C O M M E M O R A T I N G
Y E A R S
A Journey of personal truth on the rIDE FOR AIDS CHICAGO CROI 2014 Conference highlights
POSITIVELY AWARE M AY+J U N E 2 0 1 4
HIV IN THE SOUTH
SOUTHern exposure In THE Southern u.S., HIV is a disease of poverty, ignorance, and racism. But itâ€™s not without beacons of hope Josh,
a college student, seeks the support of a gay family miles away from his Mississippi Delta hometown in the documentary film, deepsouth.
What is STRIBILD? STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. It combines 4 medicines into 1 pill to be taken once a day with food. STRIBILD is a complete singletablet regimen and should not be used with other HIV-1 medicines. STRIBILD does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking STRIBILD. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.
IMPORTANT SAFETY INFORMATION What is the most important information I should know about STRIBILD?
• Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking STRIBILD, your hepatitis may suddenly get worse. Do not stop taking STRIBILD without first talking to your healthcare provider, as they will need to monitor your health. STRIBILD is not approved for the treatment of HBV.
• Take a medicine that contains: alfuzosin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil when used for lung problems (Revatio®), triazolam, oral midazolam, rifampin or the herb St. John’s wort. • For a list of brand names for these medicines, please see the Brief Summary on the following pages.
• If you take hormone-based birth control (pills, patches, rings, shots, etc).
• Take any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera®).
• If you take antacids. Take antacids at least 2 hours before or after you take STRIBILD.
What are the other possible side effects of STRIBILD?
• If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD.
Do not take STRIBILD if you:
Serious side effects of STRIBILD may also include:
• Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.
• New or worse kidney problems, including kidney failure. Your healthcare provider should do regular blood and urine tests to check your kidneys before and during treatment with STRIBILD. If you develop kidney problems, your healthcare provider may tell you to stop taking STRIBILD.
• You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking STRIBILD for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
• All your health problems. Be sure to tell your healthcare provider if you have or had any kidney, bone, or liver problems, including hepatitis virus infection. • All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking STRIBILD without first talking with your healthcare provider.
Who should not take STRIBILD?
STRIBILD can cause serious side effects:
• Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain.
What should I tell my healthcare provider before taking STRIBILD?
• Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones. • Changes in body fat can happen in people taking HIV-1 medicines. • Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking STRIBILD. The most common side effects of STRIBILD include nausea and diarrhea. Tell your healthcare provider if you have any side effects that bother you or don’t go away.
• If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. Also, some medicines in STRIBILD can pass into breast milk, and it is not known if this can harm the baby.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see Brief Summary of full Prescribing Information with important warnings on the following pages.
STRIBILD is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD does not cure HIV-1 or AIDS.
I started my personal revolution Talk to your healthcare provider about starting treatment. STRIBILD is a complete HIV-1 treatment in 1 pill, once a day. Ask if itâ€™s right for you.
Patient Information STRIBILD® (STRY-bild) (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) tablets Brief summary of full Prescribing Information. For more information, please see the full Prescribing Information, including Patient Information. What is STRIBILD? • STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD is a complete regimen and should not be used with other HIV-1 medicines. • STRIBILD does not cure HIV-1 or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses. • Ask your healthcare provider about how to prevent passing HIV-1 to others. Do not share or reuse needles, injection equipment, or personal items that can have blood or body fluids on them. Do not have sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. What is the most important information I should know about STRIBILD? STRIBILD can cause serious side effects, including: 1. Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take STRIBILD or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis: • feel very weak or tired • have unusual (not normal) muscle pain • have trouble breathing • have stomach pain with nausea or vomiting • feel cold, especially in your arms and legs • feel dizzy or lightheaded • have a fast or irregular heartbeat 2. Severe liver problems. Severe liver problems can happen in people who take STRIBILD. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems: • your skin or the white part of your eyes turns yellow (jaundice) • dark “tea-colored” urine • light-colored bowel movements (stools) • loss of appetite for several days or longer • nausea • stomach pain You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking STRIBILD for a long time. 3. Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) infection and take STRIBILD, your HBV may get worse (flare-up) if you stop taking STRIBILD. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. • Do not run out of STRIBILD. Refill your prescription or talk to your healthcare provider before your STRIBILD is all gone
• Do not stop taking STRIBILD without first talking to your healthcare provider • If you stop taking STRIBILD, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking STRIBILD Who should not take STRIBILD? Do not take STRIBILD if you also take a medicine that contains: • adefovir (Hepsera®) • alfuzosin hydrochloride (Uroxatral®) • cisapride (Propulsid®, Propulsid Quicksolv®) • ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, Migranal®), ergotamine tartrate (Cafergot®, Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, Wigrettes®), and methylergonovine maleate (Ergotrate®, Methergine®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • oral midazolam • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil (Revatio®), when used for treating lung problems • simvastatin (Simcor®, Vytorin®, Zocor®) • triazolam (Halcion®) • the herb St. John’s wort Do not take STRIBILD if you also take any other HIV-1 medicines, including: • Other medicines that contain tenofovir (Atripla®, Complera®, Viread®, Truvada®) • Other medicines that contain emtricitabine, lamivudine, or ritonavir (Atripla®, Combivir®, Complera®, Emtriva®, Epivir® or Epivir-HBV®, Epzicom®, Kaletra®, Norvir®, Trizivir®, Truvada®) STRIBILD is not for use in people who are less than 18 years old. What are the possible side effects of STRIBILD? STRIBILD may cause the following serious side effects: • See “What is the most important information I should know about STRIBILD?” • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking STRIBILD. Your healthcare provider may tell you to stop taking STRIBILD if you develop new or worse kidney problems. • Bone problems can happen in some people who take STRIBILD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones. • Changes in body fat can happen in people who take HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen. The exact cause and long-term health effects of these conditions are not known. • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
The most common side effects of STRIBILD include: • Nausea • Diarrhea Tell your healthcare provider if you have any side effect that bothers you or that does not go away. • These are not all the possible side effects of STRIBILD. For more information, ask your healthcare provider. • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. What should I tell my healthcare provider before taking STRIBILD? Tell your healthcare provider about all your medical conditions, including: • If you have or had any kidney, bone, or liver problems, including hepatitis B infection • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. - There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you take STRIBILD. - You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. - Two of the medicines in STRIBILD can pass to your baby in your breast milk. It is not known if the other medicines in STRIBILD can pass into your breast milk. - Talk with your healthcare provider about the best way to feed your baby. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements: • STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. • Be sure to tell your healthcare provider if you take any of the following medicines: - Hormone-based birth control (pills, patches, rings, shots, etc) - Antacid medicines that contain aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take STRIBILD - Medicines to treat depression, organ transplant rejection, or high blood pressure - amiodarone (Cordarone®, Pacerone®) - atorvastatin (Lipitor®, Caduet®) - bepridil hydrochloride (Vascor®, Bepadin®) - bosentan (Tracleer®) - buspirone - carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) - clarithromycin (Biaxin®, Prevpac®) - clonazepam (Klonopin®) - clorazepate (Gen-xene®, Tranxene®) - colchicine (Colcrys®) - medicines that contain dexamethasone - diazepam (Valium®)
- digoxin (Lanoxin®) - disopyramide (Norpace®) - estazolam - ethosuximide (Zarontin®) - flecainide (Tambocor®) - flurazepam - fluticasone (Flovent®, Flonase®, Flovent® Diskus®, Flovent® HFA, Veramyst®) - itraconazole (Sporanox®) - ketoconazole (Nizoral®) - lidocaine (Xylocaine®) - mexiletine - oxcarbazepine (Trileptal®) - perphenazine - phenobarbital (Luminal®) - phenytoin (Dilantin®, Phenytek®) - propafenone (Rythmol®) - quinidine (Neudexta®) - rifabutin (Mycobutin®) - rifapentine (Priftin®) - risperidone (Risperdal®, Risperdal Consta®) - salmeterol (Serevent®) or salmeterol when taken in combination with fluticasone (Advair Diskus®, Advair HFA®) - sildenafil (Viagra®), tadalafil (Cialis®) or vardenafil (Levitra®, Staxyn®), for the treatment of erectile dysfunction (ED). If you get dizzy or faint (low blood pressure), have vision changes or have an erection that last longer than 4 hours, call your healthcare provider or get medical help right away. - tadalafil (Adcirca®), for the treatment of pulmonary arterial hypertension - telithromycin (Ketek®) - thioridazine - voriconazole (Vfend®) - warfarin (Coumadin®, Jantoven®) - zolpidem (Ambien®, Edlular®, Intermezzo®, Zolpimist®) Know the medicines you take. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Do not start any new medicines while you are taking STRIBILD without first talking with your healthcare provider. Keep STRIBILD and all medicines out of reach of children. This Brief Summary summarizes the most important information about STRIBILD. If you would like more information, talk with your healthcare provider. You can also ask your healthcare provider or pharmacist for information about STRIBILD that is written for health professionals, or call 1-800-445-3235 or go to www.STRIBILD.com. Issued: October 2013
COMPLERA, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein are the property of their respective owners. © 2014 Gilead Sciences, Inc. All rights reserved. STBC0076 03/14
MAY+JUNE 2014 VO LU M E 2 6 N U M B E R 4
POSITIVELY AWARE JOURNALISM. INTEGRITY. HOPE.
ed itor- i n - C h i ef
a ssociate ed itor
Sue Saltmarsh copy Ed itor
C r e ativ e d ir ector
Joshua Thorne W eb M a ster
Jason Lancaster proo fr e a d er
co ntri b u ti n g writers
Laura Jones Jim Pickett Carlos A. Perez Andrew Reynolds Matt Sharp p h oto g r a p h ers
Chris Knight Joshua Thorne a dv ertisi n g
Lorraine Hayes D e p artments
6 In Box
S u b scriptio n s
In praise of Chris Clason; life-saving Drug Guide.
7 editor’s Note 5050 N. Broadway St., SUITE 300 Chicago, IL 60640-3016 phone: (773) 989–9400 fax : (773) 989–9494 email : email@example.com
8 Readers Poll 9 Briefly
16 Conference Update Developments from CROI.
M ay + J u n e 2 014
Riding toward the truth A journey of personal truth on the Ride for AIDS Chicago. by Rob Campbell
Updated pediatric treatment guidelines; caped crusaders; ‘unprotected’ becomes ‘condomless’ as the CDC is pressed to change its terminology.
ON THE COVEr and on this spread: Images from the documentary deepsouth Courtesy of Lisa Biagiotti. Go to deepsouthfilm.com.
45 My kind of life
Can we finally call it safe sex?
P OS ITIV ELY AWA R E
AVA I L A B L E O N LY O N p ositive lyaware . com
25 years of being Positively Aware A look back at PA’s HIV coverage over the magazine’s 25-year history. By Enid VÁzquez
CROI: PrEP, pediatrics By Enid VÁzquez
Southern exposure—HIV IN THE SOUTH C over Features
HIV in the South is not without beacons of hope. By Rick Guasco
The big (not-so) easy
It isn’t easy living in Louisiana with HIV and the ACA. By Sue Saltmarsh
Latino immigrants and HIV/AIDS. By Octavio J. Vallejo, MD, MPH
Sweet teeth Alabama
Jeff Hill makes oral health matter for his patients at the University of Alabama at Birmingham’s 1917 Clinic. By Sue Saltmarsh
The doctor will see you—online Telemedicine cuts the distance between doctor and patient. By Rick Guasco
From global action to Southern initiative
A drug company funds programs in hard-hit regions. By Enid VÁzquez
CLEAR the way
Chandler Bearden helps Southern gay men navigate their way through risk. by Mark S. King
Pictured: A candlelight remembrance ceremony froM the Documentary film, deepsouth.
P OS ITIV ELY AWA R E
M AY + J UNE 2 014
I N B OX Clapping for Clason
Thank you for the wonderful article and blog covering my uncle Chris Clason (positivelyaware.com/2014/14-01/makea-difference.shtml). The article captured Chris perfectly. Our family is so grateful for the work you do every day. Thank you! —Karol Clason Kalamazoo, Michigan
Great job on Positively Aware (Jan+Feb issue). The issue was above and beyond, particularly the story on Chris Clason. Touching and informative, it was truly wonderful. Kudos! —James Olson, Jr. Birmingham, Michigan
Thank you so much for PA’s “The 50+ Issue!” As a gay man who is 52 years old and HIV-positive for over 24 years, this was a welcome topic. I read this issue from cover to cover. The articles and contributors were all very informative. Real people living with this very real disease, with very useable information. TPAN has provided great services to the HIV community. My support of TPAN goes back to when it was first located on the
south side of Belmont Avenue. For many years, I was a support group facilitator both at the Belmont location and at the location on North Broadway. Today, I live in Las Vegas and always look forward to PA’s Facebook postings, as well as the hard copy of PA in my mailbox. I see copies of PA at “The Center” here in Las Vegas. PA travels very well to the desert! TPAN and PA, thank you to the staff for all the dedication to this community. —Jack R. Kelly Las Vegas
As a very senior longtime survivor of HIV, I just wanted to say thanks for the recent uplifting 50+ issue of Positively Aware . I’m 83 and have had an HIV diagnosis for 29 years. I’m currently doing very well on the getting-old combination of Epzicom and Sustiva. The road ahead for us looks promising, but we can’t be complacent or drop the fight for public awareness. —Anonymous via the Internet
Drug Guide lifesaver
Last year your Drug Guide saved my life, literally! I am in prison and the Guide showed
me that two of the medications the prison had me on were stopping my antiretrovirals from working. When I showed the doctor the information in the Guide, he immediately changed my medication and now my CD4 count has gone up from 180 to a stable 500 and my viral load is undetectable. Please send me your 2014 Drug Guide! —Kevin S. Miami
Thank you for yet another superb Positively Aware Annual HIV Drug Guide. I am sure you are aware that in addition to the valuable information contained in the articles and comments, the drug chart has enormous unspoken value. At the Cook County Jail, those charts are posted in all clinical areas including the intake facility and emergency room. We serve more than 150 HIV-positive individuals on any given day, with several new patients entering the compound every day of the year. It is common for patients to be unfamiliar with the names of their medications, but many can easily identify them off the charts. Without them, it is likely there would be delays in receipt of antiviral treatments. Your charts are literally saving lives! Kudos and much respect for you and the entire TPAN organization for another job well done. —Chad Zawitz, MD Clinical Coodinator of HIV Medicine, Cook County Jail
Let’s CONNECT. All communications (letters, email, online posts,
etc.) are treated as letters to the editor unless otherwise instructed. We reserve the right to edit for length, style, or clarity. Let us if know you prefer we not use your name and city. You can also write: Positively Aware 5050 N. Broadway St., Suite 300, Chicago, IL 60640-3016.
© 2014. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5050 N. Broadway St., Suite 300, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, send email to firstname.lastname@example.org. Six issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable to contribute. We accept submission of articles covering medical or personal aspects of HIV/AIDS, and reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN, Positively Aware, and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number. Please include your name and phone number with your submission. Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Awaree are not necessarily those of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician.A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively Aware, association with TPAN, or contributions to this journal.
Congratulations on another fantastic Drug Guide. Best one yet! Thank you for making this available to the HIV community. So many people rely on this issue of Positively Aware every year. —Glen Pietrandoni, RPH, AAHIVP Senior Director, Virology Specialty Products and Services Walgreen Co.
I have been taking Truvada for PrEP. My partner is HIV-positive and I am negative. We are relatively safe and he takes his meds and has an undetectable HIV status. I go for a test every eight weeks and so far, I have always tested negative. —Shaun via the Internet
M ay + J u n e 2 014
P OS ITIV ELY AWA R E
E d i tor ’ s not e
Photo: CHRIS KNIGHT
remember learning the song “Dixie (I Wish I was in Dixie)” when I was a kid in school, and I hail from the North! I never understood what it really meant, or from where it originated. But whether or not you believe that the lyrics of the song—which was originally performed during blackface minstrel shows in the mid 1800s and then became the Confederacy’s anthem during the Civil War—are racist, one thing is for sure. If you are living in the U.S. South today, the odds are stacked against you, especially when it comes to HIV/AIDS.
