred from performingmore often dailyin patients activities) taking was ISENTRESS trouble sleeping plus Truvada — This(4%) side versus effect Sustiva occurred plus more Truvada often (3%)in patients taking ISENTRESS plus Truvada Experienced(4%) versus Sustivaless effect plus on Truvada LDL cholesterol (3%) (“bad” cholesterol) Experienced— Cholesterol less increased effect on anLDL average cholesterol of 7 mg/dL(“bad” withcholesterol) ISENTRESS plus Truvada — Cholesterolversus 21 increasedmg/dL with an Sustiva average plus of 7Truvada mg/dL with ISENTRESS plus Truvada versus— When 21 mg/dL they began with Sustiva the study, plus the Truvada average LDL cholesterol of patients on ISENTRESS — Whenplus theyTruvada began was the 96 study, mg/dL the versus average 93 mg/dLLDL cholesterol for those ofon patientsSustiva pluson ISENTRESS Truvada plus Truvada was 96 mg/dL versus 93 mg/dL for those on Sustiva plus Truvada Ask your doctor about ISeNTReSS. Model Ask your doctor about ISeNTReSS. Model Not sure where to start? Visit isentress.com/questions Not sure where to start? Visit isentress.com/questions INDICATIONS INDICATIONS When ISENTRESS has been given with other anti-HIV drugs, side effects included nausea, headache, ISENTRESS is a medicine used to treat the human immunodeficiency virus (HIV).ISENTRESS must be taken with Whentiredness, ISENTRESS weakness, has trouble been sleeping,given with stomach other anti-HIVpain, dizziness, drugs, depression, side effects and included suicidal thoughtsnausea, headache,and actions. ISENTRESSother HIV medicinesis a medicine to improveused to treatyour thechances human of immunodeficiencyfighting the virus. Youvirus must(HIV). remainISENTRESS under yourmust doctor’s be taken care. with tiredness,People takingweakness, ISENTRESS trouble sleeping, may still stomachdevelop infections,pain, dizziness, including depression, opportunistic and suicidal infections thoughts or other and actions.conditions other HIV medicines to improve your chances of fighting the virus. You must remain under your doctor’s care. ISENTRESS has not been studied in children. Peoplethat occur taking with ISENTRESS HIV infection. may still develop infections, including opportunistic infections or other conditions ISENTRESS has not been studied in children. that occur with HIV infection. ISENTRESS will not cure HIV or reduce your chance of passing it to others. Tell your doctor about all of your medical conditions, including if you have any allergies, are pregnant or plan ISENTRESS will not cure HIV or reduce your chance of passing it to others. Tellto your become doctor pregnant, about all or of are your breast-feeding medical conditions, or plan toincluding breast-feed. if you ISENTRESShave any allergies, is not recommended are pregnant or for plan use IMPORTANT RISK INFORMATION to duringbecome pregnancy. pregnant, Women or are breast-feeding with HIV should or notplan breast-feed to breast-feed. because ISENTRESS their babies is not could recommended be infected forwith use HIV IMPORTANTSevere, life-threatening, RISK and INFORMATIONfatal skin reactions and allergic reactions have been reported in some patients taking duringthrough pregnancy. their breast Women milk. with HIV should not breast-feed because their babies could be infected with HIV Severe,ISENTRESS. life-threatening, If you develop and fatal a rash skin with reactions any of and the allergicfollowing reactions symptoms, have stop been using reported ISENTRESS in some and patients contact taking your through their breast milk. ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements. blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing. used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements. blistersSometimes or peeling allergic of skin, reactions redness can or affect swelling body of organs, the eyes, like swelling the liver. of Contactthe mouth your or doctorface, problems right away breathing. if you have any You are encouraged to report negative side effects of prescription drugs to the FDA. You are encouraged to report negative side effects of prescription drugs to the FDA. Sometimesof the following allergic signs reactions or symptoms can affect of bodyliver problems: organs, like yellowing the liver. of Contact the skin your or whites doctor of right the eyes,away darkif you or have tea coloredany Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. of urine,the following pale colored signs stools/bowelor symptoms movements, of liver problems: nausea/vomiting, yellowing of loss the skinof appetite, or whites pain, of the aching eyes, or dark tenderness or tea colored on the Please read the Patient Information on the adjacent page for more detailed information. urine,right pale side colored below thestools/bowel ribs. movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on the Please read the Patient Information on the adjacent page for more detailed information. right side below the ribs. Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Need help paying for ISENTRESS? Call 1-866-350-9232 ChangesYour immune in your system immune may system get stronger (Immune and Reconstitution begin to fight Syndrome) infections can that happen have been when hidden you start in your taking body HIV for medicines. a long time. Need help paying for ISENTRESS? Call 1-866-350-9232 YourTell immune your doctor system right may away get if strongeryou start and having begin new to symptomsfight infections after thatstarting have your been HIV hidden medicines. in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV medicines. Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking CopyrightINFC-1032967-0000 © 2012 Merck Sharp03/12 & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. ContactISENTRESS. your doctor This isimmediately because on if rareyou occasionsexperience muscle unexplained problems muscle can pain,be serious tenderness, and can or leadweakness to kidney while damage. taking INFC-1032967-0000Sustiva is a registered 03/12 trademark of Bristol-Myers Squibb is a registered trademark of Gilead Sciences, Inc. ISENTRESS. This is because on rare occasions muscle problems can be serious and can lead to kidney damage. SustivaTruvada is a registered trademark of Bristol-Myers Squibb Truvada is a registered trademark of Gilead Sciences, Inc. Patient Information ISENTRESS® (eye sen tris) (raltegravir) Film-Coated Tablets ISENTRESS® (eye sen tris) (raltegravir) Chewable Tablets

Read this Patient Information before you start taking ISENTRESS and each time you get a refill. Liver problems may be caused by an allergic reaction. Contact your doctor There may be new information. This information does not take the place of talking with your right away if you have any of the following signs or symptoms of liver problems: doctor about your medical condition or your treatment. ° yellowing of the skin or whites of the eyes What is ISENTRESS? ° dark or tea colored urine ISENTRESS is a prescription HIV medicine used with other HIV medicines to treat adults and ° pale colored stools/bowel movements children 2 years of age and older with human immunodeficiency virus (HIV-1) infection. HIV is ° nausea/vomiting the virus that causes AIDS (Acquired Immune Deficiency Syndrome). ° loss of appetite pain, aching or tenderness on the right side below the ribs When used with other HIV medicines, ISENTRESS may reduce the amount of HIV in your blood ° (called “viral load”). ISENTRESS may also help to increase the number of CD4 (T) cells in your • Changes in your immune system (Immune Reconstitution Syndrome) can happen blood which help fight off other infections. Reducing the amount of HIV and increasing the when you start taking HIV medicines. Your immune system may get stronger and begin CD4 (T) cell count may improve your immune system. This may reduce your risk of death or to fight infections that have been hidden in your body for a long time. Tell your doctor infections that can happen when your immune system is weak (opportunistic infections). right away if you start having new symptoms after starting your HIV medicine. • Phenylketonuria (PKU). ISENTRESS Chewable Tablets contain phenylalanine as part of It is not known if ISENTRESS is safe and effective in children under 2 years of age. the artificial sweetener, aspartame. The artificial sweetener may be harmful to people ISENTRESS does not cure HIV infection or AIDS. People taking ISENTRESS may still develop with PKU. infections or other conditions associated with HIV infection. Some of these conditions are The most common side effects of ISENTRESS include: pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. • headache • trouble sleeping Patients must stay on continuous HIV therapy to control infection and decrease Less common side effects include: HIV-related illnesses. • nausea • dizziness Avoid doing things that can spread HIV-1 infection to others: • tiredness • depression • Do not share needles or other injection equipment. • weakness • suicidal thoughts and actions • Do not share personal items that can have blood or body fluids on them, • stomach pain like toothbrushes and razor blades. Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while • Do not have any kind of sex without protection. Always practice safe sex by using taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to a latex or polyurethane condom to lower the chance of sexual contact with semen, kidney problems. vaginal secretions, or blood. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor if you have any questions on how to prevent passing HIV to other people. These are not all the possible side effects of ISENTRESS. For more information, ask your What should I tell my doctor before taking ISENTRESS? doctor or pharmacist. Before taking ISENTRESS, tell your doctor if you: • have liver problems. Call your doctor for medical advice about side effects. You may report side effects to FDA • have phenylketonuria (PKU). ISENTRESS Chewable Tablets contain phenylalanine at 1-800-FDA-1088. as part of the artificial sweetener, aspartame. The artificial sweetener may be How should I store ISENTRESS? harmful to people with PKU. Film-Coated Tablets: • have any other medical conditions. • Store ISENTRESS Film-Coated Tablets at room temperature • are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm between 68°F to 77°F (20°C to 25°C). your unborn baby. Pregnancy Registry: You and your doctor will need to decide if taking ISENTRESS is Chewable Tablets: right for you. If you take ISENTRESS while you are pregnant, talk to your doctor about • Store ISENTRESS Chewable Tablets at room temperature how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the between 68°F to 77°F (20°C to 25°C). registry is to follow the health of you and your baby. • Store ISENTRESS Chewable Tablets in the original package with the bottle tightly closed. • are breastfeeding or plan to breastfeed. • Keep the drying agent (desiccant) in the bottle to protect from moisture. - Do not breastfeed if you are taking ISENTRESS. You should not breastfeed if Keep ISENTRESS and all medicines out of the reach of children. you have HIV because of the risk of passing HIV to your baby. - Talk with your doctor about the best way to feed your baby. General information about ISENTRESS Tell your doctor about all the medicines you take, including: prescription and non- Medicines are sometimes prescribed for conditions that are not mentioned in Patient prescription medicines, vitamins, and herbal supplements. Taking ISENTRESS and certain Information Leaflets. Do not use ISENTRESS for a condition for which it was not prescribed. Do other medicines may affect each other causing serious side effects. ISENTRESS may affect not give ISENTRESS to other people, even if they have the same symptoms you have. It may the way other medicines work and other medicines may affect how ISENTRESS works. harm them. Especially tell your doctor if you take: This leaflet gives you the most important information about ISENTRESS. • rifampin (Rifadin, Rifamate, Rifater, Rimactane), a medicine commonly used If you would like to know more, talk with your doctor. You can ask your doctor or pharmacist for to treat tuberculosis. information about ISENTRESS that is written for health professionals. Ask your doctor or pharmacist if you are not sure whether any of your medicines are For more information go to www.ISENTRESS.com or call 1-800-622-4477. included in the list above. What are the ingredients in ISENTRESS? Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Do not start any new medicines while you are taking ISENTRESS ISENTRESS Film-Coated Tablets: without first talking with your doctor. Active ingredient: raltegravir How should I take ISENTRESS? Inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate • Take ISENTRESS exactly as prescribed by your doctor. dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated • You should stay under the care of your doctor while taking ISENTRESS. hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. • Do not change your dose of ISENTRESS, switch between the film-coated tablet and the The film coating contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, chewable tablet or stop your treatment without talking with your doctor first. red iron oxide and black iron oxide. • Take ISENTRESS by mouth, with or without food. ISENTRESS Chewable Tablets: • If your child is taking ISENTRESS, your child’s doctor will decide the right dose based on your child’s age and weight. Active ingredient: raltegravir • ISENTRESS Chewable Tablets may be chewed or swallowed whole. Inactive ingredients: hydroxypropyl cellulose, sucralose, saccharin sodium, sodium citrate • ISENTRESS Film-Coated Tablets must be swallowed whole. dihydrate, mannitol, red iron oxide (100 mg tablet only), yellow iron oxide, monoammonium • If you miss a dose, take it as soon as you remember. If you do not remember until it glycyrrhizinate, sorbitol, fructose, natural and artificial flavors (orange, banana, and masking is time for your next dose, skip the missed dose and go back to your regular schedule. that contains aspartame), crospovidone, magnesium stearate, sodium stearyl fumarate, Do not double your next dose or take more than your prescribed dose. ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, • If you take too much ISENTRESS, call your doctor or go to the nearest emergency room hypromellose 2910/6cP, PEG 400. right away. This Patient Information has been approved by the U.S. Food and Drug Administration. • Do not run out of ISENTRESS. Get your ISENTRESS refilled from your doctor or pharmacy before you run out. Distributed by: What are the possible side effects of ISENTRESS? Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. ISENTRESS can cause serious side effects including: Whitehouse Station, NJ 08889, USA • Serious skin reactions and allergic reactions. Severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. Revised December 2011 If you develop a rash with any of the following symptoms, stop using ISENTRESS and 6083816 contact your doctor right away: ° fever ° muscle or joint aches ° redness or swelling of the eyes Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. ° generally ill feeling ° blisters or sores in mouth ° swelling of the mouth or face All rights reserved. INFC-1032967-0000 03/12 ° extreme tiredness ° blisters or peeling of the skin ° problems breathing U.S. Patent Nos. US 7,169,780 Money well spent Opt-out testing in prisons can catch STD cases— and save taxpayers money in the long run

By Chad Zawitz, MD

How much do you think it would cost the health Despite all these efforts, sexually trans- department of a major American city to reduce the amount of mitted infections continue to plague our communities. gonorrhea, Chlamydia, syphilis and possibly even HIV by 20%? Perhaps another approach might be to More importantly, if you had to devise the simplest and most seek out a subpopulation that has a higher cost-effective way to do this, how would you do it? than average prevalence of infections. Better yet would be if that population could Millions have been spent on print peer and provider education. Schools be gathered into one location to streamline ads in magazines and newspapers, TV teach sexual health. Public health agencies testing, diagnosis, treatment, and linkage spots, billboards, and Internet messages. spend millions more performing services to care. In most major metropolitan areas, Additional monies have been spent for such as partner tracking and notification. such places exist: jails and prisons.

