IMMEDIATE RELEASE: February 9, 2012
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.
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 SalvageTherapies.org.
“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
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 form.