Southern states represent 37 percent of the U.S. population, but account for 50% of new infections. Eight of the 10 states in the U.S. that have the highest rate of infection are in the South, as are nine of the 10 states with the highest rates of deaths due to AIDS. Those are sobering statistics. There are a number of socio-economic, cultural, and institutional (not to mention political) reasons as to how we got to where we are today, including poverty, limited access to care, and a complete breakdown in our educational system. But how do we even begin to address the epidemic amidst these circumstances? According to the Southern AIDS Coalition, “Federal funds do not meet the needs of those living with HIV in the South and are not equally distributed across the country. The HIV/AIDS outbreak is at a state of emergency in the southern United States. The disparate impact of this epidemic on Southern citizens, especially within communities of color, must be addressed.” By now we’ve all heard the somewhat clichéd statistic that rates of HIV/AIDS in the Southern U.S. rival some of those in sub-Saharan Africa. But it bears repeating here, and while the statistics are indeed grim, there are some glimmers of hope on the horizon. In a story on telemedicine, Rick Guasco explains how technology is optimizing access to HIV care and treatment in the rural South. Dr. Jeff Hill, of the renowned 1917 Clinic in Birmingham, Alabama, tells us why dental health is so important for people with HIV in a story by Sue Saltmarsh. Associate Editor Enid Vázquez looks at how the Positive Action U.S. Southern Initiative is helping to reduce stigma and discrimination and provides treatment education to some of the communities in the South that are hardest hit. There are countless individuals and organizations in the South doing great work—including Chandler Bearden from Atlanta, Georgia. Author, activist, and blogger Mark S. King profiles Chandler and Positive Impact’s MISTER Center that empowers gay men to help them navigate their own sexual health and life goals.
Also in this issue, Octavio Vallejo of AIDS Project Los Angeles looks at the impact that HIV has had on Latinos in the South, particularly among the immigrant population. The Nation’s Zoe Anderson posted in a recent blog that, “There are two policies on the table that could have a profound effect on the rate of new infections in the United States, which has hovered near 50,000 new cases a year for a decade: the expansion of Medicaid, and comprehensive immigration reform. The implications of these policies for HIV are magnified by the fact that their impact would be particularly strong in the South.” Every state in the Deep South (except Arkansas) has opted out of the expansion of Medicaid, but time and elections will hopefully, eventually, be on our side (when Medicaid was first introduced in the ’60s it took a few years before every state came on board). However, that doesn’t help the people in those states now who are uninsured but don’t qualify for Medicare, and can’t afford to participate in the insurance exchanges offered by the Affordable Care Act. Over the years I’ve come to realize and understand that words are sometimes imbued with double meanings, or laced with history and sometimes even hate. Cultural differences often color the way we perceive ourselves, our circumstances, and the people around us. Sometimes, we need to let go of the things that once brought us comfort or that we deemed harmless and “acceptable.” Things and people change. Society shifts. If we attempt to stay rigid and in one place, the separation between us all grows until the chasm is so wide that it can never be bridged. So let’s create a new anthem, one that is all-inclusive, and leads us toward a better tomorrow, to a place where all of us are represented, and where each of us have a voice. That’s where I wish to be.
Cultural differences often color the way we perceive ourselves, our circumstances, and the people around us. Sometimes, we need to let go of the things that once brought us comfort or that we deemed harmless and ‘acceptable.’
Follow Jeff @PAEDITOR
Take care of yourself, and each other.
P OS ITIV ELY AWA R E
M AY + J UNE 2 014
R ea d er s p oll In the March+April issue, we asked
YO UR C O MM E N T S
How often do you discuss medication issues with a pharmacist?
“l always take advantage of the pharmacist consults whenever
I’ve been prescribed a new medication. I do this especially to learn about interactions with over the counter supplements or to be more informed about possible food restrictions for the drugs that have been prescribed by my doctors.”
“I find the pharmacist to be an untapped resource of
information. I get useful answers. There have been times I got, ‘I don’t know,’ when it came to a drug-drug interaction, but for the most part, a pharmacist can be a walking PDR (Physicians’ Desk Reference) and is always willing to help.”
“My peer treatment advocate knows way more about
antiretrovirals than my pharmacist does.”
This issue’s question
Have you experienced any problems with ACA exchange insurance plans? vote at positivelyaware.com or on facebook:
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Pediatric treatment guidelines updated
Making babies while on PrEP
U.S. pediatric HIV treatment guidelines were updated February 12.
In March, a U.S. perinatal guidelines update discusses HIV prevention for conceiving a child with the use of preexposure prophylaxis (PrEP). The guidelines panel recommends that for serodiscordant couples (where one person has HIV and the other doesn’t), the positive partner attain maximum viral suppression before attempting conception; that PrEP may be offered to the HIV-negative partner for the time of conception; and notes that pregnancy is not a contraindication for PrEP. The panel also notes there are no studies showing the effectiveness of PrEP for conception when the positive partner is on HIV therapy with a suppressed viral load.
Among the changes:
VÁZQUEZ: CHRIS KNIGHT. NORMAL HEART: Jojo Whilden/HBO.
CD4 count can be measured less frequently (every six to 12 months) for children and adolescents who are adherent to therapy, are well above the threshold for prevention of opportunistic infections, have sustained suppression of viral load, and have had stable clinical status for more than two to three years.
Once-daily Prezista/Norvir is now recommended for adolescents ages 12 and up
Clinically stable children with undetectable viral load and stable CD4 counts for more than six months can switch from twicedaily to once-daily abacavir (Ziagen, also in Epzicom) as part of a once-daily combination.
A discussion of the Mississippi baby case, where infection can no longer be found in an infant treated very early with potent therapy, has been added.
See more changes in the section “What’s New in the Guidelines” at aidsinfo.nih.gov.
‘The Normal Heart’ premieres May 25 on HBO At the height of the AIDS epidemic in New York City, ACT UP founder Larry Kramer wrote The Normal Heart, a Tony-award winning autobiographical play depicting his struggles watching friends and lovers dying daily and the stigmatization of those with AIDS, and showing the ways in which the LGBT community came together to support and fight for each other. The Ryan Murphy film stars Mark Ruffalo, Matt Bomer, Taylor Kitsch, Jim Parsons, Alfred Molina, and Julia Roberts. See the trailer at bit.ly/1jw9K1E.
Video illustrates PrEP
Prezista/COBI pill on the way
The University of Connecticut and Stroger Hospital of Cook County in Chicago created a colorful five-minute video on using Truvada for HIV prevention, showing how HIV infects cells and how the drug protects them. Go to whatisprep.org, which also includes a list of resources.
Long-term survivors day June 5 Let’s Kick ASS (AIDS Survivor Syndrome) is lead sponsor of the first National HIV/AIDS LongTerm Survivors Awareness Day on Wednesday, June 5. This year’s theme is “We’re Still Here.” “It highlights the profound experiences and unique issues of long-term survivors, both HIVpositive and negative, who are still alive despite the devastating toll from surviving the most significant epidemic of our time,” the group said in a press release. For updates, go to letskickass.org.
The first complete HIV treatment in one pill (a single tablet regimen) that contains a protease inhibitor is on the way. In April, Janssen Therapeutics announced that it had filed a New Drug Application (NDA) with the FDA for approval of its Prezista drug combined with a drug-level booster from Gilead Sciences called cobicistat (COBI). The top-gun Prezista is one of two protease inhibitors on the preferred list of U.S. treatment guidelines from the Department of Health and Human Services (DHHS).
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Briefly Gay men’s sexual health The San Francisco AIDS Foundation convened a think tank in December to discuss ways in which information about new HIV prevention methods can be conveyed to gay men and in turn, how to encourage those men to discuss their sexual health needs and at least one of these methods, PrEP, with their medical providers. “Through education, empowerment, and mobilization, gay men can take back the pleasure, intimacy, connection, emotion, and love that their sexual health agenda historically has been denied,” the think tank states in a report issued February 25. Read it at betablog.org/ how-to-improve-gay-mens-sexual-health.
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New AIDS policy chief appointed The Obama administration appointed Douglas M. Brooks, MSW, as the next director of the Office of National AIDS Policy (ONAP) on March 24. Previously, Brooks DOUGLAS M. Brooks was Senior Vice President for Community Health and Public Policy at the Justice Resource Institute and a member of the President’s Advisory Council on HIV and AIDS (PACHA) since 2010. His personal experience living as a black, gay man with HIV is expected to keep him clearly connected to the realities faced by people living with HIV and their allies.
PRO Men mixer
Shannon weber (left) with PA associate editor Enid VÁzquez
Caped crusader I was dubbed a “caped crusader” for promoting safer options for HIV-positive individuals trying to conceive a child … and I have the cape to prove it. Thanks to Shannon Weber of the Bay Area Perinatal AIDS Center (BAPAC) and the PRO Men (Positive Reproductive Outcomes for Men) out of San Francisco General Hospital’s Ward 86 for presenting me with the cape.
Take Complera with food… …unless you’re the unlucky patient of a Chicago doctor who told her patient to take it on an empty stomach, an error compounded by instructions from the pharmacy. Being a relatively newer HIV medication, Complera’s requirements might take some time to be well understood. Still, food requirements should be easy—and basic—for medical providers to grasp. Just read our Drug Guide. P OS ITIV ELY AWA R E
The Positive Connections project of BAPAC and PRO Men held its first mixer in January. Reported budding young reporter Sheldon Kilpack, “This Mixer event was dreamed up during the previous month’s PRO Men support group as a way to bring together people with HIV to meet others and learn more about having the sex life you want and the family you want.” See his full report on this page online. Two new videos, on adherence and disclosure, debuted at the event. Go to hiv.ucsf.edu/care/ perinatal/pro_men.html.
Nearly half of adolescents who have had
HIV since birth may be at increased risk for cardiovascular disease—including heart attack and stroke—later in life, says an NIH report. Go to nih.gov for details on the finding from the Pediatric HIV/AIDS Cohort Study (PHACS).
BROOKS: Marilyn Humphries. WEBER AND VÁZQUEZ: JESSICA Terlikowski
One out of three HIV-positive young males who had sex with other males had very high levels of the virus. There were 852 young people ages 12 to 24 in the study of the Adolescent Medicine Trials Network for HIV/ AIDS Interventions (ATN). Males who had sex with other males experienced the highest average viral loads, greater than 115,000 copies per mL, and for males overall, the average was 106,000. In contrast, females had an average of 48,000 copies per mL. The study concluded that efforts to diagnose and treat people with HIV should focus largely on youth, particularly those males who have sex with males, noting that one in four new infections occur in this age group. The study was published in the journal AIDS.
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What a difference a word makes ‘Unprotected’ becomes ‘condomless’ as science and advocacy push the CDC By Jim Pickett
Anal or vaginal intercourse without condoms can be called a lot of things, like “bareback,” “raw,” “natural,” or “procreative.” For decades we have also equated this behavior with “unprotected” sex. This has led to many of us conceiving sex without condoms as “reckless,” “dangerous,” and “irresponsible.” But this past January, due to a rapidly evolving scientific evidence base and powerful national grassroots advocacy, the Centers for Disease Control and Prevention (CDC) agreed to stop calling condomless sex “unprotected.” Say what? The CDC? One of the most important health organizations on the planet, not known for being wild and crazy or going off half-cocked, is redefining the meaning of HIV protection? This is not simply a semantic change— it signals a seismic shift in the HIV prevention paradigm we have subscribed to for decades. Gay men in particular considered condom use as one of the most important things we could do as gay citizens, brothers, friends, and lovers. This was especially true during the height of the epidemic in the ’80s and ’90s before the advent of highly effective antiretroviral therapy, when we were being wiped off the map. We saved each other’s lives wearing condoms. In terms of HIV prevention, this means the very simplistic message of “just wear a condom every time” is headed to the circular file where it belongs. Don’t get me wrong, condoms (both male and female) remain critically important tools with which to avoid HIV infection. They stay in the toolbox. We aren’t throwing them out—just ditching the narrow messaging. Thankfully, condoms are not alone anymore in terms of proven strategies to prevent HIV. And we shouldn’t pretend they are. We need to fess up and acknowledge that while simple in terms of messaging, “just” wearing a condom every time is not something many folks are able to achieve over their sexual lifetimes. As it turns out, using a condom every single time is difficult
and inconsistent use reduces their efficacy to levels where you might as well not be using them at all. The very reason the U.S. has committed many billions of dollars for research into vaccines and other new prevention technologies like microbicides and PrEP is due to the inability of human beings to use condoms every time, leading to about two million new infections globally every year. What are these prevention options the CDC was thinking about when, prompted by the HIV Prevention Justice Alliance (HIV PJA) and 86 other national organizations in an open letter, it changed its mind on “unprotected?” First, they include a number of scientifically proven ways ARV drugs can be used to prevent HIV. When ARVs are used by HIV-positive people and they are able to achieve undetectable levels of virus in their blood, they are rendered practically incapable of passing HIV to their partners, even if they aren’t using condoms consistently for anal/vaginal intercourse. This is a relatively new finding. Treatment is treatment, and treatment is prevention, too. Another new strategy involved HIVnegative people taking a daily dose of Truvada (a combination of two ARV drugs) as PrEP or pre-exposure prophylaxis. Doing so, they reduce their chances of becoming infected by upwards of 90%. HIV drugs can also be used after a potential HIV exposure, called PEP or post-exposure prophylaxis. We’ve known about PEP for a long time, but have been rather lousy about publicizing and using it. So PrEP and PEP are part of HIV prevention, too. Other tools include choosing partners and behaviors based on sero-status (whether they’re HIV-positive or not). Two bona fide HIV-negative people cannot
pass HIV to one another, for instance. And certain positions carry more HIV risk than others—like being on top (insertive) is less risky compared to being on the bottom (receptive). Many refer to choosing partners, positions, and behaviors based on sero-status as “sero-adaptation.” Advocates also asked the CDC to start acknowledging “positioning” when categorizing risk. These strategies are admittedly limited. They work, to varying degrees, to prevent HIV. Treatment and PrEP work quite well, when people take their pills. But none of these strategies are magic. They aren’t silver, gold, or platinum bullets. They don’t prevent other STDs, and they don’t prevent pregnancy. Similarly, oral and injectable contraceptives protect against unwanted pregnancy, but do not prevent STDs or HIV. Seatbelts aren’t perfect either. Ideally, future scientific achievements will provide us with “multi-purpose” strategies that could provide protection against STDs and pregnancy. That work is ongoing and something we all need to pay attention to. In the meantime, we have new methods that work quite well in reducing HIV risk. People who don’t use condoms all the time (or never) now have choices to protect themselves from HIV. That is a big, big deal. We need to deploy these strategies smartly and strategically, coupled with accurate, nuanced prevention messaging that includes condoms, but does not defer to them. “We must continue to engage the CDC, community organizations, and community members,” says Suraj Madoori of the HIV Prevention Justice Alliance, a human rights and social justice collaborative. “It’s up to all of us to implement these changes.” Jim Pickett is Director of Gay Men’s Health for the AIDS Foundation of Chicago, co-founder of International Rectal Microbicide Advocates (IRMA), and creator of myprepexperience.blogspot.com.
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PREZISTA® is always taken with and at the same time as ritonavir (Norvir ®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food. • The use of other medicines active against HIV in combination with PREZISTA®/ritonavir (Norvir ®) may increase your ability to ﬁght HIV. Your healthcare professional will work with you to ﬁnd the right combination of HIV medicines • It is important that you remain under the care of your healthcare professional during treatment with PREZISTA® PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.® Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.
IMPORTANT SAFETY INFORMATION What is the most important information I should know about PREZISTA®? • PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?” • PREZISTA® may cause liver problems. Some people taking PREZISTA,® together with Norvir ® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA.® If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems • Tell your healthcare professional if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite • PREZISTA® may cause a severe or life-threatening skin reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild Who should not take PREZISTA®? • Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,® Embolex,® Migranal®), ergonovine, ergotamine (Cafergot,® Ergomar ®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor ®), simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®
Rifamate,® Rimactane®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), or telaprevir (Incivek™) • Before taking PREZISTA,® tell your healthcare professional if you are taking sildenaﬁl (Viagra,® Revatio®), vardenafil (Levitra,® Staxyn®), tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor ®), rosuvastatin (Crestor ®), pravastatin (Pravachol®), or colchicine (Colcrys,® Col-Probenecid®). Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements. What should I tell my doctor before I take PREZISTA®? • Before taking PREZISTA,® tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia • Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding — The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA® is right for you — Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk What are the possible side effects of PREZISTA®? • High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA® • Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA.® The cause and long-term health effects of these conditions are not known at this time • Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to ﬁght infections that have been hidden • The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA® or any other medicines without ﬁrst talking to your healthcare professional You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please refer to the ritonavir (Norvir ®) Product Information (PI and PPI) for additional information on precautionary measures. Please read accompanying Patient Information for PREZISTA® and discuss any questions you have with your doctor.
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.
Once-Daily PREZISTA® (darunavir) taken with ritonavir and in combination with other HIV medications can help lower your viral load and keep your HIV under control. The PREZISTA® Experience isn’t just an HIV treatment. It’s an HIV treatment experience as unique as you. Find out if the PREZISTA® Experience is right for you. Ask your healthcare professional and learn more at PREZISTA.com
Snap a quick pic of our logo to show your doctor and get the conversation started.
Please read the Important Safety Information and Patient Information on adjacent pages.
Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2014 01/14 006960-131202
IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) (darunavir) Oral Suspension PREZISTA (pre-ZIS-ta) (darunavir) Tablets Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Also read the Patient Information leaflet for NORVIR® (ritonavir). What is the most important information I should know about PREZISTA? • PREZISTA can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section “Who should not take PREZISTA?” • PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIR® (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. • Tell your healthcare provider if you have any of the below signs and symptoms of liver problems. • Dark (tea colored) urine • yellowing of your skin or whites of your eyes • pale colored stools (bowel movements) • nausea • vomiting • pain or tenderness on your right side below your ribs • loss of appetite PREZISTA may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below: • fever • tiredness • muscle or joint pain • blisters or skin lesions • mouth sores or ulcers • red or inflamed eyes, like “pink eye” (conjunctivitis) Rash occurred more often in people taking PREZISTA and raltegravir together than with either drug separately, but was generally mild. See “What are the possible side effects of PREZISTA?” for more information about side effects. What is PREZISTA? PREZISTA is a prescription anti-HIV medicine used with ritonavir and other anti-HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called “viral load”). PREZISTA may also help to increase the number of white blood cells called CD4 (T) cell which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections). PREZISTA does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA. Avoid doing things that can spread HIV-1 infection. • Do not share needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• D o not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people. Who should not take PREZISTA? Do not take PREZISTA with any of the following medicines: • alfuzosin (Uroxatral®) • dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®) methylergonovine • cisapride • pimozide (Orap®) • oral midazolam, triazolam (Halcion®) • the herbal supplement St. John’s Wort (Hypericum perforatum) • the cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®, Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®) • rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) • sildenafil (Revatio®) only when used for the treatment of pulmonary arterial hypertension. Serious problems can happen if you take any of these medicines with PREZISTA. What should I tell my doctor before I take PREZISTA? PREZISTA may not be right for you. Before taking PREZISTA, tell your healthcare provider if you: • have liver problems, including hepatitis B or hepatitis C • are allergic to sulfa medicines • have high blood sugar (diabetes) • have hemophilia • are pregnant or planning to become pregnant. It is not known if PREZISTA will harm your unborn baby. Pregnancy Registry: You and your healthcare provider will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is follow the health of you and your baby. • are breastfeeding or plan to breastfeed. Do not breastfeed. We do not know if PREZISTA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using PREZISTA and certain other medicines may affect each other causing serious side effects. PREZISTA may affect the way other medicines work and other medicines may affect how PREZISTA works. Especially tell your healthcare provider if you take: • other medicine to treat HIV • estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom. • medicine for your heart such as bepridil, lidocaine (Xylocaine Viscous®), quinidine (Nuedexta®), amiodarone (Pacerone®, Cardarone®), digoxin (Lanoxin®), flecainide (Tambocor®), propafenone (Rythmol®) • warfarin (Coumadin®, Jantoven®) • medicine for seizures such as carbamazepine (Carbatrol®, Equetro®, Tegretol®, Epitol®), phenobarbital, phenytoin (Dilantin®, Phenytek®) • medicine for depression such as trazadone and desipramine (Norpramin®) • clarithromycin (Prevpac®, Biaxin®) • medicine for fungal infections such as ketoconazole (Nizoral®), itraconazole (Sporanox®, Onmel®), voriconazole (VFend®) • colchicine (Colcrys®, Col-Probenecid®) • rifabutin (Mycobutin®) • medicine used to treat blood pressure, a heart attack, heart failure, or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Combigan®) • midazolam administered by injection • medicine for heart disease such as felodipine (Plendil®), nifedipine (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®) • steroids such as dexamethasone, fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®) • bosentan (Tracleer®) • medicine to treat chronic hepatitis C such as boceprevir (VictrelisTM), telaprevir (IncivekTM)
IMPORTANT PATIENT INFORMATION • m edicine for cholesterol such as pravastatin (Pravachol®), atorvastatin (Lipitor®), rosuvastatin (Crestor®) • medicine to prevent organ transplant failure such as cyclosporine (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®) • salmeterol (Advair®, Serevent®) • medicine for narcotic withdrawal such as methadone (Methadose®, Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®) • medicine to treat schizophrenia such as risperidone (Risperdal®), thioridazine • medicine to treat erectile dysfunction or pulmonary hypertension such as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®) • medicine to treat anxiety, depression or panic disorder such as sertraline (Zoloft®), paroxetine (Paxil®, Pexeva®) • medicine to treat malaria such as artemether/lumefantrine (Coartem®) This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider. How should I take PREZISTA? • Take PREZISTA every day exactly as prescribed by your healthcare provider. • You must take ritonavir (NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first. • Take PREZISTA and ritonavir (NORVIR®) with food. • Swallow PREZISTA tablets whole with a drink. If you have difficulty swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your health care provider will help decide whether PREZISTA tablets or oral suspension is right for you. • PREZISTA oral suspension should be given with the supplied oral dosing syringe. Shake the suspension well before each use. See the Instructions for Use that come with PREZISTA oral suspension for information about the right way to prepare and take a dose. • If your prescribed dose of PREZISTA oral suspension is more than 6 mL, you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to divide the dose. Ask your healthcare provider or pharmacist if you are not sure. • If you take too much PREZISTA, call your healthcare provider or go to the nearest hospital emergency room right away. What should I do if I miss a dose? People who take PREZISTA one time a day: • If you miss a dose of PREZISTA by less than 12 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. • If you miss a dose of PREZISTA by more than 12 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time. People who take PREZISTA two times a day • If you miss a dose of PREZISTA by less than 6 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. • If you miss a dose of PREZISTA by more than 6 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time. If a dose of PREZISTA is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA at any one time. What are the possible side effects of PREZISTA? PREZISTA can cause side effects including: • See “What is the most important information I should know about PREZISTA?” • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA. • Changes in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and longterm health effects of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine. • Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA. The most common side effects of PREZISTA include: • diarrhea • headache • nausea • abdominal pain • rash • vomiting Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PREZISTA. For more information, ask your health care provider. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. How should I store PREZISTA? • Store PREZISTA oral suspension and tablets at room temperature [77°F (25°C)]. • Do not refrigerate or freeze PREZISTA oral suspension. • Keep PREZISTA away from high heat. • PREZISTA oral suspension should be stored in the original container. Keep PREZISTA and all medicines out of the reach of children. General information about PREZISTA Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a condition for which it was not prescribed. Do not give PREZISTA to other people even if they have the same condition you have. It may harm them. This leaflet summarizes the most important information about PREZISTA. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZISTA that is written for health professionals. For more information, call 1-800-526-7736. What are the ingredients in PREZISTA? Active ingredient: darunavir Inactive ingredients: PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment), purified water. PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide). PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide). PREZISTA 800 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, hypromellose. The film coating contains: OPADRY® Dark Red (iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide). This Patient Information has been approved by the U.S Food and Drug Administration. Product of Ireland Manufactured by: PREZISTA Oral Suspension PREZISTA Tablets Janssen Pharmaceutica, N.V. Janssen Ortho LLC, Beerse, Belgium Gurabo, PR 00778 Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 Revised: December 2013 NORVIR® is a registered trademark of its respective owner. PREZISTA® is a registered trademark of Janssen Pharmaceuticals © Janssen Pharmaceuticals, Inc. 2006 007653-131217
CONFERENCE UPDATE CROI 2014
More than 4,000 researchers from 85 countries gathered for the 21st Conference on Retroviruses and Opportunistic Infections, better known as CROI, in March in Boston to share the latest studies, developments, and research methods in the ongoing efforts against HIV/AIDS, hepatitis, and related infectious diseases. By Jeff Berry and Enid Vázquez
GSK1265744 (744) is an integrase inhibitor that’s an analogue (similar chemical) of dolutegravir (Tivicay). A long acting formulation (744 LA) is now being studied alone as an injectable for prevention of HIV (see online extra), as well as in combination with a long-acting formulation of the non-nuke rilpivirine (TMC278 LA, in oral form known as Edurant) for treatment of HIV. A Phase 2b study (LATTE) randomized patients to one of four groups in a 24-week oral induction phase, three groups receiving 10, 30, or 60 mg of 744 plus two NRTIs of choice (either TDF/FTC [Truvada] or ABC/3TC [Epzicom]), and a fourth group given efavirenz (Sustiva) plus two NRTIs. Those in the 744 arms who had a viral load of less than 50 copies at 24 weeks discontinued the NRTI backbone and added 25 mg of rilpivirine (RPV) to their 744 dose for the oral maintenance phase of the study. In a planned 48-week analysis of this 96-week study of 243 treatment-naïve patients, there was an overall response rate of 82% undetectable viral load (less than 50 copies per mL) for those 16
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in the 744 groups, compared to 71% for those in the efavirenz (EFV) group. In the maintenance phase of the study using an intent-to-treat analysis (looking at everyone in the study whether they completed or not), 93 percent in the 744+RPV arm, and 94 percent in the EFV+NRTIs achieved a viral load of less than 50 copies per mL. 744 LA has a long half-life (40 days) and could be given every three months, which is why these formulations have such strong appeal, as they would improve adherence. Drugs that have a long half-life can stay in the blood for longer periods of time at decreasing levels; this is known as the “tail.” Lead study investigator David Margolis of GSK pointed out that it’s important with long-acting injectables to understand how to “manage” the tail (so that patients are not exposed to suboptimal therapy and increased risk for developing drug resistance). There is now a second Phase 2b study planned that will evaluate the long-acting injectable regimen using 744 LA, plus TMC278 LA, given every three months.
Long-acting shot for treatment and prevention
BMS-663068 attachment inhibitor BMS-663068 (068) is a first-in-class attachment inhibitor in development by Bristol Myers-Squibb. 068 is a prodrug, meaning it metabolizes into another drug once inside the body. 068 works by binding to HIV-1 gp120, a protein on the outer envelope of the virus, which blocks initial viral attachment and entry into the host CD4+ T-cell. A Phase 2b study of 254 treatment-experienced individuals looked at five treatment groups, four with varying doses of 068 (400 or 800 mg twice daily, or 600 or 1200 mg once daily), and a control arm of 300 mg Reyataz (atazanavir) boosted with 100 mg Norvir (ritonavir), each with a background of Isentress (raltegravir) twice daily plus Viread (tenofovir) once daily. The median (half above, half below) age in the study was 39 years and 60 percent were male, 43 percent of participants had viral loads greater than 100,000 copies and the median CD4 count was 230 (38 percent had fewer than 200 CD4s). Across all arms, 20–40 percent had baseline NRTI/NNRTI resistance. A lead-in sevenday monotherapy substudy of approximately 10 subjects per 068 dose showed average viral load reductions of 0.7 to 1.5 log10 copies/mL at day eight. Through week 24, 69–80 percent of 068-treated participants and 75 percent of those treated with Reyataz/ Norvir had viral loads of less than 50 copies/mL. Similarly, 78–87 percent of those in the 068 arms had viral loads of less than 50 copies/mL at week 24 compared with 86 percent
of those on Reyataz/Norvir. All 068 doses were well tolerated and no serious or adverse events (SAEs or AEs) leading to discontinuation were related to the study drug. Presenter and study author Jay Lalezari said that speaking as a member of the activist community with which he self-identifies, BMS should be commended for bringing forward a new compound with a unique mechanism of action (something that’s especially important for individuals with multi-class drug resistance or in need of a new class of drug).
Second baby clears HIV after aggressive treatment at birth At this year’s conference there was news of a second baby who appears to have cleared HIV following treatment soon after birth, as well as a follow up on the Mississippi baby. At last year’s CROI, we first heard the news of the Mississippi baby who was infected at birth and treated with cART (combination antiretroviral therapy) within 30 hours using a much more aggressive three-drug therapeutic regimen rather than the standard three-drug preventive regimen recommended by pediatric guidelines. Although both infants have some evidence of HIV, virus that can replicate itself has not been found, supporting the theory that very early cART may prevent the virus from forming reservoirs during perinatal infection. Reservoirs are places where HIV “hides” in the body, waiting to be stimulated into replication. The Long Beach baby, as the second baby is being described, was born to a
mother who is HIV-positive and mentally ill. The baby, who tested positive at four hours after birth, was given a more aggressive three-drug treatment regimen followed by a four-drug regimen. The baby is now nine months old, is still on treatment but has sero-reverted and now tests HIV-negative. Doctors are considering doing a brief treatment interruption at two years of age to see what happens.
Smaller reservoirs in kids Dr. Deborah Persaud, who presented the data on the two infants in HIV remission, also reported findings which show smaller HIV reservoirs in children whose therapy controls their virus by age one. “Reducing proviral reservoir size is an important prerequisite for achieving HIV-1 remission for which antiretroviral therapy can be discontinued without viremic rebound,” the study abstract noted.
New infections related Researchers at the University of California, San Francisco looked at clusters of related new infections in that city. It’s already known that people who don’t know they have HIV are more likely to infect others than those who are aware of their status, and that recently infected individuals in particular, with a sky-high amount of virus in their system, are especially infectious. This research team found that many new infections in the city were genetically linked, meaning that there were sex partners in common. Thus, they concluded that the chain could be broken. Overlapping with new HIV infections was the diagnosis of
another sexually transmitted infection (STI), “thereby pointing to intervention opportunities to interrupt HIV transmission.” Of 1,311 people newly diagnosed with HIV between 2005 and 2011, 12 percent had a recent STI diagnosis, 15 percent were recently infected, and 45 percent were part of a transmission cluster, pointing to the infections being related.
Race and age in Atlanta Atlanta-based researchers from Emory University and Georgia State University noted that HIV prevalence and incidence is higher among black men who have sex with men (BMSM) as opposed to white MSM (WMSM), and that individual risk factors do not account for the disparities. (Prevalence refers to the overall percentage of a population who have a disease, while incidence is the number of new cases in a population in a specific period of time.) The InvolveMENt study tested a group of 454 BMSM and 349 WMSM for HIV and STIs every three to six months and completed surveys of individual and partner risk behaviors. They found that one in 10 BMSM were infected with HIV by age 25, while none of the WMSM had been. The team reported that the results echo other findings of disparities between the races and “highlight the 18-24 year [age] period as critical for prevention, and that educational and other prevention services need to start before 18.” They also said that “partner pool” greatly affects the races and positive men should be able to access treatment in order to reduce transmission risk. After the presentation, Jeanne
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Couples not transmitting HIV There were many interesting and important reports from CROI this year, with none able to stand above the rest. The PARTNER study, however, is one to follow for future development. That study reported that people with well controlled
HIV don’t transmit it to their HIV-negative primary partners. “The basic fact is that of 44,500 acts of condomless sex, there was not one infection,” Jens Lundgren, MD, of the Center for Viral Diseases and the Copenhagen HIV Program and the University of Copenhagen, said following a press conference. The international study with 894 gay and straight couples in which the HIV-positive partner had a viral load of less than 200 copies per mL, found a median (half above, half below) of 45
a technician removes a case of modified cells from storage in an ultra-low temperature freezer for final testing prior to infusion.
Zinc fingers point the way In a paper published in the New England Journal of Medicine during the week of the conference, researchers from the National Institutes of Health (NIH) reported on yet another study using gene therapy with zinc-finger nucleases (ZFN). ZFN are substances that work at the molecular level to alter the CCR5 receptor on cells, which helps HIV enter those cells, and people who naturally don’t have it or have altered versions of it can either resist HIV infection or have infections that are extremely slow to do any damage. The very small NIH study took cells from 12 individuals with HIV, altered those cells with ZFN to “snip” the CCR5 receptors, stimulated the cells to multiply, and infused the cells back into the patients. Four weeks later, half of the participants had their HIV therapy interrupted. The study reported that the therapy appeared safe and that genetically modified cells appeared to be protected against HIV. ZFN is one of the technologies leading to talk of a “functional cure.” 18
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sex acts a year without condoms, as reported by the HIVnegative partner. Condomless sex with an outside partner was reported by 27 percent of the MSM and two percent of the heterosexuals. A few infections occurred but were not linked to the primary partner. While the risk of transmission in couples appears “extremely low, uncertainty about the risk remains, particularly over receptive anal sex. Additional follow-up in MSM is essential to provide more precise estimates for transmission risk given the current assumptions of safety in some communities.” The zero percent infection is actually an estimate. Lundgren said that “without research, all you’re left with is belief.” Simon Collins, a writer and editor for i-Base, an HIV treatment and advocacy organization in London, and a community representative in the study, said guys “would just die” if a man at a bar told them he had HIV, but the real threat was the guy next door who doesn’t know he has it. Dr. Joel Gallant’s blog at hivforum.tumblr.com, as well as other reports available online, offer more on this important topic.
Microbicide drugs in and out Of two drugs that showed anti-HIV activity in test tubes and were tested in vaginal rings, only one blocked the virus in cervical tissue. Dapivirine, an experimental HIV medication was successful, while, disappointingly, maraviroc (on the market as Selzentry) wasn’t. Tissue samples were collected from 48 women who used vaginal rings coated with medication for 28 days.
Microbicide film Dapivirine was also studied—for the first time—as an intravaginal film. The product is like a piece of Scotch tape, only thicker and sticky all over. While it successfully released dapivirine into genital tissue, some of the women found it hard to place correctly. More work needs to be done to improve this aspect of a vaginal film to protect against HIV infection. It was hoped that film could provide more efficient drug delivery to tissue, with greater privacy and less leakage than gels. While the dapivirine gel used by some of the women in the FAME-02 study led to similar plasma levels as the film, tissue levels of dapivirine were four times higher for the gel than the film.