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 23

Open and shut cases

Events that affected gonorrhea case reporting in Chicago, 2000-2008 15,000 14,871 ➚ Mile Square Chicago Dept. 14,324 STD clinic of Public Health 13,812 closes Electronic medical

records Electronic

12,121 31st Street Laboratory 12,000 STD clinic closes R➚ eporting begins ➚ 10,935 STD screening ➚ 10,509 CASES 9,888 at Cook County 9,549 9,000 Jail ends 9,388 Targeted➚ STD screening 6,000 at Cook County ➚ Jail re-starts Targeted STD screening at Cook County Jail ends

Cook County

3,000 Evanston STD clinic begins STD clinic➚ charging fees closes for STD visits

0 2000 2001 2002 2003 2004 2005 2006 2007 2008

STI testing lessons doesn’t mean there was any less gonor- be cost-effective, but the biggest “bang In Chicago, this very scenario played out rhea in Cook County. It just means that the for your buck” occurs when screening is in reverse. In April 2002–March 2003 the largest single-site testing and treatment applied to populations where the presence Cook County Jail performed “universal facility in the county had ceased to have an of disease is predicted to be higher than voluntary screening” for gonorrhea and impact. All those previously diagnosed and average. Correctional settings represent Chlamydia. More than 85% of men and treated cases were going untreated and an ideal example of a population that may women entering the facility participated ultimately returned to the community to be receive the biggest direct benefit from in testing, leading to large numbers of spread to new partners. opt-out HIV testing. The U.S. prevalence diagnoses and treatment.1 An estimated By 2008, the number of new cases of HIV is estimated to be between 0.3 to one in five cases of gonorrhea in the entire diagnosed in Cook County had increased 0.5%, but in jails and prisons the rate is county was diagnosed and in most cases by nearly 10% in a single year. This was three to five times higher (as many as 2.5 treated during incarceration at the jail. without having resumed large scale test- people out of 100). The reason for the Testing was switched to symptoms- ing at the Cook County Jail. These were all higher rate is because many people who based screening only in March 2003. In cases diagnosed at the community-level are incarcerated have a higher prevalence the following year, the number of cases of clinics and other health care settings. It of HIV risk factors (e.g., injection drug gonorrhea and Chlamydia that were diag- was clear that the jail served a massively users, sex workers, the mentally ill, and nosed in the jail declined by nearly 80%! important role in the cycle of transmission “risk-takers”). Further, jails and prisons While this is not exactly comparing apples of sexually transmitted diseases. By focus- tend to represent a similar economic strata to apples, it demonstrates the power and ing initiatives on correctional facilities, as those who do not routinely have access dramatic impact opt-out testing can have communities have that cost-effective mag- to health care in their communities (the on the community. All those undiagnosed ical constellation of high disease burden, un- or underinsured) and therefore are and untreated patients are potential vec- captive audience, screening, treatment, less likely to have been offered testing tors of disease transmission in the com- and linkage to care. prior to incarceration. munity at large. Might jails and prisons be able to have It is estimated that as many as 25% of In 2007, all intake screening was discon- a similar impact on HIV? all Americans who are infected with HIV tinued, and the number of cases of gonor- are currently unaware of their diagnosis. rhea diagnosed in the County reached its HIV testing behind bars This means there may be more than lowest point in more than seven years. This HIV testing is generally considered to 250,000 citizens who are not in care and

24 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m Screenings make a difference Reported chlamydia and gonorrhea from Cook County Jail before and after discontinuation of universal STD screening

BEFORE: April 2002–March 2003 AFTER: April 2003–March 2004

Gonorrhea Chlamydia

Broad JM, Cox T, Rodriguez S, Mansour M, Mennella C, Swallow-Murphy D, Raba J, Wong W. The Impact of discontinuation of male STD screening services at a large urban county jail—Chicago, 2002-2004. Sex Transm Dis 2009, 36(2): S49-S52

therefore not on medications. An estimat- testing in all prenatal panels, and utilizing results in minutes, and most importantly, ed 20% of all HIV-positive people will pass opt-out testing wherever possible. the ability to give the preliminary result through a correctional facility at some to the patient before they are gone. The point. Their health may be in jeopardy, Opting out advantages of plasma ELISA testing include but in a broader view, public health is also Opt-out testing is a method where every- lower cost, delayed results (a benefit if directly affected. HIV-positive patients one who engages a particular care setting patients are not stable enough to hear not diagnosed and not on treatment are will be tested unless they decline. Due to results immediately), and less utilization of more infectious and may not be taking laws that vary from state to state, consent space and staffing in a busy intake setting. additional precautions to safeguard their still must be acquired in most instances. Delivering test results may seem like partners (condoms, strategic positioning, Fortunately, verbal consent (which must it should not be an issue in a jail setting serosorting, altering sexual practices, still be documented in the medical record) where you have a captive audience to abstinence, etc.). The financial impact of is acceptable in most cases. This is impor- give results from a slower test such as an delayed access to HIV treatment is also tant because high-volume settings such ELISA. The reality is that many detainees substantially greater. Presenting with as jails and emergency rooms must have leave jails in hours to days depending advanced HIV leads to longer and more streamlined and efficient procedures to on their charges, are released on home- frequent hospitalizations, more medication screen as many patients as possible. Any monitoring, or are bailed out. Waiting even expenses, more utilization of HIV primary additional steps, such as finding and filling two or three days may mean up to 30% of care resources, and so on. out a lengthy written consent form, adds those tested might not receive their result. In 2006 the CDC issued a recom- substantial time to each patient encounter. Furthermore, is a jail intake facility an ideal mendation that HIV testing should be Once the patient has consented and place to tell someone for the first time considered a routine part of an effort to agrees to participate in opt-out screening, they probably have HIV? Intake facilities diagnose and ultimately treat the “missing they are sent for an HIV test. There are are generally hot, crowded, high-pressure 25%.” This included testing anyone ages basically two major types of HIV tests that environments where there is little real 13–64 in all health care settings, increased can be used in an opt-out setting: ELISA privacy, if any. Incoming detainees are frequency of screening for those at higher antibody tests (blood) or a rapid test often intoxicated or coming down from a risk for HIV, eliminating separate written (finger stick or oral swab). The advantages high, possibly angry about being arrested, consent, eliminating the requirement of rapid testing include being less invasive mentally unstable (especially the people for prevention counseling, including HIV than a blood draw (no needles in veins), with severe mental health concerns), and

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 25 This process nearly tripled the number of HIV, syphilis, and GC/Chlamydia tests performed in the full calendar year of 2010. Many of these women remained in the facility long enough to not only receive their results, but to complete treatment (in the case of GC/Chlamydia) or linkage to care (in the case of those diagnosed with HIV). With “second-chance” testing offered at later times during their incarceration, an additional 20–30% of women ultimately agreed to be tested. The Chicago Department of Public Health was notified of any women leaving the jail before their results were available in order to attempt to locate them in their communities to provide treatment, as well as to notify sexual partners. Cermak Health Services provides health care to approximately 9,000 detainees at the You might still be asking, “So why does Cook County Department of Corrections. this matter to me?” Remember, the majority of men and women entering a jail do not physically and emotionally exhausted. performed increased by more than 68% in go to prison or otherwise just disappear. Imagine a health care provider telling you just one year simply by implementing the They return to their communities, bringing your result, then sending you back out into 2006 CDC recommendation for opt-out any untreated communicable diseases a bullpen with 60 other detainees who are HIV screening.2 Not only were more tests they have with them. With government yelling, jostling for space, and maybe even conducted, but more results were available budgets stretched thin, focusing limited reading the new look of shock on your and delivered. This ultimately led to more resources to sites with the ability to have face. patients becoming linked to care in their the greatest impact is wise. Some people In a prison setting, most inmates have communities, and this led to more diagno- may harbor resentment that tax dollars a clearly defined sentence. The health care ses made in an earlier stage of the disease are being used to improve the health of staff knows the exact date of release from (the average baseline CD4 went from 262 people who may have broken the law, but the facility, and therefore, there’s a higher to 332 in the first year alone). In addition, this is shortsighted. In the long run, spend- probability that those who are tested will more people aware of their status means ing your tax dollars in jails and prisons for receive their result. Additionally, by the more people on treatment. More people HIV and STI testing and treatment has a time inmates reach prison, they are usually on treatment means less chance of infect- major downstream benefit to the broader sober, better rested (as compared to the ing new partners. That was clearly shown community. day they went to jail), and more emotion- with HPTN 052, a study of more than 1,700

ally and mentally stable. In resource- couples in which successful treatment for references, s n limited settings, including correctional of the HIV-positive partner led to a 96% Go to PosItivelyAware.com facilities, screening with a less-expensive decrease in transmission. Awareness of test (ELISA) may make expanded screen- one’s HIV status also often means behav- ing via opt-out more palatable to the ioral changes to protect partners. Fewer Chad Zawitz, MD, is Attending Physician orrectio budget-makers. Lastly, with known dis- newly infected people means additional and Clinical Coordinator of HIV/Infectious t of C charge dates, linkages to HIV care in the benefits to the community at large. Disease Services for Cermak Health n community become at least a little easier With renewed support from the county Services at the Cook County Jail, provid- than they are in a jail setting (where one government, the Cook County Jail in ing care to HIV-positive detainees and rtme pa never really knows if or when the patient Chicago began opt-out HIV and STI (sexu- inmates there and also at his continuing

will be leaving). ally transmitted infection) screening in care clinic at the CORE Center. In 2005, he ty De

April 2011 for females entering the facility. received the HIV Leadership Award as Up un o Community benefits More than 7,000 female intakes occurred and Coming Physician from The Body.com. k C As a real-world example, in 2006-2007, from April through the end of 2011. More Dr. Zawitz has written for Positively oo Washington, D.C. began expanded routine than 50% agreed to participate in HIV Aware on a variety of topics, including HIV screening in health care settings, opt-out screening, and more than 60% the physician’s comments in the 2006

including jails. The number of HIV tests in gonorrhea and Chlamydia screening. 10th Annual HIV Drug Guide. Photo: C

26 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m POSITIVE PROGRESS Improvements in HIV testing, treatment, and continuity of care

By Sue Saltmarsh

from the Centers for Disease Control and personal privacy going on, so while many Prevention (CDC) to the smallest AIDS service organization in the civil liberty advocates would find the idea of mandatory testing yet another invasion country, most agree that the first step to stopping the HIV epidemic of privacy, there is still the problem of risk in its tracks is to get all adults tested and, if positive, into treatment. to public health when inmates are released, go back to their communities, and trans- Numerous studies have shown that struggle with is that with opt-out testing mit HIV unknowingly to their partner or being on antiretroviral treatment sup- in correctional settings, only an estimated partners because they opted out of being presses viral load and reduces the chance 50% of the inmates choose to take the test. tested or didn’t know their status. of transmitting the virus. So being able to But mandatory testing would require a sig- test more people would be an “everybody- nificant trade-off—the individual inmate’s Prison health care wins” situation, right? (See page 23 for right to privacy vs. the protection of the Anyone who works in the fields of HIV/AIDS, Dr. Chad Zawitz’s take on opt-out testing.) public health. In the environment of a social work, or law enforcement, as well as One thing that HIV/AIDS advocates prison, there’s already enough violation of anyone who is or has been incarcerated,

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 27 should know that the condition of health n To provide comprehensive medi- processing facility for male inmates in care in our country’s correctional institu- cal treatment to inmates who are state custody—that the disparity between tions is lacking, to say the least. HIV-positive the intent of the law and what was actu- Here at PA we frequently hear from n To promote HIV/AIDS awareness and ally going on first surfaced. When JHA inmates who are not able to be adherent prevention among inmates asked for the lab reports that should have with their HIV regimen because facility per- n To encourage inmates to take personal accompanied the testing, they discovered sonnel don’t understand the importance of responsibility for their health that the testing was not being done. uninterrupted treatment with a consistent n To reduce the risk of inmates spreading Maki is concerned that the same thing combination of medicines, or they miss HIV throughout the community upon is happening with hepatitis C testing, in their doses due to being on lockdown, or their release some ways an even greater risk than HIV they develop resistance to one drug, but for inmates. are not able to change their regimen. In Illinois, in August of 2011, an amend- Maki explained that within the On the other side, prison administra- ment was added to the Unified Code of Department of Corrections (DOC), there tors deal with funding cuts from the state Corrections that provides HIV testing be is often miscommunication and evidently, or federal government and are frequently offered to inmates on an opt-out basis people on staff at the facility, as well as faced with not having the money to pay with no co-pay. It also directs that pre-test those at other facilities, thought the tests for enough nurses and doctors, let alone information be provided to the inmate and were taking place when indeed they were the expensive drugs used to treat not informed consent obtained as required in not. This would often lead to inmates not

prevalence of HIV in prisons is up to five times higher than outside the cells, though it is also true that 5X most new infections happen outside prison walls.

only HIV, but also any other illnesses the the AIDS Confidentiality Act. The amend- being offered the test because the staff inmates live with. ment also speaks to the release of inmates thought they’d already had it or it had Add to that the high risk behavior that from prison, providing that all inmates due been done at another facility. JHA was goes on in prison (sex, consensual or not; to be released receive “appropriate infor- suspicious when the number of new diag- tattooing; needle sharing; etc.) and it’s no mation in writing, by video, or other elec- noses was much lower than expected. wonder that the prevalence of HIV in pris- tronic means, concerning HIV and AIDS.” One of Maki’s frustrations was with the ons is up to five times higher than outside law itself. The way the statute is written, the cells, though it is also true that most John Howard Association testing is not mandatory—it says the facility new infections happen outside prison The John Howard Association (JHA) is “may conduct” opt-out testing—so the pris- walls. Unfortunately, other factors associ- a non-profit organization that works in on itself can “opt out” of providing it just as ated with high risk for HIV—poverty, race, Illinois to achieve “a fair, humane, and the inmates can opt out of taking a test. drug abuse, and stigma for instance—are cost-effective criminal justice system There is also lack of clarity in the at play in communities that also have the by promoting adult and juvenile prison language of the law about the timing of highest crime rates. reform, leading to successful re-integra- the testing. According to an internal JHA tion and enhanced community safety.” memo, “Although the amended statutes Legislative efforts Teams of four to six trained volunteers led undoubtedly were born of the best inten- However, there are attempts to reduce the by JHA staff conduct tours of Illinois’ state tions, they are ambiguous as to whether transmission of HIV in correctional facili- correctional facilities. The observations HIV testing must be provided to inmates ties. On the federal level, Congresswoman of the volunteers are recorded in written upon initial entry into DOC, at the point Maxine Waters (D-CA) introduced the reports prepared by JHA, focusing on such of reception and classification. To provide “Stop AIDS in Prison Act” in December issues as medical and mental health care, opt-out HIV testing when an inmate is 2011. Besides also providing for opt-out disciplinary procedures, and the physical about to be released from prison (as some testing in all federal prisons, it goes fur- condition of facilities. facilities do), rather than at the point of ther, listing the following purposes: John Maki, Executive Director of JHA, initial entry into the system is counterpro- spoke with PA about the state of HIV ductive, particularly if the goal is to pro- n To stop the spread of HIV among testing in these facilities. Maki said it was mote early detection, entry into care, and inmates during the monitoring of the Northern prophylactic treatment to reduce second- n To protect prison guards and other Reception and Classification Center—the ary infection and mortality, and prevent personnel from HIV infection nation’s largest intake, classification, and further disease transmission.”

28 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m The good news is that JHA’s investiga- computer, via Skype or a similar service, telemedicine and medical conditions at tion of the situation led to pinning down a with HIV-positive inmates, monitor their DOC. Though there are obvious problems, timetable with the DOC for implementa- lab tests, and discuss any questions or he gave the DOC credit for doing some tion this spring and Maki says JHA will concerns they may have about their drug innovative things, such as their partnering hold them to that. regimen. with the AIDS Foundation of Chicago to “It’s getting rave reviews!” Maki produce and screen “Outside the Walls,” a The funding barrier exclaimed. “Not knowing anything about video educating inmates on HIV treatment When an inmate is identified as HIV-positive telemedicine, when I first heard about it I and prevention and encouraging them the DOC is legally obligated to provide thought it seemed like a way of cheating to take charge of their health upon their “medical care while incarcerated, counseling, on care,” he admitted. “But when I really release (see Briefly, page 10). and referrals to support services.” looked at it, I realized that it was really However, the JHA memo states that improving the quality of care.” Hope for the future “implementation [of the statute] relating He also pointed out that, though it was What would Maki ultimately like to see in to treatment is ‘subject to appropriation,’” not the goal, telemedicine is providing terms of HIV and the DOC? i.e., the legislature actually providing DOC oversight by getting “another pair of eyes” “I think the opt-out testing is a good with the funds necessary to fulfill the on the medical conditions in DOC. He start,” he said. “But I’d like to see the DOC mandate. So unless the legislature comes went on to say that since the implementa- really seeing diagnosis and treatment edu- up with that funding, there is no duty to tion of telemedicine, reports have shown cation as part of its mission and that it’s

Small victories mean a lot and even small changes CHANGE can be really powerful. implement the statute. There is also a improvement in the delivery of meds to really instrumental to public health.” He’d financial disincentive for the DOC to test inmates and their adherence to their HIV also like to see more emphasis on preven- inmates upon entry rather than waiting to regimens. He would love to see it expand- tion, including condoms being provided. test them when they are nearing release, ed to serve inmates with other conditions To Maki, continuity of care is also thereby avoiding the cost of treating them besides HIV, especially since telemedicine crucial and that means from the point while they are in custody. enables the prisons to gain the benefit of of entry, through the sentence, to the And so a vicious cycle of unknown HIV experts in specific diseases at a fraction of transition back to the community. He status, risky behavior that results in more the cost. mentioned Sheridan Correctional Center infections, leading to more HIV-positive “It’s really the best of both worlds,” and Southwestern Illinois Correctional inmates being released without knowing said Maki. “You’re saving money while Center, the so-called “drug treatment of their infection, ending with ongoing you’re providing better care.” prisons,” as places that focus on provid- new infections in the community is There is also exciting potential for tele- ing continuity of care. The fact that they perpetuated. medicine to provide some “infrastructure” focus on treating drug addiction and the With so many states in financial trou- that could be used by parole officers to other issues that often come with it gives ble, it seems likely that the same situation better understand and monitor the medi- them a somewhat different mindset than exists throughout the country and perhaps cal needs of their parolees. Maki wishes other prisons and it encourages a focus on in federal prisons as well. And funding for that parole officers and soon-to-be parol- continuity of care. Plus, the drug treatment Medicaid, community health centers, and ees could meet well ahead of the release facilities often have better resources than HIV prevention is cut with no thought to date in order to establish awareness of other facilities. the long-term consequences. the inmate’s medical and mental health A man who likes a challenge, Maki admits needs, as well as providing a better foun- to being “intrigued” by the “messiness” Telemedicine dation for this most important relationship of the whole situation. He takes the DOC But there is some good news, at least between the inmate and law enforcement. at their word when they say the testing here in Illinois. A partnership of DOC with “An inmate is going to live or die by their program will be implemented in the spring. the University of Illinois Medical School parole officer,” says Maki, so the more the While it is just a first step in the right direc- is providing telemedicine monitoring of officer knows, the better the outcome for tion, in a system where things are so dys- HIV-positive inmates, a program that Maki them both. functional, he says, “Small victories mean is enthusiastic about. Telemedicine allows Maki says that JHA intends to use an a lot and even small changes can be really for an HIV specialist to communicate by upcoming grant to delve into the issue of powerful.”

