Activists Caution HIV+ Patients and their Physicians About Monotherapy in Upcoming Access Program

IMMEDIATE RELEASE: February 9, 2012

Nelson Vergel (
Activists Caution HIV+ Patients and their Physicians About
Monotherapy in Upcoming Access Program
New York, February 9, 2012—AIDS activists and physician advocates welcome
the news that ViiV Healthcare will be providing 
expanded access of dolutegravir (DTG), a new investigational integrase
inhibitor for HIV patients with few remaining HIV treatment options.  However, they warn patients and physicians to
avoid functional monotherapy, or the introduction of dolutegravir as an
“add-on” to a failing treatment regimen if the patient’s virus is
resistant to all other currently available antiretroviral drugs (ARVs).  Functional monotherapy has been shown to
permit rapid HIV resistance to new medications, which can result in more rapid
disease progression, health deterioration, and death.
Currently, the
U.S. Department of Health and Human Services (DHHS) adult HIV treatment guidelines
recommend three ARVs be given in combination to suppress HIV.  But many patients have HIV that has mutated
rendering their virus multi-drug resistant (MDR-HIV).  Those with MDR-HIV cannot construct a viable
HIV suppressive regimen with current FDA-approved and commercially available
ARVs.  “The DHHS guidelines specify
that patients that have developed
HIV drug resistance to all commercially available antiretrovirals require
access to at least two new active drugs to maximize their chances for treatment
response.  However, “another new drug to
combine with dolutegravir will not be commercially available for at least two
years, and some patients cannot wait that long,” said Nelson Vergel, an
activist founder of 
“For them, access to another research drug in combination with DTG
is the only hope for survival,” added Vergel.
In studies to date, dolutegravir (DTG) appears to be
the most potent integrase inhibitor soon to enter the ARV market.  Unlike Gilead’s upcoming elvitegravir, DTG
has been shown to be effective against HIV that has developed resistance to
Merck’s Isentress (raltegravir), the only FDA-approved integrase inhibitor currently
on the market.
Fortunately, another new ARV that can help patients with
MDR-HIV is in active development and clinical trials.  Ibalizumab, a monoclonal antibody from a
small biotech firm, Taimed Biologics, may soon be available via patient participation
in research studies.  While ibalizumab
has yet to enter phase three studies, it can also be provided to patients at
risk of death via a named (or single) patient
application permitted by the FDA via a physician’s direct
request to Taimed.  However, it is for
the company to approve such requests for compassionate access.
There are no documented estimates of how many people have
MDR-HIV in the United States.  A report in the Journal of Clinical
Infectious Diseases
estimates that about 260,000 patients are being
treated with HIV in the United States. 
However, it is virtually impossible to know how many are now without
sufficient treatment options since no registry for such patients exists.  But most experts agree that this population
is probably small – possibly up to 10% of the total in treatment.
“With little immune function left and resistance to all
approved HIV medications, I have tried desperately to get access to two new
drugs to help save my life,” said Christopher Cacioppo, a patient with MDR-HIV
in  San Diego who believes he is running
out of time. “My doctor tells me that I have little choice but to wait for the
dolutegravir expanded access program and some as yet unknown and unavailable
second new drug.”
A coalition of activists and physicians have been in
discussions with Taimed and ViiV for nearly two years to obtain
compassionate-use access to their new ARVs in combination for those with
MDR-HIV in greatest need of new treatment options.  The AIDS Community Research Initiative of
America (ACRIA), a New York City-based community research and education organization, and physicians in
San Francisco have proposed solutions to overcome this “two-drug access
barrier” in an effort to secure urgent access to patients across the country.
Physicians and providers with patients with
MDR-HIV in need of two new ARVs are urged to complete this

Fw: Hot Topics at The Body’s “Ask the Experts” Forums

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Subject: Hot Topics at The Body’s “Ask the Experts” Forums

If you have trouble reading this e-mail, you can see the online version at:
February 7, 2012 Visit the Forums “Hot Topics” Library Change/Update Subscription


 How Do I Deal With the Uncertainty of Living With HIV?
I’ve found it stressful to see people who are being successfully treated for HIV die between 50 and 60 years old. I just turned 48. What if my number is up in the next decade? Suppose I spend all my money doing things I want to do now, then live into retirement and have nothing saved because I didn’t expect to live that long? What if I save lots of money, then die before I’m able to use it? How am I supposed to enjoy my life day by day?

David Fawcett, Ph.D., L.C.S.W., responds in the “Mental Health and HIV” forum

 Returning to Work: How Will I Keep Paying for My HIV Care?
Ever since being placed on Social Security Disability Insurance (SSDI) due to an AIDS diagnosis in 2008, all I could think about was returning to the workforce and finding my place in the community again. However, I’m terrified of losing my ability to pay for my HIV meds and medical care. What do I need to be aware of as I prepare to return to work?

Jacques Chambers, C.L.U., responds in the “Workplace and Insurance Issues” forum


 Should I Treat My Enlarged Parotid Glands?
I’ve been looking for information on electron radiation therapy for the treatment of enlarged parotid glands, which can cause facial distortion — particularly a “moon face” look. Does this treatment method have any clinical benefit besides improving quality of life through cosmetic benefits? Does it have any effect on viral load or CD4 count? Where can I get more information?

Nelson Vergel responds in the “Nutrition and Exercise” forum

what's fueling hiv in black america?
hands Today, Feb. 7, is National Black HIV/AIDS Awareness Day in the U.S. In observance of the day, asked African-American HIV/AIDS experts to cut through the hype and tell us in plain language what factors are really to blame for the persistence of HIV in African-American communities.