PrEP news: Viread vs. Truvada The presentation of Jared Baeten of the University of Washington on the Partners PrEP study seemed to come straight out of two years ago, until he got to the point of the update: the study team was revealing that tenofovir (Viread) alone worked almost as well at preventing HIV in the nearly 5,000 couples in the study as Truvada, which contains tenofovir along with emtricitabine (Emtriva). There is a cost-savings advantage to using just tenofovir. Although there was a statistically significant difference in the relative risk reduction of becoming infected (85% for Viread vs. 93% for Truvada), the study reported that, “Among heterosexual men and women, once-daily oral [Viread] and [Truvada] are safe and
Photo: PENN MEDICINE
Marrazzo, MD, of the University of Washington, said there is a need to provide PrEP rather than watch men get infected with HIV.
provide high and comparable risk reduction against HIV-1 acquisition.”
Isentress/Prezista vs. Prezista/Truvada HIV treatment guidelines from the Department of Health and Human Services recommend first-line therapy that includes Truvada or Epzicom, but there have been hopes of being able to drop these drugs for those who can’t take them or can’t tolerate them. The NEAT001/ANRS143 study in 15 European countries compared patients who were starting therapy on Isentress with Prezista/Norvir vs. those starting with Prezista/Norvir and Truvada and found noninferiority. For people with a CD4 cell count of less than 200, however, the Isentress + Prezista/Norvir was inferior, and it was almost inferior for individuals with viral loads greater than 100,000 copies per mL. These results are from nearly two years of therapy with 805 patients.
Isentress, Prezista, and Reyataz Meanwhile, here in the U.S., the ACTG 5257 study looked at alternatives to a Sustivabased standard bearer (such as Atripla), noting that the drug is “not suitable for all HIVinfected persons.” The study compared three other recommended first-line therapies and found that while all of them led to high and equivalent rates of virus control, when combining virus control and tolerability, the Isentress regimen was superior to the regimens containing either Reyataz or Prezista, and Prezista was
superior to Reyataz. Results are from 96 weeks. Superiority over Reyataz was driven by lower tolerability due to jaundice, or yellowing of the skin and eyes, which gave it the highest discontinuation rate, 15%. (The study used an unusual term, “tolerability failure.”) In contrast, only one percent of the people put on Isentress and five percent of those on Prezista discontinued those drugs. Isentress’ superiority over Prezista was driven by a combination of viral load and tolerability differences, in this case, greater gastrointestinal toxicity with Prezista. There were 1,800 study participants, with a good number of women (24 percent), blacks (42 percent), and Latinos (22 percent), along with 34 percent whites.
Sensitive test finds drug resistance
the drug resistant viral mutations tested was with K65R, an uncommon but clinically significant viral mutation. The presence of this mutation can point to drug resistance to tenofovir (Viread, also found in Truvada, Atripla, Complera, and Stribild) and abacavir (Ziagen, also found in Epzicom). Most prescribed HIV drug regimens in the U.S. include Truvada. The presence of the K65R mutation went from 0% with standard tests to 1.7% with the more sensitive test. For these samples taken from outside large urban areas, the CDC reported that the greatest amount of resistant virus was found in youth younger than 20 years old, primarily black, and “underscore the importance of prevention efforts for at-risk youth.”
New NNRTI: MK-1439
That wild-type virus may
An experimental HIV
not be so wild. Newly infected people can be expected to have wild-type virus, which has no evidence of drug resistance that would limit the effectiveness of HIV treatment. People can be infected with drug-resistant virus from a positive partner, however, especially with greater use of HIV therapy, which can lead to drug resistance with incorrect or incomplete use. With more sensitive resistance tests, CDC researchers were able to find HIV drug resistance in blood samples of newly diagnosed individuals who have never taken HIV meds. Whereas conventional screening found 7.9% prevalence of transmitted resistance (not that unusual), a more sensitive test found double that rate, 16.6%, which is of much greater concern. The greatest difference found for
medication in the same drug class as efavirenz (Sustiva, found in Atripla) did as well as efavirenz when both were paired with Truvada in an early 24-week study. MK-1439, a second-generation once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI), is expected to work in people who have drug resistance to NNRTIs. There were 208 patients in this dose-ranging study, and the dose going forward into a large Phase 3 study later this year will be 100 mg once daily. MK-1439 (generic name doravirine) has some of the same central nervous system side effects that efavirenz does (e.g., dizziness, insomnia), however, there were fewer discontinuations for any reason in the doravirine arm (7.8%) than in the efavirenz arm (16.3%).
HCV at CROI By Lynda Dee
HCV was a major feature of the 21st annual CROI. The cure for HCV is literally around the corner. This article will cover HCV highlights at CROI for both co-infected and mono-infected people. The biggest news for people who are co-infected is that so far the new Direct Acting Antiviral (DAA) drugs have the same effectiveness and side effects in co-infected people as they do in mono-infected people. This means that coinfected people should not have to wait to use the new interferon- or interferon/ribavirin-free DAAs when they are FDA approved later this year— if they can afford them. The new DAA combination studies in mono-infected people have between a 90 and 100% cure rate which is measured by a sustained virologic response (no rebounding viral load) 12 weeks after the completion of therapy (SVR12), some with only 6 to 12 weeks of therapy and without the life-altering side effects that accompany the traditional 48 weeks of interferon/ribavirin (IFN/r) treatment. Studies of IFN/r-free DAA combinations in people with HCV alone are further along than studies of co-infected people. The latest co-infection results are from patients still using regimens containing IFN/r. But the effectiveness and similar side effect profiles in those studies bode well for the DAA combinations in people who are co-infected. >>
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Doug Dieterich from New York presented data from an open-label study of faldaprevir plus IFN/r for 24 to 48 weeks in co-infected patients with no prior HCV treatment (treatment-naïve), or in those who relapsed after completing prior HCV therapy (relapsers). People who did well quickly were treated for only 24 weeks in what is called responseguided therapy. Although this study did include IFN/r, the take-home message is that it cured 83 percent of prior relapsers and 69 percent of treatmentnaïves and 71 percent of those cured had HCV genotype (GT) subtype 1a, traditionally the hardest HCV genotype to treat. The side effects experienced by co-infected people were also very similar to those in monoinfected patients. The data was even better with simeprevir (Olysio), a next-generation, FDA approved protease inhibitor (PI) plus IFN/r in a mix of naïve and previously treated patients in a study also presented by Doug Dieterich. Simeprevir is dosed only once daily unlike earlier HCV PIs that require dosing three times per day. Cure rates, which are now measured by SVR12, were 74 percent overall and 89 percent in the response-guided patients who, because they initially did well on treatment, received only
24 weeks of therapy instead of 48 weeks. Side effects were also similar to those experienced by mono-infected patients, except for more rash events in coinfected patients. The best results for coinfected patients were presented by Susanna York of North Carolina in a study of sofosbuvir (Sovaldi) plus ribavirin (RBV) but without interferon in naïve co-infected people with various HCV genotypes for 12 and 24 weeks. Sofosbuvir (SOF), arguably the most promising new DAA, and to date the most expensive, is FDA approved for both mono- and co-infected patients. The cure rate for GT 1 patients on SOF plus RBV was 76%, 88% in GT 2 patients, but only 67% of GT 3 patients after 12 weeks of therapy. SVR rates were higher with 24 weeks of therapy and were 92 percent for GT 2 and 94 percent for GT 3 patients. Side effects included fatigue, insomnia, headache, and nausea, all RBV-associated toxicities. While T-cell counts dropped, T-cell percentages, a more accurate measure of T-cell performance, remained the same. SOF is also being studied with GS 5885, now known as ledipasvir (LDP), in a one pill, once-daily, fixed dose combination (FDC), in co-infected people. SVR12 rates have been as high as 100% in mono-infected
people on 12 weeks of treatment, without the terrible IFN/r-associated side effects. Gilead, the manufacturer of the FDC, filed for FDA approval of SOF plus LDP in mono-infected patients with GT 1 in February. Studies on mono-infected people on 12 weeks of therapy showed an SVR of 67 percent for GT 1a treatment-naïve patients on daclatasvir and simeprevir plus RBV, 90 percent SVR in GT 1a people on daclatasvir, asunaprenavir, and BMS791325, and 99 percent in easier to treat GT 1b patients on firsttime therapy taking ABT450/r plus ABT333 plus RBV. The most exciting HCV news was the six-week versus 12-week data presented by Anita Kohl from the NIH. In mono-infected people, there was a 100% cure rate on 12 weeks of Gilead’s SOF plus LDP, a 95% cure rate on six weeks of SOF + LDP + GS 9669, a new non-nucleoside NS5B inhibitor, and a 100% cure rate on six weeks of SOF + LDP + GS9451, a new protease inhibitor. DAAs have revolutionized HCV treatment. One of the major questions remaining is whether people will be able to afford the new HCV treatments. Lynda Dee is a long-time activist involved with HIV and HCV drug development as well as pricing and access issues.
25 YEARS OF BEING POSITIVELY AWARE FROM PA’s MAY/JUNE 2003 ISSUE: CROI coverage included immunebased therapies, hepatitis C co-infection, and HIV drugs in development (that would become Aptivus, Emtriva, Lexiva, Reyataz, and Selzentry), and contained articles by prominent treatment advocates still in the struggle: Daniel Raymond, Matt Sharp, and Tracy Swan. Wrote Sharp, “People with AIDS must continue to proactively monitor pharmaceutical pricing discussions during the development of all new drugs. There should be a demand for worldwide access to all new drugs from day one. … The American Foundation for AIDS Research has a telling advertisement that reads, ‘1 million treated for HIV … 41 million to go.’”
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Prevention is always in fashion Working with young men for a PrEP study By Enid Vázquez
You gotta love a scientific presentation in which Beyoncé and Lady Gaga come up. Presenter Christopher Balthazar, MA, was answering a question from the audience about successfully using social media to recruit young men who have sex with men (YMSM) into a study. “In terms of recruitment, we have ads,” said Balthazar. “One of the interesting things we learned is that initially, when targeting people who identified as males who have sex with other males, we didn’t see a lot of responses, but those responses increased significantly once we targeted people based on who they ‘like’ or follow on Facebook. So if they like Beyoncé or Lady Gaga, we found that by having our ads appear on those people’s screens we were able to really engage more people who were eligible and interested in our project.” Project PrEPare, out of Cook County’s John Stroger Hospital in Chicago, evolved through the Adolescent Trials Network (ATN) for HIV studies in youth. Although young men of color who engage in gay sex are, overall, at very high risk for HIV, study slots weren’t easy to fill. The study staff found that in the poor communities of color where they focused recruitment efforts, the HIV prevention
Photo: ENID VÁZQUEZ
pill Truvada (pre-exposure said Balthazar. “We found a lot prophylaxis, or PrEP) was either of people within the community unknown or plagued with mishad never heard of it and when conceptions and even disdain. introducing a new concept to “We had some young people people, there’s always some we ran into—quite a few—who skepticism involved.” somehow believed that PrEP Recruiting through was for people who were prosocial media miscuous,” said Balthazar. “We often heard the term ‘Truvada “We found that embracing whore’ being thrown around, technology is really the way which was really unfortunate, to to reach young people,” said hear a biomedical intervention Balthazar. “We learned that such as PrEP, which could be we needed to communicate very efficacious in reducing the through Facebook.” acquisition of HIV, have such The 64 young men in the a negative reputation in the study changed their phone community.” numbers four or five times There was obviously a need a year, “but none of them for lots of community-based changed their Facebook,” a education. comment that brought laughter “The first barrier was lack of from the audience. “A phone community support,” Balthazar call doesn’t work. You may call, said. “One of the things we but they won’t answer.” Instead, found was that community text messaging worked to leaders and leaders of comget through to participants, munity organizations were conprovided that the latest phone cerned about the message that number was available. Of the we were sending by providing many conversations early on PrEP to young people. Many with participants, most of them of them questioned if we were were by text. giving them permission to have All in all, 71 percent of study more frequent condomless sex participants were recruited by providing PrEP. through social media and 13 “Was there more condomless percent through GPS mobile sex? We’re not seeing it. In fact, apps such as GRINDR, a dating we’re seeing the exact opposite. app for gay men. Only five perThere’s more condom use and cent were recruited following fewer partners. They feel more presentations and four percent empowered. That’s the goal—to through health care provider take control of your sexual referrals. The 15–17-year-olds health,” said Balthazar. were the most difficult to enroll. Even when community members were supportive, Challenges referrals to the study were difficult to come by. Some people Working with young people were nervous about referring in a large city presented several young people without obtainchallenges, as did working with ing permission from parents, large institutions set in their ways. though it was legal to enroll Transportation and time youth into the study without added up to one big barrier. parental permission. Youth were often far away and “Another barrier was this lack of knowledge around PrEP,” not out of school in time to
London Dorris (left) and Christopher Balthazar
get to the study site before it closed. Project PrEPare found it helpful to pay for cabs to overcome the problem of timing, as well as providing safety in getting through some dangerous areas of the city. Negotiating with the clinic was necessary as well. Security guards had to be informed that there would be patients coming in after normal hours. Staff begged the radiology lab, which only saw patients up to 3:00 p.m., to stay open until 6:00. Ditto for the blood lab, so that specimens could be collected later in the day. Project PrEPare takes a behavioral biomedical approach—medication plus extensive support, including counseling. The young men received extensive PrEP education; engaged in a support group using the Many Men, Many Voices (3MV) model, highly rated by the CDC; and were provided with integrated Next Step Counseling (iNSC) at every visit. It provided neutrality and allowed them to feel comfortable discussing very personal situations. It also helped them with adherence; many had trouble at the start remembering to take their daily pill, as well
as coming up with strategies to reduce any potential “social harm.” such as someone seeing their study medication, Googling it, and assuming that they had HIV (which happened in a few cases). Some of the youth were concerned about being guinea pigs; “so we explained what FDA approved means and how the efficaciousness of PrEP is no longer a question,” Balthazar said.
VIEW conference videos,
abstracts, and podcasts are available at croi2014. org. Christopher Balthazar’s presention with study participant London Dorris’s comments is also available at the site (although you may have to hit the presentation buttons more than once for the presentation to come up). See the entry, I’d
rather be a Truvada whore than an ARV whore, in the author’s blog, Tell it to Enid at http://bit.ly/PznHOx.
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COMPLERA is a prescription medicine used as a complete HIV-1 treatment in 1 pill a day. It is for adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood. COMPLERA can also replace current HIV-1 medicines for some adults who have an undetectable viral load (less than 50 copies/mL) and whose healthcare provider determines that they meet certain other requirements. COMPLERA does not cure HIV-1 or AIDS.
COMPLERA is a complete HIV-1 treatment in only 1 pill a day. Ask your healthcare provider if COMPLERA may be the one for you.
Pill shown is not actual size.
What is COMPLERA?
COMPLERA (emtricitabine 200 mg, rilpivirine 25 mg, tenofovir disoproxil fumarate 300 mg) is a prescription medicine used as a complete HIV-1 treatment in one pill a day. COMPLERA is for adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood (this is called ‘viral load’). COMPLERA can also replace current HIV-1 medicines for some adults who have an undetectable viral load (less than 50 copies/mL) and whose healthcare provider determines that they meet certain other requirements. COMPLERA combines 3 medicines into 1 pill to be taken once a day with food. COMPLERA is a complete single tablet regimen and should not be used with other HIV-1 medicines. It is not known if COMPLERA is safe and effective in children under the age of 18 years. COMPLERA does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking COMPLERA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.
IMPORTANT SAFETY INFORMATION What is the most important information I should know about COMPLERA?
COMPLERA can cause serious side effects: • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat. • Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain. • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions. • Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking COMPLERA, your hepatitis may suddenly get worse. Do not stop taking COMPLERA without first talking to your healthcare provider, as they will need to monitor your health. COMPLERA is not approved for the treatment of HBV.
Who should not take COMPLERA?
Do not take COMPLERA if you: • Take a medicine that contains: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek), rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin), rifapentine (Priftin), dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole sodium (Protonix), rabeprazole (Aciphex), more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate, or the herbal supplement St. John’s wort. • Take any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera).
starting treatment with COMPLERA. If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider may also check your kidneys during treatment with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself. • Changes in liver enzymes: People who have had hepatitis B or C, or who have had changes in their liver function tests in the past may have an increased risk for liver problems while taking COMPLERA. Some people without prior liver disease may also be at risk. Your healthcare provider may do tests to check your liver enzymes before and during treatment with COMPLERA. • Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones. • Changes in body fat can happen in people taking HIV-1 medicines. • Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking COMPLERA. The most common side effects of COMPLERA include trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression. Other common side effects include vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), and pain. Tell your healthcare provider if you have any side effects that bother you or do not go away.
