POSITIVELY AWARE J U LY+AU G U S T 2 0 1 3
HIGH RISK?
Some of the groups that are most vulnerable to HIV— and how to keep them safe
A NEW FACE ‘A Day with HIV’ leads to a new outlook
SPECIAL SECTION
HEP C MEDS
Ingredients for a cure
ABOUT PREZISTA
®
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.
28PRZDTC0288R8
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.
ily
Once-Da
PREZISTA ^ EXPERIENCE
Discover the
®
Once-Daily PREZISTA® (darunavir) isn’t just an HIV treatment. It’s an HIV treatment experience as unique as you. That’s why you should ask your healthcare professional if the PREZISTA® Experience is right for you. Once-Daily PREZISTA® taken with ritonavir and in combination with other HIV medications can help lower your viral load and keep your HIV under control over the long term. In a clinical study* of almost 4 years (192 weeks), 7 out of 10 adults who had never taken HIV medications before maintained undetectable† viral loads with PREZISTA® plus ritonavir and Truvada.® Ask your healthcare professional about the PREZISTA® Experience. And be sure to visit DiscoverPREZISTA.com for tools and helpful information to find out if the PREZISTA® Experience might be right for you.
Please read the Important Safety Information and Patient Information on adjacent pages.
Snap a quick pic of our logo to show your doctor and get the conversation started. *A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346). †Undetectable was defined as a viral load of less than 50 copies per mL. Registered trademarks are the property of their respective owners.
Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2013 02/13 K28PRZ121037
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. Manufactured by: PREZISTA Oral Suspension PREZISTA Tablets Janssen Pharmaceutica, N.V. Janssen Ortho LLC, Beerse, Belgium Gurabo, PR 00778 Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 Revised: April 2013 NORVIR® is a registered trademark of its respective owner. PREZISTA® is a registered trademark of Janssen Pharmaceuticals © Janssen Pharmaceuticals, Inc. 2006 991772P
t
e
n
t
h
a
n
n
i
v
e
r
sa
r
y
RIDE FOR AIDS Chicago
POSITIVELY AWARE
PROD U C ED BY
JOURNALISM. INTEGRITY. HOPE.
e d itor - in - C hie f
Jeff Berry
associate e d itor Enid
Vázquez
copy E d itor
Sue Saltmarsh
proo frea d er
Jason Lancaster
We b M aster
Joshua Thorne
C reative d irector
Rick Guasco
Keith R. Green Liz Highleyman Sal Iacopelli Laura Jones Jim Pickett Matt Sharp contri b uting writers
Chris Knight Joshua Thorne
photographers
Join us for the ride of our lives. JULY 13–14.
M e d ical a dvisors
Daniel S. Berger, MD Gary Bucher, MD Joel Gallant, MD Swarup Mehta, PharmD
T itl e S p o n s o r a dvertising in q uiries
Lorraine Hayes l.hayes@tpan.com
event sponsors S u b scription services
Ian Ponsetto distribution@tpan.com
POSITIVELY AWARE C lo si n g c e r e m o n i e s s p o n s o r
www.rideforaids.org 4
J u ly+Au g u s t 2 013
P OS ITIV E LY AWA R E
IS PUBLISHED BY
5537 N. Broadway St. Chicago, IL 60640 phone: (773) 989–9400 fax : (773) 989–9494 email : inbox@tpan.com www.positivelyaware.com
JULY+AUGUST 2013 V OLU M E 2 5
Departments
6 In Box and
Readers Poll
7 editor’s Note
The struggle to be authentic.
12 Briefly
Non-daily PrEP studied. HIV in semen. Tenofovir gel for rectal use. New HCV drugs speeding toward approval. Website links people to HIV studies.
49 WHOLISTIC PICTURE
NUMBER 4
Features
17 The right to be healthy as who you are
A global transgender rights movement is on the horizon.
by Cecilia Chung
21 On HIV, black gay men, and the path forward
Younger men are extremely vulnerable to infection.
by Charles Stephens
24 Risky business
Sex workers are threatened by laws and policies that add to their risk of HIV.
by enid Vázquez
The other side of disclosure.
32 Sticking it to HIV
Funding needle exchange programs would save lives and money.
by Sue Saltmarsh
S pecial section
35 HEP C MEDS:
Ingredients for a cure
47 A new face
A look at the new and better therapies coming to your pharmacy soon.
Taking a picture for A Day with HIV leads to a new outlook.
by RIck Guasco
by Brett Grodeck
O nline e x tras
Profiles—Views from the inside Drug users talk about TPAN’s needle exchange program. By Sue Saltmarsh
On the cover and this page Photography by Chris Knight Cover model: Tessa THOMPSON MODEL THIS PAGE: DANTé alexander
positivelyaware.com/2013/13-04/ profiles.shtml
More from CROI HIV-positive straight men—no longer alone. Plus, positive men preparing for babies. By ENid Vázquez
positivelyaware.com/2013/13-04/ croi.shtml
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
5
I N B OX
|
R eaders po l l
inbox@tpan.com + @posaware
In the MAY+JUNE issue, we asked
Condomonium! As a patient at Callen-Lorde in NYC,
I’m privileged to read your wonderful magazine every new issue and always learn much from it, as I’m sure many others do, which is why I’m writing. There are problems with your website and a recent article and this is detrimental to your mission. I was alarmed to see in your recent article, Better Safer than Sorry [by Sue Saltmarsh, May+June issue], that the author parenthetically cites using sheepskin condoms as “safer,” when it is known that HIV can pass through natural membrane. The author goes on further to only cite petroleum-based products as potentially damaging to condoms generically, instead of specifically saying that any latex-based barrier is dangerously weakened by ALL oil-based products, natural or synthetic. Lastly, mentioning rimming under “safest” practices seems irresponsible, despite the explanatory paragraph that follows. It’s certainly not impossible to transmit HIV through rectal/oral pathways. Basically what I am saying is that, while the article is sincere in its efforts to put across safer sex information in an easily-digestible manner, readers could sadly misinterpret this information. As a respected journal and wonderful voice in this community, it’s your responsibility to make sure that this essential information is disseminated accurately. I’m sure this was an oversight, but I wanted to make sure this was brought to your attention. —Jeremiah Sue Saltmarsh responds: Thank you, Jeremiah, for taking the time to write. As you point out, condoms made of natural membrane, as in sheepskin condoms, are porous and have been shown in
Do you talk about HIV status with potential sex partners?
laboratory studies to allow viruses like HIV and hepatitis C through, and I didn’t mean to imply that they were safe. We’re sorry for the misunderstanding. You’re right about the use of oil-based lubricants of any kind damaging latex condoms. It’s important to make sure your lube is water- or silicone-based if your condoms are latex (oils are safe for polyurethane) and when shopping for lube, to read the label to see if it is compatible with your condom of choice. We apologize for the omission. Lastly, according to research and consultation with HIV specialists, there have been no documented cases of HIV being transmitted through rimming. We hope you continue to read and enjoy Positively Aware and don’t hesitate to let us know if you ever have other concerns!
Please add me to your mailing list. I am a peer educator in the PACE (Prisoners’ AIDS Counseling & Education) Program in New York state. With recent budget cuts, the NY DOC has lost interest in funding educational resource materials, despite such materials being a bargain compared to the later bill for health care, as HIV/AIDS rates grow in the prison population. Another contributing factor is that prisoners coming in these days are no longer afraid of “the monster.” Better drug regimens becoming available have led people at high risk to believe that HIV/AIDS is “no big deal”—until they find out they’re positive and are standing in line for meds, fighting docs for adequate care. Thank you for helping me educate them about the realities of HIV. —Garry
Never Rarely
6%
4%
Sometimes 16%
Yes
74%
Your comments: “Not only is it the right thing to do morally, it is also the right thing to do legally. However, I really only feel at ease with a partner that is also poz as there is a mutual understanding of what one has to deal with on a daily basis.” “Absolutely. If you can’t talk about your HIV status with someone, you shouldn’t be having sex with them.” “I’m still learning how to disclose it without them running like I just pulled a knife out.” “I was lied to—why would any person put another through that? Letting the other person make the choice just makes things easier.” “I always bring up the issue of testing, and when my partner got their last HIV test. It is 2013—it is irresponsible not to!”
Dannemora, NY
“Only if we have unprotected sex..” C o n n ect to P o s i t i v e ly Awa r e this issue’s poll question:
positivelyaware.com
/PositivelyAware
@PosAware
inbox@tpan.com
All communications (letters, email, 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, 5537 N. Broadway St., Chicago, IL 60640. 6
J u ly+Au g u s t 2 013
P OS ITIV E LY AWA R E
Do you think decriminalizing prostitution would reduce new HIV infections? cast your vote at
positivelyaware.com
E ditor ’ s not e
|
Jeff Berry @PAEditor
The struggle to be authentic
I
Photo: Chris Knight
have recently come to the realization that my struggle for authenticity is going to be a life-long journey. I feel as though there have been two “me’s” for as long as I can remember. There is the person inside myself with all of my hopes, fears, doubts, and dreams. Then there is the persona that I outwardly project to the rest of the world, whose behavior is “acceptable,” who fits the “norms,” while still reflecting bits and pieces of the “me” inside. As I have gotten older, I’ve grown more comfortable with merging these two personas, but I never seem to get to the point where I feel I can be completely authentic, inside and out. And as the clock ticks and time passes, the urgency to get to that point seems to increase exponentially. I know that a lot of that dichotomy, if not all of it, is deeply rooted in being sexually abused as a child by my father, and the shame that grew out of that. Shame that soon became a pattern that I would continue to repeat over and over again through drug abuse, promiscuity, infidelity, and broken promises. Secrets that grew out of the one Big Secret, driving the shame, the cycle, year after year, with no seeming way out. Ultimately, I ended up contracting HIV because of the risks that I continued to take and my “chosen” behaviors, that seemed to be out of my control and impossible to change. The sex and the drugs became a way to selfmedicate and numb the shame and feelings of worthlessness and insecurity, if only fleetingly. Of course, those behaviors only led to more shame, which then required more self-medication, and, well, you get the picture. In this issue we look at some of the communities that are at increased risk for HIV—including transgender individuals, young black gay men, sex workers (including youth), and injection drug users—and what can be done on an advocacy and policy level to try to create change and reduce new infections. One of my co-workers prefers to use the phrase “especially vulnerable” communities instead of “at-risk” or “high-risk,” because, as she puts it, no one thinks that they are at risk. A member of our A Day with HIV in America Facebook group said it best in response to a comment from another member who was expressing frustration at the continued rate of new infections, and how we are missing the mark when it comes to HIV/AIDS education and prevention.
“Education is only part of the solution. People generally know condoms work, etc. [But] we [must] also make inroads into de-stigmatizing addiction and sex work, increasing access to treatment rather than criminalizing drug use, improving equity in access to care and economic justice, [ending] homelessness, beginning to bring a compassionate understanding to trans and gender non-conforming lives and a myriad of other ways our mainstream culture, and even the mainstream lesbian and gay culture, communicate who is valued and who is disposable. [Until we do,] knowing how to use a condom, latex barrier, or needle exchange won’t increase the likelihood that a person on the margins will find it in themselves to care to protect themselves or even have the power of choice to choose to protect themselves. Lord knows I wouldn’t have HIV if I had been helped in my 20s to feel loved, valued, and given access to the care that would have healed my body and soul.”
Until we are able to put a voice to those things within ourselves and in our own communities that perpetuate shame and stigma, we will always be one step behind and trying to play catch-up.
So there you have it. Until we are able to put a voice to those things within ourselves and in our own communities that perpetuate shame and stigma, we will always be one step behind and trying to play catch-up. Until we are able to come from a place of authenticity, we can never fully address the blame, judgment, and stigma that drive and fuel this epidemic. So my struggle to be authentic continues, day to day, week to week, year after year. Some days are better than others, but each day is a gift, an opportunity to give myself the ability to trust that whatever deep, dark secret lies buried deep within, when finally laid bare for all to see, it will only help to dissolve once and for all the shame and stigma that never really existed in the first place—other than in the power I (unwittingly) chose to give it. It will end when I choose to give myself power over it. Be good to yourself and each other.
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
7
The
one
for me
Patient model. Pill shown is not actual size.
What is COMPLERA? COMPLERA is a prescription HIV medicine that is used as a complete regimen to treat HIV-1 in adults who have never taken HIV medicines before and who have an amount of HIV in their blood (this is called “viral load”) that is no more than 100,000 copies/mL. COMPLERA contains 3 medicines – rilpivirine, emtricitabine and tenofovir disoproxil fumarate. 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. Avoid doing things that can spread 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, do not share personal items that may contain bodily fluids. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others.
IMPORTANT SAFETY INFORMATION What is the most important information you 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 have ever taken other anti-HIV medicines. COMPLERA may change the effect of other medicines and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses. Do not take COMPLERA if you also take these medicines: • anti-seizure medicines: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek) • anti-tuberculosis medicines: rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin) and rifapentine (Priftin) • proton pump inhibitors for stomach or intestinal problems: esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), dexlansoprazole (Dexilant), omeprazole (Prilosec), pantoprazole sodium (Protonix), rabeprazole (Aciphex) • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate • St. John’s wort (Hypericum perforatum) If you are taking COMPLERA you should not take other HIV medicines or other medicines containing tenofovir (Viread, Truvada, Stribild or Atripla); other medicines containing emtricitabine or lamivudine (Emtriva, Combivir, Epivir, Epivir-HBV, Epzicom, Trizivir, Atripla, Stribild or Truvada); rilpivirine (Edurant) or adefovir (Hepsera). In addition, tell your healthcare provider if you are taking the following medications because they may interfere with how COMPLERA works and may cause side effects: • certain antacid medicines containing aluminum, magnesium hydroxide, or calcium carbonate (examples: Rolaids, TUMS). These medicines must be taken at least 2 hours before or 4 hours after COMPLERA. • medicines to block stomach acid including cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine HCL (Zantac). These medicines must be taken at least 12 hours before or 4 hours after COMPLERA. • any of these medicines: clarithromycin (Biaxin); erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral) methadone (Dolophine); posaconazole (Noxifil), telithromycin (Ketek) or voriconazole (Vfend). • medicines that are eliminated by the kidneys like acyclovir (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), valacyclovir (Valtrex) and valganciclovir (Valcyte).
COMPLERA.
A complete HIV treatment in only 1 pill a day. COMPLERA is for adults who have never taken HIV-1 medicines before and have no more than 100,000 copies/mL of virus in their blood.
Ask your healthcare provider if it’s the one for you.
These are not all the medicines that may cause problems if you take COMPLERA. Tell your healthcare provider about all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.
The most common side effects reported with COMPLERA are trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression. Some side effects also reported include vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles) and pain.
Before taking COMPLERA, tell your healthcare provider if you: • Have liver problems, including hepatitis B or C virus infection, or have abnormal liver tests • Have kidney problems • Have ever had a mental health problem • Have bone problems • Are pregnant or planning to become pregnant. It is not known if COMPLERA can harm your unborn child • Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, COMPLERA may pass through breast milk and could cause harm to the baby
This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking COMPLERA, and call your healthcare provider for medical advice about side effects.
COMPLERA can cause additional serious side effects: • New or worsening kidney problems, including kidney failure. If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider may need to do regular blood tests. • 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 need 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 additional tests to check your bones. • Changes in body fat can happen in people taking HIV medicine. • Changes in your immune system. 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 new symptoms after starting COMPLERA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. Additional Information about taking COMPLERA:
• Always take COMPLERA exactly as your healthcare provider tells you to take it. • Take COMPLERA with a meal. Taking COMPLERA with a meal is important to help
get the right amount of medicine in your body. (A protein drink does not replace a meal).
Stay under the care of your healthcare provider during treatment with COMPLERA and see your healthcare provider regularly. Please see Brief Summary of full Prescribing Information with important warnings on the following pages.
