1. positivelyaware.com
September+OCTOBER 2012
CURE NEWS FROM
AIDS 2012
facing up
to lipoatrophy
POSITIVE
Women
Making decisions, creating
policy, and improving lives
2. ABOUT PREZISTA ®
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option Rifamate,® Rimactane®), sildenafil (Revatio®) when used to treat
in the class of HIV (human immunodeficiency virus) medicines known as pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/
protease inhibitors. ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™),
PREZISTA® is always taken with and at the same time as ritonavir (Norvir ®), or telaprevir (Incivek™)
in combination with other HIV medicines for the treatment of HIV infection • Before taking PREZISTA, tell your healthcare professional if you are
®
in adults. PREZISTA® should also be taken with food. taking sildenafil (Viagra, Revatio®), vardenafil (Levitra,® Staxyn®),
®
• The use of other medicines active against HIV in combination with tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor ®), rosuvastatin
PREZISTA®/ritonavir (Norvir ®) may increase your ability to fight HIV. (Crestor ®), pravastatin (Pravachol®), or colchicine (Colcrys,®
Your healthcare professional will work with you to find the right Col-Probenecid®). Tell your healthcare professional if you are taking
combination of HIV medicines estrogen-based contraceptives (birth control). PREZISTA® might reduce
the effectiveness of estrogen-based contraceptives. You must take
• It is important that you remain under the care of your healthcare additional precautions for birth control, such as condoms
professional during treatment with PREZISTA®
This is not a complete list of medicines. Be sure to tell your
PREZISTA® does not cure HIV infection or AIDS and you may healthcare professional about all the medicines you are taking or
continue to experience illnesses associated with HIV-1 infection, plan to take, including prescription and nonprescription medicines,
including opportunistic infections. You should remain under the vitamins, and herbal supplements.
care of a doctor when using PREZISTA. ®
What should I tell my doctor before I take PREZISTA®?
Please read Important Safety Information below, and talk to your
healthcare professional to learn if PREZISTA® is right for you. • 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
IMPORTANT SAFETY INFORMATION
• Tell your healthcare professional if you are pregnant or planning
What is the most important information I should know
to become pregnant, or are breastfeeding
about PREZISTA®?
— The effects of PREZISTA® on pregnant women or their unborn
• PREZISTA® can interact with other medicines and cause
babies are not known. You and your healthcare professional will
serious side effects. See “Who should not take PREZISTA®?”
need to decide if taking PREZISTA® is right for you
• PREZISTA® may cause liver problems. Some people taking
— Do not breastfeed. It is not known if PREZISTA® can be passed
PREZISTA, together with Norvir ® (ritonavir), have developed liver
®
to your baby in your breast milk and whether it could harm your
problems which may be life-threatening. Your healthcare professional
baby. Also, mothers with HIV should not breastfeed because HIV
should do blood tests before and during your combination treatment
can be passed to your baby in the breast milk
with PREZISTA. If you have chronic hepatitis B or C infection, your
®
healthcare professional should check your blood tests more often What are the possible side effects of PREZISTA®?
because you have an increased chance of developing liver problems • High blood sugar, diabetes or worsening of diabetes, and increased
• Tell your healthcare professional if you have any of these signs and bleeding in people with hemophilia have been reported in patients
symptoms of liver problems: dark (tea-colored) urine, yellowing taking protease inhibitor medicines, including PREZISTA®
of your skin or whites of your eyes, pale-colored stools (bowel • Changes in body fat have been seen in some patients taking HIV
movements), nausea, vomiting, pain or tenderness on your right medicines, including PREZISTA. The cause and long-term health
®
side below your ribs, or loss of appetite effects of these conditions are not known at this time
• PREZISTA® may cause a severe or life-threatening skin • Changes in your immune system can happen when you start taking
reaction or rash. Sometimes these skin reactions and skin rashes HIV medicines. Your immune system may get stronger and begin
can become severe and require treatment in a hospital. You should to fight infections that have been hidden
call your healthcare professional immediately if you develop a rash.
However, stop taking PREZISTA® and ritonavir combination treatment • The most common side effects related to taking PREZISTA® include
and call your healthcare professional immediately if you develop any diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is
skin changes with these symptoms: fever, tiredness, muscle or joint not a complete list of all possible side effects. If you experience these
pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed or other side effects, talk to your healthcare professional. Do not stop
eyes, like “pink eye.” Rash occurred more often in patients taking taking PREZISTA® or any other medicines without first talking to your
PREZISTA® and raltegravir together than with either drug separately, healthcare professional
but was generally mild You are encouraged to report negative side effects of
Who should not take PREZISTA®? prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
• Do not take PREZISTA® if you are taking the following
28PRZDTC0288R8
medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45, ® Please refer to the ritonavir (Norvir ®) Product Information (PI and PPI)
Embolex, Migranal ), ergonovine, ergotamine (Cafergot, Ergomar ®),
® ® ® for additional information on precautionary measures.
methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral Please read accompanying Patient Information for PREZISTA®
midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort and discuss any questions you have with your doctor.
(Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor ®),
simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®
4. IMPORTANT PATIENT INFORMATION
PREZISTA (pre-ZIS-ta) • o not have any kind of sex without protection. Always practice
D
(darunavir) safe sex by using a latex or polyurethane condom to lower the
Oral Suspension chance of sexual contact with semen, vaginal secretions, or blood.
PREZISTA (pre-ZIS-ta) Ask your healthcare provider if you have any questions on how to
(darunavir) prevent passing HIV to other people.
Tablets Who should not take PREZISTA?
Read this Patient Information before you start taking PREZISTA and Do not take PREZISTA with any of the following medicines:
each time you get a refill. There may be new information. This • lfuzosin (Uroxatral®)
a
information does not take the place of talking to your healthcare • ihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergonovine,
d
provider about your medical condition or your treatment. ergotamine (Cafergot®, Ergomar®) methylergonovine
Also read the Patient Information leaflet for NORVIR® (ritonavir). • isapride
c
What is the most important information I should • imozide (Orap®)
p
know about PREZISTA? • ral midazolam, triazolam (Halcion®)
o
• REZISTA can interact with other medicines and cause serious
P • he herbal supplement St. John’s Wort (Hypericum perforatum)
t
side effects. It is important to know the medicines that should not be • he cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®,
t
taken with PREZISTA. See the section “Who should not take Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®)
PREZISTA?” • ifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®)
r
• REZISTA may cause liver problems. Some people taking PREZISTA
P • ildenafil (Revatio®) only when used for the treatment of pulmonary
s
in combination with NORVIR® (ritonavir) have developed liver arterial hypertension.
problems which may be life-threatening. Your healthcare provider Serious problems can happen if you take any of these medicines with
should do blood tests before and during your combination treatment PREZISTA.
with PREZISTA. If you have chronic hepatitis B or C infection, your
healthcare provider should check your blood tests more often What should I tell my doctor before I take PREZISTA?
because you have an increased chance of developing liver problems. PREZISTA may not be right for you. Before taking PREZISTA, tell your
• ell your healthcare provider if you have any of the below signs and
T healthcare provider if you:
symptoms of liver problems. • ave liver problems, including hepatitis B or hepatitis C
h
• ark (tea colored) urine
D • re allergic to sulfa medicines
a
• ellowing of your skin or whites of your eyes
y • ave high blood sugar (diabetes)
h
• ale colored stools (bowel movements)
p • ave hemophilia
h
• ausea
n • re pregnant or planning to become pregnant. It is not known if
a
• omiting
v PREZISTA will harm your unborn baby.
• ain or tenderness on your right side below your ribs
p Pregnancy Registry: You and your healthcare provider will need to
• oss of appetite
l decide if taking PREZISTA is right for you. If you take PREZISTA
while you are pregnant, talk to your healthcare provider about how
PREZISTA may cause severe or life-threatening skin reactions or rash. you can be included in the Antiretroviral Pregnancy Registry. The
Sometimes these skin reactions and skin rashes can become severe purpose of the registry is follow the health of you and your baby.
and require treatment in a hospital. You should call your healthcare • re breastfeeding or plan to breastfeed. Do not breastfeed. We do
a
provider immediately if you develop a rash. However, stop taking not know if PREZISTA can be passed to your baby in your breast
PREZISTA and ritonavir combination treatment and call your healthcare milk and whether it could harm your baby. Also, mothers with HIV-1
provider immediately if you develop any skin changes with symptoms should not breastfeed because HIV-1 can be passed to the baby in
below: the breast milk.
• fever
Tell your healthcare provider about all the medicines you take including
• iredness
t prescription and nonprescription medicines, vitamins, and herbal
• uscle or joint pain
m supplements. Using PREZISTA and certain other medicines may affect
• listers or skin lesions
b each other causing serious side effects. PREZISTA may affect the way
• mouth sores or ulcers
other medicines work and other medicines may affect how PREZISTA
• ed or inflamed eyes, like “pink eye” (conjunctivitis)
r works.
Rash occurred more often in patients taking PREZISTA and raltegravir Especially tell your healthcare provider if you take:
together than with either drug separately, but was generally mild. • edicine to treat HIV
m
See “What are the possible side effects of PREZISTA?” for more • strogen-based contraceptives (birth control). PREZISTA might
e
information about side effects. reduce the effectiveness of estrogen-based contraceptives. You
What is PREZISTA? must take additional precautions for birth control such as a condom.