What should I tell my healthcare provider before taking COMPLERA?
All your health problems. Be sure to tell your healthcare provider if you have or had any kidney, mental health, bone, or liver problems, including hepatitis virus infection. • All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking COMPLERA without first talking with your healthcare provider. • If you take antacids. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA. • If you take stomach acid blockers. Take acid blockers at least 12 hours before or at least 4 hours after you take COMPLERA. Ask your healthcare provider if your acid blocker is okay to take, as some acid blockers should never be taken with COMPLERA. • If you are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking COMPLERA. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. Also, some medicines in COMPLERA can pass into breast milk, and it is not known if this can harm the baby. •
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
What are the other possible side effects of COMPLERA?
Serious side effects of COMPLERA may also include: • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood tests to check your kidneys before
Learn more at www.COMPLERA.com
Brief Summary of full Prescribing Information COMPLERA® (kom-PLEH-rah) (emtricitabine 200 mg, rilpivirine 25 mg, tenofovir disoproxil fumarate 300 mg) tablets Brief summary of full Prescribing Information. For more information, please see the full Prescribing Information, including Patient Information. What is COMPLERA? • COMPLERA is a prescription medicine used as a complete HIV-1 treatment in one pill a day. COMPLERA is for adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood (this is called ‘viral load’). Complera can also replace current HIV-1 medicines for some adults who have an undetectable viral load (less than 50 copies/mL) and whose healthcare provider determines that they meet certain other requirements. • COMPLERA is a complete regimen and should not be used with other HIV-1 medicines. HIV-1 is the virus that causes AIDS. When used properly, COMPLERA may reduce the amount of HIV-1 virus in your blood and increase the amount of CD4 T-cells, which may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak. • COMPLERA does not cure HIV-1 or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses. • Ask your healthcare provider about how to prevent passing HIV-1 to others. Do not share or reuse needles, injection equipment, or personal items that can have blood or body fluids on them. Do not have sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. What is the most important information I should know about COMPLERA? COMPLERA can cause serious side effects, including: • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis: – feel very weak or tired – have unusual (not normal) muscle pain – have trouble breathing – having stomach pain with nausea or vomiting – feel cold, especially in your arms and legs – feel dizzy or lightheaded – have a fast or irregular heartbeat • Severe liver problems. Severe liver problems can happen in people who take COMPLERA. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems: – your skin or the white part of your eyes turns yellow (jaundice) – dark “tea-colored” urine – light-colored bowel movements (stools) – loss of appetite for several days or longer – nausea – stomach pain
• You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time. • Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) infection and take COMPLERA, your HBV may get worse (flare-up) if you stop taking COMPLERA. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV with your healthcare provider. – Do not run out of COMPLERA. Refill your prescription or talk to your healthcare provider before your COMPLERA is all gone. – Do not stop taking COMPLERA without first talking to your healthcare provider. – If you stop taking COMPLERA, your healthcare provider will need to check your health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking COMPLERA. Who should not take COMPLERA? Do not take COMPLERA if you also take any of the following medicines: • Medicines used for seizures: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine (Trileptal); phenobarbital (Luminal); phenytoin (Dilantin, Dilantin-125, Phenytek) • Medicines used for tuberculosis: rifabutin (Mycobutin); rifampin (Rifater, Rifamate, Rimactane, Rifadin); rifapentine (Priftin) • Certain medicines used to block stomach acid called proton pump inhibitors (PPIs): dexlansoprazole (Dexilant); esomeprazole (Nexium, Vimovo); lansoprazole (Prevacid); omeprazole (Prilosec, Zegerid); pantoprazole sodium (Protonix); rabeprazole (Aciphex) • Certain steroid medicines: More than 1 dose of dexamethasone or dexamethasone sodium phosphate • Certain herbal supplements: St. John’s wort • Certain hepatitis medicines: adefovir (Hepsera), lamivudine (Epivir-HBV) Do not take COMPLERA if you also take any other HIV-1 medicines, including: • Other medicines that contain tenofovir (ATRIPLA, STRIBILD, TRUVADA, VIREAD) • Other medicines that contain emtricitabine or lamivudine (ATRIPLA, Combivir, EMTRIVA, Epivir, Epzicom, STRIBILD, Trizivir, TRUVADA) • rilpivirine (Edurant) COMPLERA is not for use in people who are less than 18 years old. What are the possible side effects of COMPLERA? COMPLERA may cause the following serious side effects: • See “What is the most important information I should know about COMPLERA?” • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking COMPLERA. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: – feeling sad or hopeless – feeling anxious or restless – have thoughts of hurting yourself (suicide) or have tried to hurt yourself • Change in liver enzymes. People with a history of hepatitis B or C
virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with COMPLERA. Liver problems can also happen during treatment with COMPLERA in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with COMPLERA. • Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones. • Changes in body fat can happen in people taking HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known. • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having any new symptoms after starting your HIV-1 medicine. The most common side effects of COMPLERA include: • Trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, depression Additional common side effects include: • Vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. • These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider. • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. What should I tell my healthcare provider before taking COMPLERA? Tell your healthcare provider about all your medical conditions, including: • If you have or had any kidney, mental health, bone, or liver problems, including hepatitis B or C infection. • If you are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child. – There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you take COMPLERA. – You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. – Two of the medicines in COMPLERA can pass to your baby in your breast milk. It is not known if this could harm your baby. – Talk to your healthcare provider about the best way to feed your baby. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements: • COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works. • If you take certain medicines with COMPLERA, the amount of COMPLERA in your body may be too low and it may not work to help
control your HIV-1 infection. The HIV-1 virus in your body may become resistant to COMPLERA or other HIV-1 medicines that are like it. • Be sure to tell your healthcare provider if you take any of the following medicines: – Antacid medicines that contain aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA. – Certain medicines to block the acid in your stomach, including cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine hydrochloride (Zantac). Take the acid blocker at least 12 hours before or at least 4 hours after you take COMPLERA. Some acid blocking medicines should never be taken with COMPLERA (see “Who should not take COMPLERA?” for a list of these medicines). – Medicines that can affect how your kidneys work, including acyclovir (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), valacyclovir (Valtrex), and valganciclovir (Valcyte). – clarithromycin (Biaxin) – erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone) – fluconazole (Diflucan) – itraconazole (Sporanox) – ketoconazole (Nizoral) – methadone (Dolophine) – posaconazole (Noxafil) – telithromycin (Ketek) – voriconazole (Vfend) Know the medicines you take. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Do not start any new medicines while you are taking COMPLERA without first talking with your healthcare provider. How should I take COMPLERA? • Stay under the care of your healthcare provider during treatment with COMPLERA. • Take COMPLERA exactly as your healthcare provider tells you to take it. • Always take COMPLERA with food. Taking COMPLERA with food is important to help get the right amount of medicine in your body. A protein drink is not a substitute for food. If your healthcare provider decides to stop COMPLERA and you are switched to new medicines to treat HIV-1 that includes rilpivirine tablets, the rilpivirine tablets should be taken only with a meal. Keep COMPLERA and all medicines out of reach of children. This Brief Summary summarizes the most important information about COMPLERA. If you would like more information, talk with your healthcare provider. You can also ask your healthcare provider or pharmacist for information about COMPLERA that is written for health professionals, or call 1-800-445-3235 or go to www.COMPLERA.com. Issued: December 2013
COMPLERA, the COMPLERA Logo, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, TRUVADA, VIREAD, and VISTIDE are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein are the property of their respective owners. ©2014 Gilead Sciences, Inc. All rights reserved. CPAC0098 02/14
Southern lights In the South, HIV is mostly a disease of poverty, but there are beacons of hope by Rick Guasco
strip of rich land runs through the heart of Alabama. Known as the Black Belt, the region gets its name from the dark, fertile soil here. A rich agricultural land, at one time, this was one of the wealthiest parts of the United States. Things are very different now. The Black Belt has been poverty-stricken for decades, made even more poor by the fact that agriculture no longer drives the area’s economy. And where there is poverty, there are often high rates of HIV. If the South is the region of the U.S. hardest by HIV, the Black Belt is one of the places hardest hit by HIV in the South. “We see HIV as a disease of poverty in Alabama, as it is in much of the South, and in many other parts of the world,” says Michael Murphree, executive director of Medical AIDS Outreach of Alabama (MAO), an HIV/AIDS service organization that covers about two-thirds of the state. “HIV and poverty walk together hand in hand.” “I think it’s very clearly linked to poverty,” Murphree adds. “But I think it’s also that we are the most conservative in so many things. If you look at who says we don’t want to have any Medicaid expansion, we don’t want to have the Affordable Care Act [ACA]. All these things they say we don’t need to improve our health care system, they are the exact same states where HIV is so high, diabetes is running rampant, heart disease is out of control. Health care outcomes are hurt as a result, and our politicians can’t seem to grasp that because they are so adamant in following some party line.”
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Murphree estimates that 45 percent of MAO’s clients are uninsured; most of them won’t be able to get into the ACA exchanges because they don’t make enough money to afford it. Unless Alabama and other Southern states decide to expand Medicaid, these individuals will still have no health insurance. MAO operates several clinics and satellite facilities throughout Alabama, covering about two-thirds of the state. When the agency decided to expand beyond its original locations in Montgomery and Dothan, it relied on data and maps put together by AIDSVu to find the areas of greatest need. AIDSVu compiles data from the Centers for Disease Control and Prevention (CDC) along with state and county health departments to generate demographic maps which depict county-level information about HIV cases based upon age, race, gender, and income. (The interactive maps are available at aidsvu.org.)
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“The AIDSVu data were helpful,” Murphree says. “They showed us that HIV rates were [very] high in rural Alabama, particularly in areas in the Black Belt.” Looking at the maps of income and reported HIV cases, Murphree found they overlapped. The counties with the worst poverty also had the highest incidences of HIV. Based on the AIDSVu maps, MAO decided to open satellite care clinics in Clayton, Florence, Greensboro, Selma, Sipsy, and Troy. The agency serves approximately 1,300 clients, according to Murphree. Will Rutland grew up in San Francisco, though he has roots in the South. When he and his wife decided to move to a place where they could work to help the most disadvantaged people, their choice was
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Rate of adults and adolescents living with HIV per 100,000 people. 0–40 41–54 55–67 68–82 83–103 104–134 135–174 175–244 245–383 384+ Data not shown data not released Data Source: Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention. Note: Data include people with a diagnosis of HIV infection, regardless of stage, and have been statistically adjusted to account for reporting delays and missing riskfactor information, but not for incomplete reporting.
clear—the Black Belt. Not only was there poverty and a disproportionately high rate of HIV, but there were very few resources available. “At the time, the general population of Alabama was 4.8 million people—three of them were specialists with the American Academy of HIV Medicine,” says Rutland, an IT specialist who set up a telemedicine system for MAO and other agencies. (Editor’s note: There are 11 specialists in Alabama accredited by the HIV Medicine Association. See page 36 for more on telemedicine.) If resources are scarce, then the fear that others, even family members, may learn of your HIVpositive status only further discourages some people from getting medical care. Avoiding stigma—and gossip—can be especially difficult in close-knit communities
such as those in rural areas of the South; the organist at church might also be the receptionist at your doctor’s office. Rutland learned that the solution to these challenges was to partner with existing organizations that had already developed good reputations in their communities. Partnering with Selma AIR (AIDS Information and Referral) and with the Whatley clinic through the University of Alabama at Birmingham’s (UAB) medical school, helped to connect to the community while maintaining some discretion. “One of the reasons we worked so hard to establish the partnership with UAB is because the university runs a family medicine clinic in Selma, it’s one of the primary medical facilities in that area,” Rutland explains. “It’s a catch-all clinic for the community, so it was a boon for us to have our facility inside their facility. That way, people could be there for any reason. It automatically gives people cover.” Overcoming HIV in the South means overcoming many other challenges that the South faces. Yet poverty, politics, stigma, and accessibility are not issues unique to the South. However, the solutions might require inventive thinking. The question is will municipalities and states listen when people like Murphree and Rutland come up with their innovative ideas? Or will the policy makers of the South continue to be proof of how ignorance and ideology can lead to the desperation of the most vulnerable of its residents?
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The Big (Not-So) Easy It isn’t easy living in Louisiana with HIV and the ACA
A By Sue Saltmarsh
statement on the website for the Department of Health & Human Services’ (DHHS) Health Resource and Service Administration (HRSA) touts the Affordable Care Act as “an historic opportunity for people living with HIV, including those currently receiving services through the Ryan White Program, to increase their access to affordable, quality health care.”
Contrary to that statement, in February, an alarm sounded throughout the HIV community in the U.S. that even got the attention of people not usually concerned with HIV issues. Louisiana, and subsequently North Dakota, ACA exchange insurers were rejecting Ryan White payments for premiums for HIV-positive consumers who would have no insurance without the “third-party payment.” First there was a report from Reuter’s (http://reut.rs/1dI8nn6) which was, of course, picked up by major mainstream news outlets, then PNHP (Physicians for a National Health Program) weighed in (bit.ly/1g2D87b) and got the single-payer advocacy world buzzing. Reuter’s opened with, “The U.S. Centers for Medicare and Medicaid Services (CMS), in an effort to keep insurers from denying coverage to people with HIV/AIDS, may strengthen its position on health plans accepting third-party payments, such as those under the 1990 Ryan White Act.” “One of the advantages of the Affordable Care Act (ACA) is that private insurers can no longer reject the applications of individuals with serious, expensive disorders, such as HIV/AIDS,” wrote Don McCanne, MD, of PNHP. “But the response of Blue Cross and Blue Shield of Louisiana [BCBSLA]—the largest insurer in Louisiana—is another example of how private insurers are not inclined to change from their business model to a patient service model.” So what was the justification behind BCBSLA’s policy? Spokesman John Maginnis explained to Reuter’s that the 28
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policy is an “anti-fraud measure” and said at the end of February, “In no event will coverage be provided to any subscribers, as of March 1, 2014, unless the premiums are paid by the subscriber (or a relative) unless otherwise required by law.” And as it turns out, the law did require it. It was Lambda Legal’s lawsuit that led to a temporary restraining order and then a March 10 hearing that resulted in BCBSLA, Louisiana Health Cooperative, and Vantage Health Plan (all of the insurers selling plans on the Louisiana exchange) to continue accepting federally-funded third-party premium payments on behalf of lowerincome Louisianans living with HIV through November 15, 2014, when the next open enrollment period begins. Then, on March 14, the CMS issued an interim final rule stating that insurers selling policies on insurance exchanges must accept payments for premiums and costsharing sums from the Ryan White HIV/AIDS program beyond 2014.
Medicaid expansion and other issues Louisiana, along with every other state in the South, where infection rates rival sub-Saharan Africa, has refused to expand its Medicaid program, leaving thousands who would have qualified under the new financial criteria out in the cold, making “too much” to meet the limit of 100% of the Federal Poverty Line (FPL) and too little to afford premiums, even with subsidies. Expansion would have qualified any adult
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aged 19–64 making less than 133% of FPL, including childless adults. Not that 133% of poverty level is better than 100%—living on $15,521 per year is barely, if at all, more comfortable than living on $11,670. But without Medicaid expansion, and now without food stamps and housing assistance due to cuts, and help with heating and transportation costs also shrinking, not to mention the Emergency Unemployment Compensation program expiring in December, leaving 1.3 million Americans without benefits, it seems like there is no deck that’s not stacked against the poor and the sick. There are also questions about access to medications and to HIV specialists. It was reported in December that expensive HIV drugs were being dropped from the formularies of the most “affordable” exchange plans. Combination pills like Atripla, one pill taken once a day, were being dropped or insurers were requiring patients to take each of the component drugs separately—multiple pills, several times a day in some cases. Also being dropped are HIV and other specialists from provider networks, leaving people to choose between trusted providers, experienced in handling the complicated treatments of HIV and co-morbidities, and unknown providers, with unknown knowledge of HIV, its treatment, possible complications, and other conditions that may require their own specialists. As Brandon Macsata, CEO of the ADAP Advocacy Association said, “What is happening with BCBSLA and BCBSND is one of the unintended consequences of the Affordable Care Act. Unfortunately, we have one political party that is obsessed with blowing it up and offering nothing comprehensive to replace it, and another political party in complete denial over the mess that is really unfolding on the ground. The losers in this fiasco won’t be the government agencies, or the insurance companies, or even the doctors and hospitals. Patients will be the ones to lose.”
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Your donation of:
covers one hepatitis C test with pre- and post-test counseling.
pays for one two-hour group therapy session with a licensed therapist.
covers the cost of one therapy session with a licensed therapist.