Learn more at www.COMPLERA.com
Patient Information
•
COMPLERA (kom-PLEH-rah) (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) 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 HIV (Human Immunodeficiency Virus) medicine that is used to treat HIV-1 in adults – who have never taken HIV medicines before, and – who have an amount of HIV in their blood (this is called ‘viral load’) that is no more than 100,000 copies/mL. Your healthcare provider will measure your viral load.
(HIV is the virus that causes AIDS (Acquired Immunodeficiency Syndrome)). •
COMPLERA contains 3 medicines – rilpivirine, emtricitabine, tenofovir disoproxil fumarate – combined in one tablet. It is a complete regimen to treat HIV-1 infection and should not be used with other HIV medicines.
•
It is not known if COMPLERA is safe and effective in children under the age of 18 years old.
•
COMPLERA does not cure HIV infection or AIDS. You must stay on continuous therapy to control HIV infection and decrease HIV-related illnesses.
•
Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people. Do not share or re-use needles or other injection equipment, and do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal fluids or blood.
Who should not take COMPLERA? Do not take COMPLERA if: • your HIV infection has been previously treated with HIV medicines. •
you are taking any of the following medicines: – anti-seizure medicines: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine (Trileptal); phenobarbital (Luminal); phenytoin (Dilantin, Dilantin-125, Phenytek) – anti-tuberculosis (anti-TB) medicines: rifabutin (Mycobutin); rifampin (Rifater, Rifamate, Rimactane, Rifadin); rifapentine (Priftin) – proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems: esomeprazole (Nexium, Vimovo); lansoprazole (Prevacid); dexlansoprazole (Dexilant); omeprazole (Prilosec, Zegerid); pantoprazole sodium (Protonix); rabeprazole (Aciphex) – more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate – St. John’s wort (Hypericum perforatum)
•
If you take COMPLERA, you should not take: – Other medicines that contain tenofovir (Atripla, Stribild, Truvada, Viread)
What is the most important information I should know about COMPLERA? COMPLERA can cause serious side effects, including: • Build-up of lactic 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 – have stomach pain with nausea (feeling sick to your stomach) or vomiting – feel cold, especially in your arms and legs
– Other medicines that contain emtricitabine or lamivudine (Combivir, Emtriva, Epivir or Epivir-HBV, Epzicom, Trizivir, Atripla, Truvada, Stribild) – rilpivirine (Edurant) – adefovir (Hepsera) What should I tell my healthcare provider before taking COMPLERA? Before you take COMPLERA, tell your healthcare provider if you: • have or had liver problems, including hepatitis B or C virus infection, kidney problems, mental health problem or bone problems •
– feel dizzy or lightheaded 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)
are breast-feeding or plan to breast-feed. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. Do not breastfeed if you are taking COMPLERA. At least two of the medicines contained in COMPLERA can be passed to your baby in your breast milk. We do not know whether this could harm your baby. Talk to your healthcare provider about the best way to feed your baby.
– loss of appetite for several days or longer
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
– nausea
•
– stomach pain •
are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child. Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
– have a fast or irregular heartbeat •
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 let your COMPLERA run out. 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.
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.
COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects. 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 infection. The HIV virus in your body may become resistant to COMPLERA or other HIV medicines that are like it.
Especially tell your healthcare provider if you take: • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. If you take an antacid during treatment with COMPLERA, take the antacid at least 2 hours before or at least 4 hours after you take COMPLERA. •
•
a medicine to block the acid in your stomach, including cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine hydrochloride (Zantac). If you take one of these medicines during treatment with COMPLERA, take the acid blocker at least 12 hours before or at least 4 hours after you take COMPLERA. any of these medicines (if taken by mouth or injection): – clarithromycin (Biaxin) – erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone) – fluconazole (Diflucan)
•
trouble sleeping (insomnia)
•
abnormal dreams
•
headache
•
dizziness
•
diarrhea
•
nausea
•
rash
•
tiredness
•
depression
Additional common side effects include: •
– itraconazole (Sporanox)
vomiting
•
– ketoconazole (Nizoral)
stomach pain or discomfort
•
– methadone (Dolophine)
skin discoloration (small spots or freckles)
•
pain
– posaconazole (Noxafil) – telithromycin (Ketek) – voriconazole (Vfend) •
The most common side effects of COMPLERA include:
medicines that are eliminated by the kidney, including acyclovir (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), valacyclovir (Valtrex), and valganciclovir (Valcyte)
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 or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).
What are the possible side effects of COMPLERA?
How should I take COMPLERA?
COMPLERA can cause serious side effects, including: • See “What is the most important information I should know about 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 a meal. Taking COMPLERA with a meal is important to help get the right amount of medicine in your body. A protein drink does not replace a meal.
•
Do not change your dose or stop taking COMPLERA without first talking with your healthcare provider. See your healthcare provider regularly while taking COMPLERA.
•
If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take your dose of COMPLERA with a meal as soon as possible. Then, take your next dose of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by more than 12 hours of the time you usually take it, wait and then take the next dose of COMPLERA at the regularly scheduled time.
•
Do not take more than your prescribed dose to make up for a missed dose.
•
•
New or worse kidney problems, including kidney failure, can happen in some people who take COMPLERA. Your healthcare provider should do blood tests to check your kidneys before starting treatment with 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 additional tests to check your bones.
•
Changes in body fat can happen in people taking HIV 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 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 new symptoms after starting your HIV medicine.
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: January 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. ©2013 Gilead Sciences, Inc. All rights reserved. CPAC0014 03/13
Briefly Enid Vázquez @ENIDVAZQUEZPA
Oa danyECaPin hElllP
PROtECt yOU FROM hiV
(ACTUAL SIZE)
WhO is PrEP FOR? What is PrEP? of PrEP is a new way It uses preventing HIV. , an HIV drug, Truvada person to help keep a ative who is HIV-neg ng from becomi they are infected when virus. exposed to the drugs are Although other for being tested, Truvada y the only PrEP is currentl d by the form of PrEP approve tration Adminis Drug and U.S. Food stands for (FDA). “PrEP” laxis. Pre-Exposure Prophy prevention. Prophylaxis means before you test HIV-negative You must first for PrEP. tion for Truvada can get a prescrip done to check have blood work You must also
your general health. counseling. receive safer sex You should also in combination ended to be used PrEP is recomm as using ion practices such with other prevent r to lessen g some behavio condoms and changin n. the risk of infectio to take is required. Failing Taking PrEP daily es your risk of every day increas ate levels Truvada for PrEP as a result of inadequ becoming infected blood. of the drug in your tested for includes being ly correct to Taking PrEP with blood tests months, along . HIV every three normal are ns body functio make sure your easy is known for being Although Truvada e every day may to take, using medicin people everyone. Some not be easy for e every day, to take medicin may find it difficult tolerable it is. no matter how
— lly useful in periods people e. It may be especia Unfortunately, many is at PrEP is not for everyon f high-risk activity. cted sex months or years—o at risk. Anyone having unprote ed with are don’t realize they risk has been associat rate of r, an increased high area that has a risk for HIV. Howeve activity within an networks with engaging in sexual cities) or in social large l some as bisexua as black gay, HIV infection (such infection rate (such rished a higher than average sex with men who live in impove with inhave along or other men who to health care), exchange of don’t have access e of other STDs; communities and condom use; presenc sleep or live; use of alcoto consistent or no place a or of unknown food, drugs sex for money, having a partner incarceration; or hol or illicit drugs; factors listed above. with any of the HIV status, along
Are you Sure you’re
HIV-NegAtIVe?
as long (and in some cases to eight weeks a test. During It can take two to show up on months) for HIV as three to six w”), you may test (called the “windo with HIV. this period of time actually infected though you are testing for HIV-negative even This is why regular e.” negativ “false nearly half of This is called a estimated that important. It’s result of the HIV is extremely States are the ns in the United it, many of all new HIV infectio know they have don’t who HIV with n. 20% of people w” stage of infectio them in this “windo
dO What PrEP dOEsn’t
every day HIV. But taken you 100% against It will not protect effective. can be up to 94% as directed, PrEP before a a pill you can pop g-after pill” or It is not a “mornin it every day. You need to take d.” weeken “big dia, STDs such as chlamy you from other It won’t protect or syphilis. herpes, ea, gonorrh It does not prevent
pregnancy.
Learn about the use of medications for HIV prevention before (PrEP) and after (PEP) sexual exposure. See the new PrEP page from TPAN (publisher of Positively Aware) at tpan.com/ prep and Fenway Health’s new PEP page at talkpep.org. The theme of TPAN’s educational effort is “One pill a day can help protect you from HIV.” Included is a PrEP factsheet, an entertaining and informative video by TPAN HIV prevention specialist Ken Williams (from his KenlikeBarbie vlog), along with links to everything PrEP from positivelyaware.com and other sources of information, such as the FDA and HIV service providers. Go to tpan.com/prepsurvey and be sure to take the survey.
Non-daily PrEP studied The HIV Prevention Trials Network (HPTN) is enrolling participants for the international ADAPT (Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking) Study which will investigate the use of non-daily PrEP and identify PrEP pill-taking schedules that encourage adherence, determining if these schedules influence healthier sexual behavior. ADAPT will look at the use of Truvada for PrEP taken either once a day, twice a week along with another pill after sex, or only before and after sex. For more information, go to hptn.org or call 888-460-9817.
HIV in semen Researchers from the California Collaborative Treatment Group (CCTG) found HIV in semen for 10% of the 114 men on antiviral medication whom they studied. The majority, 88 percent, had undetectable viral loads (less than 50 copies 12
J u ly+Au g u s t 2 013
P OS ITIV E LY AWA R E
per mL), and the remaining 12 percent had less than 500 copies per mL. It’s known that individuals may have undetectable viral loads in blood but detectable virus in genital fluids, which may increase the risk of HIV transmission. There have been rare cases of transmission in the presence of undetectable viral loads. The results were published online in the April 6 issue of Clinical Infectious Diseases and a more detailed report can be found at aidsmap. com.
Sustiva now for babies Previously, Sustiva could not be taken by children younger than five years old. In May, the FDA approved the use of Sustiva (efavirenz) for children at least three months old and weighing at least 7 pounds, 11 ounces (3.5 kg). For those who can’t swallow capsules, the capsule contents can be administered with a small amount of food or infant formula using the capsule sprinkle method of administration
Tenofovir gel safe for rectal use A reformulated version of an anti-HIV gel developed for vaginal use was found to be safe and acceptable by HIV-negative men and women who used it rectally, according to an early Phase 1 clinical trial published on April 3 in PLOS ONE. The study was conducted by the Microbicide Trials Network (MTN) at three U.S. sites with 65 men and women.
OI guidelines updated The guidelines for opportunistic infections (OIs) in people with HIV were updated May 7. Among the updates is new information about diagnosis and management of immune reconstitution inflammatory syndrome (IRIS). There is also updated information on the treatment of hepatitis B and C, revised information on immunization (including HPV), and drug interactions with antivirals. Go to aidsinfo.nih.gov.
Navajo nation sees rise in HIV An April report from the federal Indian Health Service noted 47 new cases of HIV for 2012 on the Navajo reservation, which spans Arizona, New Mexico, and Utah. The number is up 20% from 2011, according to an article in The New York Times on May 19. This was the highest number of new diagnoses ever recorded for the tribe. Nearly half of the new infections were in men who have sex with men. There are more Navajo living with HIV than any other tribe.
Photo: Joshua Thorne
The difference between PEP and PrEP
(see the Sustiva drug label). There were also label updates to information on pediatric patients.
Help to end HIV discrimination laws The Positive Justice Project (PJP) in May released an “outreach toolkit” to help interested individuals address their legislators about H.R. 1843, the REPEAL HIV Discrimination Act sponsored by Congresswoman Barbara Lee (D-California). Among the talking points listed is this nugget: “In most states, individuals with no intent to transmit HIV, including those who use protection to prevent transmission, are punished as harshly
Sofosbuvir up for fast-track approval In April, Gilead Sciences submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for sofosbuvir, a once-daily nucleotide NS5B inhibitor. According to Gilead, their application included data that supports the use of sofosbuvir and ribavirin as an all-oral therapy for patients with hepatitis C genotypes 2 and 3, and in use with ribavirin and injectable pegylated interferon for those with genotypes 1, 4, 5, and 6 who have never received hep C treatment before. The drug was granted a Fast Track Designation by the FDA, and, if approved, could be available as early as the fall of this year.
Simeprevir for HCV gets priority review Janssen announced that the FDA has granted Priority Review to its New Drug Application for simeprevir (TMC435). The drug is a NS3/4A protease inhibitor taken as a 150 mg capsule once daily ribavirin and pegylated
as individuals who seriously harm or kill another person through vehicular homicide or intentional physical assault.” Go to hivlawandpolicy.org/resources/view/844.
Take UCSF’s HIV treatment survey The University of San Francisco (UCSF) is offering a national survey of people with HIV. “We are conducting this internetbased survey in an effort to better understand how HIV-positive individuals engage in their medical care; including
interferon for chronic genotype 1 hepatitis C disease in people with compensated liver disease, including all stages of fibrosis. The company announced that it expects to hear back from the FDA later this year.
AbbVie HCV combo on FDA fast track AbbVie announced in May that its investigational direct-acting antiviral for hepatitis C therapy has received Breakthrough Therapy Designation from the FDA. The designation is similar to Priority Review and Fast Track Designation, with all three speeding up the agency’s consideration of a new treatment for a life-threatening condition. The Breakthrough Designation is for a drug that treats a serious or life-threatening condition and may demonstrate substantial improvement over available therapies. AbbVie’s combined ABT-450/r + ABT-267 + ABT-333 with or without ribavirin was studied in patients with HCV genotype 1, both those whose previous treatment for the virus failed and those on treatment for the first time.
their relationship with their health care provider, appointment-keeping, reasons why people miss their HIV medications, as well as how technology can be used to help HIV-positive individuals in their HIV care.” Help research—take the survey at https://ucsf.co1.qualtrics.com/ SE/?SID=SV_agG84ZvIr8uC0DP .
Clean: Overcoming Addiction Addiction Treatment Forum newsletter recently featured an Amazon.com book review of Clean: Overcoming Author David Sheff Addiction and Ending America’s Greatest Tragedy, by David Sheff. According to the review, “Addiction is a preventable, treatable disease, not a moral failing. As with other illnesses, the approaches most likely to work are based on science—not on faith, tradition, contrition, or wishful thinking. These facts are the foundation of Clean, a myth-shattering look at drug abuse by the author of [the bestselling memoir] Beautiful Boy.” Go to atforum.com to see the current and past issues.
U.S. Conference on AIDS set for Sept. 8–11 The 2013 United States Conference on AIDS (USCA), will take place September 8–11, 2013, at the Hyatt Regency in New Orleans, Louisiana. USCA is the largest AIDS-related gathering in the U.S., bringing together thousands of workers from all fronts of the HIV/ P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
13
B R I E F LY Sign up for our weekly email newsletter. go to positivelyaware.com/subscribe
AIDS epidemic to build national support networks, exchange the latest information, and learn cutting-edge tools to address the challenges of HIV/AIDS. For more information or to register, go to nmac.org.
Get answers to your HIV questions
Good Dog
Fred Says YouTube appeal helps HIV-positive teens “What does Fred Say?” The answer, from the adorable, fundraising Yorkie’s YouTube debut: “Together we can make the world better for people with HIV.” Not yet three years old, the lifesaving pooch has been raising money for HIV-positive adolescents since he was a puppy. In the video, Robert Garofalo, MD, talks poignantly about the darkest days of his life and how everything turned around with his adoption of Fred, who brings him peace and joy. Garofalo was inspired to share Fred’s gift for creating happiness while at the same time raising money for the Gender, Sexuality, and HIV Prevention Center of Lurie Children’s Hospital in Chicago, where he (Garofalo, not Fred) is director and also head of the Adolescent/ Young Adult HIV Program. Images of Fred grace greeting cards, T-shirts, and a coffee mug, with proceeds helping teens. There’s even a plush Yorkie Fred available. While addressing serious topics, the video will have you “LOL”-ing at Fred’s antics. Just one dollar can buy an e-card. Adding up those dollars means transportation, meals, lab work, counseling, and more for teens living with HIV who have no insurance. Watch the video at youtube.com/ watch?v=M8nncYE0_nI.