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 29 COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil Save up to You may be able to save on the co-pay for fumarate) is a prescription medicine used as a complete your COMPLERA prescription with a Gilead single-tablet regimen to treat HIV-1 in adults who have HIV Co-pay Assistance Card. never taken HIV medicines before. COMPLERA does not $ cure HIV or AIDS or help prevent passing HIV to others. 200 Call 1-877-505-6986 for more information per month or visit www.COMPLERA.com.* one The for me COMPLERA. A complete HIV treatment in only 1 pill a day.

Ask your healthcare provider if it’s the one for you.

Patient model. Pill shown is not actual size.

INDICATION Do not take COMPLERA if you are taking the following medicines: Before taking COMPLERA, tell your healthcare provider if you: Common side effects associated with COMPLERA: • other HIV medicines (COMPLERA provides a complete treatment for HIV infection.) • have liver problems, including hepatitis B or C virus infection • trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, COMPLERA® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate • the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®, • have kidney problems nausea, rash, tiredness, and depression 300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), • have ever had a mental health problem (emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate) Other side effects associated with COMPLERA: phenytoin (Dilantin®, Dilantin-125®, Phenytek®) • have bone problems combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat • vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), • the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®, • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before. and pain Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®) your unborn child COMPLERA does not cure HIV and has not been shown to prevent passing HIV • a proton pump inhibitor medicine for certain stomach or intestinal problems, • are breastfeeding; women with HIV should not breast-feed because they can pass Tell your healthcare provider if you have any side effect that bothers you or that to others. It is important to always practice safer sex, use latex or polyurethane including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), HIV through their milk to the baby does not go away. These are not all the possible side effects of COMPLERA. For more condoms to lower the chance of sexual contact with any body fl uids, and to never omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®) information, ask your healthcare provider or pharmacist. Call your healthcare provider Contact your healthcare provider right away if you experience any of the re-use or share needles. Do not stop taking COMPLERA unless directed by your • more than 1 dose of the steroid medicine dexamethasone or dexamethasone for medical advice about side effects. following serious or common side effects: healthcare provider. See your healthcare provider regularly. sodium phosphate You are encouraged to report negative side effects of prescription drugs to the Serious side effects associated with COMPLERA: • St. John’s wort (Hypericum perforatum) FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. • New or worse kidney problems can happen in some people who take COMPLERA. • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) IMPORTANT SAFETY INFORMATION If you have had kidney problems in the past or take other medicines that can cause Take COMPLERA exactly as your healthcare provider tells you to take it • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®, kidney problems, your healthcare provider may need to do blood tests to check your • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to Contact your healthcare provider right away if you get the following side effects Epivir® or Epivir-HBV®, Epzicom®, Trizivir®) kidneys during your treatment with COMPLERA help get the right amount of medicine in your body. A protein drink does not replace or conditions while taking COMPLERA: • rilpivirine (Edurant™) • Depression or mood changes can happen in some people who take COMPLERA. a meal • Nausea, vomiting, unusual muscle pain, and/or weakness. These may be • adefovir (HEPSERA®) • Stay under the care of your healthcare provider during treatment with signs of a buildup of acid in the blood (lactic acidosis), which is a serious Tell your healthcare provider right away if you have any of the following symptoms: In addition, also tell your healthcare provider if you take: COMPLERA and see your healthcare provider regularly medical condition feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium • Light-colored stools, dark-colored urine, and/or if your skin or the whites of your hurting yourself (suicide) or have tried to hurt yourself carbonate. Take antacids at least 2 hours before or at least 4 hours after you Please see Patient Information for COMPLERA on the following pages. eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), • Bone problems can happen in some people who take COMPLERA. Bone problems take COMPLERA with liver enlargement (hepatomegaly), and fat in the liver (steatosis) include bone pain, softening or thinning (which may lead to fractures). Your * The co-pay program covers up to $200 per month for 1 year from card activation or until the • a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine • If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly healthcare provider may need to do additional tests to check your bones card expires, up to $2400 in a calendar year. The program is subject to change or cancellation (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without • Changes in body fat can happen in people taking HIV medicine. These changes at any time. medicines at least 12 hours before or at least 4 hours after you take COMPLERA may include increased amount of fat in the upper back and neck (“buffalo hump”), ﬁ rst talking to your healthcare provider. Your healthcare provider will monitor ® ® ® • the antibiotic medicines clarithromycin (Biaxin ), erythromycin (E-Mycin , Eryc , breast, and around the main part of your body (trunk). Loss of fat from the legs, your condition ® ® ® ® ® Ery-Tab , PCE , Pediazole , Ilosone ), and troleandomycin (TAO ) arms and face may also happen. The cause and long-term health effect of these COMPLERA may affect the way other medicines work, and other medicines may • ® an antifungal medicine by mouth, including fl uconazole (Difl ucan ), itraconazole conditions are not known affect how COMPLERA works, and may cause serious side effects. ® ® ® ® (Sporanox ), ketoconazole (Nizoral ), posaconazole (Noxafi l ), voriconazole (Vfend ) • Changes in your immune system (Immune Reconstitution Syndrome) can happen ® • methadone (Dolophine ) when you start taking HIV medicines. Your immune system may get stronger and This list of medicines is not complete. Discuss with your healthcare provider all begin to fi ght infections that have been hidden in your body for a long time. Tell prescription and nonprescription medicines, vitamins, or herbal supplements you your healthcare provider if you start having new symptoms after starting your are taking or plan to take. HIV medicine Learn more at www.COMPLERA.com

Ask your healthcare provider if it’s the one for you.

Patient model. Pill shown is not actual size.

PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd Ad page 1 • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5” Postively Aware Ad page 2 • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5” Postively Aware FDA-Approved Patient Labeling COMPLERA may help: Also tell your healthcare provider if you take: The most common side effects of COMPLERA include: Patient Information • Reduce the amount of HIV in your blood. This is called your “viral load”. • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium • trouble sleeping (insomnia) ® COMPLERA (kom-PLEH-rah) • Increase the number of white blood cells called CD4+ (T) cells that help fight off carbonate. Take antacids at least 2 hours before or at least 4 hours after you take • abnormal dreams (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets other infections. COMPLERA. • headache • ® Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your a histamine-2 blocker medicine, including famotidine (PEPCID ), cimetidine • dizziness Important: Ask your doctor or pharmacist about medicines that should not be (TAGAMET®), nizatidine (AXID®), or ranitidine hydrochloride (ZANTAC®). Take these immune system. This may reduce your risk of death or infections that can happen when • diarrhea taken with COMPLERA. For more information, see the section “What should I tell my medicines at least 12 hours before or at least 4 hours after you take COMPLERA. your immune system is weak (opportunistic infections). • nausea healthcare provider before taking COMPLERA?” • the antibiotic medicines clarithromycin (BIAXIN®), erythromycin (E-MYCIN®, ERYC®, • rash Read this Patient Information before you start taking COMPLERA and each time you COMPLERA does not cure HIV infections or AIDS. ERY-TAB®, PCE®, PEDIAZOLE®, ILOSONE®), and troleandomycin (TAO®) • Always practice safer sex. ® • tiredness get a refill. There may be new information. This information does not take the place of • an antifungal medicine by mouth, including fluconazole (DIFLUCAN ), itraconazole • Use latex or polyurethane condoms to lower the chance of sexual contact with any ® ® ® • talking to your healthcare provider about your medical condition or treatment. (SPORANOX ), ketoconazole (NIZORAL ), posaconazole (NOXAFIL ), voriconazole depression body fluids such as semen, vaginal secretions, or blood. ® (VFEND ) Additional common side effects include: • What is the most important information I should know about COMPLERA? Never re-use or share needles. • ® methadone (DOLOPHINE ) • vomiting Ask your healthcare provider if you have any questions about how to prevent passing COMPLERA can cause serious side effects, including: Ask your healthcare provider or pharmacist if you are not sure if your medicine is • stomach pain or discomfort HIV to other people. 1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in one that is listed above. • skin discoloration (small spots or freckles) some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic Who should not take COMPLERA? Know the medicines you take. Keep a list of your medicines and show it to your • pain acidosis is a serious medical emergency that can lead to death. • Do not take COMPLERA if your HIV infection has been previously treated with healthcare provider and pharmacist when you get a new medicine. Your healthcare Tell your healthcare provider if you have any side effect that bothers you or that does Lactic acidosis can be hard to identify early, because the symptoms could seem like HIV medicines. provider and your pharmacist can tell you if you can take these medicines with not go away. symptoms of other health problems. Call your healthcare provider right away if you • Do not take COMPLERA if you are taking certain other medicines. For more COMPLERA. Do not start any new medicines while you are taking COMPLERA without get any of the following symptoms which could be signs of lactic acidosis: information about medicines that must not be taken with COMPLERA, see “What first talking with your healthcare provider or pharmacist. You can ask your healthcare These are not all the possible side effects of COMPLERA. For more information, ask your • feeling very weak or tired should I tell my healthcare provider before taking COMPLERA?” provider or pharmacist for a list of medicines that can interact with COMPLERA. healthcare provider or pharmacist. • have unusual (not normal) muscle pain Call your doctor for medical advice about side effects. You may report side effects to • have trouble breathing What should I tell my healthcare provider before taking COMPLERA? How should I take COMPLERA? FDA at 1-800-FDA-1088 (1-800-332-1088). • have stomach pain with Before you take COMPLERA, tell your healthcare provider if you: • Stay under the care of your healthcare provider during treatment with COMPLERA. - nausea (feel sick to your stomach) • • have liver problems, including hepatitis B or C virus infection Take COMPLERA exactly as your healthcare provider tells you to take it. How do I store COMPLERA? - vomiting • • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important have kidney problems • • feel cold, especially in your arms and legs Store COMPLERA at room temperature 77 °F (25 °C). • have ever had a mental health problem to help get the right amount of medicine in your body. A protein drink does not • feel dizzy or lightheaded • Keep COMPLERA in its original container and keep the container tightly closed. • have bone problems replace a meal. • • have a fast or irregular heartbeat • Do not use COMPLERA if the seal over the bottle opening is broken or missing. • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm Do not change your dose or stop taking COMPLERA without first talking with your 2. Severe liver problems. Severe liver problems can happen in people who take your unborn child healthcare provider. See your healthcare provider regularly while taking COMPLERA. Keep COMPLERA and all other medicines out of reach of children. COMPLERA or similar medicines. In some cases these liver problems can lead to death. Pregnancy Registry. There is a pregnancy registry for women who take antiviral • If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take Your liver may become large (hepatomegaly) and you may develop fat in your liver medicines during pregnancy. Its purpose is to collect information about the health your dose of COMPLERA with a meal as soon as possible. Then, take your next dose General information about COMPLERA: (steatosis) when you take COMPLERA. of you and your baby. Talk to your healthcare provider about how you can take part of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by Medicines are sometimes prescribed for purposes other than those listed in a Patient in this registry. more than 12 hours of the time you usually take it, wait and then take the next dose Call your healthcare provider right away if you have any of the following symptoms Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed. • are breast-feeding or plan to breast-feed. The Centers for Disease Control and of COMPLERA at the regularly scheduled time. of liver problems: Do not give COMPLERA to other people, even if they have the same symptoms you have. Prevention recommends that mothers with HIV not breastfeed because they can pass • Do not take more than your prescribed dose to make up for a missed dose. • your skin or the white part of your eyes turns yellow (jaundice). It may harm them. the HIV through their milk to the baby. It is not known if COMPLERA can pass through • When your COMPLERA supply starts to run low, get more from your healthcare provider • dark “tea-colored” urine your breast milk and harm your baby. Talk to your healthcare provider about the best or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in This leaflet summarizes the most important information about COMPLERA. If you • light-colored bowel movements (stools) way to feed your baby. your blood may increase if the medicine is stopped for even a short time. would like more information, talk with your healthcare provider. You can ask your • loss of appetite for several days or longer • If you take too much COMPLERA, contact your local poison control center or go to the healthcare provider or pharmacist for information about COMPLERA that is written • nausea Tell your healthcare provider about all the medicines you take, including prescription nearest hospital emergency room right away. for health professionals. For more information, call (1-800-445-3235) or go to • stomach pain and nonprescription medicines, vitamins, and herbal supplements. www.COMPLERA.com. You may be more likely to get lactic acidosis or severe liver problems if you are COMPLERA may affect the way other medicines work, and other medicines may What are the possible side effects of COMPLERA? affect how COMPLERA works, and may cause serious side effects. If you take certain female, very overweight (obese), or have been taking COMPLERA or a similar COMPLERA may cause the following serious side effects, including: What are the ingredients of COMPLERA? medicines with COMPLERA, the amount of COMPLERA in your body may be too low and medicine containing nucleoside analogs for a long time. • See “What is the most important information I should know about COMPLERA?” Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil it may not work to help control your HIV infection. The HIV virus in your body may become 3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection • New or worse kidney problems can happen in some people who take COMPLERA. fumarate resistant to COMPLERA or other HIV medicines that are like it. and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A If you have had kidney problems in the past or take other medicines that can cause Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not take COMPLERA if you also take these medicines: kidney problems, your healthcare provider may need to do blood tests to check your COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV • COMPLERA provides a complete treatment for HIV infection. Do not take other HIV kidneys during your treatment with COMPLERA. cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The therapy with your healthcare provider. medicines with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, ® ® ® • Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare • the anti-seizure medicines carbamazepine (CARBATROL , EQUETRO , TEGRETOL , any of the following symptoms: triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow provider before your COMPLERA is all gone. TEGRETOL-XR®, TERIL®, EPITOL®), oxcarbazepine (TRILEPTAL®), phenobarbital - feeling sad or hopeless #6 aluminum lake. ® ® ® ® • Do not stop taking COMPLERA without first talking to your healthcare provider. (LUMINAL ), phenytoin (DILANTIN , DILANTIN-125 , PHENYTEK ) - feeling anxious or restless ® ® • If you stop taking COMPLERA, your healthcare provider will need to check your health • the anti-tuberculosis medicines rifabutin (MYCOBUTIN ), rifampin (RIFATER , - have thoughts of hurting yourself (suicide) or have tried to hurt yourself This Patient Information has been approved by the U.S. Food and Drug Administration ® ® ® ® often and do regular blood tests to check your HBV infection. Tell your healthcare RIFAMATE , RIMACTANE , RIFADIN ) and rifapentine (PRIFTIN ) • Bone problems can happen in some people who take COMPLERA. Bone problems Manufactured and distributed by: provider about any new or unusual symptoms you may have after you stop taking • a proton pump inhibitor medicine for certain stomach or intestinal problems, include bone pain, softening or thinning (which may lead to fractures). Your Gilead Sciences, Inc. ® ® ® COMPLERA. including esomeprazole (NEXIUM , VIMOVO ), lansoprazole (PREVACID ), omeprazole healthcare provider may need to do additional tests to check your bones. Foster City, CA 94404 ® ® ® (PRILOSEC ), pantoprazole sodium (PROTONIX ), rabeprazole (ACIPHEX ) • Changes in body fat can happen in people taking HIV medicine. These changes may What is COMPLERA? • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium include increased amount of fat in the upper back and neck (“buffalo hump”), breast, Issued: August 2011 COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that: phosphate and around the main part of your body (trunk). Loss of fat from the legs, arms and • is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the • St. John’s wort (Hypericum perforatum) face may also happen. The cause and long term health effect of these conditions are COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and virus that causes AIDS (Acquired Immunodeficiency Syndrome). If you are taking COMPLERA, you should not take: not known. the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies. • contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) • Changes in your immune system (Immune Reconstitution Syndrome) can happen ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, COMBIVIR®, when you start taking HIV medicines. Your immune system may get stronger trademarks referenced herein are the property of their respective owners. virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an EPIVIR® or EPIVIR-HBV®, EPZICOM®, TRIZIVIR®) and begin to fight infections that have been hidden in your body for a long time. HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). © 2012 Gilead Sciences, Inc. All rights reserved. • rilpivirine (EDURANT™) Tell your healthcare provider if you start having new symptoms after starting your It is not known if COMPLERA is safe and effective in children under the age of 18 years. • adefovir (HEPSERA®) HIV medicine. 202123-GS-000 02AUG2011 CON12383 3/12

PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd PALIO Date: 03.15.12 • Client: Gilead • Product: Complera • File Name: 21207_pgitvd_jrnl_copay_Postively_Aware.indd BS page 1 • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5” Postively Aware BS page 2 • Trim: 8” x 10.5” • Bleed: 8.5” x 11” • Live: 7” x 9.5” Postively Aware FDA-Approved Patient Labeling COMPLERA may help: Also tell your healthcare provider if you take: The most common side effects of COMPLERA include: Patient Information • Reduce the amount of HIV in your blood. This is called your “viral load”. • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium • trouble sleeping (insomnia) ® COMPLERA (kom-PLEH-rah) • Increase the number of white blood cells called CD4+ (T) cells that help fight off carbonate. Take antacids at least 2 hours before or at least 4 hours after you take • abnormal dreams (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets other infections. COMPLERA. • headache • ® Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your a histamine-2 blocker medicine, including famotidine (PEPCID ), cimetidine • dizziness Important: Ask your doctor or pharmacist about medicines that should not be (TAGAMET®), nizatidine (AXID®), or ranitidine hydrochloride (ZANTAC®). Take these immune system. This may reduce your risk of death or infections that can happen when • diarrhea taken with COMPLERA. For more information, see the section “What should I tell my medicines at least 12 hours before or at least 4 hours after you take COMPLERA. your immune system is weak (opportunistic infections). • nausea healthcare provider before taking COMPLERA?” • the antibiotic medicines clarithromycin (BIAXIN®), erythromycin (E-MYCIN®, ERYC®, • rash Read this Patient Information before you start taking COMPLERA and each time you COMPLERA does not cure HIV infections or AIDS. ERY-TAB®, PCE®, PEDIAZOLE®, ILOSONE®), and troleandomycin (TAO®) • Always practice safer sex. ® • tiredness get a refill. There may be new information. This information does not take the place of • an antifungal medicine by mouth, including fluconazole (DIFLUCAN ), itraconazole • Use latex or polyurethane condoms to lower the chance of sexual contact with any ® ® ® • talking to your healthcare provider about your medical condition or treatment. (SPORANOX ), ketoconazole (NIZORAL ), posaconazole (NOXAFIL ), voriconazole depression body fluids such as semen, vaginal secretions, or blood. ® (VFEND ) Additional common side effects include: • What is the most important information I should know about COMPLERA? Never re-use or share needles. • ® methadone (DOLOPHINE ) • vomiting Ask your healthcare provider if you have any questions about how to prevent passing COMPLERA can cause serious side effects, including: Ask your healthcare provider or pharmacist if you are not sure if your medicine is • stomach pain or discomfort HIV to other people. 1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in one that is listed above. • skin discoloration (small spots or freckles) some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic Who should not take COMPLERA? Know the medicines you take. Keep a list of your medicines and show it to your • pain acidosis is a serious medical emergency that can lead to death. • Do not take COMPLERA if your HIV infection has been previously treated with healthcare provider and pharmacist when you get a new medicine. Your healthcare Tell your healthcare provider if you have any side effect that bothers you or that does Lactic acidosis can be hard to identify early, because the symptoms could seem like HIV medicines. provider and your pharmacist can tell you if you can take these medicines with not go away. symptoms of other health problems. Call your healthcare provider right away if you • Do not take COMPLERA if you are taking certain other medicines. For more COMPLERA. Do not start any new medicines while you are taking COMPLERA without get any of the following symptoms which could be signs of lactic acidosis: information about medicines that must not be taken with COMPLERA, see “What first talking with your healthcare provider or pharmacist. You can ask your healthcare These are not all the possible side effects of COMPLERA. For more information, ask your • feeling very weak or tired should I tell my healthcare provider before taking COMPLERA?” provider or pharmacist for a list of medicines that can interact with COMPLERA. healthcare provider or pharmacist. • have unusual (not normal) muscle pain Call your doctor for medical advice about side effects. You may report side effects to • have trouble breathing What should I tell my healthcare provider before taking COMPLERA? How should I take COMPLERA? FDA at 1-800-FDA-1088 (1-800-332-1088). • have stomach pain with Before you take COMPLERA, tell your healthcare provider if you: • Stay under the care of your healthcare provider during treatment with COMPLERA. - nausea (feel sick to your stomach) • • have liver problems, including hepatitis B or C virus infection Take COMPLERA exactly as your healthcare provider tells you to take it. How do I store COMPLERA? - vomiting • • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important have kidney problems • • feel cold, especially in your arms and legs Store COMPLERA at room temperature 77 °F (25 °C). • have ever had a mental health problem to help get the right amount of medicine in your body. A protein drink does not • feel dizzy or lightheaded • Keep COMPLERA in its original container and keep the container tightly closed. • have bone problems replace a meal. • • have a fast or irregular heartbeat • Do not use COMPLERA if the seal over the bottle opening is broken or missing. • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm Do not change your dose or stop taking COMPLERA without first talking with your 2. Severe liver problems. Severe liver problems can happen in people who take your unborn child healthcare provider. See your healthcare provider regularly while taking COMPLERA. Keep COMPLERA and all other medicines out of reach of children. COMPLERA or similar medicines. In some cases these liver problems can lead to death. Pregnancy Registry. There is a pregnancy registry for women who take antiviral • If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take Your liver may become large (hepatomegaly) and you may develop fat in your liver medicines during pregnancy. Its purpose is to collect information about the health your dose of COMPLERA with a meal as soon as possible. Then, take your next dose General information about COMPLERA: (steatosis) when you take COMPLERA. of you and your baby. Talk to your healthcare provider about how you can take part of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by Medicines are sometimes prescribed for purposes other than those listed in a Patient in this registry. more than 12 hours of the time you usually take it, wait and then take the next dose Call your healthcare provider right away if you have any of the following symptoms Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed. • are breast-feeding or plan to breast-feed. The Centers for Disease Control and of COMPLERA at the regularly scheduled time. of liver problems: Do not give COMPLERA to other people, even if they have the same symptoms you have. Prevention recommends that mothers with HIV not breastfeed because they can pass • Do not take more than your prescribed dose to make up for a missed dose. • your skin or the white part of your eyes turns yellow (jaundice). It may harm them. the HIV through their milk to the baby. It is not known if COMPLERA can pass through • When your COMPLERA supply starts to run low, get more from your healthcare provider • dark “tea-colored” urine your breast milk and harm your baby. Talk to your healthcare provider about the best or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in This leaflet summarizes the most important information about COMPLERA. If you • light-colored bowel movements (stools) way to feed your baby. your blood may increase if the medicine is stopped for even a short time. would like more information, talk with your healthcare provider. You can ask your • loss of appetite for several days or longer • If you take too much COMPLERA, contact your local poison control center or go to the healthcare provider or pharmacist for information about COMPLERA that is written • nausea Tell your healthcare provider about all the medicines you take, including prescription nearest hospital emergency room right away. for health professionals. For more information, call (1-800-445-3235) or go to • stomach pain and nonprescription medicines, vitamins, and herbal supplements. www.COMPLERA.com. You may be more likely to get lactic acidosis or severe liver problems if you are COMPLERA may affect the way other medicines work, and other medicines may What are the possible side effects of COMPLERA? affect how COMPLERA works, and may cause serious side effects. If you take certain female, very overweight (obese), or have been taking COMPLERA or a similar COMPLERA may cause the following serious side effects, including: What are the ingredients of COMPLERA? medicines with COMPLERA, the amount of COMPLERA in your body may be too low and medicine containing nucleoside analogs for a long time. • See “What is the most important information I should know about COMPLERA?” Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil it may not work to help control your HIV infection. The HIV virus in your body may become 3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection • New or worse kidney problems can happen in some people who take COMPLERA. fumarate resistant to COMPLERA or other HIV medicines that are like it. and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A If you have had kidney problems in the past or take other medicines that can cause Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not take COMPLERA if you also take these medicines: kidney problems, your healthcare provider may need to do blood tests to check your COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV • COMPLERA provides a complete treatment for HIV infection. Do not take other HIV kidneys during your treatment with COMPLERA. cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The therapy with your healthcare provider. medicines with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, ® ® ® • Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare • the anti-seizure medicines carbamazepine (CARBATROL , EQUETRO , TEGRETOL , any of the following symptoms: triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow provider before your COMPLERA is all gone. TEGRETOL-XR®, TERIL®, EPITOL®), oxcarbazepine (TRILEPTAL®), phenobarbital - feeling sad or hopeless #6 aluminum lake. ® ® ® ® • Do not stop taking COMPLERA without first talking to your healthcare provider. (LUMINAL ), phenytoin (DILANTIN , DILANTIN-125 , PHENYTEK ) - feeling anxious or restless ® ® • If you stop taking COMPLERA, your healthcare provider will need to check your health • the anti-tuberculosis medicines rifabutin (MYCOBUTIN ), rifampin (RIFATER , - have thoughts of hurting yourself (suicide) or have tried to hurt yourself This Patient Information has been approved by the U.S. Food and Drug Administration ® ® ® ® often and do regular blood tests to check your HBV infection. Tell your healthcare RIFAMATE , RIMACTANE , RIFADIN ) and rifapentine (PRIFTIN ) • Bone problems can happen in some people who take COMPLERA. Bone problems Manufactured and distributed by: provider about any new or unusual symptoms you may have after you stop taking • a proton pump inhibitor medicine for certain stomach or intestinal problems, include bone pain, softening or thinning (which may lead to fractures). Your Gilead Sciences, Inc. ® ® ® COMPLERA. including esomeprazole (NEXIUM , VIMOVO ), lansoprazole (PREVACID ), omeprazole healthcare provider may need to do additional tests to check your bones. Foster City, CA 94404 ® ® ® (PRILOSEC ), pantoprazole sodium (PROTONIX ), rabeprazole (ACIPHEX ) • Changes in body fat can happen in people taking HIV medicine. These changes may What is COMPLERA? • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium include increased amount of fat in the upper back and neck (“buffalo hump”), breast, Issued: August 2011 COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that: phosphate and around the main part of your body (trunk). Loss of fat from the legs, arms and • is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the • St. John’s wort (Hypericum perforatum) face may also happen. The cause and long term health effect of these conditions are COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and virus that causes AIDS (Acquired Immunodeficiency Syndrome). If you are taking COMPLERA, you should not take: not known. the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies. • contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) • Changes in your immune system (Immune Reconstitution Syndrome) can happen ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, COMBIVIR®, when you start taking HIV medicines. Your immune system may get stronger trademarks referenced herein are the property of their respective owners. virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an EPIVIR® or EPIVIR-HBV®, EPZICOM®, TRIZIVIR®) and begin to fight infections that have been hidden in your body for a long time. HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). © 2012 Gilead Sciences, Inc. All rights reserved. • rilpivirine (EDURANT™) Tell your healthcare provider if you start having new symptoms after starting your It is not known if COMPLERA is safe and effective in children under the age of 18 years. • adefovir (HEPSERA®) HIV medicine. 202123-GS-000 02AUG2011 CON12383 3/12

by Claire Farel, MD, MPH

“Well, I’m 36 years old, I’m an African American woman drugs, food, housing, or survival, or “trans- in prison, I’m HIV-positive, and my favorite color is purple.” actional” sex. It is a logical target, as women who have been in prison have a higher rate For the past year I have been conduct- among incarcerated African American of transactional sex and may be more likely ing a study of women like this one, inter- women has been twice that of free African to rely on it again. Transactional sex is an viewing them about their lives and their American women for years. What makes important risk factor for HIV in itself and risk for HIV. My research has me focused being in prison so risky? in the vulnerability it conveys—a woman on risk—which is substantial. According to Most women in prison are not there having sex for survival may not be able to the latest report from the CDC, in 2009 for a life sentence—they do their time, negotiate condom use or other safer-sex one in every 139 women in the U.S. will be often for a financial or drug-related crime, measures. She may have an increased diagnosed with HIV in her lifetime, with and return to life outside bars, typically number of partners. Many of the women in numbers jumping to one in 32 African within a year. This is where real life comes our study who reported a history of trans- American women.1 But I was losing sight in: money, food, sex, families, violence, actional sex knew they were putting them- of the fact that these were real people mental illness, and the temptation to selves at risk. Many of them had been tested with families and dreams and, yes, favorite return to whatever activities led to the for HIV in the past. But what about women colors. prison sentence. As one woman told me, who don’t see themselves as at risk? What Just because I was thinking about HIV “It’s there. It’s always there.” Too often about women who trust their partners, or did not mean that they were. Women in this endangers a released woman’s health, assume their partners are HIV-negative, or prison have high rates of poverty, mental either through neglect of her own HIV care who think this is a disease that affects other illness, histories of physical and sexual or, in the case of an HIV-negative woman, people? This is the more insidious problem. abuse, substance abuse, and lack of social substance abuse and sex that put her at If something about being in prison, a com- support. It can be a disheartening setting risk of contracting HIV. bination of factors in a woman’s life that for those with an eye toward public health When health care providers think about led her to that point, increases HIV risk, this but also a galvanizing one. Where I work preventing HIV in high-risk women, we represents a key opportunity for testing, in North Carolina, the prevalence of HIV think about sex being exchanged for money, prevention, and change.