PREZISTA is a prescription anti-HIV medicine used with ritonavir and • edicine for your heart such as bepridil, lidocaine (Xylocaine
m
other anti-HIV medicines to treat adults with human immunodeficiency Viscous®), quinidine (Nuedexta®), amiodarone (Pacerone®,
virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a Cardarone®), digoxin (Lanoxin ®), flecainide (Tambocor ®),
protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune propafenone (Rythmol®)
Deficiency Syndrome). • arfarin (Coumadin®, Jantoven®)
w
• edicine for seizures such as carbamazepine (Carbatrol®, Equetro®,
m
When used with other HIV medicines, PREZISTA may help to reduce Tegretol®, Epitol®), phenobarbital, phenytoin (Dilantin®, Phenytek®)
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 • edicine for depression such as trazadone and desipramine
m
which help fight off other infections. Reducing the amount of HIV and (Norpramin®)
increasing the CD4 (T) cell count may improve your immune system. • larithromycin (Prevpac®, Biaxin®)
c
This may reduce your risk of death or infections that can happen when • edicine for fungal infections such as ketoconazole (Nizoral®),
m
your immune system is weak (opportunistic infections). itraconazole (Sporanox®, Onmel®), voriconazole (VFend®)
PREZISTA does not cure HIV infection or AIDS and you may continue to • olchicine (Colcrys®, Col-Probenecid®)
c
experience illnesses associated with HIV-1 infection, including • ifabutin (Mycobutin®)
r
opportunistic infections. You should remain under the care of a doctor • edicine used to treat blood pressure, a heart attack, heart failure,
m
when using PREZISTA. or to lower pressure in the eye such as metoprolol (Lopressor®,
Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®,
Avoid doing things that can spread HIV-1 infection. Combigan®)
• Do not share needles or other injection equipment. • idazolam administered by injection
m
• o not share personal items that can have blood or body fluids on
D • edicine for heart disease such as felodipine (Plendil®), nifedipine
m
them, like toothbrushes and razor blades. (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®)
7. SEP+OCT 2012
VOLUME 24 NUMBER 6
D e pa r t m e n t s
6 In Box
6 Readers’ poll
7 editor’s Note
What is a woman?
13 Briefly
FDA approves Truvada for HIV prevention. Rapid
home HIV test approved. Initial study results find
dolutegravir/Epzicom is superior to Atripla.
34 Conference Update
News from the XIX International AIDS Conference in
Washington, D.C.
44 ask the HIV specialist
Safe sex is for seniors, too.
45 WHOLISTIC PICTURE
Battle of the sexes?
c o v e r F e at u r e s
22 Securing care for HIV-positive women
Challenges and solutions for women living with HIV.
26 Black women, society, and HIV
An expert talks about the context of infection.
28 ‘Everyone needs a support system’
How one therapist helps HIV-positive women learn
to take care of themselves.
30 Nine months to birth day
HIV and pregnancy—keeping yourself and your
baby healthy.
F e at u r e
41 The mirror has two faces
A personal account of using facial filler for lipoatrophy.
On the cover and this page:
Tamara wilson, HIV-Positive since 1999,
photographed by chris Knight
P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 2 01 2 5
8. In Box join the conversation: inbox@tpan.com and @posaware Readers’ poll
In the JULY+AUGUST issue, we asked
HIV testing in prison? Before you tested HIV-positive,
did you think you were at risk?
First let me say this is I had no idea that anyone
strictly my opinion in has the same problems as No. I didn’t
answer to your reader’s me. The issue touched me 8% think
poll question concern- deeply. about it.
ing HIV testing in prison. Simply knowing you’re 16%
Yes, but I
I believe it should be there, that I can reach out practiced
required upon entering to someone for information safer sex.
and leaving prison. seems to make everything a 24% Yes, but I
Prior to my incarcera- little bit better. I’m not sure thought I was
at low risk.
tion, I worked at Prevention how to receive future issues,
Point Philadelphia (a needle but put me on your mailing
Yes, but I 33%
didn’t care.
exchange program), the Gay list if at all possible! 19%
& Lesbian AIDS Education —Dwayne E.
Initiative, and I spoke at various events Florida
about HIV/AIDS in the prison system. I’ve
been positive for 18 years and for the last Good wishes Your comments:
11 years I’ve been trying to get as many Comment on July+August Editor’s Note: “I barebacked all the way after my first
people tested as possible. Thank you for the uplifting article, “Wish encounter—I have no one to blame but
At present, I have three and a half years HIV Away.” Though easier said than done, I myself and my lack of self-esteem.”
left on my sentence. During my incarcera- know that I’ll be able to pick my head up in
tion, I have been a Peer Educator teaching the morning and continue on with a posi- “After I found out, I wanted to kill myself—
a class called Positive Voices behind the tive outlook on the day. I’m not at the stage my partner never told me he had HIV.”
Walls (a little plug never hurts!) and an yet where people can know, only because
advocate for testing. I’m open about my I’m just two months into this disease, but I “Before I tested positive, I always
HIV status, so HIV can have a “face” that know I will get there (fingers crossed). practiced safe sex. But I also remember
defies the expectations of some of the —Steven feeling like no matter how much of a
men in here. via thebody.com good boy I was, HIV was going to get me.”
After taking my class for 16 weeks, I
have seen men’s attitudes change com- Hidden no more “I practiced safer sex until depression
pletely because they see me living healthy, I have to let you guys know how much and drugs got in my way.”
happy, with a loving family, and looking I appreciated the article, “The Hidden
forward to a long life. People,” in your January+February 2012 “I never thought about it. I suspect I
So, yes, testing should be mandatory, issue. I would love to have the Muslim was infected in 1986. At that time, there
along with education and good informa- brothers come to Memphis to speak in the wasn’t much information available
tion about prevention. very near future. My southern hat goes off about infection and I had no idea what
—Larry to the writer Sue Saltmarsh for the article. behavior was risky and what wasn’t.”