14
J u ly+Au g u s t 2 013
P OS ITIV E LY AWA R E
HIV specialist Dr. Joel Gallant, author of 100 Questions and Answers about HIV and AIDS and longtime contributor to the Positively Aware Annual HIV Drug Guide, is reviving the online Patient Forum he ran at Johns Hopkins University. HIV patients can send their questions to http://hivforum.tumblr.com. Said Dr. Gallant, “Readers can post questions about HIV and AIDS, keeping in mind that the purpose of the Forum is not to give medical advice, or to be a substitute for your interactions with your own health care provider.” Dr. Gallant is now the Associate Medical Director of Specialty Services at Southwest CARE Center in Santa Fe.
ResearchMatch.org helps link people to HIV studies “ResearchMatch.org will make a dramatic difference in accelerating HIV cure research by connecting researchers with volunteers who want to help but don’t know how to get involved or where to turn,” said HIV treatment activist Nelson Vergel of the Program for Wellness Restoration, or PoWeR, about his recent collaboration with the only non-profit clinical trials registry connecting research teams with potential study participants. “The hope is that many people will register to volunteer and that academic and research institutions will take advantage of this free service that promotes faster study enrollment.”
Free HIV prevention resource now available Mapping Pathways: Developing evidencebased, people-centred strategies for the use of antiretrovirals as prevention is the first international report on HIV prevention with antiretroviral (ARV) drugs that brings scientific evidence together with community perspectives. It is available online (open access), to help communities, prevention programmers, funders, and policymakers decide whether, and how, an ARV-based strategy could work in their locality. Archbishop Desmond Tutu penned the foreword, “All Science is Local”, reflecting the necessity to address local perspectives and contexts. The book was produced by Mapping Pathways, a community-led research project involving RAND Europe, AIDS Foundation of Chicago, and other partners in India, South Africa, and the United States. Go to mappingpathways.blogspot.com.
AIDS—The early years: Protest led by Gay Men’s Health Crisis.
Exhibit relives early plague years The New York Historical Society Museum & Library honors early AIDS activism in AIDS in New York: The First Five Years. The exhibit draws from the New York Public Library and NYU archives, as well as the National Archive of LGBT History. The exhibit of posters, photographs, and artifacts will run through September 15.
Photo: New York Historical society museum
E-NEWS |
YOu’VE COmE A LONg WAY mANAgINg YOuR HIV.
NOW, ON TO HIV-RELATED EXCESS AbDOmINAL FAT.
www.egrifta.com
Indication: EGRIFTA® (tesamorelin for injection) is a daily injectable prescription medicine to reduce the excess abdominal fat in HIV-infected patients with lipodystrophy. Limitations of use: • The impact and safety of EGRIFTA® on cardiovascular health has not been studied • EGRIFTA® is not indicated for weight-loss management • It’s not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications • EGRIFTA® is not recommended to be used in children Important Risk Information Do not use EGRIFTA® if you: • Have pituitary gland tumor, pituitary gland surgery, or other problems related to your pituitary gland • Have active cancer (either newly diagnosed or recurrent) or are receiving treatment for cancer • Are allergic to tesamorelin or any of the ingredients in EGRIFTA®, including mannitol or sterile water • Are pregnant or become pregnant before using EGRIFTA®, tell your healthcare provider if you: • Have or have had cancer • Have diabetes • Are breastfeeding or plan to breastfeed • Have kidney or liver problems • Have any other medical condition • Take prescription or non-prescription medicines, vitamins, or herbal supplements EGRIFTA® may cause serious side effects, including: • Serious allergic reaction. Stop using EGRIFTA® and get emergency help right away if you have any of the following symptoms: rash over your body, hives, swelling of your face or throat, shortness of breath or trouble breathing, fast heartbeat, feeling of faintness or fainting • Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome) • Increase in glucose (blood sugar) intolerance and diabetes. Your healthcare provider will measure your blood sugar periodically • Injection-site reactions, such as redness, itching, pain, irritation, bleeding, rash, and swelling. Change (rotate) your injection site to help lower your risk for injection-site reactions The most common side effects of EGRIFTA® include: • joint pain • numbness and pricking • pain in legs and arms • nausea • swelling in your legs • vomiting • muscle soreness • rash • tingling • itching EGRIFTA® will NOT cure HIV or lower your chance of passing HIV to others. 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.
Actual patient living with HIV since 2000
You can receive valuable information about ways to discuss this condition and EGRIFTA® with your doctor when you sign up at egrifta.com/info or call the AXIS Center2/13 at 877-714-AXIS (2947) 111122-102311
Please see Consumer Brief Summary of EGRIFTA® on following page.
Consumer brief Summary for EGRIFTA® (tesamorelin for injection) EGRIFTA® (eh-GRIF-tuh) (tesamorelin for injection) for subcutaneous use Read the Patient Information that comes with EGRIFTA® before you start to take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is EGRIFTA®? • EGRIFTA® is an injectable prescription medicine to reduce the excess in abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTA® contains a growth hormonereleasing factor (GRF) • The impact and safety of EGRIFTA® on cardiovascular health has not been studied • EGRIFTA® is not indicated for weight-loss management • It is not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications • It is not known if EGRIFTA® is safe and effective in children. EGRIFTA® is not recommended to be used in children Who should not use EGRIFTA®? Do not use EGRIFTA® if you: • have pituitary gland tumor, pituitary gland surgery, or other problems related to your pituitary gland • have or have had a history of active cancer (either newly diagnosed or recurrent) • are allergic to tesamorelin or any of the ingredients in EGRIFTA®. See the end of this leaflet for a complete list of ingredients in EGRIFTA® • are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA® and talk with your healthcare provider. See “What should I tell my healthcare provider before using EGRIFTA®?” What should I tell my healthcare provider before using EGRIFTA®? Before using EGRIFTA®, tell your healthcare provider if you: • have or have had cancer • have diabetes • are breastfeeding or plan to breastfeed. It is not known if EGRIFTA® passes into your breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking EGRIFTA® • have kidney or liver problems • have any other medical condition Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. EGRIFTA® may affect the way other medicines work, and other medicines may affect how EGRIFTA® works. Know the medicines you take. Keep a list with you to show your healthcare provider and pharmacist when you get a new medicine. How should I use EGRIFTA®? • Read the detailed “Instructions for use” that comes with EGRIFTA® before you start using EGRIFTA®. Your healthcare provider will show you how to inject EGRIFTA® • Use EGRIFTA® exactly as prescribed by your healthcare provider • Inject EGRIFTA® under the skin (subcutaneously) of your stomach area (abdomen) • Change (rotate) the injection site on your stomach area (abdomen) with each dose. Do not inject EGRIFTA® into scar tissue, bruises, or your navel • Do not share needles or syringes with other people. Sharing of needles can result in the transmission of infectious diseases, such as HIV What are the possible side effects of EGRIFTA®? EGRIFTA® may cause serious side effects including: • Serious allergic reaction. Some people taking EGRIFTA® may have an allergic reaction. Stop using EGRIFTA® and get emergency help right away if you have any of the following symptoms: – a rash over your body
– hives – swelling of your face or throat – shortness of breath or trouble breathing – fast heartbeat – feeling of faintness or fainting • Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome) • Increase in glucose (blood sugar) intolerance and diabetes. Your healthcare provider
will measure your blood sugar periodically • Injection-site reactions. Change (rotate) your injection site to help lower your risk for
injection-site reactions. Call your healthcare provider for medical advice if you have the following symptoms around the area of the injection site: – bleeding – redness – rash – itching – swelling – pain – irritation The most common side effects of EGRIFTA® include: – joint pain – nausea – vomiting – pain in legs and arms – rash – swelling in your legs – itching – muscle soreness – tingling, numbness, and pricking 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 EGRIFTA®. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. To report side effects, contact EMD Serono toll-free at 1-800-283-8088, ext. 5563. You may report side effects to the FDA at 1-800-FDA-1088. Keep EGRIFTA® and all medicines out of the reach of children. general information about the safe and effective use of EGRIFTA®: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EGRIFTA® for a condition for which it was not prescribed. Do not give EGRIFTA® to other people, even if they have the same symptoms you have. It may harm them. Do not share your EGRIFTA® syringe with another person, even if the needle is changed. Do not share your EGRIFTA® needles with another person. This Patient Information leaflet summarizes the most important information about EGRIFTA®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about EGRIFTA® that is written for healthcare professionals. For more information about EGRIFTA®, go to www.EGRIFTA.com or contact the AXIS Center toll-free at 1-877-714-2947. What are the ingredients in EGRIFTA®? Active ingredient: tesamorelin Inactive ingredients: mannitol and Sterile Water for Injection
EMD Serono, Inc. is a subsidiary of Merck KGaA, Darmstadt, Germany
©2013 EMD Serono, Inc. 130219-133638 2/13 All rights reserved. EGRIFTA is a registered trademark of Theratechnologies Inc.
B:10.75”
S:9.5”
T:10.5”
The Right to Be Healthy as Who You Are
a global transgender rights movement is on the horizon
Photo: Chris Daley
By Cecilia Chung
O
n December 10, 2012 , International Human Rights Day, the global HIV community issued a call to action to people living with HIV worldwide to unite around a common Global Advocacy Agenda (hivadvocacynow.org). The agenda came out of the Positive Leadership Summit that took place during the International AIDS Conference last July in Washington, D.C. For many here in the United States, the global HIV community seems like a foreign concept, but when you look closer at the three main points of the Global Advocacy Agenda, you will probably recognize them right away and may be inspired to join the fast growing movement like many of us have.
The three areas of focus of the Global Advocacy Agenda are 1) prevention, treatment, care, and support; 2) human rights; and 3) community strengthening and mobilization, and activism. Some of the efforts that the global community of people living with HIV/AIDS (PLWHA) is committing to include advocacy for increased access to antiretroviral medications for those who need them; access to pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP); increased access to diagnostics and monitoring technologies (for CD4, viral
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
17
Just as we see transgender people struggle
for legal and political rights, we are also seeing similar battles in the public health arena.
load and drug resistance); eradicating stigma and discrimination; ending HIV-related criminalization; strengthening engagement with networks of key populations and the full diversity of people living with HIV; and increasing representation of people living with HIV in policy and legislative bodies.
But where is the transgender community? Here in the United States, one of the key vulnerable populations that continue to report experiencing heightened stigma and discrimination in a wide range of settings is the transgender community. Transgender people, particularly trans women of color, consistently and increasingly report encountering prejudice, violence, and institutionalized discrimination in health care, housing, employment, education, and the criminal justice system. HIV-positive trans women and trans women of color disproportionately experience greater health disparities where, in some urban areas, the incidence of infection is around 30 to 40%. Recently published data from the Johns Hopkins School of Public Health appeared to capture the attention of providers and researchers in the HIV community. They found that the HIV risk burden of transgender people is 49 times higher than for other adults of similar reproductive age, but most of the long-time advocates with whom I have spoken were not surprised by the numbers. Interestingly, according to the report, the risk burden of transgender people did not differ between high-income and low-income countries. Unfortunately, the study also found that the prevalence of stigma and discrimination is universal, regardless of the wealth and region. The transgender community, like any other community, is not monolithic. We live in both urban and rural areas; are young, middle-aged, and old; transition to become our authentic selves when we are children, adolescents, adults, later in life, and even in
18
J u ly+Au g u s t 2 013
our twilight. Transgender women, and the communities we live in, are diverse in terms of race, income, sexual orientation, and national origin. Although we have always been around, we are still rendered invisible by our national census and as a result, there are no accurate data showing the true size of our population. The poor understanding of the transgender community and lack of anti-discrimination laws have led to family rejection, employment discrimination, homelessness, poor economic conditions, traumas, substance abuse, poor mental health, police harassment, criminalization, and HIV. Many continue to be discriminated against by service and health care providers. As this article is being written, the transgender community is still actively fighting against bad, stigmatizing legislation being passed in some states, while celebrating anti-discrimination laws being passed in others. Until there are real, federal anti-discrimination laws for all transgender, lesbian, gay, and bisexual Americans and immigrants to count on, health care access and outcomes for the more vulnerable members in the transgender community who are at risk or living with HIV will likely be a mixed bag. Of course, with the AIDS crisis now entering its fourth decade, we cannot help but ask what progress has been made here in the U.S., especially in vulnerable populations such as the transgender community. Unfortunately, there is no simple answer to the question. Just as we see transgender people struggle for legal and political rights, we are also seeing similar battles in the public health arena. Thankfully, we have leaders and allies who advocate tirelessly for us and over the past 10 years, we have seen some momentum to bring about positive change in HIV testing, prevention and treatment, and research, as well as surveillance.
What is missing? During the Second National Transgender Health Summit, the San Francisco Department of Public Health
P OS ITIV E LY AWA R E
presented data from a local study that supported the recent report by the Johns Hopkins School of Public Health. In the San Francisco study, 77 percent of the transgender women reported being linked to primary care within three months of their HIV diagnosis and 87 percent had received care in the past six months. In addition, 35 percent reported CD4 counts below 350 and 65 percent were currently on ART. However, less than half reported being virologically suppressed. Consistent with the Johns Hopkins study, transgender women in San Francisco have a very high prevalence of HIV. Moreover, a large proportion of them were not currently on ART and the majority was not virologically suppressed, indicating potential for increased transmission. These data also show that HIV-positive trans women report one of the highest community viral loads and higher mortality rates among all HIV-positive populations. These data, which will be presented again at the United States Conference on AIDS (USCA) this coming September, beg the question: San Francisco has long been viewed as an urban area with culturally competent clinics, providers, and relatively abundant resources for trans women living with HIV. Yet if trans women—even in a culturally competent, resource-rich setting—are still not able to stabilize their CD4 and viral load, adhere to their antiretroviral medications, and attain optimal health outcomes, what is really going on? Could these poor health outcomes be tied to provider discrimination in a city where an anti-discrimination ordinance was passed in the mid ’90s and the first public health clinic for the transgender community opened its doors around the same time? What are the conditions that set HIV-positive trans women apart from others living with HIV, when given equal access to resources and psychosocial support? Could fear of disclosure cause a delay in seeking health care in some trans women who may not have documented immigration status? Again, such a hypothesis is
Stigma and disclosure are all too familiar
to most of us in the transgender community, as they go hand in hand with acceptance and rejection.
quickly dispelled since San Francisco is one of the few cities to have a sanctuary policy in place. So it seems that after spending more than half of this article looking at all the possible reasons why trans women living with HIV are not doing as well as they should, given all the resources and support, we must ask: what are we missing?
Seeking answers through innovation The outlook may not be as grim as it sounds. The Centers for Disease Control and Prevention (CDC), in response to recommendations from transgender advocates for how to collect better data on gender identity, is revising the national system for reporting HIV cases. Intake and surveillance forms will now indicate both sex assigned at birth and current gender identity. Hopefully, this will improve the likelihood of accurately identifying diagnoses of HIV infection among transgender individuals and enable trans women at risk to feel more comfortable in seeking HIV counseling and testing, rather than feeling as if they are being misgendered. Also, in an unprecedented effort, the Presidential Advisory Council on HIV/AIDS (PACHA) adopted a resolution early this year with fifteen specific recommendations to various federal health agencies, which include: Removing barriers to HIV prevention, testing, treatment, and access to care for transgender people; n Urging the inclusion of trans women in re-entry services for recently incarcerated individuals; n Developing and funding research that targets social determinants of transgender health, and n Removing all trans-specific exclusions in all health plans.