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Latino immigrants living with HIV/AIDS in the southern United States
by Octavio J. Vallejo, MD, MPH
ajor changes are occurring in the landscape of HIV/ AIDS work that seeks to attain unfettered access to health care for everyone living with HIV in hopes of turning the tide of this epidemic. At the same time, Latino immigrants in the southeastern United States are facing the deepest differences in rates of HIV disease, quality of life, and health disparities caused by marginalization, discrimination, and unequal access to care. Moreover, low levels of knowledge related to the mechanisms of HIV infection, multiple sexual partners, low condom use, and alcohol and drug use make the perfect combination, the “perfect storm,” for HIV exposure and infection.
In recent years, the Latino community in the southeastern states has grown rapidly. Agriculture in Alabama, Georgia, and Florida, as well as construction work, service industry jobs, and manufacturing activities in Arkansas, Louisiana, Tennessee, and the Carolinas are driving this growth. It is a fact that Latino immigrants bring cheap labor that substantially helps the economy 30
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of these states. Currently, one in three Latinos in the U.S. resides in the South and estimates of immigration trends assess that the Latino population will double to 30 percent. Many of these immigrants came from Mexico, the Caribbean, and Central and South America, trying to run away from poor living conditions, violence, and lack of opportunities. They come here to work and
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in return they receive low wages, hostility, and abuse. Indeed, the current social and legal climate in the region leads them to face systemic discrimination, marginalization, and consequently increased vulnerability to HIV infection.
Give me your tired, your poor, Your huddled masses yearning to breathe free, The wretched refuse of your teeming shore. Send these, the homeless, tempest-tossed to me, I lift my lamp beside the golden door!
Contrary to Emma Lazarus’ inscription on the Statue of Liberty, instead of being welcomed through the “golden door,” many Latinos find themselves treated more like “wretched refuse.” It is necessary to understand and expose the disparities they experience in
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AT LEFT: The Latino Commission on AIDS conducts a number of programs in the south. Treatment Now/Tratamiento Ahora is an HIV treatment advocacy training conducted in Spanish with HIV service providers from North Carolina’s Research Triangle.
order to have an informed citizenry that can advocate and demand from state politicians, senators, Congress, and the president that they abide by the United Nations’ declaration, “All human beings are born free and equal in dignity and rights.”
Latino immigrants in the South and HIV: a deadly combination
Photo: ERIK VALERO/LATINO COMMISSION ON AIDS
The Latino community in the United States has the second highest rate of HIV infection and also has the poorest social determinants that increase their vulnerability to HIV, according to the World Health Organization (WHO). Social determinants are the circumstances in which people are born, grow up, live, work, and age, as well as the systems put in place to deal with illness, and are influenced by economics, social policies, and politics. These social determinants are very well described in the medical and social literature; however, the necessary changes to reshape these factors are far from occurring. These factors are severely exacerbated in new settlement areas, such as the southeastern U.S., by
state and local governments. These governments do nothing to prohibit or stop exploitation and discrimination against Latinos; some of them have enacted ordinances that limit services to immigrants, making sure that they will feel unwelcome and making their lives extremely difficult. In addition, Latino immigrants engage in new sexual behaviors that increase their risk to HIV infection. They seek companionship to compensate for the alienating aspects of the migration experience and face fewer constraints or social control on behaviors as a result of their anonymity. All these factors, along with the exposure to sexual behaviors and practices previously not experienced or which they found unacceptable in the past (for example, the exchange of sexual services for money, food, or lodging), are realities that Latino immigrants encounter and use for their survival.
The case of Juan A. Juan was 22 when he arrived in New Orleans four months after Hurricane Katrina. He came legally to the U.S. through
a guest worker program from a little town in Queretaro, Mexico with some training as an electrician and in construction. Juan shared an apartment with six other men older than him. They spent every weekend drinking alcohol to alleviate the work pressure and loneliness; it was during these heavy drinking weekends when he started having receptive anal sex without a condom with his roommates. Nobody in the group ever spoke about this situation. This behavior for Juan and the other men was something that they did while under the influence of alcohol, when they couldn’t clearly recall what happened. He decided to stay in New Orleans after the guest worker program, working intermittently in odd jobs. His drinking incidents occurred more often, and he usually ended up having sex with other men. Juan tested positive for HIV at the emergency room during a severe case of respiratory infection and learned that his CD4 count was 70. He was released with a note of medical referral, but did not follow up. The fear and feelings of loneliness and shame kept him from seeking HIV care. He found comfort by taking some pills that a friend gave him in order to have energy to work. He was given crystal meth without knowing its addictive nature. Juan ended up homeless and sick in the hospital where he was referred to the NO/AIDS Task Force. He has been taking antiretroviral therapy for almost three years and attending support groups to overcome the addiction to crystal meth; he is now 31 years old. He is not willing to let his family in Mexico know about his condition. He also refuses to identify himself as gay. He is working as a dishwasher and has dreams of one day returning to Mexico after saving enough money to build a house, and finding a wife, having children, and going back to his traditional life. Juan’s case is not uncommon, says Noel
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Twilbeck, CEO of NO/AIDS Task Force. “Latinos like Juan arrive for our services at advanced stages of HIV infection without knowing anything about HIV or AIDS. The problem is that the frequency of appearance of similar cases is not decreasing and makes us aware of the severe needs of this population subgroup in terms of education and testing services. At NO/AIDS Task Force, we are working at increasing our outreach activities and expanding testing opportunities to the communities that are at higher risk of HIV infection.” But more work is necessary to bring down the barriers that individuals face accessing education, prevention, and care services, says Twilbeck. In November last year, NO/AIDS became a Federally Qualified Health Center (FQHC) and they are looking to expand their health care services to all, regardless of their ability to pay. “NO/AIDS Task Force already has bilingual services and our culturally competent and sensitive staff is eager to help. In this way, we will bring more opportunities to serve Latinos and teach them about HIV/ AIDS, and hopefully this education will help to reduce the stigma that acts as a major deterring factor in accessing timely testing and health care services.”
The Southern impact The impact that HIV has on Latinos in the South is already noticeable: the high frequency of sexually transmitted infections (STIs) and their late diagnosis and late access to care bring severe consequences. Latinos often receive an AIDS diagnosis within 12 months of learning their HIV status. The evidence of these negative factors is reflected in a study that assesses demographic and clinical factors between racial/ethnic groups at the time of HIV care initiation at the University of North Carolina Center for AIDS Research Clinical Cohort (http://cid.oxfordjournals.org/ content/53/5/480.full). They found that Latinos are more likely to initiate HIV care later in the course of illness than are blacks or whites and accounted for a majority of AIDS-defining events, meaning that when Latinos were diagnosed with HIV, they were in advanced stages of AIDS. The authors only recommend strategies to improve earlier HIV testing among Latinos. However, 32
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Under the current circumstances, how can we expect Latinos to increase their utilization of HIV testing services when they fear the risk of being deported or discriminated against?
these findings corroborate and highlight the importance of the social determinants among this population subgroup shaped by their level of income, lack of power and resources, and the existing policies against them. The necessary changes needed to help Latinos in this region are beyond public health efforts. The changes need to occur at the local, state, and federal level within the highest political spheres. Under the current circumstances, how can we expect Latinos to increase their utilization of HIV testing services when they fear the risk of being deported or discriminated against? In 2012, the Southern AIDS Coalition (SAC) published its updated manifesto with a policy brief and recommendations. In this document, SAC attempts to mobilize communities and influence policy makers to stem the growing epidemic in the South. To address the issues of Latinos in the South SAC calls upon state legislators, state and local health departments, health care providers, AIDS service organizations, and community-based organizations to consider the necessary changes in legislation, funding, and service delivery programs to improve the health conditions of Latino immigrants. However, those calls need to be supported and amplified by sound national policies such as immigration reform, immigrant-friendly health care reform, and federal protection of labor laws. The current efforts to increase health care access to all through the Affordable Care Act (ACA) do not reach the Latino immigrants in this region. Several Southeastern states have passed legislation that prohibits undocumented immigrants
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from accessing medical care, thus the effect of the ACA among this population subgroup is failing in its original intent. The intersection between care, research, social justice, human rights, public health, and politics is real in the field of HIV/AIDS. Each of them is important to reach successful outcomes. It is not possible to advance only in one or two and neglect the rest. In reality, this is what is currently happening in the work of HIV/AIDS among Latinos and immigrants. On one hand, we already know how to provide better services to them and we also know the importance of their inclusion in the process of developing successful care and public health programs. But on the other hand, the necessary changes to secure their dignity and basic human rights have not been attained yet. I have been working on HIV/AIDS for almost 24 years. I have witnessed the amazing scientific progress that will allow the control of this epidemic; I know that we already have the tools to turn the tide of new HIV infection among Latino immigrants. Indeed, we now have PrEP (preexposure prophylaxis), an effective way to prevent new HIV infections for individuals at high risk. Imagine the implementation of PrEP for participants on guest worker programs. Imagine the cost benefit of having healthy seasonal migrant workers when they arrive and keeping them healthy for their return. Imagine policy makers of U.S. and Latin American countries working together to provide PrEP along with basic human rights to these immigrant workers who just want to work and provide for their families. Just imagine.
Dr. Octavio Vallejo is a Capacity
Building Assistance Provider at AIDS Project Los Angeles (APLA). He says his destiny hit him as he watched a young boy die of AIDS in a Mexico City hospital without painkillers to ease the suffering. Dr. Vallejo, who was a doctor at a hospital that houses 65% of Mexico’s pediatric AIDS cases, said his young patients pushed him into his mission in life. Dr. Vallejo came north to find solutions, and in the process emerged as a vital asset in the Los Angeles’ AIDS community—a key link between traditionally white AIDS services and the growing number of HIV-positive Latinos.
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Sweet Teeth Alabama Dr. Jeff Hill makes oral health matter for his patients at UAB’s 1917 Clinic By Sue Saltmarsh
T Photo: UAB
he 1917 Clinic in Birmingham, Alabama, started in 1988 in response to the growing AIDS epidemic in communities within Alabama and surrounding states. The clinic is named after its original address, 1917 5th Avenue South and kept its name when it moved in 1993 to its current location at 908 South 20th Street.
The Clinic’s medical staff provides a specialized environment in which to treat patients with HIV and one of those doctors is dentist Jeffery Hill. In 2010, a patient of his called POSITIVELY AWARE to passionately plead that an article be published about Dr. Hill. Though perhaps four years late in that patient’s estimation, an issue focusing
on HIV in the South seemed the perfect opportunity to finally give Dr. Hill the attention his patient felt he deserves. Dr. Hill’s voice seemed to reflect the care and dedication that his patient had spoken so fervently about. Filled with warm, Southern gentility, he told the story of how he became the 1917’s first dentist. “It was not a conscious decision right
off the bat. In my senior year of dental school here at UAB, I was trying to decide what I wanted to do after I graduated. I was investigating different opportunities—residencies, private practice, etc.—and I had been talking to some of my faculty mentors about the possibility of joining the faculty and teaching at the dental school. I liked the idea of that, but I didn’t want to do it all of the time—I wanted to be able to treat patients as well.” A friend of Hill’s suggested he get in touch with the co-founder and medical director of the clinic, Jim Raper, who’d indicated that they were looking for a dentist. A new door opened for Hill, who talked to Raper and Dr. Michael Saag, co-founder
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The best of luck Commenting on the rarity of finding a dentist on site in HIV medical clinics, Hill says, “It’s rather unique—I don’t know of another facility that has it all in one building—a medical clinic, dental clinic, pharmacy, research, and social work—plus if a patient needs to be admitted to the hospital, then it really is all right here, a one-stop shop, so to speak. “It’s been really good for us, too,” he continues, “making it possible to have a really close working relationship with the rest of the medical team.” Regular provider meetings enable all of the practitioners—doctors, nurses, dentists, hygienists—who share patients to come together and learn from each other. Educational presentations are given about different issues and Dr. Hill gives one on oral health issues several times a year. There are also monthly Strategic Planning Team meetings where the directors of the different divisions discuss how the clinic is doing and form future strategies for continued success. “The more I talk to colleagues around the country who provide HIV dental care, the more I find out how lucky I’ve been to be in a facility like this and part of the vision of the people who created it all,” Hill says. The ‘f’ word Funding, the bane of all HIV/AIDS 34
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service providers, is luckily not the threat to the 1917 Clinic that it is to many other organizations across the country. The clinic is funded by a variety of sources. It receives Ryan White money, grants from the National Institutes of Health (NIH), and with the UAB 1917 Clinic Cohort, runs a prospective, observational HIV clinical cohort study established in 1992, which has generated over $20 million in external funding. But where the money comes from and how it is attained may not be the most important aspect of the clinic’s “culture.” Dr. Hill is not a political junkie. When asked to comment on the sorry state of HIV/AIDS funding, especially in the Southern states, he admitted that he relies on colleagues to stay on top of politics; his focus is elsewhere. “I really try to focus on caring for my patients and making sure I have a good, happy, experienced, capable staff,” he says. “We’re a very small group, but we’re all here because this is what we want to do. “I’ve never felt constrained, that I can’t do something because I can’t find a way to get it paid for,” Hill remarks. “Of course, I’m always aware that the majority of the money we get is federal grant money and I want to be a good steward of that. I’m very conscious of it when developing treatment plans and strategies for patients. I want to do the most good for the most people with the amount of money we have, but fortunately, I really haven’t had to say ‘I can’t do that,’ because we always find a way to do it.” There have been times when a year’s worth of funding runs out in nine months and “things have to be put on hold.” But they somehow always bounce back. A new funding cycle starts and things return to normal, but the obvious dedication to patients is embodied in “finding a way” to get what they need done.
Treating patients The clinic as a whole serves close to 5,000 people per year and close to 1,200 of them visit the dental clinic. Dr. Hill is now one of two dentists and there is still a waiting list from several weeks to a couple months to get an appointment, depending on the urgency of the need. True emergency patients are seen as soon as possible.
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The most common thing Dr. Hill sees in his patients is general dental disease— decay, missing teeth, periodontal disease, the things any dentist would tell any patient to look out for. “The greatest amount of work that we do is just good general dentistry,” he says. “Some of our cases are quite complicated as far as being able to restore the patient to a good, functional point, but very little of that is directly related to their HIV status.” He explained that for many, their background, level of education, socioeconomic status, and general oral health knowledge is more likely to be at the root of their dental problems than is being HIV-positive. But some things that are exacerbated by HIV, especially in those with advanced disease and a depleted immune system.
and researcher at the clinic. He also spoke to the chairman of the dental school and worked out an arrangement that would make him a pioneer—the first (and still only) faculty member to split his time between teaching and seeing patients. While the bureaucracy was being set in place, Dr. Hill educated himself on HIV and oral health—something which had not been taught in dental school and about which there was little information. Armed with his new knowledge and freshly graduated, he “went from one side of the chair to the other,” starting his work as professor and director of the dental clinic in 1995. Since then he has been a constant there and one of the few HIVspecialized dentists in the country.
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1917 Clinic co-founders Michael Saag, MD (sitting) and James Raper, PhD, CRNP.
“As the immune system weakens, you have to worry about opportunistic infections, even KS [Kaposi’s sarcoma]. The amount of bacteria load that can be in the oral environment, like with cavities and gum disease, and if the patient also happens to be diabetic, that can really throw a wrench into it,” he explains. “But if they’ve got HIV and an otherwise healthy mouth, they’re probably going to be just fine.” According to him, even HIV medications don’t cause any direct HIV complications. But many patients are taking multiple medications besides their HIV meds that can cause dry mouth, or changes in quantity or the buffering capacity of saliva, which can lead to cavities and gum disease. “The best thing would be to promote preventive care, rather than emergency,
episodic care,” he says, echoing the sentiments of many providers in many disciplines.
Attention must be paid Dental care, like vision care, is a “forgotten child” within the American healthcare system. Only 11 states offer extensive Medicaid coverage for adult dental services, and it isn’t included in most major medical insurance policies, or any adult ACA exchange policies (though available for children), and Dr. Hill thinks it should be. “I think that it should be included—not just in terms of the National Strategy on HIV/AIDS, but I personally believe that good dental care should be available for all people. There should be a way that anyone
who needs it can get the oral healthcare that they need.” As far as the National Strategy goes, he says there’s now a push to bring more awareness to the importance of oral health and how it’s part of a holistic approach to treating HIV patients, “that it’s important for them to have good care for their oral health, for their systemic well-being, and even from the standpoint of social issues, self-esteem, all those sorts of things.” Hill has been involved with a HRSA HIV/ AIDS bureau project for the last two years as part of a team charged with creating a guide to oral health care for people living with HIV/AIDS which is targeted towards primary care providers, internists, physicians’ assistants, and nurses. The guide consists of a five-part online curriculum, with each part covering a different topic in a Power Point presentation that you can run through with speakers’ notes and references available. In the first part, there’s an embedded video of Dr. Hill demonstrating how to perform an oral exam (available at youtube.com/watch? v=QRwGSfzqclQ&feature=youtu.be). Two webinars launched the series in March and were also recorded for anyone to hear. Obviously, Dr. Hill’s patient was not exaggerating when gushing about his compassionate, knowledgeable, dedicated care. It is rare to find a medical provider of any kind who will take the time to connect on a human level with their patients and the ones who do are not easily given up by patients who trust them. We can only hope that Dr. Hill is passing this valuable ability on to his students as he continues to teach tomorrow’s dentists. But perhaps he sums it up best in his own words: “Everybody appreciates being treated with dignity,” says this true healer. “And I think they deserve to be.”