White Deer, Pennsylvania And love to Karim Rush, Shadeed Jenkins,
and Iman Boyd. “I thought those who caught HIV led
You’re not the only one Great job, POSITIVELY AWARE! You reckless lives, taking drugs and hav-
Finally, I’ve found relief! On May 21st, I guys rock! ing many anonymous partners and
read my first ever issue of Positively —Anthony Hardaway unprotected sex. I was naïve to believe
Aware—the March+April Drug Guide. via the Internet I would be OK if I limited myself to one
casual partner every few months.”
Do the write thinG. Positively Aware treats all communications (letters, e-mail,
etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for this issue’s poll question:
length, style, or clarity. Unless you tell us not to, we will use your name and city. Who is more stigmatized
because of HIV?
Positively aware We read you.
5537 N. Broadway St. SHare your comments
Chicago, IL 60640 about our articles at cast your vote at
inbox@tpan.com POSITIVELYAWARE.COM positivelyaware.com
6 SEPTE M B E R +O C TO B ER 201 2 P os i t i v e lyAware .com
9. Editor’s NOTE
Jeff Berry
@PAeditor
What is a woman?
I’ve had many teachers in life, including women up of mostly women, HIV-positive There are
who have taught me particularly important lessons about educator and activist Linda Scruggs countless
said it best by stating she wasn’t examples in
courage, strength, resilience, caring, and compassion. going to ask for anything, because our culture of
women have been asking to be strong, coura-
Cindy, the oldest of my three sisters, realized at an counted in for the last two decades. “Today I stand here geous women
early age that it was her job to help look after the other to give you some directions. We’ve decided to stop ask- and their
four kids in the Berry clan. My sister Barb became a ing, and maybe you just need the recipe.” many accom-
veterinarian, the first doctor in our family. The one who Scruggs called for meaningful involvement of women plishments
was closest to me in age, Wendy, became my best friend at every level, from the government to local communities and contribu-
growing up. My mother Norma went back to work when and organizations, and also made it clear that women are tions to the
I started preschool in the early 1960’s, and continued not just asking for male-run organizations that “tolerate” a world. So why
working as a schoolteacher and elementary school prin- women’s program. “We need the support and resources… is it that so
cipal until she retired. And my grandmother, Ruby, lived to give us the power to heal our sisters, to change our many women
to be 101, and would often recount to us colorful stories men. We are the mothers of the earth.” who are in
from her life, such as the one about traveling all day in In her talk, Scruggs also shared part of what she says positions
a covered wagon to see the Wright Brothers perform got her to the stage that day. She learned she was HIV- of power
breathtaking feats in their amazing flying machines. positive while visiting a perinatal clinic and was 13-weeks and leader-
All these women and others demonstrated to me pregnant, and had to decide whether to terminate the ship appear
wonderful qualities that I respected and admired, and pregnancy and live five years, or have the baby and pos- threatening
sought to emulate and incorporate into my own sense sibly live three. She says she’s glad that day the doctor to so many
of values and ideals. There are countless examples in was wrong, and her son, Isaiah, was born free of HIV, who live in
our culture of strong, courageous women and their and he just recently turned 21. our male-
many accomplishments and contributions to the world. “I could’ve made the decision to have an abortion. dominated
So why is it that so many women who are in positions An abortion would not have been the first one I had had, society?
of power and leadership appear threatening to so many but I had an experience with God. I had an experience
who live in our male-dominated society? that…made me really look and reflect about women.
A recurring theme at this year’s International AIDS After all, what is a woman who thinks she’s ugly? What
Conference was the role of women in ending the is a woman who feels she has no self-value? What is a
epidemic. In her address at the conference opening woman who allows not one, but two men to rape her in
plenary, Secretary of State Hillary Clinton talked about silence? What is a woman who allows an uncle to molest
the essential role of communities, especially people liv- her and others and still be silent?... What is a woman
ing with HIV, in turning the tide on the epidemic. “And it who feels that she’s been broken and voiceless? What is
will come as no surprise to you,” Clinton told the packed a woman who’s afraid of understanding herself? What
audience, “that I would like to highlight the particular is a woman who spent a lifetime trying to be someone
role that women play.” other than herself?
Clinton pointed out that in Sub-Saharan Africa “I’ll tell you, that cold November day, that woman
women account for 60% of people living with HIV. was me, but it was through the support of this commu-
“Women want to protect themselves, and they want nity that I was able to find a voice and a place, that
PHOTO: Chris Knight
adequate health care, and we need to answer their call,” I could be just who I say I am. I am a woman.”
said Clinton. “Every woman should be able to decide
when and whether to have children. This is true if she is Take care of yourself, and each other.
HIV-positive or not. Women need and deserve a voice in
the decisions that affect their lives.”