A San Francisco study, supporting data from the Johns Hopkins School of Public Health, revealed that among transgender women‌
87%
had received care in the past six months
77%
were linked to primary care within three months of testing positive
65%
were currently on ART
n
Another groundbreaking effort that we should pay close attention to is the Special Projects of National Significance (SPNS) Program by the Health Resources
35%
had a CD4 count below 350
However,
less than half reported being virologically suppressed.
and Services Administration (HRSA). The Enhancing Engagement and Retention in Quality HIV Care for Transgender Women of Color Initiative is a multi-site demonstration project. It provides funding to nine sites and one Evaluation and Technical Assistance Center (ETAC), during federal fiscal years 2012 through 2016. It provides support to organizations that will design, implement, and evaluate innovative interventions in order to improve timely entry, engagement, and retention in quality HIV care for trans women of color. The primary focus of this initiative is to identify, as well as successfully engage and retain in care, trans women of color who are at high risk of HIV or are already infected but are unaware of their HIV status; are aware of their HIV but have never been engaged in care; are aware but have refused referral to care; or have dropped out of care. The nine sites of this federally-funded, five-year initiative include: TransActivate by Bienestar Human Services, Inc., Los Angeles; TransLife Care Project (TLC Project) by Chicago House and Social Service Agency, Chicago; TransAccess by the City and County of San Francisco; Transgender Women Engagement and Entry to Care Project (TWEET Care Project) by Community Healthcare Network, New York City; The Alexis Project, Los Angeles; Drop-In Program at Howard Brown Health Center, Chicago; The Butterfly Project by Public Health Institute, Oakland, CA; The Infini-T Project by Research Foundation of the State University of New York, Albany, NY; and The Brady Martell Project by TriCity Health Center, Fremont, CA. Will these innovative projects be successful in improving the health outcomes of trans women of color living with HIV? Will there be a decrease in the number of new HIV infections among high-risk trans women of color as a result of these special projects? Will these new interventions be adequate to improve the quality of lives of these vulnerable members of our community? What about high-risk trans women and trans women living with HIV in many POSITIVELY AWARE
J u ly+Au gust 2013
19
Perhaps what trans women living with HIV really need is what all of us need—a cheerleader
to stand by our side, reminding us hope is not lost. southern states where HIV is on the rise, and AIDS funding is at risk of being cut?
Let’s talk about stigma Lately, there has been more discussion about HIV stigma and disclosure. Stigma and disclosure are all too familiar to most of us in the transgender community, as they go hand in hand with acceptance and rejection. Stigma also prevents bad laws from being repealed and good laws from passing. With stigma, be it cultural, social, or institutional, we trans women seem to enjoy a greater share of negative stereotyping than our lesbian, bisexual, and gay brothers and sisters. Perhaps it would come as no surprise that many trans women who are at high risk of or living with HIV have also faced rejection by their families and local communities. Granted, stigma may not be the only influencing factor in many women’s lives. Other factors such as social support systems, education levels, and housing situations also play crucial roles in their health outcomes, but personally, as someone who has lived the life, survived, and tells the tale, I would venture to say that we should never underestimate the force of stigma nor the power of hope. In the three short years that I thought my family had rejected me, I began to selfmedicate, lost my apartment, became HIVpositive and even had multiple episodes of traumas, none of which my college education prepared me for. What I knew was that stigma—both social and internalized—continued to chip away at my sense of purpose until one day, I no longer had a reason to get out of bed. While we face similar barriers when compared to other populations living with HIV, trans women of color are more likely to experience stigma and family rejection before they are infected with HIV. So why do we mostly talk about hormones and gender affirmation when many of these women may have given up hope? If we don’t address how we deal with stigma, both internal and external, what rational explanation do we have for highrisk behaviors such as silicone pumping 20
J u ly+Au g u s t 2 013
P OS ITIV E LY AWA R E
(injections of silicone into the body without medical supervision)? And can this theory be proven? The short answer: maybe. For the first time, we will be working with the global HIV community to measure the impact of stigma on HIV-positive people. This global program, the PLHIV Stigma Index, is guided by an international partnership consisting of the Global Network of People Living with HIV (GNP+), the International Community of Women Living with HIV (ICW), and UNAIDS. The survey has already been rolled out in over 45 countries and more than 40,000 people living with HIV around the world have participated. The PLHIV Stigma Index is currently being introduced to the U.S. for the first time, guided by the North American affiliate of the Global Network of People Living with HIV (GNP+ NA). In order for the survey to effectively reflect the local epidemics, local people living with HIV will be trained to administer it. It also means an opportunity to include HIV-positive trans women of color to get actively involved with the data gathering processes.
Is there a simple solution to the madness? We have searched high and low for that magic formula, the innovative strategy, the groundbreaking intervention that would achieve virological suppression, increase CD4s, and reduce HIV incidence among trans women of color. We have read about programs utilizing peer/patient health navigators to overcome barriers to treatment. But conceivably, any deep philosophical discussion about the meaning of life, and how to stay alive, might seem a luxury we cannot afford as we feel the
grip of AIDS on our neck and are reminded of how unlovable we are. Perhaps what trans women living with HIV really need is what all of us need—a cheerleader to stand by our side, reminding us hope is not lost and helping us discover new purposes that make each day worth waking up to. For me, when I began to realize that I have a chosen family around me and was able to replace internal stigmatizing messages with gratitude, I quickly saw an improvement in my emotional and mental state; soon enough, I saw an improvement in my physical health. I am extremely grateful that my family is back in my life today, but had I not held on to hope when I was stabbed during a would-be sexual assault on one August night eighteen years ago, I would not be sitting here writing this article. Maybe that is the simple solution to the complex problems—building our own family; mentoring one another when our biological families are absent from our lives; keeping ourselves—all of us—safe and healthy; sharing our hopes and dreams with one another until our sisters have their own hopes and dreams again. When I reconciled with my family and I saw my grandparents as my authentic self for the first time, it was my birthday and my grandma said to me, “You look beautiful.” That was the moment I’d waited my entire life for and I could not be happier. Had I given up on living, I would not have had that moment or the next six years with her. In this new century, with all the new science, researchers are continuing to race for a vaccine and eradication of HIV. And as we all begin to envision a cure for AIDS, let’s not lose sight that an AIDS-free generation begins with a simple yet powerful practice—unconditional love.
Cecilia Chung is the Senior Strategist of the Transgender Law Center, a National Advisory Board Member of UCSF Center of Excellence for Transgender Health and a board member of Global Network of People Living with HIV, North America. Appointed by Mayor Ed Lee to the San Francisco Health Commission on April 2012, Cecilia is the first transgender woman to hold that position. She has been living with HIV for 20 years, and is currently on ART with an undetectable viral load.
the Path Forward Younger Black gay men are extremely vulnerable to infection By Charles Stephens
I
t’s not yet clear how the summer of 2012 will be remembered in the greater cultural narrative of HIV. There were a series of milestones that provided both the blueprints and context for how we should move forward, and the hope that our efforts might actually be successful. In the course of a few weeks during the summer, the Supreme Court upheld the Affordable Care Act, the U.S. Food and Drug Administration (FDA) approved both the OraQuick In-Home HIV Test and Truvada as PrEP, and the first International AIDS Conference was held in the United States in years.
These events, singularly critical, pleasing to most, and inspiring, taken together were nothing short of breathtaking. During that same summer, there was another event, the reporting of the results from the HPTN 061 or BROTHERS (Broadening the Reach of Testing, Health Education, Resources and Services for Black Men Who Have Sex With Men) Study—which demonstrated that despite our most significant advances, we still have a long way to go. The BROTHERS study assessed whether certain strategies could show potential for decreasing the spread of HIV among black gay, bisexual, and other men who
have sex with men (MSM). A total of 1,561 men enrolled in six cities: Atlanta, Boston, New York, Los Angeles, San Francisco, and Washington, D.C., and the study was conducted over the course of two years: 2009–2011. This was the first large study in the U.S. to determine the actual rate of new HIV infections among this group. The study indicated heightened rates of new HIV infections in black gay, bisexual, and MSM in the U.S. This was particularly the case for younger men. Of study participants, those 30 years of age and younger became HIV-infected at a rate of 5.9 percent per year, three times the rate of white gay and
bisexual men in the U.S overall. To paint a perhaps more vivid picture, the rate of HIV among black gay and bisexual men overall in this study was comparable to the rate seen in the general populations of the subSaharan African countries hardest hit by the HIV epidemic. This would again be reinforced later on in December 2012, when the CDC reported that though HIV was on the decline for black women, which is clearly a hopeful sign (and such signs are hardly in abundance), it was also discovered that in the same period between 2008 and 2010 young black men had more new infections than any other subgroup. So what are we to do with this information? The facts are clear—black gay men are disproportionately impacted by HIV, particularly with new HIV infections, and young black gay men are extremely vulnerable. We are in a time of immense optimism thanks to the new range of strategies we have at our disposal, while at the same time we face the sobering fact that race, sexual identity, and social class continue to
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
21
shape the U.S. epidemic. We must begin by assessing the current landscape of HIV prevention, part of which involves rethinking some of the misconceptions about black gay men as they relate to HIV.
Misconceptions
O
3x A U.S. study concluded that African American MSM 30 years of age and younger became HIV-infected AT three times the rate of white gay and bisexual men overall—comparable to the overall infection rate of sub-Saharan Africa. 22
J u ly+Au g u s t 2 013
ne of the assumptions I often hear made about young black gay men is that they lack sufficient fear around HIV, that HIV rates keep increasing because they are having more unprotected sex and they aren’t afraid enough. This line of reasoning suggests that in the 1980s, people were frightened, they went to funerals all the time, so they modified their behaviors. This is both true and false. On one hand, it’s simplistic to assume that fear manifests the same way for everyone or that the logical response of fear of HIV automatically leads someone to 100% condom use. I’ve administered many HIV tests to black gay men and no one has ever skipped out of my office after they received their HIV-positive results. I’ve also gone through enough “scares” with friends, where we stayed up late the night before a test because they were anxious or afraid. No, fear is definitely real. On the other hand, there isn’t just fear, and for that matter, the opposite of fear isn’t always courage or even indifference. I would suggest that a lot of black gay men have become kind of numb around HIV. Many of us were born right before or after AIDS and came out after protease inhibitors, and have been both inundated with HIV statistics and facts all of our lives, while robbed of a meaningful narrative to make sense of things. For those of us that came of age mostly understanding being black and being gay in the context of HIV, I think the response, for a lot of us, has not been fear as we typically understand it, but more of a numbness. The way that we have sex and even the way that we love have evolved out of being told we must fear everyone that looks like us. Social change isn’t always preceded by political shifts, but can also be fueled by scientific ones. Innovation in scientific research not only impacts how we operate and move through the world, but also how
P OS ITIV E LY AWA R E
we view it. Scientific research for black gay men, and specifically HIV research, has and will undoubtedly continue to play as significant a role on the cultural stage in evolving the structural conditions that they experience as celebrities coming out of the closet and the increasing acceptance of marriage equality. That being said, research does not exist alone but always in conversation with policy and practice. Here are some considerations for next steps in how research, advocacy, and practice should grapple with black gay men and HIV.
Research
T
he prevailing wisdom, and this has certainly been reinforced in the research literature, is that it’s not that black gay men engage in higher risk behaviors than white gay men. HIV incidence is not so much merely a matter of behaviors, but there are structural factors that also must be considered. These structural realities, and the social forces that shape these realities, are not only a part of the larger story of why black gay men are so impacted by HIV, but an indispensable and central part of that story. Researchers must continue to respond and probe more carefully the social drivers of HIV among black gay men, particularly young black gay men. It’s extremely valuable for us to look at HIV incidence and the association of structural factors such as economic distress, employment and housing instability, poverty, anti-gay and HIV stigma, sexual abuse, and how these forces collide to make an already vulnerable population more vulnerable. Researchers should also continue to consider “resilience.” Not merely as a kind of individual act, but also how organizations, particularly black gay organizations institutionalize policies and ritualize practices that inspire resilience. We must continue to look not only in our present moment but to the past as well, to see how earlier generations of black gay men were resilient. Nowhere is this more evident than in the 1980s, during the “black gay arts movement,” where we see some of the most stunning and epic acts of resistance and resilience. That being said, public health, from a research, policy, and practice perspective, has been and will continue to
be indispensable to the development of any successful research around black gay men. The seriousness of HIV among black gay men necessitates bringing in others from diverse disciplines to also weigh in and pose questions.
Advocacy
R
ecognizing the potential for the Affordable Care Act to improve health outcomes and create more parity in healthcare, I believe it provides one of the greatest hopes for helping us expand treatment for people living with HIV. We recognize from the research realm that when someone is HIV-positive and in treatment and can achieve a suppressed viral load, they are much more likely to have better health outcomes and are less likely to transmit HIV. Therefore ensuring that people who are HIV-positive have access to treatment is extremely important, including from a policy and advocacy perspective. Thus, I believe championing the full implementation of the Affordable Care Act should be a part of the agenda. Stigma is also a critical area for advocacy. For black gay men, who experience oppression as intersectional (i.e. grappling with racism and homophobia, in addition to other issues like classism), stigma might operate in very nuanced ways. And though there have been very innovative anti-stigma campaigns, particularly through social marketing and the dissemination of messaging on a community level, which is an important way to create new narratives around what it means to be black and gay in our culture, it’s also critical to focus on the institutional level. Specific neighborhoods, professional associations, faith communities, schools, and other institutions that have shown an inclination toward anti-gay stigma must be targeted specifically, with campaigns that are precise in messaging. The specificity would help address the particular kind of stigma that manifests in those places.
Practice makes perfect Biomedical. Implementation of strategies such as PrEP (pre-exposure prophylaxis) and Treatment as Prevention are key, because having more prevention options
will increase the opportunities for black gay men to develop a plan that works for them. Having more options is better. Structural. Grappling with the social drivers of HIV is an important movement forward. Housing instability, economic distress, and unemployment are frequently referenced as being associated with HIV risk for black gay men. Black gay men’s sexual networks have also been recognized as a factor for HIV risk. And despite engaging in far less risky behavior than their white counterparts, black gay men are more likely to come in contact with HIV through their sexual networks. Because of higher prevalence of HIV within these networks, they are vulnerable not just by behavior, but also by likelihood of exposure. That is not to suggest that black gay men having sex with each other is inherently a risk factor for HIV, a notion that if we aren’t careful, we might unintentionally perpetuate and reproduce stigma. Rather it speaks to the more concentrated HIV prevalence among black gay men. This also necessitates an important paradigm shift in HIV prevention and treatment, where our efforts recognize not only individuals, but couples, groups, social networks, and communities. Further, we must continue to develop programming that seeks to ensure housing, employment assistance programs, social network-based HIV prevention education and messaging, and anti-stigma social marketing campaigns. These are all core strategies to ensuring better prevention and treatment access for black gay men. Behavioral. From a programmatic perspective, the starting point for implementing any kind of sexual health education has to acknowledge the complex role sex has in our lives. It may be useful also to develop interventions in a far more collaborative way across disciplines and bring in cultural theorists, humanists, anthropologists, and sexologists along with behavioral scientists.
It’s also important that any programming related to HIV prevention recognizes that risk is constantly negotiated and behavior change can’t be on a binary of good and bad, but has to exist on a continuum that changes based on the terms set by those involved—perhaps this is where the harm reductionists have been very wise. There have been some attempts to think about gender role expectations, sexual identity, and practice, usually in the context of power, such as an assumption that being a bottom would make someone feel disempowered to assert sexual agency (the ability to choose) when it comes to condom use and resist assertive communications. This is of course valuable. However, more has to be done from a programmatic perspective to also think about “condomless” sex too, particularly around how the sharing and reception of bodily fluids for some gay men might have an erotic charge, and how to build out a prevention program and sexual health curricula with that understanding in mind. Finally, reaching very vulnerable groups of black gay men and connecting them with their HIV status is important. Making HIV testing accessible, including HIV testing in nontraditional venues, and eliminating barriers must be coupled with candid and practical sexual health education. Innovations such as couples’ HIV testing and in-home testing might also prove valuable for black gay men, because any HIV prevention strategy has to be able to be mapped on to black gay men’s lived experiences. Though the impact of HIV among black gay men is considerable, we currently have the tools to help reduce it. Ensuring access to health care through the Affordable Care Act, more robust research on black gay men, and ensuring innovations in HIV prevention, particularly in the biomedical realm with such strategies as PrEP, will help us move the needle in the epidemic and make significant progress in changing the narrative of black gay men as it relates to HIV.