34 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m Several studies have looked at the prac- Another large study from the HIV by a number of other factors, including tice of “opt-out” HIV testing, or testing that Prevention Trials Network (HPTN), called mental illness and poor access to health is performed unless a person specifically HPTN 064 or the ISIS study, looked at care. The prison system in our state tries declines, among men and women entering women living in areas with a high preva- to offer a range of resources to women jail or prison. The findings on jailed popula- lence of poverty and HIV in the Northeast about to face this turbulent time: safer sex tions found that, in 2007, the majority of and Southeast U.S. Most women were education, mental health counseling, and, if persons “opting in” to HIV testing who African American or Hispanic. The rate the period of incarceration is long enough, tested HIV-positive on jail entry were not of new HIV infection was found to be five sometimes substance abuse treatment, previously known to be HIV-positive. Of times higher than the national average for GED preparation, or job training. But with these, the percentage of women who were African American women, comparable to relatively short prison sentences, the threat diagnosed HIV-positive for the first time rates in some countries in Sub-Saharan of budget cuts, and a population with an

The rate of new HIV infection was found to be five times higher than the national average for African American women, 5X comparable to rates in some countries in Sub-Saharan Africa.

when entering jail was almost twice that of Africa. The same study also looked at overwhelming range of needs, we can men. Included in the highest-risk groups these women and their male partners and always do more to help keep women who for a new HIV diagnosis were individuals found that in many of these partnerships, are being released from prison healthy. from the southern U.S., African Americans, one or both partners had never been I am asked all the time why people don’t women, and people between the ages of tested for HIV. The results of the study’s just use condoms and why women don’t 40 and 49. This study also noted that 30% HIV testing found more than five times as insist on them. If their lifetime risk of HIV of newly-diagnosed men and women iden- many serodiscordant (when one partner is or another sexually transmitted infection tified themselves as at “no risk” or reported HIV-positive and the other is HIV-negative) is so high, why don’t they? These are real only “low-risk” sexual partnerships. partnerships than were reported by study women in situations that are all too com- Importantly, these numbers do not include participants.4, 5 Transactional sex is risky, mon. None of them is clueless about the jailed men and women who “opt out,” but sometimes a partnership is too. fact that a condom may protect her, but the many of whom were already known to be What does this tell us about African condom question is much more knotty. A HIV-positive and didn’t want to go through American women in prison and their life- history of sexual and/or physical abuse is another test.2 Jail stays are usually shorter time risk of HIV? Quite a bit. Many of these very common and, for some women, speak- than prison stays and may represent an women are returning to the communities ing up may not be an option. Many of these abbreviated opportunity for public health studied in the ISIS study. Most of these women view their relationships as com- intervention if people are released quickly women get HIV from male partners—intra- mitted ones, ones in which they choose to without going to prison. Another recent venous drug use is less common in the forgo a condom as an indication of trust or study compared the practice of “opt-in” Southeast U.S.—in communities with high deference to a partner’s preference. Maybe to “opt-out” HIV testing among people rates of both HIV and incarceration like the they hope to become pregnant. Maybe they entering prison and found that there was a ones in the ISIS study. The majority of men don’t feel comfortable negotiating condom low rate of previously undetected HIV. The and women in prison in North Carolina use, or think that HIV is something that people who were HIV-positive tended to are African American, as are the majority happens to other people. They are compli- know they were positive entering prison, of those in prison who are HIV-positive. cated people, with complicated lives and unlike the earlier study of jailed men and Incarceration and HIV are dual epidemics favorite colors, and it is clear that we can women.3 that, in our state, feed off crack cocaine, do better in helping them lead the healthy Entering prison is a memorable and poverty, and destabilized relationships. lives they deserve. defining period, one of forced sobriety and Repeat incarcerations are the norm. This is guaranteed food and shelter but accompa- the “real life” stuff that the women in my for references, nied by a host of other burdens, stressors, study face when they leave prison.6, 7 Go to PosItivelyAware.com and painful reminders. Amidst this chaos, Other recent studies have underscored these men and women may not be expe- the high-risk period following release and riencing the wake-up call that an HIV test shown a greatly increased risk of death in Claire Farel, MD, MPH, is an Infectious represents for many outside the prison the few weeks following prison release. This Diseases physician and HIV clinical walls. We may not be catching new cases risk remained increased for years following researcher at the University of North at the time they enter prison, but that does release.8, 9 Living a healthy life as an HIV- Carolina. Her research interests lie in the not change lifetime HIV risk for many and positive person may not be in the cards for intersection of incarceration and HIV risk, for women in particular. our patients. Their risk of death is increased especially among women.

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 35 DISCONNECTED.

Incarceration cuts you off from your North Carolina prison facilities to learn more about the committed relationships social network—and HIV thrives on that of prison inmates.14 by Maria Khan, PhD and Matthew Epperson, PhD Among the inmates, 52% reported having a primary partner at the time of incarceration. The inmates’ lives had been highly Most people are not surprised to learn that HIV interconnected with those of their partners. infections cluster in jail and prison inmates. At any given time, there The majority of inmates reported that prior to the incarceration they had lived together are over 2.2 million adults in U.S. jails and prisons, and one of every with their partners (85%), had seen their seven HIV-infected Americans are released from these facilities each partners daily or nearly daily (88%), and year.1 Correctional facilities are holding places for those among the had been in long-term relationships with them, for six months or longer (64%) or most economically and socially disadvantaged in the U.S. on and off for a number of years (30%). Over half reported that their partners in the These populations are disproportion- returning home after incarceration for fear community had relied on them financially. ately affected by adverse life circumstances of again encountering family members, Inmates who were in committed relation- and behaviors, such as drug use, that drive friends, and acquaintances who were part of ships prior to the incarceration reported HIV risk. However, the process of incarcer- a lifestyle that led to the incarceration, such much lower levels of pre-incarceration mul- ation itself may also contribute to infection as one characterized by drug use or trade.8 tiple partnerships and sex trade than those However, one unintended effect of who did not have committed partners, incarceration is to weaken and, in some highlighting the protective effect of these cases, permanently fracture ties to com- partnerships. Over half of inmates’ relation- mitted partners, family members, and ships had ended during the incarceration. friends who are positive influences and These findings suggested to us that those transmission. who provide important sources of social who have lost a primary partner during Having a history of support. Losing a committed partner, in incarceration may experience heightened incarceration or having an inti- particular, has potential consequences levels of sexual risk-taking as they re-enter mate partner who has been incar- for an inmate’s HIV risk. Those who are the community. cerated are correlates of HIV risk in committed partnerships are less We also interviewed a number of indi- behaviors and sexually transmitted likely to engage in multiple sexual viduals at social venues in a North Carolina infection, independent of important partnerships.9,10 Consequently, the city to assess how commonly people in factors such as poverty and substance destabilization and dissolution the community reported having been in use.2-7 There is emerging evidence to of committed relationships that a relationship that was interrupted by suggest that incarceration may lead to occurs during incarceration could incarceration.15 The results told the HIV risk because incarceration disrupts promote HIV risk-taking upon same story—incarceration-related social and sexual networks, and HIV release. relationship disruption and dis- thrives on network disruption. solution was common. Relationship damage Among men who had Separation Many inmates are in commit- ever been incarcerated for Because incarceration removes an indi- ted relationships when they one month or longer, vidual from society, it is expected that ties leave for jail or prison, and 43% had a marital or between offenders and members of their many of these relationships non-marital primary networks will be weakened. This can be end during the incarcera- partner at the a positive event for the offender if ties in tion.11-15 We interviewed a time of the the community were negative influences. sample of HIV-positive longest For example, some inmates are wary of men incarcerated in prior

3636 | | m A my A +y J +un J une e2 02 1 0 2 1 2 pPositivelyAwo s i t i v e lyawaarr e e . . c c o o m m Among inmates, 52% reported having a primary partner. Over half of those 52% relationships ended during incarceration.

sentence. Among women, 22% had ever contribute to HIV risk during re-entry in a During an incarceration, the prisoner’s had a primary partner who had been number of ways. First, if an inmate loses a partner may seek other partners to fill incarcerated for one month or longer. Of stable partner during incarceration, upon an emotional or financial void.18 We have those who were in a relationship that was release, he may seek new partners and found that incarceration is associated disrupted by incarceration, more than 40% potentially engage in multiple partnerships with elevated levels of HIV risk behaviors of men and 30% of women reported the and/or buy sex for money or drugs to not only of the offender but also of their relationship ended during the incarcera- meet needs for sexual and emotional com- sexual partners.2-7 tion. Further, those who had lost a partner panionship. In addition, losing a partner Given the high rates of incarceration in during incarceration were twice as likely during incarceration may lead to distress many U.S. communities, the influence of to report recent multiple partnerships as and mental health problems. Specifically, incarceration on inmates and their families those who remained with their committed incarceration weakens social cohesion and is high. The fracturing of networks that partner during the incarceration. support networks when an individual most occurs during incarceration appears to It’s not surprising that relationships needs them—during the stressful periods influence HIV risk-taking. For these rea- end during incarceration, given the barri- of incarceration and re-entry.21-45 An inmate sons, it is critical to promote efforts which ers to maintaining ties during detention. may experience stress during the incar- will diminish the disruptive effects of Incarceration physically divides ceration due to loss of freedom, isolation, incarceration on healthy relationships, and prisoners and stigma.18 The period of re-entry is also to understand the public health implica- from their highly stressful, because released inmates tions of incarceration-related relationship intimate must negotiate a place to live, employ- disruption. partners, mak- ment, re-establishing family ties, and ing maintenance returning to high-risk situations.16,19 Social for references, of the relation- support may buffer the stress associated Go to PosItivelyAware.com ship difficult. with incarceration and re-entry by enabling Partners may speak the inmate to cope, thereby reducing nega- infrequently by tele- tive emotional and behavioral responses.46 Maria R. Khan is an Assistant Professor phone, as calling is restrict- However, losing a partner may lead to in the Department of Epidemiology and ed by prison regulations, is distress and diminish mental health.47,48 In Biostatistics at the University of Maryland monitored for security purposes, turn, the former inmate may self-medicate College Park School of Public Health. Her and is expensive.16 Likewise, logisti- with drugs or sex. recent work has focused on investigating cal and financial obstacles can prevent While incarceration disrupts existing STI/HIV among those with a history of incar- visitation, especially because many inmates networks, it also helps form new ones and ceration. She was recently funded by the are held far from their home communi- may lead to involvement in high-risk social National Institute on Drug Abuse to study ties.16 Even when visitation occurs, physical and sexual networks. There is evidence that how incarceration-related dissolution of rela- contact is often prohibited and lack of incarceration introduces inmates into high- tionships influences the HIV risk of African privacy prevents partners from maintain- risk networks characterized by high levels American men released from prison. ing intimacy during the incarceration.17 For of drug trade and use (i.e., gangs).49,50 The example, in many states, conjugal visits are networks may have high levels of sexual Matthew W. Epperson is an Assistant not permitted. Even written communica- risk-taking and infection, thereby leading Professor in the School of Social Service tion is affected, as prisons screen incoming to increased risk of sex with an infected Administration at The University of letters for security reasons. Physical separa- partner.51-53 Hence, by destabilizing existing Chicago. His primary focus is intervention tion during incarceration can lead to loneli- networks, incarceration may influence HIV research on co-occurring problems of ness and emotional division which puts risk not only by increasing the numbers of HIV, substance abuse, mental illness, and considerable stress on relationships during partners a former inmate has but also by criminal justice involvement. Before earn- incarceration.18-20 changing the types of partners a former ing his PhD in social work from Columbia inmate may have sex with. University, Dr. Epperson spent 15 years as Consequences of instability Finally, when offenders leave for jail a social worker in behavioral health and Loss of a partner during incarceration may or prison, they leave behind loved ones. criminal justice settings.

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 37 Prosecuting HIV: Take the Test—and Risk Arrest? by Sean Strub Consenting adults. No intent to harm. Undetectable viral load. A condom was Imagine meeting someone online, having a nice chat, used. No HIV transmission. Twenty-five and then deciding to hook up. You have HIV, but you’re adherent years in prison. This isn’t hypothetical; it is exactly what happened in a recent case to your meds and have had an undetectable viral load for years. in Iowa. In fact, as of July 2009 Iowa had You and your sexual partner use a condom. Sometime later, the convicted nearly 1% of all Iowans with HIV under their HIV-specific criminal statute. partner learns you have HIV and presses charges against you for There have been hundreds of prosecu- failing to disclose your HIV status prior to sex. tions for HIV crimes in the U.S., all over the country. As of today, 36 states and Your life is suddenly turned upside dollars for legal fees for the impending territories have HIV-specific statutes, but down, with your name and picture prosecution. a targeted law isn’t required to prosecute splashed across the media. You are called If convicted, you face decades in pris- an HIV crime. These prosecutions usually an “AIDS Monster.” You and your family on, lifetime registration as a sex offender, have little bearing on the actual level of and friends feel humiliated and embar- and other restrictions; if acquitted, your risk of HIV transmission, ignoring factors rassed. Your employment, housing, and life is still never the same, because you will like whether a condom was used or the relationships may be put in jeopardy and always be known as the “AIDS Monster.” viral load of the person with HIV. you need to find tens of thousands of Think about that for a moment: It’s important that people with HIV

38 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m and their advocates Stigma discourages people at risk from adequate to meet the Ryan White require- understand the issues accessing care—including testing for HIV— ment, but many added HIV-specific laws at stake, the risk they and it discourages people who know they (see map). These vary widely, both in what present for people are HIV-positive from disclosing to potential they punish and sentencing provisions. with HIV, and how sexual partners and others. Much of this In states without HIV-specific statutes, they may undermine stigma is based in racism and homophobia. criminal law (and in one recent case, an public health strate- Nothing drives stigma more than when anti-terrorism statute) has been used to gies to reduce HIV government sanctions it by enshrining prosecute people with HIV for behaviors transmission. The discriminatory practices in the law. That that posed little or no risk of transmis- issue is complicated, is what has happened with HIV, resulting sion. In these cases, HIV, or the blood, especially since the in the creation of a “viral underclass” of semen, or saliva of a person with HIV, is public is generally people with rights inferior to other citi- often characterized as a “deadly weapon.” supportive of criminal zens. Stigma driven by HIV criminalization Heterosexual men of color are the most prosecution of people promotes illegal discrimination against likely to be prosecuted. with HIV who do not people with HIV, including prohibitions on Typically, sentencing is vastly dispro- disclose their HIV certain occupations and licensing. portionate to the harm caused or the level status to a partner After three decades of the epidemic, of risk present in the sexual encounter. In before sex. One study, people with HIV continue to experience one Texas case, a man was sentenced to from the University punishment, exclusion from services, and 35 years in prison for spitting at a police of Minnesota, a presumption of guilt in a host of set- officer. In fact, about 25% of recent pros- showed that about tings and for practices that are, for those ecutions are for behaviors like spitting or two-thirds of gay who have not tested positive for HIV, biting, which pose no measurable risk of men supported such unremarkable. HIV transmission. Many of the prosecutions prosecutions; among This is reflected perhaps most dramati- for failing to disclose prior to sex have very young gay men, cally in the criminal prosecution of people been of someone with an undetectable it approached 80%. who know they have HIV but are unable viral load and/or who used a condom, but Even among gay men to prove they disclosed their status prior who is still sentenced to decades in prison. with HIV, it was nearly to sexual contact. The ostensible purpose The ethical obligation of people with 40%. Outside of gay men, it is likely that of these statutes is to deter HIV-positive HIV to disclose health factors that could put support for these statutes is even higher. people from putting others at risk. The sexual partners at risk was codified in the Criminalization supporters often believe inherent problem with these laws is that Denver Principles, the historic 1983 mani- these statutes are effective in reducing HIV they focus primarily on the existence of festo that launched the AIDS empower- transmission, but there are no data to sup- proof of disclosure, not on the nature ment movement. Defining what constitutes port this; in fact, there is a growing body of the exposure, the actual level of risk a risk sufficiently serious to require such of research demonstrating that they do present, or whether HIV was transmitted. disclosure is where it gets tricky. not reduce HIV transmission and may even Consequently, as studies have demon- The Denver Principles also recognize contribute to its further spread. strated, they do nothing to advance their sexual freedom as a fundamental human intended purpose. right, noting that people with HIV have A Viral Underclass a right “to as full and satisfying sexual Since the earliest days of the AIDS epi- The Origins of and emotional lives as anyone else.” Fully demic, stigma has been a major obstacle HIV Criminalization integrating people with HIV into society, to effective HIV prevention and care. Even The legal obligation to disclose stems, in in part by allowing them to have fulfilling as fear of contagion from casual contact part, from the 1990 Ryan White CARE Act. sexual lives without the risk of incarcera- has lessened over the years, profound That legislation required that states dem- tion, is critical to combating the stubborn stigma persists. People with HIV face judg- onstrate an ability to prosecute intentional stigma that remains an enormous obstacle ment, marginalization, discrimination, and HIV exposure, a recommendation from the to preventing new HIV infections. misunderstanding about the actual risks of head of President Reagan’s AIDS commis- The fact that HIV is so linked with transmission. sion. At the time, it was widely believed homosexuality and communities of color Many people with HIV internalize and that simple exposure to the virus—or hav- has made it easier to “punish” people with accept this judgment, perpetuating the ing intimate contact with someone who HIV—an example of how race or sexuality perception of those with HIV as toxic, was infected—was a “death sentence.” This can be used to form policies that isolate highly infectious, or dangerous to be requirement was dropped in the 2000 individuals and limit their freedoms. around. This has serious adverse effects renewal of Ryan White, but the criminal- Ethical obligations aside, criminalizing on them personally, as well as for the ization statutes it spawned remain in force. the sexual conduct of those living with broader effort to combat the epidemic Some states considered their exist- HIV is justified only when there is proof while protecting sexual freedoms. ing assault and public health statutes of the intent to harm another person, like