Editor’s Note Dr. Michael Saag’s memoir was published as this issue went to press, Positive: One Doctor’s Personal Encounters with Death, Life, and the U.S. Healthcare System. Go to positivethebook.com.
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The doctor will
Telemedicine is extending the accessibility of HIV treatment in the by Rick Guasco
t starts out like any other visit to the doctor. You check in, and a nurse takes your temperature and blood pressure. You’re asked how you’ve been feeling; are there any symptoms or other complaints you want to talk with the doctor about? Now that the nurse has gathered the necessary general information, you walk into another room, ready to see the doctor.
And that’s when the camera turns on and the doctor appears on a large flat screen television. Think of it as a souped-up version of the video chat service Skype. A camera, a high-definition TV monitor plugged in to a laptop computer, and some medical equipment linked to the Internet are used to connect a doctor in one city to a patient at a clinic miles away. Known as telemedicine, this technology has been in use for more than a decade, and has been used in Africa, and is now helping overcome some of the obstacles to providing treatment to people living with HIV in the South. A 48-year-old African American gay man who has been HIV-positive for 26 years, James (not his real name, to protect his privacy) lives in Selma, Alabama. His doctor, Prashanth Bhat, MD, MPH, AAHIVS, is based in Montgomery, about 55 miles away. The telemedicine project at Selma AIR (AIDS Information and Referral) is how James has been seeing his doctor every month for over a year. James has been a client at Selma AIR since 1996. At the beginning of 2013, James was told that the agency was launching a telemedicine project and that he would be seeing a new doctor over the system. “I was a little apprehensive about it at first,” James admits. “I didn’t know how it would work. When they described it, my only concern was that I wanted to see the doctor in person first before seeing him on the screen.” James got to meet Dr. Bhat in person for 36
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their initial appointment. That face-to-face meeting was important, he says, so that he could establish a connection with his new doctor. A year into his telemedicine appointments, James comfortably talks with the nurse standing next to him in the examination room and with Dr. Bhat on the monitor. “We have such a good rapport,” James says, “I’m so comfortable with the telemedicine screen and with Dr. Bhat.” When James came down with a respiratory infection, he was diagnosed and able to receive treatment through the telemedicine system. At the Selma clinic, a nurse listened to James’ lungs using a special stethoscope. The stethoscope uses the same Bluetooth technology as a wireless computer mouse to transmit sound picked up by the stethoscope to the nurse’s laptop. The sound, and other data, is then relayed to the doctor’s computer in Montgomery. “It can be five miles away, 50 miles away, 5,000 miles away,” Dr. Bhat says, “as long as we have a good Internet connection, my stethoscope will be able to hear my patient.” At his end, Dr. Bhat wears a similar stethoscope that has been “mated” with the nurse’s. The doctor is able to adjust the volume, as well as record and play back the audio, and can even add the recording to James’ medical file. The telemedicine project at Selma AIR is part of a much larger collaborative effort that includes Medical AIDS Outreach of Alabama, AIDS Action Coalition in Huntsville, and Whatley Health Services, a primary health clinic in Tuscaloosa
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started by the University of Alabama at Birmingham. The technology isn’t without its shortcomings. A poor camera angle or lighting could affect how the doctor-patient bond is established. Microexpressions, subtle reactions that can reveal emotions on a patient’s face that quickly disappear, might not be captured by the camera or noticed on the monitor by the doctor. However, telemedicine can increase access to medical care in areas where there is virtually no medical care. Fifty of Alabama’s 67 counties are covered by the telemedicine project. The system has four hub sites at which a doctor or nurse practitioner is based, Montgomery, Dothan, Tuscaloosa, and Huntsville—and six spoke sites, Selma, Sipsy, Greensboro, Florence, Clayton, and Troy, where a nurse is located. Two more spoke sites are planned by the end of the year.
Setting the stage Before telemedicine, medical care
in the area was more like a traveling road show. “We’d literally pack up our clinic—our charts, the phlebotomist, the nurse, our social worker—and get into a van to go to our satellite facility in Selma, which is about an hour and 15 minutes away,” Dr. Bhat says. “As a result, we were seeing patients for only four hours in an eight-hour day. With telemedicine, I see patients eight hours—four hours on Wednesday morning and four hours on Thursday morning.” The project is the brainchild of Michael Murphree, CEO of Medical AIDS Outreach of Alabama. At a social workers’ conference, Murphree saw an exhibit that explained how a telemedicine system could be used to provide care. After learning of an AIDS United grant that funded innovative projects, Murphree contacted
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see you—online rural South
the AIDS Action Coalition. Like Medical AIDS Outreach, the coalition’s Ryan Whitefunded clinic covers a large service area and it turned out they were looking into telemedicine as well. The two agencies then approached Whatley Health Services, which also joined the collaborative. AIDS United came through with a $1.2 million grant spread out over three years. The project also receives support from the Centers for Disease Control and Prevention (CDC) through the Alabama Department of Public Health, and through fundraising by the three collaborative agencies.
Lights. Camera. Medicine!
Web cam: Hemera/iStock stethoscope: SP Services
In addition to medical care, the col-
laborative found that telemedicine has the potential to provide other services, such as support groups. People who are dually diagnosed with HIV and substance use issues meet in one clinic, facilitated by a therapist at another location. The telemedicine cameras can detect sound, automatically focusing on whatever individual in the group is speaking. “We have several clients who always dress up for the camera every time they have an appointment or are in a group,” Murphree says. “They love being on camera. One of the guys admits that for him, it’s his American Idol moment. He never misses an appointment.” In fact, the project is credited with keeping patients in care. The telemedicine program’s patient retention rate of 92 percent matches the clinic’s own overall rate. “At first we were concerned how clients would respond, but they have bought into telemedicine,” Murphree says. “In some cases, I feel they really believe that the quality of care is better because, frankly, they see all this expensive equipment being used for them. They think it’s great.”
Using the same technology as a Bluetooth wireless computer mouse, this stethocope can send your heartbeat across the internet.
“Telemedicine is an ambitious idea, and not just for the reasons you might imagine,” says MAO’s Will Rutland, who was in charge of setting up the collaborative’s telemedicine system. “There was no fiber optic cabling. You’re running on copper wires, like old style telephone land lines.”
Ready for prime time Only fiber optic cable has the datacarrying capacity to allow for video conferencing. It would be a year into the planning of the telemedicine project before fiber optic cable would come to the area. Another challenge Rutland and the collaborative faced was where to best position the few resources and facilities they had. “You’re dealing with the most resourcedeprived area in the entire state,” Rutland says. “Here’s our population, here’s where they are located, now how do we reach them? The answer to that question is that you have to do it very deliberately. What few resources you have, you have to put them in exactly the right places. And that’s where AIDSVu was so incredibly helpful.” AIDSVu is a compilation of online interactive maps that display HIV prevalence data and is maintained by the Rollins School of Public Health at Emory University in partnership with Gilead Sciences, Inc., the maps offer a demographic look at HIV in the U.S—by age, race, gender, and income level. By visualizing the data from various sources, AIDSVu maps illustrate the rates of HIV and can pinpoint the areas of greatest need for services. “We could look at the data and say, here’s who needs us and here’s where we can make the greatest impact upon their
lives,” Rutland says. Using AIDSVu, the collaborative decided where it would locate its telemedicine clinics. (You can view the maps yourself, at aidsvu.org.) But even as technological and logistical challenges were being overcome, Rutland and the collaborative faced another hurdle. The law in Alabama had to be changed. “We had to get the Alabama Board of Medical Examiners to sign off on telemedicine as a viable method of administering care.” Without their approval, Rutland says, telemedicine would not be legally recognized by the state as a form of health care. The sticking point was that the new technology would bring in new doctors— competition for the few physicians already practicing in the areas that would be served by telemedicine. “Once we explained what we were doing, expanding health services, everyone was incredibly receptive,” Rutland says. “They had the power to say no, and instead, they said yes. I think it’s a great testament to their character.” The emergence of telemedicine is bringing more doctors to rural parts of the South. Rutland hopes to become one of those new doctors. Having been a lawyer in San Francisco who came to the South to fight for underserved communities, Rutland has left Medical AIDS Outreach to study medicine and become an HIV specialist. “I hope all my classmates will decide to become HIV specialists in the rural South,” Rutland says. “That would be a great longterm solution to providing health care. Telemedicine is the next best thing for right now.” An extended version of this
story is available at positivelyaware. com/2014/14-04/telemedicine.
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From Global Action to Southern Initiative A drug company funds HIV programs in hard-hit regions By Enid Vázquez
id to Inmate Mothers in Montgomery, Alabama. Jacksonville Area Sexual Minority Youth Network in Florida. Union Mission in Savannah, Georgia. Brotherhood, Incorporated in New Orleans. My Brother’s Keeper in Ridgeland, near Jackson, Mississippi.
These are a few of the organizations in the southern U.S. receiving funding for HIV services through the Southern Initiative of ViiV Healthcare. The drug giants Pfizer and GlaxoSmithKline (GSK) formed ViiV (pronounced veev) in 2009 to take over their HIV drugs and continue HIV drug development. With the new company came GSK’s Positive Action funding program for HIV services and its director, South Carolina native Michael N. Joyner. Positive Action focused on global outreach—in Africa, Asia, Europe, and Latin America—helping community
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projects that work on prevention, stigma, and discrimination and help patients with treatment education and adherence. But then Dr. Manuel Gonçalves, Joyner’s new boss, and ViiV’s Head of Government Affairs, Patient Advocacy, Community Partnerships, Access, and Communications, looked at the HIV statistics in the South and came to the same conclusion that others had: HIV in some of the Southern states rivaled that in countries in sub-Saharan Africa. “We have to re-evaluate our funding, and look at who’s most vulnerable,” he told Joyner.
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And so the Southern Initiative was born, with the help of consultants from such organizations as the National Black Gay Men’s Advocacy Coalition. “We’re looking at the quintessential issue of health inequity, and geographic inequities,” said Joyner. “We’re looking at vulnerable populations such as MSM [men who have sex with men], especially black MSM. “A lot of funding goes to urban areas. Our programs are in small towns, such as the panhandle in northern Florida. Northern Florida is very rural. It’s two different populations, with South Florida having the large cities,” said Joyner. The largest town in the panhandle is Tallahassee, the state capital, with a population of only 180,000. The Positive Action Southern Initiative now reaches vulnerable
S O U TH E R N E X P O S U R E Carol Potok, of Aid to Inmate Mothers (Center, in red shirt and black jacket), with the women of Tutweiler Prison.
populations in 10 states from El Paso, Texas to Newport News, Virginia. The project focuses on smaller grants that help organizations fill gaps in their services, rather than replicate or fund what’s already being done. For example, The Rural Women’s Health Project in Gainesville, Florida historically served African American women, but was able to extend their services to migrant Latino workers. Big Bend Cares, serving eight counties in the primarily rural “big bend” region of Tallahassee, Florida, serves black MSM, but many of those men are in relationships with black women or white MSM, so the group now provides outreach to them as well. AID to Inmate Mothers helps formerly and currently incarcerated women who have children, but the Southern Initiative allows the organization to provide HIVspecific counseling, preventative education, and pre- and post-release connection to medical care. “It allows me to bring people with HIV into the prison, people who have been in prison themselves,” said Executive Director Carol Potok. “We now do both re-entry and supportive counseling, thanks to the grant.” Previously, the organization did not have resources for women outside Tutweiler Prison, but can now reach out to them after they leave, helping them to access
medication and housing, and acclimate to being on the outside. “We’ve been able to do some things that are pretty amazing,” Potok said. Brotherhood, Incorporated helps people access health care and information, as well as housing. The initiative supports the organization’s DollHouse Program serving recently incarcerated HIV-positive African American transgender women. “They really, really understand their clients and the barriers they face,” said Joyner, “and they’re brilliant at understanding how the system works and figuring out how to get around it, not letting limitations get in the way.” The DollHouse program is a perfect example. Mark Johnson, executive director of Brotherhood, Incorporated and his staff had no experience with the transgender population but quickly realized there was a serious problem and wanted to address it. Johnson said his organization had obtained CDC funding for HIV testing and counseling and “once we did that, we really saw the need for additional services. There is a deficit here in services related to transgender individuals, both male-to-female and female-to-male.” Impassioned about serving this group, Johnson struggled to show there was a need for services by fighting for a change in testing forms.
Transgender women were being listed under the category of men who have sex with men, so “we couldn’t demonstrate there was a need.” Getting the form changed took two years. “Since our inception we’ve tried to find the groups with the most pressing need,” said Johnson. “I love to see the impact these programs have on people,” said Joyner. “They are vulnerable politically, religiously—every dynamic you can think of. It really impacts the way individuals live—blacks, undocumented Latinos—everybody. It makes me believe we’re doing the right thing.” Joyner said transportation is a big problem, sometimes due to the need for a specialist, but also because people may not want to get health care locally for fear of having their HIV status outed. Even in Atlanta, he said, some women have to take three buses to get to SisterLove, so transportation can still be an issue in larger areas. Western North Carolina AIDS Project in Asheville serves a huge area and the Southern Initiative funds a telemedicine program whereby doctors can see patients in rural remote areas via computer. “The key to the Southern Initiative is enhancements to already successful programs,” said Joyner.
Photo AND MAP: SOUTHERN AIDS INITIATIVE
Member agencies of the Positive Action Southern Initiative Network
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Making a positive impact: chandler bearden (far right) attends a counselor’s training.
CLEAR the WAY
Chandler Bearden helps Southern gay men navigate their way through risk
hen he was a teenager, Chandler Bearden made the move to Atlanta, Georgia, for reasons many gay men will recognize. He wanted to escape his small southern town and be in a city where he could safely come out. The transition was liberating, but it wasn’t always easy.