Charles Stephens is the AIDS United Southern Regional Organizer. His writing has appeared in The Georgia Voice, The Atlanta Journal-Constitution, Lambda Literary Review, The Gay and Lesbian Review, Alternet, WireTap, and the anthologies Think Again, If We Have to Take Tomorrow, and most recently in For Colored Boys Who Have Considered Suicide When the Rainbow is Still Not Enough. He also has a Huffington Post Gay Voices blog. P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
23
Risky busine
Sex workers are threatened by laws and policies that add to their risk of By Enid Vรกzquez
24
J u ly+Au g u s t 2 013
P OS ITIV E LY AWA R E
E
ngaging in prostitution is officially known to put people at greater risk of HIV infection. Ironically, however, social harm drives HIV acquisition for sex workers, a term that’s preferred by advocates because it is not pejorative and covers a greater range of activities. These harms, as for other people with special vulnerability to infection, include such problems as lack of factual information, bad laws arising from negative attitudes, and putting ideology before science. In fact, United States policy harms sex workers worldwide, putting them at greater risk for HIV.
N
Work, not trafficking
ot all sex workers are
ness
f infection
forced or coerced into the sex trades, which include stripping and pornographic films. Movements against sex trafficking (the use of force, fraud, or coercion, or if an individual is under 18), however, for the most part blur the boundary between chosen sex work and trafficking. “We work with people who are engaged in the industry for a variety of reasons,” said Sienna Baskin, an attorney and co-director of the Sex Workers Project (SWP) of the Urban Justice Center in New York City. “Some people are forced into the sex industry or coerced. Some are engaged in sex work because of their circumstances—it may be the only option that they have. Those peoples’ experiences are very different.” Every advocate or organization supporting the human rights of sex workers admits the reality of sex trafficking and strongly opposes it, and they note that sex workers themselves are in a position to help. “I have many clients who were victims of trafficking and the person who helped them was a sex worker,” Baskin said. “You may not be exploited yourself but may be close by. We think this is a really useful and overlooked strategy.” At the same time, advocates note that many people turn to sex work because they don’t have other economic and social options. For everyone engaged in the sex trades, coerced or not, they advocate a human rights and harm reduction approach over use of the criminal justice system.
A
Human rights
t the International AIDS Conference (IAC) in Washington, D.C. in July of last year, advocates called on the U.S. government to adopt the human rights approach
to trafficking used by the United Nations. For example, in the United States there is a visa specifically for foreign victims of human trafficking, but they must testify against their trafficker, a requirement that exposes them to more trauma. In contrast, Baskin said, “A human rights approach would say, ‘Okay, this person is a victim of human trafficking. What do they need?’ They may need services or other rights they’ve been denied. We shouldn’t condition those rights on whether or not they are testifying against their trafficker, which may even be more dangerous.” One “easy” policy tool, she said, would be to take arrests and convictions for prostitution off a person’s criminal record, which could help them obtain jobs in other lines of work. At the IAC, the SWP, among other advocacy organizations, issued a list of demands under the heading A Call to Change U.S. Policy on Sex Work and HIV. Among them was to end “arrests, court proceedings, detention, mandatory testing, or government-mandated ‘rehabilitation’ programs.” Baskin said that a reference to “decriminalization” was avoided because there are so many harms that would still threaten sex workers even if sex work was legalized. For example, police harassment would likely still be prevalent. As another example, would decriminalization lead to regulation and if so, what would that regulation look like? Nevertheless, advocates for sex workers do support decriminalization. Rehabilitative programs are those mandated after an arrest for prostitution. They are sometimes called “diversion” or “alternative to incarceration” programs, and sometimes they take place in conjunction with incarceration. While some are more helpful than others, said Baskin, overall they carry the risk of forcing sex workers, into
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
25
attending activities that do not help them. “Some of these programs look at sex workers in a very judgmental way, as people who need to be fixed in some way,” she said. Moreover, “For those who engage in sex work because they have no other option … they need options, which these programs can’t always provide.” According to a media kit from the Urban Justice Center, “In many places, sex workers are routinely insulted, harassed, and assaulted by police who know there is little or no chance anyone will condemn them for it. These assaults contribute to sex workers’ physical vulnerability, poor health, and cynicism toward legal authorities and social service providers.” The kit notes that “The rights to life, safety, free speech, political action, and access to information and to basic health and education services are as important to sex workers as to anyone else. No one should lose these human rights because of the work they do. Studies show that the most vulnerable sex workers are at high risk for suffering sexually transmitted infections, including HIV/AIDS. Because they are often treated as social outcasts or criminals, sex workers can be difficult to reach with information and tools for protecting themselves and others.” A study of girls in the sex trades in Chicago by the Young Women’s Empowerment Project (YWEP) reported finding more violence and abuse at the hands of health care providers than from the police, albeit not hands-on harm. “Another thing we’ve identified in all our research is the need for health care,” Baskin continued, “which is difficult for anyone to access, but even more so for sex workers. There’s also that deep stigma. They’re afraid to talk about their lives and of being judged or not being treated, or not getting the right kind of treatment, whether it’s for sexual/ reproductive health or other kinds of care.”
A
An anti-prostitution pledge
dvocates are incensed with the
Anti-Prostitution Loyalty Oath that organizations must sign before receiving funds under the President’s Emergency Plan for AIDS Relief (PEPFAR), established by President Bush in 2008. 26
J u ly+Au g u s t 2 013
The pledge states, “The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons. None of the funds made available under this agreement may be used to promote or advocate the legalization or practice of prostitution or sex trafficking.” The Best Practices Policy Project and the Desiree Alliance noted in a joint statement, “These restrictions mean that many organizations are confused about what kinds of services they can provide to sex workers and have, in some situations, led to excellent harm reduction services being shuttered.” To clarify, simply providing sex workers with condoms violates the pledge. Serra Sippel, president of the Center for Health and Gender Equity (CHANGE), said in an IAC press release from SWP and CHANGE, “It is discriminatory policies like the anti-prostitution pledge that will keep us from ever getting ahead of HIV. There is no place for discrimination in an AIDS-free generation.”
B
HIV criminalization
askin called HIV criminalization stigmatizing and said it creates problems such as avoidance of testing or having discussions with sexual partners for fear of potential consequences, which may include criminal charges. “We are worried about how sex workers are affected by these HIV criminalization laws, because they’re already criminalized,” she said. “Will there be added penalties to this or will they have their privacy taken away if they’re mandated to be tested? There are overlapping concerns there.”
P
No safe shelter for kids
arts of the anti-trafficking movement have focused specifically on adolescents, with similar problems resulting as seen with adults. At IAC last year, one session title said it all: “Is Detention Prevention? No! HIV, Policing, and the Harms of ‘Rehabilitative’ Detention for Youth in the Sex Trade.” Young people on the panel talked about the harms they experienced in such programs. “In New York City, if a young person is
P OS ITIV E LY AWA R E
16 and is out on Christopher Street, which is a gathering place for LGBTQ youth of color, they will be exposed to stops, searches, and periodic arrests for merely being present, a person of color, and LGBTQ in a gentrifying neighborhood,” said session chair Brendan Conner, a New York City-based researcher and law school graduate. “Many young people without living wage alternatives trade sex to survive, so the arrests they are subjected to—such as loitering, criminal nuisance, and false personation [having fake ID]—should be precluded on the same principles that Safe Harbor laws apply to prevent delinquency proceedings for crimes with ‘prostitution’ in the title.” Ironically, young people may say they’re over 16 to avoid the institutionalization that is threatened by the Safe Harbor Act (the law in New York intended to protect children in sex trafficking) and its mandate that young people go into child welfare services that many have already run away from because of abusive foster families or physical and sexual violence in custody, such as at a residential treatment center or juvenile detention facility, which Conner called a prison for youth. This lie does not guarantee their safety from arrest, but may expose them to arrest for false personation. Those who are between 7 and 16, the age covered by the Safe Harbor Act, may be required to go to mandatory programs, often residential, including counseling and rehabilitative therapy, even if they have never encountered a pimp. “They are separated from their community of youth, separated from their parents, and isolated in a curriculum that tells them they need to change their behavior, because they are being brainwashed by a pimp,” Conner said. Yet, even teens with a pimp have been refused help under the Safe Harbor Act. “So rather than actually supplying the young person with services—with housing, cash assistance, treatment if they’re living with HIV or gender-affirming health care if they’re transgender—instead, the courts are going to insist that youths actually be arrested and then become wards of the state in the child welfare system,” he said. “The harm that we see is being involved in the child welfare system that disproportionately impacts young people of color and young LGBTQ people in a way that is
often violent, that exposes them to sexual trauma, that is insensitive to their specific needs or sexuality and gender expression, and actually increases the risk of HIV by virtue of involvement in the system, as well as the likelihood that they’ll be incarcerated in juvenile hall and later in adult prison. “There is another way: fully support young people in the sex trades, and let them have access to voluntary services, not mandated services, that are preventative,” Conner said. “These services would reach youth before they become subject to arrest and harassment by the police. Because if the majority are entering the sex trade because they don’t have housing, they don’t have food, they don’t have sexual health options, they don’t have treatment or medical care, then if we can provide these things, it will reduce or prevent the harm of arrest at the same time as it remedies the lack of voluntary services.” The advocates for anti-trafficking efforts have good intentions, he said, but they don’t talk with youth about their needs and end up creating policies that look good on paper but don’t work in practice. They also make it appear the overwhelming majority of youth in the sex trade are girls who are “pimped” by older men, when in fact, a groundbreaking study released in 2008 by the John Jay College of Criminal Justice in New York City reported that nearly half of the local youth in the sex trade surveyed, 45 percent, were boys, and many were transgender (eight percent). Just as importantly, only a minority, 10 percent, had a pimp, while the vast majority said they were working in the sex trade on their own. The Chicago research also found little involvement by pimps. “So when the police are applying the Safe Harbor laws, they look for youth who fit this template of the young, shivering girl with some older man nearby watching her. They apply racial and sexual stereotypes to both the young person perceived as a ‘victim’ and any person around who may fit the police profile of a pimp—including the youth’s peers. At the same time, the same police may arrest a young transgender girl, or a young boy or girl who
doesn’t have a pimp, for whom the Safe Harbor Act is not perceived to be an option,” he said. In fact, the lead researcher on the 2008 study, Ric Curtis, was quoted in the Village Voice as saying he was “outraged” that advocates continued to focus on girls, when boys were the most victimized children he met, especially straight boys. Programs that arrest and involuntary commit young people violate international legal protections under the Convention on the Rights of the Child, said Conner. He also pointed to Recommendation 3.2.7 of a report by the UN Commission on HIV and the Law. It calls for an end to “compulsory detention or ‘rehabilitative’ centers for people involved in sex work or for children who have been sexually exploited,” and offering “evidence-based, voluntary, community empowerment services” instead, along with safe settings for children.
No one, not even the youth themselves, is saying that it’s ideal for adolescents to enter the sex trades. Using a model of human rights and harm reduction, however, advocates look to what’s helpful to young people and the needs that they identify, working towards any positive change and preventing more harm. Moralizing doesn’t help, said Conner. Go to PositivelyAware.com to read more of the interview with Brendan Conner and see the September+October 2012 issue for IAC coverage on labor rights for sex workers and condom confiscation used as legal evidence of prostitution.
A study by the John Jay College of Criminal Justice in New York City reported in 2008 that of the local youth in the sex trade surveyed, 45 percent were boys, and Eight percent were transgender.
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
27
What is STRIBILD? STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. It combines 4 medicines into 1 pill to be taken once a day with food. STRIBILD is a complete single-tablet regimen and should not be used with other HIV-1 medicines. STRIBILD does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking STRIBILD. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.
IMPORTANT SAFETY INFORMATION What is the most important information I should know about STRIBILD? STRIBILD 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 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.
• Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking STRIBILD, your hepatitis may suddenly get worse. Do not stop taking STRIBILD without first talking to your healthcare provider, as they will need to monitor your health. STRIBILD is not approved for the treatment of HBV. Who should not take STRIBILD? Do not take STRIBILD if you: • Take a medicine that contains: alfuzosin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil when used for lung problems (Revatio®), triazolam, oral midazolam, rifampin or the herb St. John’s wort. • For a list of brand names for these medicines, please see the Brief Summary on the following pages. • Take any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera®). What are the other possible side effects of STRIBILD? Serious side effects of STRIBILD may also include: • 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. • Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones. • Changes in body fat can happen in people taking HIV-1 medicines. • Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking STRIBILD. The most common side effects of STRIBILD include nausea and diarrhea. Tell your healthcare provider if you have any side effects that bother you or don’t go away.
What should I tell my healthcare provider before taking STRIBILD? • All your health problems. Be sure to tell your healthcare provider if you have or had any kidney, bone, or liver problems, including hepatitis virus infection. • All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking STRIBILD without first talking with your healthcare provider. • If you take hormone-based birth control (pills, patches, rings, shots, etc). • If you take antacids. Take antacids at least 2 hours before or after you take STRIBILD. • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. Also, some medicines in STRIBILD can pass into breast milk, and it is not known if this can harm the baby. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see Brief Summary of full Prescribing Information with important warnings on the following pages.
STRIBILD is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD does not cure HIV-1 or AIDS.
I started my personal revolution Talk to your healthcare provider about starting treatment. STRIBILD is a complete HIV-1 treatment in 1 pill, once a day.
Ask if it’s right for you.
Patient Information STRIBILDTM (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 (Combivir®, Emtriva®, Epivir® or Epivir-HBV®, Epzicom®, Kaletra®, Norvir®, Trizivir®) 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 contains 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 hydrochloric (Vascor®, Bepadin®) - bosentan (Tracleer®) - buspirone - carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegreto®) - 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: August 2012
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. © 2013 Gilead Sciences, Inc. All rights reserved. QC15554 01/13
Sticking it to HIV
How lifting the ban on funding needle exchange would save lives and money By Sue Saltmarsh
I
n over 200 offices and traveling vans in 34 states,
injection drug users (IDUs) can turn in used needles and syringes, knowing they will be disposed of safely, and receive a supply of new, clean equipment thanks to needle exchange programs (NEPs), also known as syringe services programs (SSPs). It’s not cheap to run these programs and it doesn’t help that federal funding of them has been banned, even though the public health and safety benefits of these programs have been indisputably proven. One of the first good things that President Obama did when he took office in 2009 was to lift the ban on federal funding for needle exchange programs, but with the 2010 Republican takeover of the House, those days were over and the ban was quickly reinstated, leaving these programs once again in danger of closing down. In the midst of the alarm bells ringing over sequestration back in March, the Foundation for AIDS Research (amfAR) and the National Minority AIDS Council published fact sheets on the ban, stressing the importance of advocating for lifting it. They have impressive facts to back their argument. Unfortunately, in the Continuing Resolution that will fund the government until September 30, the ban was not lifted. At the time this is being written (May), uncertainty about almost everything budgetary is about the only consistency. By the time this is published, there may well be a
32
J u ly+Au g u s t 2 013
heated battle over the debt ceiling going on, Ryan White funding may be in more danger, who knows if the sequester will still be in effect or if the Affordable Care Act (ACA) has been decimated even further. But even with all that uncertainty, the facts about syringe services programs are still facts and advocacy must continue.
Show us the money
A
nyone living with HIV knows that, regardless of their own financial situation, treating HIV isn’t cheap. According to amfAR, the lifetime cost of treating someone with HIV is between $385,200 and $619,800. Because HIV-positive injection drug users are often uninsured and reliant on Medicaid, Medicare, Ryan White, or the AIDS Drug Assistance Program (ADAP) for their care and medications, most of that
P OS ITIV E LY AWA R E
cost is paid by taxpayers. Hepatitis C (HCV) is also common in IDUs and, though treatment may not be lifelong and recent advances have resulted in higher cure rates, it costs hundreds of millions of dollars annually. In addition to cutting down the rate of new HIV infections, needle exchange programs also prevent the spread of HCV. A recent study in New York City showed that from 1990 to 2001, when the number of NEPs grew, HCV prevalence among IDUs decreased from 90% to 63%. Data from a variety of studies have proven that the cost effectiveness of SSPs
cannot be denied. For legislators who claim desperate concern over the “out-ofcontrol” spending of the federal government, it would seem to be a no-brainer to fund programs that cost less than 50¢ per individual needle and syringe in order to save millions.