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 39 Prosecutorial states of America Where HIV DISCLOSURE laws stand in each state

HIV-specific statute, prosecution in past two years

HIV-specific statute, but no recent prosecutions

HIV-related proscutions, but no HIV-specific statute

a situation where someone intentionally must consider whether they also support an environment that encourages people to injected someone with HIV with a syringe or similar prosecutions of those with hepatitis get tested and disclose their status. had sex with the explicit purpose of trans- viruses, herpes, viruses like CMV, EBV, The Iowa case mentioned earlier pro- mitting the virus. Existing state and federal HPV, and other pathogens that can be vides a sobering illustration. The person criminal laws are adequate to deal with transmitted sexually. with HIV who was charged with failing to these extremely rare cases. Prosecutions in disclose his status to a sexual partner was a these instances should focus on the proof Prosecutions 34-year-old gay man. He met a male part- of intent to harm, the degree of risk present, Highly publicized HIV criminalization cases ner online and went to his house. He was and the resulting injury. are frequently driven by inaccurate and on HIV medication, had an undetectable Other cases—including some that have inflammatory media coverage and some- viral load, and used a condom when anally received widespread media attention— times by politically ambitious prosecutors. penetrating his partner, so the risk of trans- w & HIV Policy

involve people with mental health issues They feed into the public’s ignorance and mission was negligible to nonexistent. a who are recklessly and repeatedly putting anxiety about HIV, reinforce negative ste- When the partner heard the man had others at risk. Those situations should be reotypes about people with HIV, and send HIV, he went to the county prosecutor and

handled through existing public health poli- conflicting messages about the real risks pressed charges. The person with HIV was ter for l n cies for people with mental health issues. of HIV transmission. convicted and sentenced to 25 years in pris- e Those who support criminal prosecu- They depict people with HIV as danger- on. Fortunately, advocates were successful tion of people with HIV who fail to notify ous infectors who must be controlled and in getting the sentencing reviewed, and rce: C u o

partners in advance of intimate contact regulated, making it more difficult to create after serving eleven months he was released S

40 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m Not only do These Statutes require people to disclose their HIV status to potential partners, PROOF but also to be able to prove it in a court of law. on five years probation. But he must regis- to disclose their HIV status to potential advocates and policy leaders concerning ter as a sex offender for the rest of his life, partners, but also to be able to prove it in a HIV criminalization has focused on civil lib- may not be around his nieces or nephews court of law. Imagine this line at a bar: “Let’s erties concerns. Yet a growing realization without adult supervision, is subject to go home and get it on. Since I have HIV, that HIV criminalization is also a serious wearing an ankle-monitoring bracelet, and could you sign this affidavit stating that I public health challenge has helped propel cannot leave his home county without told you that? We can stop by a notary pub- the issue to the forefront. An important permission from the court. Iowa’s statute is lic on the way home and get it notarized.” step was the recognition of the need for particularly broad—in theory, it could cause Yet that scenario is not so far-fetched, changing HIV criminalization statutes in a person with HIV who kissed someone as more people with HIV are seeking ways President Obama’s National HIV/AIDS without disclosing to spend 25 years in pris- to document their disclosure, either by Strategy, released this past July: on—but other states’ statutes are equally as saving text or email messages, disclosing “Since it is now clear that spitting and absurd. Here are some examples: in the presence of a third-party witness, or biting do not pose significant risks for HIV in some cases taking a partner with them transmission, many believe that it is unfair n Texas doesn’t have an HIV-specific to a doctor’s appointment and asking the to single out people with HIV for engaging statute, but Willy Campbell, who was doctor to note the disclosure in the medi- in these behaviors and [they] should be sentenced to 35 years for spitting on a cal record. dealt with in a consistent manner without police officer, was convicted of “assault Spitting poses no risk of HIV transmis- consideration of HIV status. Some laws with a deadly weapon” even though sion. Yet in the past several years, there criminalize consensual sexual activity spit from a person with HIV doesn’t have been at least six convictions of peo- between adults on the basis that one of infect someone, let alone kill them. ple with HIV for spitting. And as a practical the individuals is a person with HIV who matter, it is the person biting, rather than failed to disclose their status to their part- n Gregory Smith was within a year of his the person bitten, who is at the greater ner. CDC data and other studies, however, release from a New Jersey prison when risk of acquiring the virus. tell us that intentional HIV transmission is he was charged with attempted mur- Criminalization is also reflected in atypical and uncommon…. [These laws] der, assault, and terrorist threats fol- “pile-on” charges and more aggressive may not have the desired effect and they lowing an incident in which he allegedly prosecution or sentencing of people with may make people less willing to disclose bit and spat on a guard (Smith denied HIV charged with other crimes. In 2009, a their status by making people feel at even the charges). An additional 25 years woman with HIV in Maine who was eligible greater risk of discrimination…. In many was added to his sentence; he died of for release was sentenced to continued instances, the continued existence and AIDS in prison. confinement when the judge learned that enforcement of these types of laws run she was pregnant. counter to scientific evidence about routes n In late 2009, using laws designed to He sought to “protect” the fetus from of HIV transmission and may undermine combat terrorism, Michigan charged infection by having the jail supervise the the public health goals of promoting HIV Daniel Allen, who has HIV, with “pos- woman’s treatment, also typifying how screening and treatment.” session of a harmful biological agent” courts sometimes elevate the perceived Early in 2011, the National Alliance after he was involved in an altercation interest of a fetus over the rights of a of State and Territorial AIDS Directors with a neighbor. Prosecutors equated pregnant woman. Although legal advo- (NASTAD) became the first major organi- his HIV infection with “possession or cates secured her release shortly thereaf- zation of public health professionals to join use of a harmful device.” ter, the desire of a federal judge to confine the effort to repeal HIV-specific criminal a woman with HIV to prison, despite testi- statutes. Their statement notes: n A man with HIV in Ohio could not prove mony that she was engaged in appropriate “HIV criminalization undercuts our most he had disclosed to his girlfriend that prenatal care, reveals ignorance and an basic HIV prevention and sexual health mes- he was positive and was sentenced to inclination to criminalize illness by even sages, and breeds ignorance, fear, and dis- 40 years in prison. He claims she knew the most educated and privileged mem- crimination against people living with HIV.” he was positive and only went to a bers of our society. Advocates who focus on the serious prosecutor after he stopped dating her What all of the cases above have in public health ramifications of HIV criminal- and moved in with another woman. common is that none of them resulted in ization can help repeal or end reliance on transmission of HIV to another person. criminalization statutes and other criminal These cases highlight one of the sig- laws that persecute and stigmatize people nificant problems with HIV criminalization A New Strategic Approach with HIV. They can also help educate law statutes: Not only do they require people Historically, the discussion among enforcement, prosecutors, and the media,

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 41 Reducing HIV transmission can only be achieved by combating criminalization, Stigma ignorance, and the associated stigma.

ultimately lessening HIV-related stigma among the most difficult to persuade to (PJP) in the fall of 2010 to end government and discrimination. get tested. The prospect of prosecution reliance on a positive HIV test result as for failing to disclose—especially since proof of intent to harm. PJP is housed at Bad Public Health Policy these prosecutions often boil down to The Center for HIV Law & Policy, a resource HIV criminalization discourages people at a “he-said/he-said” or “he-said/she- for leaders, attorneys, and advocates inter- risk from getting tested. Studies show that said” situation—is a powerful disincen- ested in HIV-related discrimination and people with HIV who are aware of their tive to disclosure. “Take the test and criminalization. PJP’s Resource Bank (hivla- status are more responsible in their sexual risk arrest” is the message increasingly wandpolicy.org) is a comprehensive data- behavior than those who are unaware they being heard on the streets. base of research, reports, court decisions, have HIV. Testing is a basic tool of HIV briefs, policy analyses, and other materials prevention as well as an essential gateway Racism and Homophobia of importance to people with HIV. to care. Prosecuting HIV nondisclosure but not Update: In recent weeks, there have Criminalization statutes also make prosecuting the failure to disclose other been a number of new developments it more difficult for people with HIV to STDs also reflects an unconscious rac- concerning criminalization. Iowa State disclose their status. Disclosing can be ism and homophobia. Human papilloma Senator Matthew McCoy introduced legisla- emotionally difficult, risking rejection virus (HPV) provides a useful contrast. tion to amend that state’s HIV statute to from family and friends—often with great HPV causes a variety of cancers, includ- make it apply only in cases where there is insult or abuse—and can jeopardize one’s ing almost all cervical, genital, and anal a malicious intent to harm the other party, employment, housing, relationships, or cancers. Cervical cancer alone killed 4,000 differentiate the penalty depending on personal safety. women in the U.S. in 2009; every year whether or not the virus was transmitted, Criminalization of HIV legitimizes the hundreds of thousands of women in the and remove the requirement that those con- ignorance, homophobia, racism, and sex- U.S. get diagnosed with cervical dysplasia, victed under the statute must be placed on phobia that fuel the inflated fears of those which is caused by HPV and is a precursor the state’s sex offender registry. Meanwhile, with HIV. It undermines efforts to prevent to cervical cancer. several Maryland legislators have introduced new HIV infections and provide access to By the age of 50 more than 80% of legislation to dramatically increase the care in many ways: American women will have contracted penalties under their statute, from three at least one strain of HPV. Yet unlike HIV, to a maximum of 25 years. Advocates in a n It undercuts the most basic HIV and HPV is not associated with “outlaw sexual- number of states have begun to organize to STD prevention message: that every ity” or with specific minority groups. HIV is build statewide coalitions to work for reform person must take responsibility for his associated with anal intercourse, gay men, of their statutes. or her own sexual health. African-Americans, and injection drug users, so racism and homophobia are inex- Go to youtube.com to watch HIV is Not n Prosecuting the failure to disclose values tricably linked with HIV stigma, discrimina- a Crime, the short film about three people the “right” to an illusion of safety over tion, and criminalization. who were prosecuted for non-disclosure, the privacy rights of those with HIV. including Nick Rhoades, the Iowa man Conclusion sentenced to 25 years and lifetime sex n Most new infections are caused by Since the earliest days of the epidemic, offender registration. sexual contact with people who are stigma and ignorance have hindered an unaware they have HIV, yet only those effective response to the HIV epidemic. Reprinted with permission from who have taken responsibility and got- Stigma and ignorance sanctioned in the Achieve, a publication of ACRIA ten tested are subject to prosecution. law are its most extreme manifestation and GMHC. and are inherently unjust. HIV-specific n Ignorance of one’s HIV status is the criminal statutes do not slow the transmis- best defense against a “failure to sion of HIV but may facilitate its further Sean Strub is executive director of The disclose” prosecution, a powerful disin- spread. Reducing HIV transmission can be Sero Project (www.theseroproject.org), centive to getting tested and learning achieved only when combatting HIV crimi- Senior Advisor to and a co-founder of the one’s HIV status. nalization and ignorance, and the associ- Positive Justice Project, founder of POZ. ated stigma, are part of the approach. com, and co-chairs the board of directors n Young African American men who To this end, nearly 40 HIV, human of the Global Network of People with HIV/ have sex with men are among those at rights, public health, and other organiza- AIDS/North America. He has been living highest risk of acquiring HIV, yet also tions founded the Positive Justice Project with HIV for more than 30 years.

42 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m Ask the HIV Specialist Joseph Bick, MD, FIDSA, AAHIVS, CCHP

You have the right to treatment Q: My brother is currently in jail, and may end up infections. By doing so, your brother will have a much doing time in prison. I know that he was doing drugs on better chance of staying off drugs when he is released, Search the street. The last time that I saw him, he had lost a lot and avoiding a return to prison. for an HIV of weight and he didn’t look healthy. I am worried that If your brother is HIV-positive, treatment can pro- Specialist™ he may have HIV. My brother is afraid to get tested, and vide him an opportunity to live a long, productive life. Finding an I do not know what to do. Please help! Unfortunately, approximately one in five Americans HIV Specialist™ —Lindsay who are HIV-positive do not even know it. Of those is easy with who are infected, one-third are diagnosed so late that AAHIVM’s A: Thanks for advocating on behalf of your brother. they develop a serious infection or cancer within one Referral Link: He is lucky to have you! year. The earlier that HIV is diagnosed, the greater the www.aahivm.org. Your brother could have HIV, though his weight chance of preventing these infections and cancers from Enter your loss might also be due to his drug use or he may have developing. In addition, HIV treatment causes HIV- ZIP code on another medical condition that needs treatment. The positive people to be much less infectious to their sex the home only way that he will find out is by seeing a health care and needle-sharing partners. page, and provider for a thorough evaluation. Please encourage your brother to get a thorough click on the Inmates of jails and prisons have a constitutional evaluation that includes testing for tuberculosis, HIV, “Go” button right to health care, including treatment for HIV disease. and hepatitis B and C. While in jail or prison, he will for a list of HIV Only by knowing his HIV status can your brother get have to fill out a form requesting to see health care staff Specialists™ the care he needs to get healthy and stay that way. for these tests. You can also help him by checking out near you. The time he spends in jail and prison is also a perfect community resources that he can transition to when he opportunity to start getting a handle on his substance gets released. Best of luck to you and your brother! abuse. If he is not ready to stop using drugs, he can —Joseph Bick, MD learn how to decrease his risk of picking up dangerous

Share your thoughts and help improve HIV education.