In a lively morning plenary session by a panel made
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15. BRIEFLY
Enid Vázquez
FDA approves Truvada for PrEP
The Food and Drug Administration (FDA) reduction counseling, consistent and participants who
in July approved Truvada as the first correct condom use, regular HIV testing, took Truvada in the
medication to help prevent HIV infec- and screening for and treatment of other prescribed once-
tion. As expected, the approval came sexually-transmitted infections, stating daily dose.
with restrictions. that “Truvada is not a substitute for safer “The Partners
Truvada, a combination of tenofovir sex practices.” PrEP trial was conducted
(Viread) and emtricitabine (Emtriva), is Truvada now carries a Boxed Warning in 4,758 heterosexual couples,
one of the most prescribed medications on its drug label alerting health care where one partner was HIV-infected and
for HIV in this country. For HIV preven- professionals and uninfected individuals the other was not (serodiscordant cou-
tion, the use of Truvada is called “PrEP,” that Truvada for PrEP must only be used ples),” the press release continued. “The
for “pre-exposure prophylaxis.” by people confirmed to be HIV-negative trial evaluated the efficacy and safety of
“[We] commend the FDA’s approval of before being prescribed the drug and [both] Truvada and [Viread] tenofovir
[Truvada] for the use of [PrEP] to prevent tested at least every three months dur- versus placebo in preventing HIV infection
HIV transmission. This approach can ing use to reduce the risk of developing in the uninfected male or female partner.
prevent many new infections and could drug resistance. Both the antiviral and the Results showed Truvada reduced the risk
dramatically impact HIV transmission PrEP dose is one pill taken once daily. of becoming infected by 75% compared
worldwide,” said Kenneth H. Mayer, MD, Truvada maker Gilead Sciences worked with placebo.
Medical Research Director and Co-chair with the FDA to create a Risk Evaluation “No new side effects were identified
of The Fenway Institute at Fenway Health. and Mitigation Strategy (REMS) for in the clinical trials evaluating Truvada
“My colleagues and I are delighted to have Truvada PrEP. The REMS focuses on a pre- for the PrEP indication. The most com-
helped to demonstrate the utility of this scriber training and education program mon side effects reported with Truvada
promising approach for HIV prevention.” in counseling and managing individuals include diarrhea, nausea, abdominal
David Ernesto Munar, President/CEO who are taking or considering Truvada for pain, headache, and weight loss. Serious
of the AIDS Foundation of Chicago, said, PrEP. The REMS looks at the elements of adverse events in general, as well as
“Our challenge now is to implement PrEP a comprehensive HIV prevention strategy, those specifically related to kidney or
as strategically as possible, and to ensure the importance of adhering to the recom- bone toxicity, were uncommon.”
the people who need it most, those who mended daily dosing regimen, and the As a condition of approval, Gilead
are most at risk for HIV, have access.” serious risks of taking Truvada for PrEP if Sciences is required to collect and
“This is an enormous turning point, a already infected with HIV or of becoming analyze samples from individuals who
real game changer, in the fight against infected while taking it. become infected with HIV while taking
HIV,” said Jim Pickett, AFC’s Director According to the press release, Truvada to see if they’ve developed drug
of Prevention Advocacy and Gay Men’s “Truvada’s safety and efficacy for PrEP resistance. The company is also required
Health. “The toolbox we have now has were demonstrated in two large, random- to collect data on women who become
Truvada as PrEP. We can look forward to ized, double-blind, placebo-controlled pregnant while taking Truvada for PrEP
more sex acts being protected, especially clinical trials. The iPrEx trial evaluated and to conduct other research.
among individuals who have already Truvada in 2,499 HIV-negative men “Today’s decision is the culmination
chosen, for whatever reason, to not use or transgender women who have sex of almost 20 years of research involving
condoms consistently.” with men and with evidence of high investigators, academic and medical
According to a press release from the risk behavior for HIV infection... Results institutions, funding agencies, and nearly
Photo: Joshua Thorne
FDA, “Truvada is to be used for [PrEP] in showed Truvada was effective in reduc- 20,000 trial participants around the
combination with safer sex practices to ing the risk of HIV infection by 42% com- world, and Gilead is proud to have been
prevent sexually-acquired HIV infection in pared with placebo in this population. a partner in this effort,” said Norbert
adults at high risk.” Efficacy was strongly correlated with Bischofberger, PhD, Executive Vice
The FDA said Truvada for PrEP should drug adherence in this trial.” President, Research and Development
be used as part of a comprehensive It was also shown in iPrEX that there and Chief Scientific Officer, Gilead
HIV prevention plan that includes risk was a 92% reduction of risk for HIV in Sciences. >>
P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 201 2 13
16. BRIEFLY
Enid Vázquez
in the greatest expansion of HIV preven- Rapid home
Moises Agosto
tion tools than at any other time in the
history of this epidemic. Coupled with the
HIV test approved
reforms included in the Patient Protection
and Affordable Care Act, as well as the In June, the Food and Drug
National HIV/AIDS Strategy, we are in a Administration (FDA) approved the
position for the first time in over three OraQuick In-Home HIV Test, an HIV
decades to finally end this epidem- self-test kit that does not require sending
ic. Today’s decision is another important a sample to a laboratory for analysis. The
step in realizing that goal.” kit, which tests a swab from your mouth,
is approved for sale in stores and online
Dolutegravir/Epzicom to anyone age 17 and older. (Although
HIV is not found in saliva, evidence of
superior to Atripla? exposure to the virus—called HIV anti-
bodies—is found in the mouth and indi-
Shionogi-ViiV Healthcare LLC announced cates infection.) A positive result at home
that initial results from its Phase 3 study must then be followed up with a confir-
SINGLE (ING114467) show superiority of matory blood test from a laboratory.