Healing potential
B
ut saving
money isn’t the only argument. SSPs provide a direct connection to substance abuse treatment, thus breaking the cycle of substance use and supporting the recovery of the people who are ready for it. If that sounds like a liberal debate point, there is also data to support the fact that SSPs help those struggling with substance use to repair their lives and become productive, contributing members of society. In one study, employment increased by almost 45% within six months for clients who went to a federally-funded SSP. Legislators in both parties who may be philosophically opposed to harm reduction should be happy to have more responsible taxpayers in the population. SSPs also provide a pathway to mental health treatment, with clients being 25% more likely to be linked to mental health care and medication.
Public protection
F
or police and other first
responders, having an SSP in an area populated by many IDUs can make a huge difference. In a recent survey of San Diego police officers, nearly 30 percent reported having been stuck by a needle at least once. Paramedics
and other emergency personnel are also at risk if needles aren’t disposed of properly. Neighborhood safety is also a consideration. SSPs encourage proper disposal of used equipment, so the probability of infected needles and syringes being thrown in public waste cans or even on the ground where neighborhood residents, including children, could come in contact with them is lessened.
Facts don’t lie So let’s review: n Decreased new HIV and HCV infections n Fewer deaths n Increased linkage to substance abuse treatment n Increased linkage to mental health treatment n Increased employment and productivity n Increased safety for first responders, medical personnel, and neighborhood residents n Improved health and happiness What could possibly be the objection? This is it—“providing clean needles will only increase injection drug use.” Just like handing out condoms makes people have more sex. Or teaching about contraception only makes more teenagers sexually active. Or having an abortion causes breast cancer. Or same-sex marriage destroys “traditional” marriage. Once again, flawed, intransigent ideology ignores the reality and stands in the way of scientifically proven fact and undeniable fiscal prudence.
What will it take?
O
ne must wonder what would have to happen for cut-happy conservatives to realize there is a point of diminishing returns. Even though common sense, and any honest medical provider, would tell them that prevention is far better than treatment—for employment, the economy, and in terms of individual and national health—such practical points seem to fall on deaf ears. Chris Collins, Vice President and
Director of Public Policy at amfAR, told Positively Aware that language about
funding SSPs is included in omnibus Appropriations bills (meaning one bill that contains appropriations for several departments) rather than in a stand-alone bill (like the Ryan White CARE Act) and that it would be wishful thinking to imagine that progress can be made for fiscal year (FY) 2013, which ends in September. Hopefully, after the 2014 election, if voters do their job, Congress will contain more legislators who would support lifting the ban. However, Collins explained, even from 2009 to 2011, when the ban was lifted, “There was no money set aside specifically to fund SSPs—it was just up to state and local governments to decide if they would use federal funds to support them.” During that time, California, Connecticut, Delaware, Illinois, Massachusetts, Minnesota, New Jersey, New Mexico, New York, Puerto Rico, Vermont, and Washington all decided in favor of it. Today, SSPs currently rely on state, municipal, and private funding. This means that only 3% of all injections estimated per year can be made safer with SSP-provided sterile syringes. “Lawmakers need to realize that SSPs save lives and dollars,” says Collins. “They need to let local and state officials decide how to use federal funds most effectively.” According to a recent analysis, the $64 million it would cost to expand SSPs to cover just 10% of all injections would prevent almost 500 new HIV infections and save the $193 million it would cost to treat those people. For every dollar spent, three would be saved—what better “ROI” (return on investment) could they ask for?
grassroots activism
W
illiam McColl, Political
Director at AIDS Action, one of the advocacy organizations working with amfAR and NMAC towards the goal of lifting the ban, said that while there is periodic consideration of introducing language in either a Senate stand-alone bill or one serving as a “vehicle,” [a bill to
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
33
It would seem to be a no-brainer
to fund programs that cost less than 50¢ per needle and syringe in order to save both millions of dollars and lives.
which SSP funding could be attached in an amendment], the reason it hasn’t been done is that if there is a lack of co-sponsors (as expected), it would weaken the legislation. So advocates end up going back to putting language for it in the big Appropriations bills. “We need to get out of that cycle,” says McColl, adding that with the minimal amount of Republican support over the last 20 years, he doesn’t see how that cycle can be broken. Both Collins and McColl mentioned the need for grassroots support, for people to become more active with their legislators and in their communities. McColl noted that Kentucky Republican Congressman Hal Rogers, Chairman of the House Appropriations Committee, has been willing to listen to law enforcement officers who are against the ban and it’s this kind of interaction that will make a difference. “We are going to have to change critical minds in the conservative wing of the Republican Party,” says McColl. “We must adapt our strategy, do one-on-one work at the local level, pull in police and first responders and religious leaders. We’re working really hard—I have faith it’s going to happen.”
Until it happens
I
n the big picture of all the funding cuts, inequality of wealth, lack of health care, social injustice at every turn, some may think spending time and effort on making injection drug use safer is a misguided goal. Injection drug users are breaking the law, after all. It’s “those people” who are creating problems, not us, right? But what about gay, lesbian, bi, and transgender people? What about children, teachers, factory workers, homeless vets? What about that police officer, ambulance driver, or firefighter who puts his life on the line to save the lives of strangers? What 34
J u ly+Au g u s t 2 013
about you? Anyone could be infected by an accidental needle stick, not to mention that HCV and other infections could be passed on to any of us. It’s not a matter of “certain people”—it’s a public health issue. By making sure needles are clean, we all benefit. No matter what other categories we fall under, we are, at our essence, creatures of the same genus. And as humans, we have the ability to make life either easier or harder for each other, to create the families, communities, and societies in which we want to live and can thrive. Maybe you have “cause fatigue”—as one activist says, “It’s not one thing, it’s everything!” Maybe it just seems best to shut your eyes, stand still, and be silent. And you can. But throughout the history
P OS ITIV E LY AWA R E
of humankind, complacency has never changed anything for the better. If you or someone you care about is struggling with injection drug use, this may be a cause for which you can choose to become an activist. Has a needle exchange program helped you or someone you know? Has an SSP in your town had to shut down due to lack of funding? Talk to your local and state politicians, start or join an advocacy group, support amfAR, AIDS Action, and NMAC in their advocacy, call, write, or email your senators and congressmen/ women. Who knows? You might be the one who makes a difference. Go to amfar.org/endtheban for more,
including video.
HEP C MEDS:
InGREDIENTS FOR A CURE
New and better hep C combination treatments coming to your pharmacy this year
I
By Brett Grodeck
f you have the hepatitis C virus— abbreviated simply as HCV—there’s good news. New reports about anti-HCV drugs are showing best-ever success rates. Several pharmaceutical companies presented results of completed and ongoing clinical trials at the 48th International Liver Congress held in Amsterdam earlier this year.
Worldwide, 170 million people have HCV. In the U.S., at least four million have HCV, making it
more prevalent than headline-grabbing HIV. While HCV lacks media attention, it has the full attention of pharmaceutical companies. By 2015, the market for HCV drugs, according to a report by MarketResearch.com, will be $12 billion annually. Pharmaceutical companies are creating and testing new HCV drugs to compete for profits. They are vying for the attention of you and your doctor. They are trying to tout their new drugs and old drugs used in new ways. These days, however, the news is genuinely impressive. >>
P OS ITIV E LY AWA R E
Inside n Current HCV treatments n A look at 11 experimental HCV drugs
J u ly+Au g u s t 2 013
35
HEP C MEDS: InGREDIENTS FOR A CURE
>> Multi-drug combinations are, in fact, showing higher-than-ever success rates, placing a cure within easier and faster reach. Interferon and ribavirin, until recently the standard of care for treating HCV, come with injections, many side effects, and low success rates. The goal will be to mix and match these new all-oral HCV drugs with as little interferon and ribavirin as possible—even none at all. HCV treatment decisions depend on your particular stage of liver damage and the type of HCV (genotype) you have. When considering treatment, remember that more and better HCV options may be available within a year. If you have HCV and HIV, treatment is still more complicated, but your options are also improving.
What an HCV cure looks like How do you measure success against a virus? One benchmark for success against HCV is called sustained virologic response, or in doctor lingo, SVR. Sustained virologic response is when the virus level stays below the current limit of detection for a given
length of time after stopping treatment. In patient lingo, that’s called undetectable. If you stop treatment, and you continue being undetectable for life, you’re cured.
Roadmap to a cure New HCV drugs haven’t been around for long. So it’s impossible to say that new HCV drugs qualify as a cure. Only time will tell. Meanwhile, here’s a cheat sheet: SVR for 4 weeks: Wait and see. SVR for 8 weeks: A good sign for continued testing in clinical trials. SVR for 12 weeks: A great benchmark to evaluate new drugs. SVR for six months: A very good sign that you’ll continue to stay undetectable. SVR for the rest of your life: That’s a cure.
Current HCV treatments HCV has six variations called major genotypes: Types 1 through 6. In the U.S., Type 1 makes up about 70% of cases, and is unfortunately the most difficult to treat. Type 2 makes up another 20% of cases. In South America and Europe, the most common is also Type 1. Some types are easier to treat than others, and there are even more variations among subtypes, such as 1a and 1b. “I tell people to think about committing a year of their lives to treating HCV—six months if they’re lucky to have a nice genotype,” says Cyril Gaultier, MD, a Los Angeles-based physician who treats HIV and HCV. “And don’t underestimate the potential side effects of these drugs.”
interferon Other names of anti-HCV interferon: n PEGylated interferon alpha 2a n PEGylated interferon alpha 2b n Pegasys n Reiferon Retard n PegIntron n Pegetron For simplification, this guide refers to pegylated interferon alpha as interferon.
36
J u ly+Au g u s t 2 013
With current therapies, interferon and a drug called ribavirin remain the cornerstone of HCV treatment. Interferon is a natural protein that your immune system secretes to help fight viruses, bacteria, parasites, and cancer cells. Researchers identified the protein while studying the flu virus in 1957. They noticed an interference effect against the flu virus and coined the term interferon. In the 1970s, an expensive man-made version was available. In the 1980s, scientists cloned the genes for interferon, which allowed drug companies to massproduce a version called recombinant interferon. In 2001, a pegylated version of interferon became available. Pegylated means that the interferon stays in your body longer, so you need fewer injections. Rather than injecting interferon three times a week, pegylated interferon is injected only once a week. Interferon comes in different “flavors,” such as alpha, beta, and gamma. The one that’s most active against HCV is interferon alpha. P OS ITIV E LY AWA R E
How interferon works
Interferon stimulates immune cells, including natural killer cells and macrophages (white blood cells that “clean up” and digest cellular debris). Side effects and drug interactions
There are problems with interferon. Death is the worst one. Death by interferon can come from worsening of existing diseases or mental problems, which can lead to suicide. People develop mood or behavior problems that get worse with interferon. Mood problems run the gamut, from irritability, depression, aggressive behavior, thoughts of hurting yourself or others, or thoughts of suicide. Former drug addicts may fall back into drug addiction or overdose. “I’ve done three courses of interferon and each time it was miserable,” says Michael K., who’s taken interferon for HCV. “There’s the needle injection. From there, it gets worse. You start feeling warm. Then you feel achy. Maybe you get a dull headache. At its worst,
it feels like a bad case of the flu—except it comes and goes over months and months. Over time, you start noticing hair loss. It wears on you. It’s easy to lose your optimism. It’s definitely not for anyone with a
history of depression.” While not everyone’s experience is the same, and some of the newer oral treatments allow for shorter duration of treatment with interferon, clearly an alternative is needed.
Nucleoside drugs The second part of the cornerstone of HCV treatment is a drug called ribavirin and it’s considered a nucleoside drug. Nucleoside is the name given to individual pieces of DNA and RNA. When a nucleoside drug interferes with the nucleoside of a virus (as it does with HIV nucleoside drugs), it can’t reproduce, so the virus dies off. In the last 10 years, the pharmaceutical companies have been creating and testing various nucleoside drugs for HCV.
ribavirin pronounced
rye-bah-VYE-rin Among the various names of ribavirin: n ribavirin n Copegus n Rebetol n Ribasphere n Vilona n Virazole n Taribavirin n viramidine n ribamidine For simplification, this guide refers only to the generic name: ribavirin.
Ribavirin is a relatively old nucleoside. In 1970,
Women and ribavirin
ICN Pharmaceuticals created the drug, but it wasn’t until 1980 that the FDA approved an inhalant form of the drug for children. The FDA then approved a pill form in 1998. However, by then the original patent owned by ICN had expired. So other pharmaceutical companies created various knock-offs of the original drug.
The second biggest problem with ribavirin is that it is teratogenic. This means the drug could potentially harm unborn children. Men aren’t supposed to take ribavirin if their female partners are pregnant. Female partners of men on ribavirin must agree to use contraceptives. Ribavirin can cause birth defects and fetal death. For this reason, the drug should never be used by pregnant women. In fact, before starting on ribavirin, women are supposed to: n have a negative pregnancy test n have monthly pregnancy tests n use two or more contraceptives during treatment n use contraceptives for at least six months after treatment
How ribavirin works
Mainly, the drug interferes with DNA and RNA in some types of viruses, which blocks the virus from reproducing. Some research suggests that ribavirin may alter the immune system so it can better fight certain viral infections. Side effects and drug interactions
Anemia is a big problem with ribavirin. Anemia is when hemoglobin, a critical type of red blood cell, declines to unhealthy levels. When taking the drug, people may see hemoglobin levels decline. The good news is that anemia is easy to detect and usually spotted early. Still, about 10 percent of people who take ribavirin have some cardiac or pulmonary issues linked to anemia.
For people with HCV and HIV
For people with HCV and HIV, two studies found drug interactions: n ribavirin plus zidovudine (Retrovir or AZT) resulted in substantially higher incidence of anemia n ribavirin plus didanosine (Videx) resulted in unacceptable levels of mitochondrial toxicity
Protease drugs In the 1990s, the protease inhibitor class of drugs was a breakthrough for HIV medicine. When used in combination with other drug classes, the protease inhibitors put the kick in the HIV cocktail. In 1996, in a single year, the HIV cocktail cut AIDS deaths in half. Protease inhibitors are potent. But they always come with side effects. One HIV protease drug worth noting is ritonavir (Norvir), pronounced rit-TAH-na-vir. It’s an older protease inhibitor, one that—by itself—has fallen out of favor. However, the surprise value of ritonavir is that it boosts the level of other drugs. Now, doctors use a pinch of ritonavir to boost other drugs. This is called ritonavir-boosted treatment. Some experimental HCV combinations include ritonavir. When ritonavir is used for HIV, some HCV drugs have unwanted drug interactions. Using ritonavir is tricky. Keep that in mind.
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
37
HEP C MEDS: InGREDIENTS FOR A CURE
Guide to HCV Drugs The following sections offer a snapshot of HCV drugs and drug combinations as of May 2013. The sections draw from published research and interim results as reported by pharmaceutical companies.
know the lingo
To better understand the following tables, here are some key definitions for terms: Genotype: There are six types of hepatitis C virus and some are harder to treat than others. SVR: Sustained virologic response is the time you stay undetectable after treatment stops. Treatment-naïve: If you’ve never tried treatment before, you’re called treatment-naïve. No offense, it’s doctor lingo. Treatment-experienced: If you’ve had treatment before, you’re called treatment-experienced. You have wisdom. For people with HCV and HIV
“Treat the HIV first, so you can treat the HCV later,” says Dr. Gaultier. “You need to fix the immune
system first with HIV treatment in order to get an optimal response from HCV treatment. If your T-cells are high, then you’ll have a better chance of success with HCV treatment. “But if your T-cells are below 300 or 400, I would worry about getting the T-cells higher and making the immune system stronger.” One other worry is the negative effect that HIV treatment has on your liver. But Gaultier notes that it really depends on the level of liver damage and the strength of the immune system. Also important is that any ribavirin-containing regimen is likely to cause unacceptable anemia in people on HIV treatment. Lastly, interferon only works when your T-cells are high. For many with HIV, unless your T-cells are 400 or higher, interferon is relatively useless.