The American Academy of HIV Medicine is currently seeking participants in a survey to learn more about attitudes towards HIV care and treatment among both providers and people living with HIV. The study is enrolling about 250 providers and 750 patients. If you are at least 18 years old and currently being treated for HIV, participate in this web-based survey and let them know what you think.

To participate in the survey, go to http://tinyurl.com/ceoutcomes

It takes approximately 15 minutes to complete the survey.

The survey will ask questions that some people may find uncomfortable to answer, such as your income, education, race, and sexual practices, but you don’t have to answer any questions you don’t want to answer and your responses will be totally confidential. Each respon- dent will be identified by a unique code. You won’t be identified by name in any database or publications that may result from this study. Each question is asked to help researchers learn how to improve HIV education for different groups of people. Your participation will be greatly appreciated! CONFERENCE UPDATE CROI 2012 SEATTLE By jeff berry, matt sharp, & Enid Vázquez

latency of HIV genetic material Pablo Tebas, MD Baby steps integrated into human cells. The UNC study looked at six HIV-positive men who had toward a cure been on stable antiretroviral regimens with viral load less By Matt Sharp than 50 copies/mL (undetectable) and CD4 cell counts Science can seem to move CD4 memory cell so that the above 500 cells/mm3. First, along at an achingly slow dormant virus can complete CD4 cells were removed and pace, especially when curing its replication process. Then, tested to establish baseline HIV is the goal. Even though theoretically, antiviral therapy virus levels inside the cell. there has been extraordinary can move in to do its job. But Then the cells were exposed progress in understanding the there are many barriers to to vorinostat, and HIV RNA virus and identifying targets completely understanding was measured to show for therapy, there is still much this process, and uncovering whether HDAC was inhibited. to learn about how HIV can be safe and effective ways that The cells were compared cured. One of HIV’s survival may lead to a functional cure before and after the single pathway combined with other mechanisms is to hide from (stopping HIV without the use dose of vorinostat. There approaches such as vaccines our own immune system’s of long-term drugs). was a two-fold increase in and immune modulators may response and to antiviral Scientists must agree on histone deacetylation after all contribute to a functional drugs that slow its progres- the best way to measure virus eight hours of the dose. All six cure. One remaining question sion. But new research is inside the CD4 memory cell participants had a response is whether these or other beginning to frame HIV cure before and after attempts at from 1.5- to 10-fold HIV approaches can target other science while we watch the activation. It is also difficult to RNA increase inside the cell, HIV reservoirs such as the developments unfold. find these cells with dormant showing that one dose of the central nervous system. There were several HIV inside. Also, finding the study drug could activate the Pablo Tebas, MD, showed oral sessions and posters best monkey model to test sleeping virus. Even though additional data from the first dedicated to viral latency, the latency and activation only one dose was used there zinc finger nuclease (SB-728) eradication, and cure strate- hypothesis is in progress, but were no drug-related adverse cohorts at UPenn and Quest/ gies in pre-clinical and animal access to study animals con- events or toxicities. “This San Francisco presented at studies, and some very tinues to be problematic. proves for the first time that CROI and ICAAC last year. The encouraging early phase In an elegant proof of there are ways to specifi- two cohorts were immunologic clinical trials. The HIV Latency concept clinical study from the cally treat viral latency, the responders with CD4 cells and Eradication: Clinical University of North Carolina, first step towards curing HIV greater than 450 and immu- Perspectives symposium David Margolis, MD, a lead- infection,” Margolis stated. nologic non-responders with was so popular that there ing cure researcher, showed Other drugs such as CD4 cells less than 500 who were two overflow rooms for for the first time that HIV pegylated interferon-alpha- all were given one infusion attendees that could not fit can be purged from resting 2a, used as one of the back- of SB-728. There have been into the main session room. cells using one dose of an bone treatments for hepatitis no serious adverse events ce.org

Trying to understand anti-cancer drug called vori- C, and disulfiram (Antabuse— except one transfusion reac- n HIV latency and attempts nostat (known as SAHA for used for treating alcoholism) tion that went away after a fere to activate or wake up suberoylanilide hydroxamic were presented at CROI with few days. After about one n so-called sleeper cells har- acid). The drug is from a large varying results. Still, the field year, dramatic CD4 increases boring the virus are in very class of drugs known as HDAC is moving ahead as indicated were seen in both groups that etroco early research stages. This (histone deacetylase inhibi- by the number of positive investigators think was related a R i is a critical HIV reservoir in tors). Histone deacetylase is results in pre-clinical, animal, to increases in IL-2, IL-7, and which scientists are trying to an important enzyme that and clinical studies pre- IL-15, cytokines associated

figure ways to wake up the contributes to maintaining sented. In time, the activation with CD4 expansion. CD4:CD8 Photo V

44 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m T-cell ratios normalized in the addressed were how to better majority of participants. After inform the community about Prevention study results infusion, SB-728 was detected cure research and clinical in peripheral blood from 90 to trials, including revision of yield more good news 700 days thus far. The modi- the cumbersome informed fied cells also traffic to the consent process. Also, the By Enid Vázquez rectal mucosa, showing that challenge researchers have in the modified cells are reaching gaining access to experimental After two years of landmark Asked about treatment as other important HIV reservoirs. drugs from other companies studies, HIV prevention con- prevention (TasP), in which One remaining question for use in their experiments tinued to dominate research successful anti-HIV treat- was whether HIV RNA would and the continuing problem news at CROI. ment of a positive partner be affected by SB-728. To of development of the best The Partners PrEP study has been shown to greatly show this, participants went assays and animal models enrolled nearly 5,000 het- reduce transmission of HIV on a treatment interruption were all discussed. Sangamo, erosexual couples where to a negative partner, Baeten during the trial. After increase the biotech company develop- one partner had HIV and the said a need for PrEP remains. in viral load levels, all had ing zinc finger technology, other didn’t. “PrEP” stands Some HIV-positive individuals significant drops in virus is now scheduling a meeting for pre-exposure prophylaxis prefer to delay therapy, he levels before resuming ARVs with a few cure research activ- (prevention), and is taken said, but at the same time, again. One man who dropped ists. Investigators from UCSF, by HIV-negative people to heterosexual couples are to undetectable levels was UNC, and the Fred Hutchinson prevent sexual transmission concerned about conceiving found to be heterozygous for Cancer Center presented proof HIV. children. Still, “we’ve been the delta 32 mutation, making grams being developed for the Final primary results from very aggressive about mak- him an “elite controller,” one Martin Delaney Collaboratory. Partners PrEP showed a ing sure infected partners whose HIV is controlled with- Activists are also working to 67% reduction in risk of HIV are treated when eligible.” In out ART. Because of this find- create community advisory infection with Viread and a some resource-poor coun- ing, a study has been enrolled positions with this ground- 75% reduction with Truvada tries, HIV-positive people are to look at this very population breaking research. (considered not to be a statis- not eligible for government- to see if the antiviral effect is The game changer at tically significant difference). sponsored antiviral treatment real. Another study is using CROI was that cure research The two HIV medications until their medical condition a single infusion of a chemo- has reached the main stage. were compared against pla- meets certain requirements, therapy drug in order to make While no one knows how long cebo (fake pill) in couples in such as a CD4+ T-cell count room for more expansion of it is going to take to find a Kenya and Uganda. under 200. “We can use PrEP the CCR5-modified CD4 cells. cure for HIV, everyone agrees “They worked approxi- as a bridge until a partner AIDS treatment activists that a lot of work remains. mately the same,” said starts treatment,” he said. have been at the table in the presenter Jared Baeten, Of the 27 individuals who latest developments in cure MD, MPH, of the University seroconverted in Partners research since Martin Delaney Diagnosed with HIV in 1988, of Washington in Seattle, PrEP, none developed drug stumbled upon the Timothy Matt Sharp’s long history in a press conference. “This resistance to Viread or Brown “Berlin patient” poster as an AIDS advocate includes was definitive protection for Truvada, the drugs studied several years ago. At CROI, belonging to ACT UP Golden people at high risk of HIV for PrEP. The development that tradition continued in a Gate; directing the education because of a known HIV- of drug resistance is a con- one-day workshop organized programs at Test Positive positive partner.” He added cern for individuals taking by activists. Leading cure Aware Network in Chicago that the results were consis- PrEP who become infected researchers, the FDA, the IAS and Project Inform in San tent no matter the viral load because HIV treatment is (International AIDS Society), Francisco; and helping to in the positive partner. For the heavily dependent on the and pharmaceutical compa- found the AIDS Treatment HIV-negative partners who use of Viread or Truvada nies developing eradication Activists Coalition. Currently, took the prevention medica- (in wealthier countries, at molecules joined activists in he acts as an international tions, side effects included least). But more and more, a robust discussion. Issues consultant. mild fatigue and nausea. prevention studies with HIV

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 45 CONFERENCE UPDATE CROI 2012 SEATTLE By jeff berry, matt sharp, & Enid Vázquez

medications are showing that adherence to preventative previous formulation was safe where they fail, it’s because medicine in people at high but bothersome. The new ART plus the drugs are not being taken risk of infection. Also of reduced-glycerin formulation new drugs as prescribed. A person’s importance in this study was of 1% tenofovir gel is moving virus can develop drug resis- that the infected women into a Phase 2, eight-week coming soon tance when medications are perceived themselves to be study. being taken inconsistently at “little or no risk of HIV Tenofovir and Truvada are By Jeff Berry (missing doses). infection.” They were actually ahead of the game now, but Deborah Donnell, PhD, of at high risk of infection and other HIV antivirals are also We often hear that there’s the University of Washington didn’t know it. being tested for prevention. not much new coming down and the Fred Hutchinson There was more welcome A small, early study with the the HIV drug development Cancer Research Center data on the potential problem new non-nucleoside rilpiv- pipeline, but there were in Seattle, illustrated this of resistance. The CAPRISA irine (Edurant) was shown to several presentations and issue with a Partners PrEP 004 research team reported penetrate vaginal and rectal plenty of posters on new HIV sub-study showing that no resistance in either the tissue and fluids in an amount drugs in development at this only nine of the 27 infected blood or the genital tracts of needed to inhibit HIV infec- year’s CROI, including two individuals had any teno- women who became infected tion. Rilpivirine was used in a new integrase inhibitors set to fovir in their blood at all at during the study. “This is a long-acting, injectable form in be approved in 2012, elvite- the time of seroconversion. good news result,” said Will this research (used intramus- gravir and dolutegravir, plus (Tenofovir is the generic Fischer of the Los Alamos cularly). The use of the HIV a reinvention of the popular name of Viread, and it is also National Laboratory. “There entry inhibitor drug Selzentry HIV drug tenofovir (Viread), found in Truvada.) “Tenofovir was only one case of high- (maraviroc) is also being also found in Truvada (emtric- detected in blood was highly level resistance and this was explored with a vaginal ring itabine/tenofovir). There was correlated with protection from a woman on placebo, so that releases maraviroc into also information regarding from HIV infection,” she said. it was presumably a transmit- the genital tract. The hope already approved drugs that “I think our results are clearly ted resistance [she picked up is that such medications will will help inform us on how to proof of concept that daily a drug-resistant virus from a help counter the adherence make better use of the drugs use of tenofovir can substan- sex partner].” CAPRISA 004 problems found with preven- that are currently in use. Go tially reduce the risk of HIV used a tenofovir gel applied tion research to date. to www.retroconference.org. infection.” vaginally. Said Susan Buchbinder, of Lut Van Damme, MD, of “I guess this decade will the San Francisco Department The Quad Family Health International, be remembered as the teno- of Public Health and the In a Phase 3 study, the once- illustrated the same concept fovir decade,” said Linda-Gail University of California, San daily single tablet regimen with the FEM-PrEP study, Bekker of the University of Francisco, “Lots of data was (STR) of elvitegravir, cobici- which disappointed HIV Capetown, while co-facilitat- presented this morning— stat, emtricitabine, and teno- advocates when a daily ing a session on the use of [showing that] HIV infections fovir, known as the “Quad,” Truvada pill failed to prevent HIV drugs for the prevention occur during periods of low was found to be non-inferior HIV in women. However, of sexually transmitted HIV. blood exposure.” See her talk to the gold standard Atripla Van Damme reported that She noted that her research on the possibilities for inter- (efavirenz/emtricitabine/ the medication was found in team has used tenofovir in all mittent PrEP (not taken daily) tenofovir) at 48 weeks. This is blood levels of less than half of its prevention studies. in the Wednesday symposium the first large head-to-head of the 33 infected women Other encouraging “Next Steps in Using ARV for study of two single-tablet- who had been given it, as tenofovir data: a small study Prevention” at www.retrocon- regimens. 700 treatment- well as in less than half of from the Microbicide Trials ference.org, along with a talk naïve individuals were the uninfected women in Network with a re-formulated from Baeten, “What Can the randomized to receive either a matched control group. tenofovir gel was found Twisted Tale of PrEP Results the “Quad” or Atripla, with According to the FEM-PrEP to be safe and acceptable Teach Us?” and two other 88% of those on the “Quad” abstract, studies will need as a rectal microbicide presentations. achieving undetectable viral to focus on what determines used daily for seven days. A load (less than 50 copies)

46 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m compared to 84% of those on NRTIs. Fewer participants greater concentration of the studies compared rilpivirine Atripla. Side effects differed on dolutegravir (3%) dis- active form of the drug within versus efavirenz (Sustiva) in between the two groups, continued therapy due to the cells, and lower levels combination with Truvada, with higher rates of nausea adverse events compared to in the bloodstream, while Epzicom, or Combivir. In a in those on the “Quad” com- Sustiva (10%). The study was allowing for smaller doses—in pooled analysis from both pared to Atripla (21% vs. 14%), not designed to demonstrate other words, greater antiviral Phase 3 studies of 1,368 while increased rates of CNS non-inferiority; however, the activity, potentially less individuals, in those with a side effects and rash were proportion of those with unde- toxic, and a smaller pill (mak- baseline CD4 count of 50 seen in those taking Atripla tectable viral load was 88% for ing it easier to co-formulate and above, responses were versus the “Quad”—abnormal the dolutegravir group (using with other drugs). Gilead is high and similar between the dreams (27% vs. 15%), insom- the 50 mg dose) compared also planning to explore use rilpvirine and efavirenz groups. nia (14% vs. 9%), dizziness to 72% for the Sustiva group, of GS-7340 as a treatment for There were lower responses (24% vs. 7%), and rash (12% with no integrase inhibitor hepatitis B. for those on rilpivirine with vs. 6%). Both groups showed resistant mutations detected a baseline CD4 count less similar low rates of discon- at 96 weeks. Two Phase 3 Other studies than 50. Responses seen with tinuation due to side effects studies are currently enrolling BMS-626529 (poster #725) rilpivirine were significantly (4–5%), and similar low rates for both treatment-naïve and is the first in its drug class, higher than with efavirenz of virologic failure (7%). -experienced individuals using an oral attachment inhibitor, with both baseline viral load In a related poster (#627) the selected 50 mg dose, and which blocks the first step in of less than 100,000 and CD4 the “Quad” showed non- an expanded access program viral entry, using a different cell count of 200 and greater. inferiority to boosted Reyataz (EAP) is now open for those target than entry inhibitors. Overall responses were lower (atazanavir/ritonavir) in failing or resistant to Isentress In a brief study, monotherapy with rilpivirine compared to combination with Truvada at (raltegravir) or elvitegravir and with BMS-663068, a pro-drug efavirenz with baseline viral 48 weeks, with 90% of those who need access to dolutegra- of “529,” did not appear to load greater than 100,000, on the “Quad” achieving vir now (see Briefly, page 8). select for BMS-626529 resis- although non-inferiority undetectable viral load com- tance for as long as eight days. between the groups was pared to 87% of those using GS-7340— Rilpivirine (Edurant) is still met. Another poster boosted Reyataz plus Truvada. son of tenofovir the newest non-nuke that (#617) demonstrated that This Phase 3 study is being GS-7340 is a pro-drug (a was approved in 2011, and rilpivirine 25 mg once daily conducted in parallel with the substance that becomes is also co-formulated with and raltegravir (Isentress) Quad vs. Atripla study dis- activated after entering the Truvada in a single-tablet 400 mg twice daily can be cussed above. body) of tenofovir (Viread). regimen known as Complera. co-administered without dose An FDA advisory commit- Peter Ruane, MD, and col- The ECHO and THRIVE modifications. tee meeting on the “Quad” is leagues conducted a 10-day scheduled for May 11. monotherapy study which Peter Ruane, MD was to compare three differ- New integrase ent doses of GS-7340 (8, 25, inhibitor and 40 mg once daily), 300 dolutegravir mg tenofovir, and GS-7340 SPRING-1 is a Phase 2b dose- placebo. The drop in viral load ce.org n ranging study of dolutegravir, was greater in the GS-7340 a once-daily unboosted groups compared to Viread, fere n integrase inhibitor, in approxi- while blood levels of tenofovir mately 200 treatment-naïve were lower in all GS-7340 individuals. The study looked groups compared to those on etroco at 10, 25, and 50 mg doses Viread. This newer version of a R i of dolutegravir compared the popular drug Viread (also to Sustiva (efavirenz), both contained in Truvada, Atripla,