 What Can I Do if I Can’t Get ADAP Coverage?
What will happen to people who can’t get access to their HIV meds through AIDS Drug Assistance Programs (ADAPs)? If income requirements for eligibility keep lowering, do people have to just not get their meds and wait to die? What are our options?

Nelson Vergel responds in the “Nutrition and Exercise” forum

 Why Would I Ever Need to Switch Meds?
Thankfully, I’ve never experienced any side effects in the past two years I’ve been taking Atripla (efavirenz/tenofovir/FTC), my first and only HIV med regimen. Is there a chance that I may one day need to change my medication? What factors would contribute to this need to switch?

Benjamin Young, M.D., Ph.D., responds in the “Choosing Your Meds” forum

 How Can I Get Rid of Loose Stools?
In my first month on HIV meds I had no side effects, except for slightly looser stools. Now, after several months, it seems my stools are always loose, regardless of what l eat. Is this common? What can I do about it?

Keith Henry, M.D., responds in the “Managing Side Effects of HIV Treatment” forum

More Questions About HIV/AIDS Treatment:


 Is Depression in Poz People Caused by the Virus Itself?
I recently saw the psychiatrist at my provider’s office due to some depressive thoughts. Is depression a common occurrence due to the virus’s effect on the body, as opposed to the psychosocial factors that contribute to depression in people living with HIV? Aren’t antidepressants just an aid until one can change the psychosocial factors and feel better on their own?

David Fawcett, Ph.D., L.C.S.W., responds in the “Mental Health and HIV” forum

 Can HIV Meds Slow the Progression of Hepatitis C?
How can HIV meds have an effect on hepatitis C virus progression? I’ve read that they can exacerbate liver damage, but is it possible that the meds could also slow liver disease progression?

Barbara McGovern, M.D., responds in the “Hepatitis and HIV Coinfection” forum

 Reactive Syphilis Test After Treatment: Is This Possible?
Is it possible to be treated successfully for syphilis and have a nonreactive test result, then have another reactive test without having had sex with anybody?

Mark Holodniy, M.D., F.A.C.P., C.I.C., responds in the “Understanding Your Labs” forum

Connect With Others Hey, Poz LGBT Folks: Share Your Coming-Out Stories!
(A recent post from the “Gay Men” board)

What has the whole “coming out” process been like as a person living with HIV who is gay, bi or transgender? Is coming out — as HIV positive and/or as LGBT — something you still struggle with? Why, or why not? I am a young person in my early 20s. I was born with HIV and I am bi, and I would love to hear other people’s stories of coming out! — Keya

Click here to join this discussion, or to start your own!

To do this, you’ll need to register with’s bulletin boards if you’re a new user. Registration is quick and anonymous (all you need is an e-mail address) — click here to get started!


 Just How Delayed Was the Most Delayed Seroconversion Ever?
I had a low-risk exposure to HIV 18 months back. I have tested negative for HIV every three months since that encounter. I’ve been reading about delayed seroconversion and I was wondering: According to available literature, what is the longest possible duration between HIV exposure and seroconversion? I read about a case in a 1997 study in which seroconversion took eight to nine months. Is that the maximum?

David Wohl, M.D., responds in the “Safe Sex and HIV Prevention” forum

 Pregnancy Has Me Anxious: Is My Risk Real?
I have a fear of contracting HIV from means that are out of my control. I’m pregnant with my fourth baby, and my fears seem to heighten when I’m pregnant. I recently went for prenatal testing and they needed to draw blood. I’m worried that when I wasn’t looking, the technician might have accidently pricked herself with the needle she then used to draw my blood. If I contracted HIV or hepatitis C, this would not only affect me but also the baby inside me. I’m really scared and would just like to enjoy my pregnancy rather than worry. Should I get tested for HIV?

Lisa B. Hightow-Weidman, M.D., M.P.H., responds in the “Safe Sex and HIV Prevention” forum


 Could Sparky’s Claws Double as HIV Transmitters?
Last week I visited an HIV-positive friend. I brought my small dog that likes to scratch people’s legs as a greeting. He scratched my friend’s leg, and a few minutes later the dog scratched my arm. Neither of us bled, but my skin did burn and get red. I know the “H” in HIV stands for “human” and dogs cannot contract it, but could the (hypothetical) blood on the dog’s nail be fresh enough to have infected me?

Richard Cordova responds in the “Safe Sex and HIV Prevention” forum

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What to do if you think you have recently been exposed to HIV

This would definitely be the HIV medication combo that I would take if I was HIV negative and wanted to treat a potential HIV exposure (condom breakage, needle stick, etc). Prior studies were done using Truvada alone (two drugs combined in one pill), but adding raltegravir to Truvada makes a lot of sense. Raltegravir (brand name Isentress) is the HIV medication that lowers HIV viral load the fastest, which is something you need if you have been exposed in the last few hours. It also happens to be a very well tolerated medication.

Note: If you get exposed to HIV, you need to treat quickly (within 72 hours), and then stay on treatment for 4-8 weeks

But a one month supply of Isentress plus Truvada would cost more than $1000. Some people call local HIV doctors or health clinics to find out who has extra medications, or just pay for the medications themselves since insurance companies do not pay for post exposure prophyplaxis treatment. And that is where the dilemma lies..

Here is a small study using the Isentress+ Truvada combo for post exposure prophylaxis :

Note: If the person that may have exposed you to HIV is on treatment and has undetectable viral load in their blood, the chances of infection are minimized.  So if you can ask that person about their lab numbers, that would provide additional information for your doctor to make a decision.

For HIV doctors around the United States: Directory of HIV Physicians