its investigational HIV medication dolute- The FDA said the test can be falsely
>> The following is from a statement gravir plus Epzicom over Atripla, one of negative for reasons that include the
from Moises Agosto, Director of the most widely prescribed antiviral med- occurrence of HIV infection within three
Treatment Education, Adherence, and ications in the country. At 48 weeks, 88% months before testing. People who
Mobilization for the National Minority of study participants on the dolutegravir engage in behaviors that put them at
AIDS Council (NMAC): regimen achieved undetectable viral increased risk of getting HIV—including
load (less than 50 copies/mL) vs. 81% of having unprotected sex with new part-
“While PrEP shows substantial promise as those on Atripla, a statistically significant ners, or injecting illegal drugs—should be
a supplement to current HIV prevention difference. The company said the dif- re-tested on a regular basis. They should
efforts, it is by no means a panacea and ference was primarily driven by a higher not interpret a negative test to indicate
is only effective when used in conjunction rate of discontinuation due to adverse that engaging in high risk behavior is
with traditional prevention and risk reduc- events in the Atripla arm. All individuals safe.
tion strategies, such as condom usage. in the study were taking antiviral therapy
“Anti-retroviral medications, like for the first time, a group that does the
Truvada, are extremely powerful drugs best in HIV treatment. There were 414
with the potential for serious side individuals put on dolutegravir and 419
effects. As such, PrEP should only be put on Atripla. Overall, 2% of those on the
used by individuals who are highly vul- dolutegravir-based regimen discontinued
nerable to HIV infection, including those due to adverse events vs. 10% of those
in sero-discordant couples, sex workers, receiving the Atripla regimen. The most
and gay men. Its efficacy is also directly common adverse events while on Atripla
related to an individual’s adherence to were neurological (reported by 41% of
a regimen, and should only be used by Atripla recipients vs. 15% of participants
those who can commit to taking it regu- receiving the dolutegravir), while the
larly. Finally, use of PrEP by individuals most common drug-related adverse
who may already be HIV-positive could events with dolutegravir were in the gas-
increase the risk of drug resistance. trointestinal system (reported by 22% of
“In recent years, there have been a people on dolutegravir vs. 22% of those
number of promising developments in given Atripla).
biomedical interventions—from treat- Dolutegravir is an investigational
ment as prevention and pre-exposure integrase inhibitor (INSTI), the same class
prophylaxis to microbicides and vaccine as Isentress, the only INSTI currently on
research. These advances have resulted the market.
14 SEP TE M B E R +O C TO BER 201 2 P os i t i v e lyAware .com
17. E-NEWS | Sign up for the weekly email newsletter of
positively aware. go to positivelyaware.com
From the Weekly E-News is an important step forward in our fight Studies find
against the disease.”
once-daily ‘Quad’
Website offers ViiV Healthcare is the first pharma-
ceutical company to support the program is safe and effective
access to HIV meds with HIV/AIDS medications and funding.
for uninsured The goal of HarborPath is to get all
HIV/AIDS medications into the program
The findings of two large international
randomized studies published in The
HarborPath, a new non-profit organiza- and serve uninsured individuals with: Lancet medical journal indicate that the
tion, has been established to create a new once-daily pill combining three
program that offers a single place where n An easy-to-use website with a single antiretrovirals and a booster molecule is
uninsured HIV-positive people who portal to determine eligibility for the a safe and effective alternative to two
otherwise qualify for manufacturer- program and to fill prescriptions for widely used drug regimens for newly
sponsored patient assistance programs participating companies’ HIV/AIDS diagnosed HIV-positive adults who have
(PAPs) can apply for and receive their medications. had no previous treatment. The study
medications. The “one stop shop” portal n Automatic notifications for both the results also indicate that the new “Quad”
will provide a streamlined, online process individual and the case manager of pill is faster acting, doesn’t have the neu-
to qualify individuals and deliver the qualification for the program. ropsychiatric side effects associated with
donated medications through a mail- n A pharmacy that ships a 3-month sup- other combinations, and could improve
order pharmacy. HarborPath will pilot the ply of all participating medications in compliance with treatment.