“Things got rough for a while in my early 20s,” says Chandler, 35, who now works as a Health and Wellness Counselor for the MISTER Center in Atlanta. Like many working in community HIV/AIDS agencies, Chandler has the kind of empathy that comes from having been there. “When I tested HIV-positive at 23, I was unemployed and occasionally homeless,” he says, without shame or regret, “and during that time HIV treatment just wasn’t a priority. It wasn’t until I navigated out of that that I could deal with it and find the resources I needed.” Remembering his own background is a driving force behind Chandler’s work with the agency. The MISTER Center is one of the newer community outreach programs of Positive Impact, an Atlanta agency that has been 40
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providing mental health services for the last 20 years to those living with HIV. Although Positive Impact offers clinical services like STD testing and treatment, the agency’s focus on the whole patient is very much in evidence. Meditation and yoga classes are both held twice per month, and participation is strong. They’re the kind of services that make sense for an agency that was founded to provide individual and group counseling. Positive Impact has always looked beyond the strictly clinical, making sure that the more emotional and even practical needs of those they serve are being addressed. The CLEAR Coaching program is a good example. The service provides one-on-one sessions of sexual health counseling that
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help men identify areas in their life where they may be putting themselves at risk for infection, or the ways in which HIV-positive men can make choices that improve their health. The coaching is meant to “increase men’s sexual health and sexual fun by increasing self-esteem about who you are, not just as a gay man but as a man,” according to the program description. It’s kind of remarkable that a free program exists that walks gay men through the minefield of sexual risk and negotiation—and that it is tailored to each individual client. “The CLEAR Coaching participants are really into it, once they enroll,” says Chandler. “At first they see it as extra time, and maybe they’re nervous about coming in here in general. But clients who go through it show improved skills and increased decision-making ability.” Potential clients might be apprehensive about the therapy for which Positive Impact is known, but the CLEAR program is something else entirely. “It isn’t about psychotherapy, but about education and awareness,” Chandler says. “The client does all the
PhotoS COURTESY OF CHANDLER BEARDEN
by Mark S. King
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‘It isn’t about psychotherapy, but about education and awareness. The client does all the work, and the counselor helps them navigate the issues they bring up, and how their sexual health can affect their life goals.’ —CHANDLER BEARDEN
work, and the counselor helps them navigate the issues they bring up, and how their sexual health can affect their life goals.” Those issues include many well understood co-factors to HIV risk that are rarely addressed so individually in community programs. Clients who are grappling with dating, who have one failed relationship after another, who struggle with intimacy or even career, can bring all those issues forward to be discussed during their CLEAR sessions. The program also specifically mentions help with “low self-esteem or feelings of self-loathing around your sexual orientation.” For many small town transplants who came to Atlanta to find acceptance (but might have brought along some punishing Bible-belt attitudes), it is comforting to know that the CLEAR program is willing to confront the issue of internalized homophobia. Chandler oversees the outreach activities for MISTER and has played Pied Piper to a growing cadre of volunteers. “My first three years here were about creating a presence in the community for MISTER,” he says, “going to events, doing one-on-one outreach in the bars, and that’s how we created a volunteer force.” Chandler’s own interests have included everything from trapeze lessons to being an active member of the leather community (he was named Mr. Atlanta Eagle in 2010), and those interests are reflected in the MISTER outreach events and a willingness to meet their audience where they are. “We’ve done some fundraising events, like a circus show with leathered rappers and sexy performers,” Chandler says. “We’re not afraid to participate in events at the cruisiest bars in town, and do HIV testing in some of the sex clubs.” MISTER volunteers will regularly conduct testing in a private area of the sex club, while other volunteers will have conversations with customers in the common areas. “I am as honest and respectful of
boundaries as I can be,” Chandler says of his approach to outreach and the kind of chats he has with men in the field. “Our conversations don’t go any further. People recognize that if they’re talking to me, they’re safe. I’m the last person to throw judgment on anybody. I’m going to listen if they need to vent, but I don’t need to respond.” Chandler’s transparency about the challenges he has faced comes in handy, strengthening his credibility with clients and serving as an inspiration. “Anything about my life is fair game,” he says. “My experience with drug and alcohol addiction, dealing with the shame and stigma of my HIV diagnosis, being rejected, attempting to serosort, or just how I was going to manage my life. It took years for me to figure that out, but it doesn’t need to. That’s why I like helping other people navigate through all this. I want to be here to make all that stuff happen for them.” Chandler is about to get his chance to increase his service to other gay men at risk. Beginning this summer, MISTER’s new Health and Wellness Counseling program will begin, and no one is more excited about it than Chandler, who will step into the role of counselor. “This is a holistic approach for newly diagnosed people and high risk negatives,” he explains. “They get a counselor for a year who works with them on overcoming any barriers in life, whatever it is that might keep them from services they need, whether it’s their health or education or their hairdo,” he adds, smiling. Those barriers are real, and Chandler knows it. “If they just got diagnosed with HIV, and they’re working part time as a server somewhere, they might need guidance to improve their situation,” he says of the myriad of practical concerns that can sidetrack long term goals and impede someone dealing with an HIV diagnosis. “Maybe they want to go back to school. We will help them get into GED prep classes, whatever we can do within that year. Or maybe they have a goal of buying a car for
work, but that’s interrupted by the costs of their diagnosis. Positive Impact has the clinical stuff, which is the core of our services, but this program is beyond that.” Having worked so hard to make MISTER a visible and active presence in the community must be exhausting, and with burnout such a common occurrence in service agencies, it’s surprising Chandler has kept up the pace for nearly four years on the job. But he knows his limitations and the importance of taking care of himself. “I love the work I do,” he says. “But there’s also an old Hindu proverb, ‘you have to drink as you pour.’ It means you can’t continue to give if you don’t take for yourself or you’re going to be empty.” Caring for himself so that he has the resources to help other people is clearly important to Chandler, and it all comes back to remembering his own journey. “It felt scary. There were people along the way who didn’t feel present or involved,” he says of that time and of the people who were unequipped to help him. “I thought there was so much work left up to me. In those times I was trying to get my life together, there was all this stuff I didn’t know I was supposed to be doing.” Chandler takes a thoughtful pause. “Then there were people who were really good, who helped me so much,” he says. “I want to be that good person.” Mark S. King chronicles his life as an HIV-positive gay man for his blog, MyFabulousDisease.com.
MISTER Center: mistercenter.org Positive Impact: positiveimpact-atl.org For more about when Chandler won Mr. Atlanta Eagle: marksking.com/my-fabulousdisease/mr-atlanta-eagle-talksleather-crystal-meth-and-hiv
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Riding Toward your Tr The Ride for AIDS Chicago is a journey to personal truth by Rob Campbell
leaned on my right leg, weary from riding 200 miles. Sweat now dried into salty patches on my limbs. In 48 hours my black Lycra cycle shorts and riding jersey had transformed from freshly laundered clothing that showed off my physique to damp, stinky fabric that clung to my body unforgivingly. The exhaustion that welled up from within exacerbated my already fragile emotional state.
The crowd’s enthusiastic cheering from the riders’ procession into the park had quieted, replaced by the humility that 300 riders had carried over the Illinois and Wisconsin topography. Pockets of friends, family, and partners gathered in solidarity for those who had tackled the two-day journey. Supporters understood the riders’ cause. The riders understood the pain. I only understood shame. During that 2012 Ride for AIDS Chicago closing ceremony I stood with friends and watched as the rider-less bicycle proceeded from the back of the park. Tears marked the faces of those who walked with it: the
HIV-positive individuals who rode annually to raise money and awareness. They were “out.” They were vocal. They were strong. I was weak. The procession silently moved to the stage as a voice explained that the bike represented those who had passed from HIV/AIDS. Underlying messages emphasized the importance of awareness, of minimizing shame, and of making it okay for HIV-positive individuals to be comfortable with and openly public about their status. Those messages were speaking to me. I was mindful that I’d kept this secret for too long. My resentment towards the
What is The Ride?
he Ride for AIDS Chicago is the annual two-day, 200-mile bicycling event produced by Test Positive Aware Network (TPAN), the oldest peer-led HIV/ AIDS services organization in Chicago and publisher of Positively Aware. The event enables TPAN and other HIV/AIDS organizations in Chicago to raise money to support their programs and services. Ride for AIDS Chicago is committed to returning 100% of pledges made to benefiting organizations. In the 11 years since the Ride began, more than $2 million has been raised. This year’s Ride for AIDS Chicago takes place the weekend of July 12–13. Riders and volunteers journey from Evanston, Illinois (a suburb north of Chicago) to Elkhorn, Wisconsin and back over two days. The route consists of shaded bike paths and country roads, and includes a number of pit stops with volunteer helpers along the way. Besides raising money, the Ride is an anti-stigma campaign. Stigma—stemming from shame, fear, or a basic lack of understanding about HIV, and more—is a major reason why people fail to get tested or get into lifesaving care and treatment. Events like Ride for AIDS Chicago help to decrease HIV stigma by humanizing those who are living with HIV (many riders are HIV-positive) and increasing the dialogue about HIV/AIDS within the broader community. People living with HIV are helped to feel less shame and are inspired to engage in the care needed to improve their health and quality of life, and those who may not know their HIV status may gain the courage to get tested. To participate or support the 2014 Ride for AIDS Chicago, go to rideforaids.org.
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gay community lingered, brought on by alienation and use of the label “clean” to describe those who are HIV-negative, suggesting those who are HIV-positive weren’t “clean,” as if we carried leprosy or the plague. Coming out was hard enough the first time 20 years ago, but to also have to break through a nearly impenetrable barrier of rejection was disheartening. I had no motivation to publicly share my status if I was to be considered undesirable. As the ceremony closed a friend congratulated me for completing my third Ride. “What a milestone and accomplishment,” he said. I appreciated his sentiment, but I felt like a fraud. Once again, I had successfully deceived more than just myself. As memories of that weekend faded, work and life took over. Responsibilities of a commute and career—and the perseverance to survive another year—overshadowed the shame that previously marked my consciousness. One year later, I half-heartedly registered for the 2013 Ride, conscious that my passion for this event had subsided. Rather than training, I spent time nursing an arthritic knee. I feared that the lingering soreness, which occasionally turned to pain under physical stress, would hold me back. The mental preparation to persevere kept at bay the emotions from the previous year’s closing ceremony that had faded away. A few weeks later, I suggested to my sister that the opening ceremonies were just a formality. Having known of my status since day one, she volunteered to provide road support to riders. We stood and listened to welcoming remarks as the sun rose above the park department building. A peaceful buzz hovered overhead as riders’ smiles beamed with excitement. The keynote speaker passionately delivered his own off-the-cuff story of having lived in shame of his HIV status. His ongoing commitment to raise awareness, remove stigma, and educate the masses was palpable. Once again the rider-less bicycle appeared with a parade of survivors who followed. Orange bandanas, symbolic
Photo COURTESY OF ROB CAMPBELL
uth of their individual and collective struggles with the disease, were tied around their appendages, standing out as a single burst of color, banding them together like brothers. They walked two by two and, as I watched them, my shame returned. As I rode out of the city, arthritic throbs kicked in and I doubted if I would finish. Flashes of the previous year’s closing ceremonies reminded me: “Those who stand with the rider-less bicycle are likely the strongest riders,” remarked the speaker, as he gestured to those who walked with the bike that day. “This disease will not stop them. They trained harder, rode faster, and likely kicked your ass,” he commented, in reference to the hundreds of other riders in the crowd. “It was personal for them.” Although the truth of the statement resonated in my heart, my mind was not easily convinced. Over the next 75 miles, I fought logic which stood firm in the belief that, sometimes, shame is best kept silent. “Fuck this” and “fuck that” bubbled up, opposing rationales for disclosing my status: fear of parental reaction; condemnation from my fellow gays; personal freedom from shame. Six hours later as I rode into camp the physical pain had subsided, but the inner struggle continued. I began to question if I could honestly return to another closing ceremony. I lingered in the picnic shelter and watched other riders finish the day. As I turned to leave that morning’s speaker was a short distance away. I panicked, briefly hesitated, and after giving it a second thought, I approached him and volunteered to wear an orange bandana. As a friend who knew my status, he jumped out of his seat and hugged me, proud of my decision. While there were no bandanas left, he offered me the one he wore on his wrist. “Take it and wear it with pride,” he said. >> FREEDOM RIDERS: Rob Campbell (center) flanked by Andrew Boyer and Maggie Bahler, taking a break during last year’s Ride for AIDS Chicago.
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>> That evening, I wrestled with the significance of the identifying fabric. Selfconsciousness overtook my short-lived confidence. In my mind, every greeting offered and every glance directed at me was accompanied by judgment. Only after I wore it for a few hours—and relocated it on my body numerous times—did I relax enough to sleep. Eight hours later my right wrist beamed bright orange when I rode out of camp. The calm Wisconsin countryside provided a scenic backdrop, but the reputation of its hills preceded them since all former riders knew of one, in particular, that was a bitch to finish. Just 20 miles into the day its double crest was long and steep. It took time to ride, forcing some to walk up it. Meanwhile, the status symbol on my body fueled insecurities as the decision to reveal my status grew into a mind fuck. I rode solo, psyching myself up with affirmations of my abilities. In between motivational cues, I looked down to breathe deeply yet out of the corner of my eye, tied to my wrist, the orange marker greeted me, a visible reminder of my non-verbal, but very public statement. Within a few hundred yards of the hill’s base, I knew I had come too far to go back. “Fuck!” I yelled. My voice echoed in the field. “Fuck this shit!”
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My speed slowed as if my bike was pulling in the opposite direction. Despite my breathlessness, I yelled more obscenities with reassurances: “I will live strong.” “I will find someone who loves me despite this disease.” “I will be free.” As I finished the hill’s first crest, relief lifted me. In the valley between the previous and the second hill, I set my bike down and approached my sister who had been cheering for the riders. “What’s wrong?” she asked with a concerned look on her face. “Nothing,” I said. “I just need a hug.” She gave me a long, intense embrace that enveloped my body. “Thank you,” I said. “Are you okay?” “Yes. I’ll be fine.” I returned to my bike and rode in peace throughout the afternoon at near personal top speeds. The burden of the last 16 hours had been all but shaken off, left in the sand on the side of the road. I completed the second day to applause from those who finished before me. The orange bandana, now a permanent piece of my emotional being, was still tied to my right wrist. I was aware that, if anyone asked about it, I would have to claim my true identity. Under a tree, surrounded by bicycles, I
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double-dosed on therapy for the day: ice for my knee and answers to the question in my mind: would I walk with the rider-less bike procession to solidify my ‘coming out’? There would be no turning back. The emotion of the experience can never be fully comprehended until you’ve stood in line. There, we prepared to walk, side by side, a common denominator displayed on every comrade’s body. Up front, the crowd’s energy seemed miles away as silence among our small group embraced the acknowledgement of our purpose. With each breath, my heart rate increased and within moments it felt like my heart would beat out of my chest. As we began to walk down the carpet of grass, red ribbons on each side welcomed us as if we were royalty. Then, I took that orange bandana off my wrist and moved it to my forehead, a location that, whether others looked for it or not, was an obvious indication. In a world of continuous judgment it was in this one symbolic gesture that I finally claimed and owned an identifiable aspect of who I am. Not self-defined. Just a simple acknowledgement that, yes, I too survived. Rob Campbell is a Chicago-based communications consultant and creative writer. His blog is at thecampbellchronicles.com.
My kind of life
Carlos A. Perez
Can we finally call it safe sex?
Photo: CHRIS KNIGHT
’ll be turning 55 this November with 35 of those years experiencing life with HIV and AIDS. I have experienced my share of HIV-induced drama and trauma with a little dash of denial here and there. And after 18 years in a loving and committed, serodiscordant relationship, soon to be a legal marriage in Illinois, I thought I had all this sexy HIV stuff figured out, and then came PrEP.
PrEP (pre-exposure prophylaxis) has been proven to be effective in protecting HIV-negative people who have sex with a partner who is HIV-positive or of unknown status and want that extra sense of security in case something goes wrong with the condom during sex or they may simply want to feel sex without a condom, that once dreaded term: bareback sex. Once PrEP begins, the HIV-negative person takes Truvada once a day and that’s it—a very easy and simple way for a serodiscordant couple to stay healthy without any HIV transmission. The idea of PrEP is nothing new. We’ve been using vaccinations, like the flu shot, or malaria medications in countries where it’s common, to stop the infection process. PrEP prescriptions are now often covered by health insurance, though be sure to check with your insurance company. Truvada is the brand name of the only FDA approved PrEP and is comprised of Viread and Emtriva. It’s manufactured by Gilead Sciences, which must be giddy since it’s one of the most successful treatments for HIV currently available and now, with its approval to be used as PrEP, it has been called the wonder pill. When I first heard about PrEP, my reaction was to think of the selfish, tactile, sensory overload of bareback sex—then reality hit. I remember when the HIV cocktail became available and many people experienced better HIV health by having their viral loads (VL) reduced to undetectable levels. I also remember attending a presentation where a well-known HIV specialist mentioned condomless sex, meaning that if someone’s VL was undetectable they could, in theory, have sex without a condom and reduce their worry of transmitting the virus. His caveat was that we should still use condoms whenever possible, but when life and sex happens and we’re not prepared, it’s nice to know the VL is undetectable. Now, even if I had a month’s worth of Truvada on hand and an undetectable VL, I still couldn’t have sex without a condom because the reality is that since I experienced the early years of HIV fears and madness, I would feel too guilty and uncomfortable and those two words are not sexy ones to take into the bedroom. However, I think if I were single, footloose, and fancy free, I would be very happy to know that PrEP is
available and that I could speak with my partner about it and we could decide together if we wanted to use PrEP as an option for safer sex protection. My partner and I began dating in April of 1996, and I remember telling him that I was HIV-positive in May. I was prepared for him to run in the other direction, but he didn’t. Instead, he thanked me for my honesty. He then told me about a few previous sexual partners who were positive but had lied or skirted around the truth, and one of these later died of AIDS, which, as you can imagine, was a little stressful for him. I guess after you have this scary scenario happen to you, you either never want to have anything to do with a positive person or you’re grateful when one is honest and shares his status. We were a serodiscordant couple dating in 1996 and 14 years later, my partner is still negative. We have also had our share of condoms breaking and a few moments of sheer abandon that, while feeling ecstatic, left me wondering and worrying, what if I infected him? This is the guilt and fear that PrEP can help conquer. Although we’re both happy to see PrEP is out there, we’re so used to things as they’ve been for so long that we feel introducing PrEP into our relationship this far into our years is not necessary. If we were having condomless sex today or if a condom broke, I would definitely take my partner to a doctor for PEP (post-exposure prophylaxis) and we would both be elated that it’s available. What our statuses tell me is that I have empirical evidence that when people disclose their status, it’s actually safer in the long run because the little secret is out of the closet. Recently at the CROI meeting, the PARTNER study showed that after following serodiscordant partners for two years of having condomless sex, when the HIVpositive partner had a VL of under 200 copies there were zero transmissions. (See more about the PARTNER study on page 18.) This is pretty exciting and indicates that when people disclose they stay healthier. When people keep HIV a secret then, as the saying goes, they and their partners stay as sick as their secrets. Blending an undetectable VL with PrEP makes me want to say that this may finally be safe sex after many years of “safer” sex. P OS ITIV ELY AWA R E
Blending an undetectable viral load with PrEP makes me want to say that this may finally be safe sex after many years of ‘safer’ sex.
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I am a husband, an Olympic gold medalist, and an actor. And I am living with HIV. TM
Greg Louganis (left) has lived with HIV since 1988.
Get the facts. Get tested. Get involved. www.cdc.gov/ActAgainstAIDS
The South is the region hardest hit by HIV in the U.S., but it's not without its beacons of hope. A look at efforts to counter poverty, igno...