Current HCV drugs Incivek generic name:
telaprevir pronounced
teh-LAP-reh-veer
The first HCV protease inhibitor to market was telaprevir, taken as two tablets, three times a day, with food (at least 20 grams of fat). Its maker Vertex earned FDA and EMA (Europe’s version of the FDA) approvals in 2011. In the U.S., Vertex branded telaprevir as Incivek. In the E.U. (European Union), the drug is called Incivo. Incivo was recently approved by the EMA for twice daily dosing. Technically, it’s supposed to be used only against HCV genotype 1 and should be taken with interferon and ribavirin. In 2012, a boxed warning was added to the label highlighting
a serious and potentially fatal rash and skin reaction in a small number of patients. If this occurs, you should discontinue use immediately and see a doctor for urgent medical care. Side effects and drug interactions
The most common side effects were rash, itching, anemia, and nausea. Some rashes and skin reactions can become fatal. Telaprevir interacts with other medications, including some HIV drugs—be sure to check the full prescribing information.
summary of telaprevir
38
J u ly+Au g u s t 2 013
DRUG COMBINATION
TREATMENT DURATION
telaprevir interferon ribavirin
12 weeks of telaprevir
interferon ribavirin
48 weeks
telaprevir interferon ribavirin
12 weeks of telaprevir
interferon ribavarin
48 weeks
P OS ITIV E LY AWA R E
48 weeks of interferon and ribavirin
48 weeks of interferon and ribavirin
GENOTYPE AND POPULATION
RESULTS
Type 1 Treatment-naïve
24 weeks after treatment, SVR was 79%
Type 1 Treatment naïve
24 weeks after treatment, SVR was 46%
Type 1 24 weeks after treatTreatment-experienced ment, SVR was 86% Type 1 24 weeks after treatTreatment-experienced ment, SVR was 22%
Victrelis GENERIC NAME:
boceprevir pronounced
bo-SEP-reh-veer
The second HCV protease inhibitor to gain FDA and EMA approval in 2011 was Merck’s boceprevir, brand name Victrelis. Boceprevir is supposed to be used with interferon and ribavirin, four capsules three times a day. While boceprevir’s original results were modest, the drug is being tested in combination with: vaniprevir (see page 44) MK-5172 (see page 44) Side effects and drug interactions
The most common side effects were rash, itching, anemia, and nausea. Some rashes and skin reactions can become fatal. Boceprevir interacts with other
Victrelis
medications, including some HIV drugs, so check the full prescribing information and remember, you can ask your pharmacist, too. For people with HCV and HIV
In February of 2012, Merck issued a warning letter that its drug boceprevir may cause undesired drug interactions when taken along with ritonavir or ritonavir-boosted HIV protease inhibitors. “The safety and efficacy of Victrelis (boceprevir) has not been established in this co-infected population,” according to the letter. “Merck does not recommend the co-administration of Victrelis and ritonavir-boosted HIV protease inhibitors.”
when taken with…
caused…
Norvir (ritonavir) plus Reyataz (atazanavir)
drug levels drop 49%
Norvir (ritonavir) plus Prezista (darunavir)
drug levels drop 59%
Norvir (ritonavir) plus lopinavir
drug levels drop 43%
Earlier clinical trial results with boceprevir DRUG COMBINATION
TREATMENT DURATION
boceprevir interferon ribavirin
48 weeks of interferon and ribavirin
interferon ribavirin
48 weeks
Type 1 Treatment-naïve
24 weeks after treatment, SVR was 38%
boceprevir interferon ribavirin
48 weeks
Type 1 Treatment-experienced
24 weeks after treatment, SVR was 66%
interferon ribavirin
48 weeks
Type 1 Treatment-experienced
24 weeks after treatment, SVR was 21%
44 weeks of boceprevir, starting at week 5 of 48
GENOTYPE AND POPULATION
Type 1 Treatment-naïve
RESULTS
24 weeks after treatment, SVR was 66%
HCV around the world
In the U.S., at least 4 million Out of 314 Million AMericans have HCV. Worldwide, Out of a population of just over 7 billion, 170 million have HCV.
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
39
HEP C MEDS: InGREDIENTS FOR A CURE
Experimental HCV drugs As of May 2013, at least three pharmaceutical companies have filed applications for new HCV drugs with the FDA. Two companies received “priority review” status, which means that the FDA should decide within six months. What’s clear is that, like HIV, there’s no single magic bullet. The path to success will be with a combination of two, three, or maybe four antiviral drugs that attack the virus from different angles. In contrast to immuneboosting drugs, drugs that directly attack are sometimes called “direct-acting antiviral agents” or DAAs. For interferon and ribavirin, the problem has been too many side effects versus too few benefits. Most people have avoided or been unable to tolerate treatment because of interferon’s flu-like symptoms that last for almost a year and cures rates of only 30 to 40%. Other people avoid ribavirin because of drug interactions and anemia. Most people figure the treatment is worse than the disease. The goal then is to mix and match new HCV drugs—with as little interferon and ribavirin as possible—to achieve lifelong SVR. Following are some of the investigational drugs that are furthest along in development.
sofosbuvir pronounced
so-FOS-bue-veer
A once-daily pill that falls into the nucleoside class. In April, Gilead submitted a new drug application to the FDA for sofosbuvir to treat HCV. Gilead also reported that the European Medicines Agency (EMA) accepted its request for “accelerated assessment” of sofosbuvir. Regulatory approvals could come by end of 2013. “If approved, sofosbuvir would shorten HCV therapy to 12-to-16 weeks,” according to Gilead, “and
depending on the genotype, would either eliminate or reduce the duration of [interferon] injections.” Side effects
Side effects occurred more often in people receiving interferon and ribavirin as compared to people receiving sofosbuvir and ribavirin. The most common side effects were fatigue, headache, nausea, insomnia, and dizziness.
sofosbuvir plus ribavirin compared against interferon plus ribavirin DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
sofosbuvir ribavirin
12 weeks
Type 2 Treatment-naïve
12 weeks after treatment, SVR was 97%
sofosbuvir ribavirin
12 weeks
Type 3 Treatment-naïve
12 weeks after treatment, SVR was 56%
interferon ribavirin
24 weeks
Type 2 Treatment-naïve
12 weeks after treatment, SVR was 78%
interferon ribavirin
24 weeks
Type 3 Treatment-naïve
12 weeks after treatment, SVR was 63%
Another study combined sofosbuvir with interferon and ribavirin among people with harder-to-treat genotypes
40
J u ly+Au g u s t 2 013
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
sofosbuvir interferon ribavirin
12 weeks
Type 1 Treatment-naïve
12 weeks after treatment, SVR was 89%
sofosbuvir interferon ribavirin
12 weeks
Type 4 Type 5 Type 6 Treatment-naïve
12 weeks after treatment, SVR was 97%
P OS ITIV E LY AWA R E
ledipasvir pronounced
le-dip-as-veer
Another Gilead drug, ledipasvir falls under the nucleoside class. Ledipasvir and sofosbuvir are being studied together—both with and without ribavirin. Gilead is working on sofosbuvir plus ledipasvir as a “fixed dose” single pill on the premise of simplifying HCV treatment. In May of 2013, Gilead reported an update to its ongoing trials of this combination—with and without ribavirin—in both treatment-naïve and
treatment-experienced people. The company is angling toward new combinations and shorter durations. Side effects
Both sofosbuvir in combination with ledipasvir, and sofosbuvir in combination with ledipasvir and ribavirin were “well tolerated,” according to the company.
Interim results from a recent study
simeprevir pronounced
si-meh-preh-veer
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
sofosbuvir ledipasvir
8 weeks
Type 1 Treatment-naïve
8 weeks after treatment, SVR was 95%
sofosbuvir ledipasvir ribavirin
8 weeks
Type 1 Treatment-naïve
8 weeks after treatment, SVR was 100%
sofosbuvir ledipasvir
12 weeks
Type 1 Treatment-naïve
4 weeks after treatment, SVR was 100%
sofosbuvir ledipasvir
12 weeks
Type 1 Treatment-experienced
4 weeks after treatment, SVR was 95%
sofosbuvir ledipasvir ribavirin
12 weeks
Type 1 Treatment-experienced
4 weeks after treatment, SVR was 95%
A second-generation HCV protease inhibitor, simeprevir is being developed by Janssen. The company has filed a new drug application with the FDA and has received priority review status. Simeprevir is one pill, taken once daily, and is also being studied in combination with other HCV drugs, such as sofosbuvir and daclatasvir, with and without ribavirin. However, the basis of the new drug application is from three key studies.
Side effects
Anemia was seen among people whose regimens contained ribavirin. At 12 weeks, about one in 10 had anemia. At 24 weeks, about one in four had anemia. Anemia was absent in ribavirin-free regimens. Common side effects were fatigue, headache, insomnia, and nausea.
results from a study
DRUG COMBINATION
TREATMENT DURATION
simeprevir interferon ribavirin
12 weeks of simeprevir
interferon ribavirin
12 weeks
Treatment with interferon and ribavirin lasted for either 24 or 36 weeks
GENOTYPE AND POPULATION
RESULTS
Type 1 Treatment naïve
12 weeks after treatment, SVR was 80% Note that 85% of people were able to stop interferon at week 24 instead of week 36
Type 1 Treatment naïve
12 weeks after treatment, SVR was 50%
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
41
HEP C MEDS: InGREDIENTS FOR A CURE
simeprevir/ sofosbuvir combination
Impressive results were seen from a trial that
For people with HCV and HIV
combined two drugs, one from Janssen and one from Gilead. The study, conducted in Japan, examined Janssen’s simeprevir and Gilead’s sofosbuvir— with and without ribavirin. The study was done in treatment-experienced people, who tend to get the lowest SVR rates. No serious side effects were seen.
Several ongoing studies are assessing simeprevir in HCV treatment-naive and HCV treatment-experienced people who are co-infected with HIV. Janssen is conducting various HIV drug interaction studies.
Interim results of this combination among treatment-experienced people
daclatasvir pronounced
dah-CLAA-tas-veer
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
simeprevir sofosbuvir
12 weeks
Type 1 Treatment-experienced
4 weeks after treatment, SVR was 93% 12 weeks after treatment, SVR was 100%
simeprevir sofosbuvir ribavirin
12 weeks
Type 1 Treatment-experienced
4 weeks after treatment, SVR was 96% 12 weeks after treatment, SVR was 100%
simeprevir sofosbuvir
24 weeks
Type 1 Treatment-experienced
4 weeks after treatment, SVR was 100% 12 weeks after treatment, SVR was 100%
simeprevir sofosbuvir ribavirin
24 weeks
Type 1 Treatment-experienced
4 weeks after treatment, SVR was 67% 12 weeks after treatment, SVR was 100%
A nucleoside drug, daclatasvir is being developed
Side effects
by Bristol-Myers Squibb (BMS). The company is clear about its plans to combine daclatasvir with two other BMS drugs into a “fixed dosed” single pill.
Nausea and dry skin were reported 10% more often with daclatasvir versus placebo.
results of a 2011 study
daclatasvir/ sofosbuvir combination
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
daclatasvir interferon ribavirin
24 weeks
Type 1 Type 4 Treatment-naïve
12 weeks after treatment, SVR was 78%
interferon ribavirin
24 weeks
Type 1 Type 4 Treatment-naïve
A controversial combination is sofosbuvir plus daclatasvir. Taken together, these two drugs deliver remarkable results with minimal side effects. Gilead, the owner of sofosbuvir, opted not to partner with Bristol-Myers Squibb, which owns daclatasvir. Gilead’s plan to forgo a partnership has sparked
12 weeks after treatment, SVR was 43%
controversy among patient advocates. See treatmentactiongroup.org/tagline/2013/spring/g-word. Side effects
Mild-to-moderate side effects included fatigue and headache. No serious side effects were seen.
highlights of a small study conducted among difficult-to-treat patients
42
J u ly+Au g u s t 2 013
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
daclatasvir sofosbuvir
24 weeks
Type 1 Treatment-experienced
4 weeks after treatment, SVR was 100% 12 weeks after treatment, SVR was 100%
daclatasvir sofosbuvir ribavirin
24 weeks
Type 1 Treatment-experienced
4 weeks after treatment, SVR was 100% 12 weeks after treatment, SVR was 95%
P OS ITIV E LY AWA R E
asunaprevir pronounced
ah-soo-nah-preh-veer
A protease inhibitor, asunaprevir is being developed
Side effects
by BMS. Last year, the company studied the combination of asunaprevir and daclatasvir among a small group of treatment-experienced people. On average, people with genotype 1 have a cure rate of about 45% when treated with interferon alpha and ribavirin.
In this small study, serious side effects did occur: fever and high bilirubin levels. The most common side effects were diarrhea and elevated liver enzymes.
results of a 2012 study
BMS-791325
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
daclatasvir asunaprevir
12 weeks
Type 1 Treatment experienced
12 weeks after treatment, SVR was 78%
A non-nucleoside drug, BMS-791325 is being
Side effects
studied by Bristol-Myers Squibb along with its drugs daclatasvir and asunaprevir. In HIV medicine, nonnucleosides are a distinct drug class. For HCV, the beneficial distinctions of a non-nucleoside drug class have yet to be fully described.
Most side effects were mild to moderate in severity. The most common was headache (about 27%). Other common side effects were loss of strength, diarrhea, and nausea.
interim results of a protease drug, a nucleoside drug, and non-nucleoside drug
faldaprevir pronounced
fal-dah-preh-veer
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
asunaprevir daclatasvir BMS-791325
12 weeks
Type 1 Treatment-naïve
12 weeks after treatment, SVR was 94% 24 weeks after treatment, SVR was 88%
asunaprevir daclatasvir BMS-791325
24 weeks
Type 1 Treatment-naïve
12 weeks after treatment, SVR was 94% 24 weeks after treatment, SVR was 94% 36 weeks after treatment, SVR was 88%
An HCV protease inhibitor, faldaprevir is being developed by Boehringer Ingelheim. The company is hoping faldaprevir becomes one ingredient in both interferon-based and interferon-free HCV combinations. “We’re developing faldaprevir as a potential foundation for both interferon-based and interferonfree treatment regimens,” said Peter Piliero, MD, at
Boehringer Ingelheim. ”We’re optimistic that ongoing studies with our pipeline compounds will lead to faldaprevir-based interferon-free regimens for patients with HCV.” Side effects
Anemia, gastrointestinal issues, and rash were the most adverse events seen in this study.
results from a recent study
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
faldaprevir (120 mg) interferon ribavirin
12 weeks of faldaprevir 24 weeks of interferon and ribavirin
Type 1 Treatment-naïve
12 weeks after treatment, SVR was 79%
faldaprevir (240 mg) interferon ribavirin
12 weeks of faldaprevir
Type 1 Treatment-naïve
12 weeks after treatment, SVR was 80%
interferon ribavirin
24 weeks of interferon and ribavirin
Type 1 Treatment-naïve
12 weeks after treatment, SVR was 52%
24 weeks of interferon and ribavirin
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
43
HEP C MEDS: InGREDIENTS FOR A CURE
vaniprevir pronounced
van-ip-preh-veer
A protease inhibitor, vaniprevir is being tested by Merck. On its own, vaniprevir may not seem remarkable. However, the company is studying the combination of vaniprevir with other drugs: boceprevir (see page 39) MK-5172 (see page 44)
Side Effects
In this study, about 5% of people reported anemia with vaniprevir.
results from a recent clinical trial
MK-5172
DRUG COMBINATION
TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
vaniprevir interferon ribavirin
24 weeks
Type 1 Treatment-experienced
24 weeks after treatment, SVR was 60%
vaniprevir interferon ribavirin
48 weeks
Type 1 Treatment-experienced
24 weeks after treatment, SVR was 80%
interferon ribavirin
48 weeks
Type 1 Treatment-experienced
24 weeks after treatment, SVR was 14%
An experimental protease drug, MK-5172 is being tested by Merck. The company is combining MK-5172 with boceprevir (page 39).