program in states with high need, includ- one package within two business days “Patient adherence to medication is
ing Alabama, Texas, and Virginia. of final approval and confirms delivery vital, especially for patients with HIV,
To create the portal, HarborPath of the medications. where missed doses can quickly lead to
worked closely with the National Alliance n Renewal reminders to individuals and the virus becoming resistant to medica-
of State and Territorial AIDS Directors case managers to improve medication tion. Older HIV treatment regimens
(NASTAD) and the Clinton Health Access adherence. involve taking several pills multiple times
Initiative (CHAI), which provided the seed n A fully automated portal that case a day,” explains Paul Sax from Brigham
funding for the organization. On World managers can access at any time and Women’s Hospital, Harvard Medical
AIDS Day 2011, President Bill Clinton noted for up-to-the-minute status of an School, lead author of the first study.
the need to fight HIV/AIDS in the U.S. individual’s application or shipment. If “Our results provide an additional highly
“I am proud that my foundation is needed, live support is also available potent, well-tolerated treatment option,
partnering with NASTAD and other through a toll-free call center. and highlight the simplicity of treatment
pharmaceutical manufacturers to make resulting from combining several anti-
sure Americans living with HIV have Murray Penner, Deputy Executive retrovirals in a single pill. Studies have
access to the life-saving medications Director at NASTAD, said, “Under the cur- shown that single pill treatments improve
they need,” said President Clinton. “This rent PAP process, an individual or their both adherence and patient satisfaction,
case manager has to apply and help prevent prescription errors,
separately to each com- thereby reducing the likelihood of treat-
pany’s program for these ment failure and drug resistance.”
medications, which can be The first study randomly assigned
complex and time-consum- 700 patients from centers across North
ing. Missing doses or failing America to start treatment with two
to fill prescriptions because different single tablet regimens—either
of complications sometimes the Quad, combining the new integrase
associated with these pro- inhibitor elvitegravir (EVG) boosted with
cesses may result in serious cobicistat (a new pharmacoenhancer;
health consequences, or COBI) plus emtricitabine/tenofovir
even death, in addition to (Emtriva/Viread), or Atripla (efavirenz/
increased transmission of emtricitabine/tenofovir), the current gold
the virus. HarborPath is standard regimen approved by the FDA
designed to address this in 2006.
urgent need in the U.S.” After 48 weeks of treatment, 88% >>
P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 201 2 15
18. BRIEFLY
Enid Vázquez
of patients given the Quad had sup- was reached by 90% of people in the first conference to be held in the U.S.
pressed viral loads (less than 50 copies/ Quad group compared with 87% in the since President Obama lifted the travel
mL), compared with 84% in the Atripla atazanavir/ritonavir/emtricitabine/teno- ban on HIV-positive people, his anticipa-
group. fovir group. tion of such events as displays of the
Adverse events that led to patients The safety of the two regimens was AIDS Memorial Quilt, a planned march
discontinuing treatment were infrequent also similar. and demonstration, the performance
and similar in both groups. Mild nausea of the Tony Award-winning play The
was more common with the Quad, but
patients were less likely to have dizziness,
PA’s editor debuts Normal Heart, as well as the many global
leaders in AIDS policy, advocacy, and
abnormal dreams, insomnia, and rash blog on HuffPo treatment advances that presented at the
compared with the Atripla regimen. conference.
The second trial included 708 Positively Aware editor Jeff Berry has
treatment-naïve adults from 146 medical joined other AIDS activists and journalists
centers across Australia, Europe, North
America, and Thailand. Patients were
such as The Body’s Kellee Turrell, the AIDS
Foundation of Chicago’s David Ernesto
Did he get infected?
randomly assigned to receive a once-daily Munar, and others in becoming a blogger In the July+August issue of Positively
Quad or a popular and recommended published by The Huffington Post. Aware, a young man in Chicago, Chris,
twice-daily combination of Norvir- In advance of the upcoming AIDS 2012 was anxiously awaiting the results of his
boosted Reyataz (atazanavir/ritonavir) World AIDS Conference, Berry wrote HIV tests following a potential exposure
plus Truvada (emtricitabine/tenofovir). “Reflections from an Epidemic: Carrying through sex (“PrEPing,” July+August).
The primary endpoint, to achieve viral the Torch to AIDS 2012.” In it, he talks Two months later, he remains
levels below 50 copies/mL by week 48, about the significance of this being the HIV-negative.
Simplify your life.
Turn your assorted prescription medicine bottles into single-dose packs.
Easy to remember. Easy to take. Each pack contains all the pills of a single dose.
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J Discount Pharmacy
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16 SE P TE M B E R +O C TO BER 201 2 P os i t i v e lyAware .com
19. TPAN, publisher of Positively Aware, is commemorating
25 years of service to Chicago’s HIV community.
Join Jamar Rogers, of NBC’s “The Voice,” for a special performance.
October 4, 2012
5:30–8:30 PM | Chicago Cultural center
Tickets available at www.tpan.com
Event sponsors ANNIVERSARY PARTNERS
$100,000 AND ABOVE $50,000 AND ABOVE
Alphawood Foundation Janssen Therapeutics
Photo: Matthew Garsteck
Bristol-Myers Squibb
$25,000 AND ABOVE $10,000 AND ABOVE
Abbott Virology AIDS Foundation of Chicago
EMD Serono Blue Cross and Blue Shield
Lloyd A. Fry Foundation of Illinois
ViiV Healthcare Cheetah Gyms
Walgreens Gilead Sciences, Inc.