Photo V in combination with two and Complera) achieves

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 47 Seen in Seattle Glimpses of the Emerald City while in town for CROI

Between presentations and networking meetings, there really wasn’t time for sightsee- ing while attending the 19th Conference on Retroviruses and Opportunisitic Infections. Still, Seattle’s beauty and charm are inescapable. Brief excursions through downtown led to the famous open-air Pike Place Market and the graffiti of nearby Post Alley. A number of eye-catching storefronts caught conference-goers’ attention, including the original Starbucks, which opened in 1971. With its own distinctly classic style, Tiffany & Co. stands out. And in a city known for its unique culture and aesthetic, the Seattle Public Library makes a modern statement on the place of design in society. photos by Jeff Berry and Enid Vázquez

48 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m The Buzz Daniel S. Berger, MD

CROI’s hep C treatment news

The revolution of treatment development with The “Breakthroughs in HCV direct acting agents against hepatitis C virus (HCV) is Treatment” session began with presentations of studies with telaprevir moving faster than a speeding bullet. As it once was for (Incivek) and boceprevir (Victrelis), treatment development of HIV, it is dramatic. both inhibitors of NS3/4A HCV protease. Both won FDA approval Thus, one of many reasons to attend the 19th in 2011 for use with pegylated interferon and ribavirin Conference on Retroviruses and Opportunistic in adults with genotype 1 chronic HCV and compen- One of many Infections (CROI), held this year in Seattle in March, was sated liver disease. However, neither boceprevir nor reasons to the intensity and new data regarding HCV treatment. telaprevir is licensed for use in HIV/HCV co-infection. attend CROI This was unusual for a conference historically focused At CROI, two co-infection studies were highlighted; was the on the basic science of HIV. both trial designs included combinations with pegylated intensity and There is a growing incidence of hepatitis C infection interferon and ribavirin (P/R), and both included the new data among HIV-positive individuals (co-infection) and it conventional “futility rules” that have become standard regarding HCV is becoming clear that HCV treatment is complicated. for patients undergoing treatment. Protocols put futil- treatment. Treatments differ in regards to HCV genotype, therapy ity rules in place so that patients who experience viral This was for treatment-naïve vs. history of treatment failure, and rebound or those who do not reach rapid declines unusual for drug-drug interactions for patients with co-infection. in hep C RNA (viral load) or undetectability within a a conference HIV specialists are accustomed to these kinds of specified time frame are discontinued from treatment, historically complex issues while gastroenterologists, busy with avoiding resistance mutations or further side effects focused on endoscopic procedures, and hospital-based infectious with failing treatment. Also discussed were HIV drug the basic sci- disease specialists, with limited office hours, may not interactions, crucial for understanding their use with ence of HIV. be able to tackle the rocketing numbers of patients with HIV treatment. HCV infection growing to monumental proportions. With many future agents becoming developed, much Telaprevir heavy lifting treating HCV-infected patients will be left Dr. Douglas Dieterich presented a trial of treatment to physicians who manage HIV disease. However, there with telaprevir (TVR) in genotype 1 HCV co-infected is a progressive decrease of physicians wanting to spe- patients; genotype 1 is the most common and, unfortu- cialize in HIV disease treatment. nately, the most difficult to treat HCV strain. A poster presented by the Swiss Cohort team Patients were administered telaprevir (750 mg every showed staggering statistics in regards to the grow- 8 hrs)+P/R for 12 weeks followed by 36 weeks of P/R ing hepatitis C epidemic among those infected by HIV. alone; in the P/R control group, patients were treated Their investigation of the MSM (men who have sex with for 48 weeks with P/R alone. Further, the trial was men) population excluded intravenous drug users and divided into parts A and B. In part A, 13 patients were heterosexuals. Of 3,333 MSM patients followed, the treated without ART (antiretrovirals); 7 randomized to incidence of new HCV infections in 2011 (compared to P/R+TVR and 6 on P/R alone. In part B, 24 patients were 1998) increased 18-fold. Identified risk factors were on Atripla, 16 treated with P/R+TVR and 8 on P/R alone. unsafe anal sex, history of syphilis, and chronic hepatitis Also, 23 patients were on ritonavir-boosted atazanavir B infection. Indeed, the take home message for clini- (Reyataz/Norvir) with either Truvada (emtricitabine/ cians is the need for increased testing for HCV and for tenofovir) or Viread/Epivir and of these, 15 were treated gay men engaged in unsafe sexual practices, the mes- with P/R+TVR and 8 with P/R alone. sage is beware and exercise prevention; one needn’t be At 12 weeks post-treatment the overall SVR (sus- engaged in intravenous drug use to become infected. tained virologic response—indicates treatment success),

PositivelyAwa r e . c o m M AY + J U N e 2 0 1 2 | 49 was 74% in the P/R/TVR-treated patients vs. 45% in In this Phase 1 trial, there were six treatment arms controls. There were no HIV treatment failures; three with doses ranging from 50 to 800 mg once daily HCV treatment failures occurred—at week 4 with one administered to genotype 1 treatment-naïve patients patient in each of the Atripla and Reyataz groups and over seven days. Thirty out of forty, or 75%, achieved one at week 12 in the Atripla group. Patient discontinu- viral load reductions to below detection at seven days ations due to futility rules were more common in the during which there were no viral breakthroughs (treat- P/R controls (32 vs. 5%) and discontinuations due to ment failures) with viral load reductions persisting for adverse events were 8% in the TVR group vs. 0% in the several days beyond administration. During the confer- P/R group. The most common side effect was fatigue in ence, information released by Merck discussed the two both groups (41-42%) with pruritis (itchy skin), nausea, higher doses being associated with an elevated liver headache, and rash being more common in the TVR enzyme signal. However, because the trial showed all treatment groups. No dosage adjustments were neces- arms, including 50 mg, to have superimposed viral load sary except for a higher dose of telaprevir (1,125 mg declines, we hope that further studies will move for- every 8 hours) required to offset reduced exposure of it ward, expecting to use the lower doses. with efavirenz (Sustiva, in Atripla). GS-7977 Boceprevir In a much anticipated session, GS-7977 was presented. Dr. Mark Sulkowski presented treatment with boceprevir Gilead Sciences has recently acquired this agent from The standard (BOC) in untreated patients with genotype 1 HCV. In this Pharmasset and it has been much in the news lately due of care for randomized study, all patients began with a lead-in of to its ability to result in SVRs without need for interfer- HCV treat- four weeks P/R therapy, followed by 64 and 34 patients on; it is also one of the agents that is ahead of others in ment includes continuing with P/R+BOC vs. P/R alone, respectively. At development for treating HCV. Currently, the standard pegylated 12 weeks post-treatment 61% on P/R+BOC vs. 27% on of care for hepatitis C treatment includes pegylated interferon P/R alone achieved an SVR. interferon despite its difficult side effects, so success- despite its HIV treatment failure occurred in three patients on ful HCV treatment without the need for interferon is of difficult side boceprevir vs. four patients on P/R alone. In a separate keen interest to both clinicians and providers. effects, so abstract (Abstract 771LB), drug-drug interactions of 7977, a nucleotide analog with potent anti-HCV treatment boceprevir with boosted protease inhibitors showed activity, is administered in one pill daily, with or without without inter- that both ritonavir-boosted protease inhibitors and food. In the prior study, Electron, patients with geno- feron is of boceprevir inhibit the same CYP3A4 enzymatic systems type 2 or 3, naïve to HCV treatment, were given 7977 keen interest. and other complex enzyme transporter interactions. At at 400 mg daily plus ribavirin for 12 weeks, but impor- the time of this study, these interactions were unknown; tantly, without pegylated interferon. Continuing, in the we now understand that boosted PIs should not be Electron study, all 40 patients studied achieved an used with boceprevir. Boceprevir reduced steady-state SVR out to 24 weeks. Moreover, one arm of the study exposure of Kaletra, Reyataz, and Prezista by 43, 49, had 7977 administered as monotherapy and 60% and 59% respectively. There is also a significant reduc- achieved SVR out to 24 weeks. tion in boceprevir exposure with Kaletra and boosted In the latest segment of Electron, the newest data Prezista. Healthcare professionals recently received a studied HCV patients with genotype 1 in two groups: letter in which Merck stressed they do not recommend null responders (those who previously failed treatment) the co-administration of Victrelis (boceprevir) and and patients naïve to HCV therapy. All patients received ritonavir-boosted HIV protease inhibitors (see Briefly, 7977 with ribavirin for 12 weeks. At the conference page 8). only the results of the null responders were available. Side effects with boceprevir treatment included Remarkably, of the 10 patients, no patient rebounded anemia, pyrexia, asthenia, decreased appetite, diarrhea, while on the 12 weeks of treatment, demonstrating vomiting, flu-like illness, and neutropenia. However, 7977 to have a high barrier for resistance. However, serious adverse events were 17% in the BOC group vs. nine out of 10 patients relapsed soon after cessation of 21% in the group taking P/R alone. treatment. The authors concluded that these particular patients with genotype 1, also previously treatment MK-5172 failures, would probably require another direct act- In another presentation, Richard Barnard presented a ing agent, such as an NS3 inhibitor. From this writer’s Phase 1 study of Merck’s next generation HCV protease standpoint, patients who fail treatment with P/R prob- inhibitor, MK-5172. Preliminary evidence shows activ- ably develop resistance; thus being offered one new ity against other protease inhibitor-resistant variants. agent (7977), although together with ribavirin, would

50 | m Ay + J un e 2 0 1 2 PositivelyAwa r e . c o m be tantamount to monotherapy. We anticipate the rilpivirine (Edurant), raltegravir (Isentress), and tenofo- results from the naïve patients to be presented at EASL vir (Viread) can be used with TMC 435 without dosage (European Association for the Study of the Liver) in adjustment. Drug-drug Barcelona this April. Lastly, for the first time, drug-drug interactions interactions were presented regarding using raltegravir (Isentress) were presented Drug Interactions with Newer Agents: in combination with boceprevir (Victrelis) with the regarding using Daclatasvir, TMC 435, and Boceprevir conclusions that boceprevir does not affect raltegravir raltegravir Daclatasvir (DCV) is a potent NS5A replication complex exposure and can be used safely. (Isentress) in inhibitor of HCV, administered once daily, currently in combination Phase 3 trials in combination with P/R. PK data showed with boceprevir no effect on tenofovir (Viread), efavirenz (Sustiva), or Dr. Daniel S. Berger is a leading HIV physician in the (Victrelis) with boosted atazanavir (Reyataz/Norvir). However, DCV U.S. and is Clinical Associate Professor of Medicine at the conclusions dosage adjustments will be needed: 30 mg when used the University of Illinois at Chicago. He is founder and that boceprevir with boosted atazanavir, 90 mg with efavirenz. Both medical director of Northstar Healthcare, has published does not affect have equivalent exposure of DCV as in the 60 mg dose extensively in such prestigious journals as The Lancet raltegravir used alone. and The New England Journal of Medicine and currently exposure and TMC 435, another potent NS3/4A protease inhibitor, serves as principle investigator at Northstar Healthcare. can be used currently in Phase 3 for genotypes 1 and 4 HCV-infected Dr. Berger has been honored by Test Positive Aware safely. patients, is about to begin trials in co-infection. Data of Network with the Charles E. Clifton Leadership Award. drug-drug interactions showed it to be not recommend- He can be reached at [email protected] and ed for use with efavirenz due to the reduced exposure www.Nstarmedical.com. to TMC 435 in the presence of efavirenz. However,

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® RIDE FOR AIDS CHICAGO JULY 14–15, 2012 sponsored by www.RIDEFORAIDS.org

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t st a h rsh e i h c ave pi hole. The law The hole. ctur s an d - - t - - E - h e h eradicating the injustice that is the true crime. true the is that injustice the eradicating at working keep all we’ll that and there, them to drive injustice allowing people fewer be will there because to shrink begin will population prison the that hope Ihave MORE!” to say, ”No start people more as streets, the hit 99% the as turning slowly is tide the perhaps aresult. as lives their lose can Trayvon Martin and Alawadi, Shaima Tiller, George Shepherd, Matthew where point to the them from different is who anyone intensity hot white with hate who Americans of minds the in also is it Sadly, children. unwanted those of care to take women those enable would that programs to fund refusing time same the at while incest and rape from resulting children the to have women forcing laws to pass try conservatives “Christian” themselves call who men white where Congress in or homeless, are families and towns ghost creating is fraud bank mortgage where neighborhoods class” “middle in or communities, own their off killing they’re that to know stupid too they’re because dren chil innocent kill bangers gang where neighborhood black apoor, in it’s whether insidious, is It of—injustice. enough than more is there that society our in thing one shrink. would population prison the that how, doubt Ihave no knew way they only the in to survive desperate were or time, wrong the at place wrong the in been mistake, a horrible made had who to those opposed as crimes destructive or violent committed had and evil truly was who us tell could that machine mystical some was there if But are. they who know they and there to be deserve who bars behind people of plenty are There you. correct me let innocent, really is prison in everyone that to buy willing naively ance companies that refuse to cover that child’s care? their sickchildat gunpoint, orare they thehealthinsur ave Breathe deep, live long. live deep, Breathe but world, the in alive to be time easy an not It’s is there prisons, and jails inside as well as here, Out liberal, heart ableeding just I’m think you case In - n o t s

force hospitaldoctors to care for them? Are they theparents who luxuries theirill-gotten gainsafford funds whoare still free to enjoy the bank robbers, ortheCEOs ofhedge forward intheirlives? Are they the M - A - Y N U J + true crime. that isthe the injustice at eradicating keep working that we’ll all there, and to drive them ing injustice people allow will befewer because there to shrink will begin on population that thepris- I have hope e 2 1 0 2

53 - A MESSAGE FROM YOUR IMMUNE SYSTEM

Talk with your doctor about ways to help protect your immune system. HIV treatment is now recommended for everyone with a T-cell count of 500 or less and should be considered when T-cells are higher than 500, according to the DHHS* and the IAS-USA†, along with other factors. Starting treatment early may help protect your immune system and vital organs. Today’s medicines may have fewer, more manageable side effects. They may help you live a longer, healthier life. Receive helpful information about living with HIV that you should know. Call toll free 1-888-447-1728, or visit TREATHIVNOW.COM.

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