Side effects:
In this study, several different doses were studied. Liver toxicity was seen at higher doses of the drug. However, the lower dose of 100 mg reduced problems with liver toxicity.
results from a recent clinical trial DRUG COMBINATION
TREATMENT DURATION
MK-5172 interferon ribavirin
12 weeks of MK-5172
boceprevir interferon ribavirin
12 weeks of boceprevir
12 or 36 weeks of interferon and ribavirin
12 or 36 weeks of interferon and ribavirin
GENOTYPE AND POPULATION
RESULTS
Type 1 Treatment-na誰ve
24 weeks after treatment, SVR was 92%
Type 1 Treatment-na誰ve
24 weeks after treatment, SVR was 54%
HCV has Six variations IN THE U.S., called major genotypes
In the U.S., Type 1 makes up about 70% of cases, and is the most difficult to treat. Type 2 makes up another 20% of cases. In Europe and South America, the most common is also Type 1.
44
J u ly+Au g u s t 2 013
P OS ITIV E LY AWA R E
ABT-450/r ABT-333 ABT-267 combination
AbbVie is a spin-off from the larger pharmaceutical giant Abbott. So this explains why the early names of experimental drugs use the “ABT” abbreviation. AbbVie is studying a combination of HCV drugs—with and without ribavirin. In May, the company announced its HCV cocktail would get a “priority review” from the FDA. AbbVie refers to its HCV cocktail as a “triple combination,” but that’s not quite right. ABT-450/r is a protease inhibitor boosted with ritonavir, so that’s two drugs. ABT-333 basically falls into the nucleoside class.
ABT-267 is a non-nucleoside drug. Benefits of non-nucleosides in HCV are still experimental.
Ribavirin, don’t forget, was also included in the following study. Side effects
Serious adverse events were seen in about two percent of participants in this study. Less severe side effects were seen in 10 percent of people in this study. The side effects included headache, fatigue, nausea, insomnia, and diarrhea.
interim results from an ongoing trial DRUG COMBINATION TREATMENT DURATION
GENOTYPE AND POPULATION
RESULTS
ABT-450/r ABT-267 ABT-333 ribavirin
12 weeks
Type 1 Treatment-naïve
12 weeks after treatment, SVR was 99% 24 weeks after treatment, SVR was 96%
ABT-450/r ABT-267 ABT-333 ribavirin
12 weeks
Type 1 Treatment experienced
12 weeks after treatment, SVR was 93%
ABT-450/r ABT-267 ABT-333
12 weeks
Type 1 Treatment-naïve
12 weeks after treatment, SVR was 90%
ABT-450/r ABT-267 ABT-333 ribavirin
24 weeks
Type 1 Treatment experienced
12 weeks after treatment, SVR was 98%
24 weeks after treatment, SVR was 93%
24 weeks after treatment, SVR was 87%
24 weeks after treatment, SVR was 95%
Better, faster, cheaper HCV drugs The goal for HCV is this: One pill, taken once a day, for three months and you’re cured. That’s reasonable. Until that time people with HCV will need to accept slow and incremental improvements. The pharmaceutical companies will need to play nice together. The FDA and EMA need to stay in the game, too. It’s rare in history that chronic viral infections are cured. An HCV cure would improve the lives of 170 million people worldwide. Without treatment, some 23 percent of people with HCV will progress to cirrhosis after 20 years. With cirrhosis comes a yearly 3 percent risk of liver cancer and a 5 percent risk of needing a liver transplant. For now, whether it’s one pill or 10, the goal for HCV treatment is achieving and maintaining SVR for life. With SVR, people with HCV, with or without HIV, can better manage fibrosis or cirrhosis. Then they’ll be healthier, they’ll use fewer health care resources, and they’ll just plain feel better.
Brett Grodeck (linkedin.com/in/brettgrodeck) is a freelance writer. Special thanks to Andrew Reynolds, Hepatitis C Education Manager, Project Inform, for his review of
this article. NEED HELP Paying for your meds? For a list of HCV drug co-pay and patient assistance programs see the March+April HIV Drug Guide or go to positivelyaware.com/copay.
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
45
A NEW
FACE Taking A picture on a day with HIV Leads to a new outlook By Rick Guasco
F
Photo: Joshua Thorne
or Kyle Meadors the face of AIDS was his cousin Vincent, who died in 1995 at the age of 27. Kyle was nine years old. “I thought he was a man in his 40s or 50s,” Kyle recalled. “He looked old and thin. HIV had ravaged him. It was a scary thing to see.”
Kyle grew up in Van Buren, Arkansas. Gay people and HIV are not subjects talked about frequently, or comfortably, in the rural South. “We had one very small gay bar—if you wanted to go to another one, you drove 45 minutes to Fayetteville or two and half hours to Little Rock,” Kyle said. “There wasn’t a lot of outreach going on. There weren’t AIDS organizations offering information and free testing. HIV was just not discussed. With all the medications that were out, a lot of younger gay men like me kind of thought HIV was over.” After his father died in 2006, Kyle tried escaping his grief by moving to Springfield, Missouri to attend Missouri State University. He became active in a Campus Ministry operated by a Catholic missionary order. His involvement with the ministry ignited Kyle’s interest in activism and social issues. The ministry operated a program on Chicago’s South Side and one of the priests, Father Tom, suggested to Kyle that
he go there. In July 2010, Kyle moved to Chicago, but before leaving Missouri, he had a sexual encounter that he acknowledges “wasn’t the safest.” Kyle developed severe flu-like symptoms soon afterward, but they passed after a couple of weeks. He got sick again in early 2011, but this time couldn’t shake the bad cold he’d developed. Thoughts of his cousin began to worry him. “I thought about [Vincent] when I had that cold that wouldn’t go away,” Kyle said. “I was afraid to get tested, because there had been a time when I had stopped practicing safe sex. I thought I was invincible because I’d gone so long having unsafe sex and nothing had ever happened, not even an STD. I was so afraid, I didn’t even want to go to a doctor’s office, so I found a place that did anonymous HIV testing.” Kyle’s HIV test came back positive. Not only did Kyle begin treatment, but the doctor provided him with information about HIV. A few months went by. “It didn’t really
Kyle Meadors’ Photo submission for A Day with HIV 2011
start to hit me until that summer that I was HIV-positive and that this was my new reality,” Kyle said. “Lots of people say that they’re still the same person, just that they are HIV-positive. I’m not the same as I was before. HIV has changed how I think about myself and how I feel about issues.” He began searching for local AIDS organizations, discovering Test Positive Aware Network (TPAN), publisher of Positively Aware . After contacting the agency, Kyle received recent issues of PA and the magazine’s HIV Drug Guide. “That magazine was a lifesaver,” Kyle said. “I still have all the issues that were sent. They’re a bit dog-eared now. There are articles in there that have sticky notes sticking out of them, because that’s where I’ve gotten a lot of my information about HIV.” It was in an issue of Positively Aware that Kyle saw a notice about A Day with HIV. Originally named A Day with HIV in America, PA’s anti-stigma campaign began in 2010. The campaign brings people
P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
47
together—regardless of their HIV status—by having them take a snapshot of themselves on a specific day, September 21st. The pictures reflect the great diversity of people who live with HIV and of those who care about them. As compelling as the images, are the stories behind them. “Reading about A Day with HIV, I felt this tug, like this was something I was supposed to take part in,” Kyle said. “Was I scared? Yes. While Positively Aware is a national publication, TPAN is based here in Chicago, where I live. It was literally almost too close to home for my comfort. Up until then, only a handful of people knew that I was HIV-positive—and nobody from my family knew.” Overcoming his initial fear, Kyle decided to submit a photo for the 2011 campaign. After sending his picture in, Kyle was notified that all the photos would be posted to adaywithhiv.com, and that a select group would be featured in the next issue of Positively Aware and published in a book. By taking part in the project, Kyle realized he could also use A Day with HIV as a way of disclosing his HIV status to his family. “Part of me wanted my picture to be in the magazine because I thought I could
think of people with HIV. There’s not a day that goes by that I don’t think of him.” In participating in A Day with HIV, Kyle has found a new activism in combating the stigma of HIV. “Stigma will always be with us unless we do something to destroy it,” Kyle said. “Being a part of A Day with HIV is one of the greatest things I’ve done in my 28 years, because maybe somewhere someone who has tested positive will see our pictures and see that you can still be happy. We can still lead ordinary lives.”
come out that way,” Kyle said. “I didn’t want to send a link to a website because my mom and my grandmother didn’t have a computer or Internet access. I wasn’t strong enough to verbally communicate to them that I am HIV-positive.” When the magazine came out, however, Kyle saw, with both disappointment and relief, that his picture wasn’t in it. Months later, he learned that his picture was in the annual book of A Day with HIV photos, and he found himself once again confronted with the issue of disclosing his status to his family—a work still in progress. “Why don’t people come out or disclose their status?” Kyle commented. “We’re afraid of rejection and we don’t want to see the look on our parents’ faces. My own coming out [as gay] to my family was a very difficult experience, so I did not want to go through having to tell them I was now HIV-positive, too. I was afraid that I would interpret their shock as rejection.” Kyle has now, for himself, replaced his cousin as the face of HIV, but it is a very different image. “When I first took part in A Day with HIV, I wanted people to see a young, healthy, 26-year-old guy, and not think of someone like Vincent when they
+
A DAY WITH HIV
Now in its fourth year, A Day with HIV will be Saturday, September 21. Everyone everywhere is encouraged to take a snapshot, capturing a moment of their daily lives, and email it along with a caption to photo@adaywithhiv.com. Full details at adaywithhiv.com. Follow A Day with HIV on Facebook and on Twitter (@A_Day_with_HIV).
Are you Aware? Get Positively Aware. ❑ 1-year subscription: $30 donation.
Six bi-monthly issues every year. Subscriptions are mailed free of charge within the U.S. to those who are HIV-positive.
❑ Bulk copies (U.S. only):
Available free of charge; however, a donation is requested to cover shipping. No international bulk orders. Minimum order 10 copies, shipped via UPS (No P.O. Box addresses): ______ copies
Bill to: Card Number Expiration date
security code
Name on Card Signature (required)
❑ Back issues: $3 per copy. Enclosed is my payment. ______ copies: May+June 2013 ______ copies: March+April 2013 (Drug Guide)
Charge my:
❑ Visa ❑ MasterCard ❑ American Express
total amount: $___________
______ copies: January+February 2013
Charges will appear on your credit card statement as TPA Network. Test Positive Aware Network (TPAN) is a not-for-profit organization dedicated to providing support and information to all people affected by HIV.
______ copies: November+December 2012
Ship to:
______ copies: September+October 2012
❑ Sign me up for the E-News, PA’s weekly email newsletter:
Name Agency (if applicable) Address
email address
❑ Enclosed is my donation of:
❑ $25 ❑ $50
❑ $100 ❑ $250 ❑ $500 ❑ $_______
Your contribution helps provide subscriptions to people who can’t afford them. All donations are tax-deductible to the full extent allowed by law.
City State
Phone
Mail to:
Positively Aware
5537 N. Broadway St. Chicago, IL 60640
Zip
Wholistic picure
|
Sue Saltmarsh
The other side of disclosure
R
Photo: CHERYL MANN
ecent circumstances brought me literally face to face with my past, including the only time I know I’ve been exposed to HIV. In 1986, I was the Wardrobe Supervisor of Hubbard Street Dance Chicago and this May 30 brought together many of the dancers, administrators, and technicians of my era at HSDC, people I had not seen in over 20 years or more, to celebrate the company’s 35th anniversary. One of those people was a man I’d been involved with in ’86 and who, while we were on tour, found out he was HIV-positive.
Though he chose not to tell his family or his fellow dancers until later, he did tell me the day after he got the news. My side of this experience was duly recorded in my ever-present journal at the time, so I looked it up. The wince resulting from seeing myself spell AIDS “aids” was thankfully trumped by my approval of the way I reacted when he told me the news. I was glad to see that my reaction then was what it would be today. There was not a nanosecond of worry that he had passed the virus on to me (yes, I got tested)—no “worried well” neurotic was I! Instead, I jumped into overdrive to make sure he didn’t have a nanosecond of doubt that this disease would not change the way I felt about him, my willingness to continue to sleep with him, or my desire to be a supportive friend. Ours was not a conventional relationship, as none of my relationships have been. “Romance” has never been a desired option for me and he knew better than to reduce what was, to me anyway, a reality-based, friends-withbenefits kind of dynamic into some sort of Hallmark card-ish stereotype. As I hear and read stories of other people’s experiences with disclosure, I wonder if my reaction was as unconventional as our relationship. According to the journal, I spent my one day off “clinging” to him, trying to comfort him, all the while feeling him withdraw into himself, his body getting tense and armored against my touch, his responses monosyllabic. By the end of the tour, he had begun avoiding my company and it was an uneasy return to Chicago with my puzzlement about what I’d done wrong and uncertainty
about what to do to fix it, if that was even possible. He eventually left the company and so did I. Our lives today are worlds apart from what they were then. He has been out about his sexuality and his HIV for years and now has a successful, multifaceted career and is partnered happily. I have worked in the nonprofit HIV/AIDS field for 21 years and am happily single. He is still strikingly handsome, I am still…me. The time we spent together during the days he was here for the 35th anniversary was a bit of a surprise to both of us, I think. It was good for us to see each other in such good places in our lives. It was good for us to remember some of the times of the past. And, for me, it was good to have a chance to clear whatever energy was left from the way we parted. I hope it was for him too. When, how, and even if you decide to disclose is an issue that definitely does not have a one-size-fits-all solution. For some, there is real danger in disclosure— physical violence, job loss, even prosecution; for others, perceived danger of family and friends rejecting them, judging them; for others still, liberation. Perhaps unfairly, but with good intent, I gave him a copy of those journal pages and after he read them, he said, “I wish I’d been stronger.” I said I didn’t think it was a matter of strength but that he just wasn’t ready to hear my reassurances of acceptance and support—he was too traumatized. I meant that and I believe it’s true, but I also want to urge anyone who’s struggling with issues of disclosure to think about not just the possibility of rejection or even condemnation, but also the possibility of steadfastness, acceptance, embrace. Yes, surviving the loss of family, friends, or a partner requires strength in great degree. But how strong do you have to be to accept friendship, help, even love? And how will you ever know if you don’t take the chance?
When, how, and even if you decide to disclose is an issue that definitely does not have a one-size-fitsall solution.
Breathe deep, live long. P OS ITIV E LY AWA R E
J u ly+Au g u s t 2 013
49
SATURDAY, AUGUST 17, 2013 Auditorium Theatre of Roosevelt University, 50 East Congress Parkway, Chicago To purchase tickets and for more information, please visit www.danceforlifechicago.com or call 312-922-5812 COMPANIES SCHEDULED TO APPEAR DanceWorks Chicago, Giordano Dance Chicago, Hubbard Street Dance Chicago, River North Dance Chicago, Thodos Dance Chicago INDEPENDENT ARTISTS Two World Premiere Performances choreographed by Harrison McEldowney & Jeremy Plummer and Randy Duncan, Abigail Simon & Mauro Villanueva perform Le Corsaire Pas de Deux Benefiting AIDS Foundation of Chicago, The Dancers’ Fund and Chicago House
SPONSORS
MEDIA PARTNERS A&U Magazine, BestGayChicago.com, ChicagoPride.com, GRAB Magazine, Positively Aware Magazine, SeeChicagoDance.com, Viral PR Agency, Windy City Media Group DANCER Andrew Murdock PHOTOGRAPHY Sandro DESIGN Brian Jones & Rutger Thiellier
TICKETS STARTING AT $50