Macy’s
MillerCoors
Steamworks
20. COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil
fumarate) is a prescription medicine used as a complete
single-tablet regimen to treat HIV-1 in adults who have
never taken HIV medicines before. COMPLERA does not
cure HIV or AIDS or help prevent passing HIV to others.
one
The for me
Patient model. Pill shown is not actual size.
INDICATION Do not take COMPLERA if you are taking the following medicines:
• other HIV medicines (COMPLERA provides a complete treatment for HIV infection.)
COMPLERA (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate
®
• the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®,
300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®),
(emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate)
phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat • the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®,
HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before.
Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®)
COMPLERA does not cure HIV and has not been shown to prevent passing HIV • a proton pump inhibitor medicine for certain stomach or intestinal problems,
to others. It is important to always practice safer sex, use latex or polyurethane including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®),
condoms to lower the chance of sexual contact with any body fluids, and to never omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)
re-use or share needles. Do not stop taking COMPLERA unless directed by your • more than 1 dose of the steroid medicine dexamethasone or dexamethasone
healthcare provider. See your healthcare provider regularly. sodium phosphate
• St. John’s wort (Hypericum perforatum)
• other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®)
IMPORTANT SAFETY INFORMATION • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®,
Contact your healthcare provider right away if you get the following side effects Epivir® or Epivir-HBV®, Epzicom®, Trizivir®)
or conditions while taking COMPLERA: • rilpivirine (Edurant™)
• Nausea, vomiting, unusual muscle pain, and/or weakness. These may be • adefovir (HEPSERA®)
signs of a buildup of acid in the blood (lactic acidosis), which is a serious
In addition, also tell your healthcare provider if you take:
medical condition • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium
• Light-colored stools, dark-colored urine, and/or if your skin or the whites of your
carbonate. Take antacids at least 2 hours before or at least 4 hours after you
eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity),
take COMPLERA
with liver enlargement (hepatomegaly), and fat in the liver (steatosis)
• a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine
• If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly
(Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these
get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without
medicines at least 12 hours before or at least 4 hours after you take COMPLERA
first talking to your healthcare provider. Your healthcare provider will monitor
• the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®,
your condition
Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®)
COMPLERA may affect the way other medicines work, and other medicines may • an antifungal medicine by mouth, including fluconazole (Diflucan®), itraconazole
affect how COMPLERA works, and may cause serious side effects. (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafil®), voriconazole (Vfend®)
• methadone (Dolophine®)
This list of medicines is not complete. Discuss with your healthcare provider all
prescription and nonprescription medicines, vitamins, or herbal supplements you
are taking or plan to take.
21. Save up to You may be able to save on the co-pay for
200
your COMPLERA prescription with a Gilead
$ HIV Co-pay Assistance Card.
Call 1-877-505-6986 for more information
per month or visit www.COMPLERA.com.*
COMPLERA. A complete HIV treatment in only 1 pill a day.
Ask your healthcare provider if it’s the one for you.
Before taking COMPLERA, tell your healthcare provider if you: Common side effects associated with COMPLERA:
• have liver problems, including hepatitis B or C virus infection • trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea,
• have kidney problems nausea, rash, tiredness, and depression
• have ever had a mental health problem
Other side effects associated with COMPLERA:
• have bone problems
• vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles),
• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm
and pain
your unborn child
• are breastfeeding; women with HIV should not breast-feed because they can pass Tell your healthcare provider if you have any side effect that bothers you or that
HIV through their milk to the baby 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 healthcare provider
Contact your healthcare provider right away if you experience any of the for medical advice about side effects.
following serious or common side effects:
You are encouraged to report negative side effects of prescription drugs to the
Serious side effects associated with COMPLERA:
• New or worse kidney problems can happen in some people who take COMPLERA.
FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you have had kidney problems in the past or take other medicines that can cause Take COMPLERA exactly as your healthcare provider tells you to take it
kidney problems, your healthcare provider may need to do blood tests to check your • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to
kidneys during your treatment with COMPLERA help get the right amount of medicine in your body. A protein drink does not replace
• Depression or mood changes can happen in some people who take COMPLERA. a meal
Tell your healthcare provider right away if you have any of the following symptoms: • Stay under the care of your healthcare provider during treatment with
feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of COMPLERA and see your healthcare provider regularly
hurting yourself (suicide) or have tried to hurt yourself
• Bone problems can happen in some people who take COMPLERA. Bone problems Please see Patient Information for COMPLERA on the following pages.
include bone pain, softening or thinning (which may lead to fractures). Your *The co-pay program covers up to $200 per month for 1 year from card activation or until the
healthcare provider may need to do additional tests to check your bones card expires, up to $2400 in a calendar year. The program is subject to change or cancellation
• Changes in body fat can happen in people taking HIV medicine. These changes at any time.
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 Learn more at www.COMPLERA.com