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

[Guest guest]

FOR

IMMEDIATE RELEASE: February 9, 2012

Contact:

Vergel (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 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 HIV 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 access application

permitted by the FDA via a physician’s direct request to Taimed. However, it is up to 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 who have uncontrolled HIV virus. 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 of them have run out of treatment options since no registry for those

patients exists. But most experts agree that this population is probably small.

"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 Cacioppo, a

patient with MDR-HIV in San Diego who

believes he is running out of time. “But 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

coversations with Taimed and ViiV for

two years to obtain compassionate access to their two active 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 barrierâ€

in an effort to secure urgent access to patients across the country.

Any physician who may have a patient with

MDR-HIV who is in dire need of two new unapproved ARVs may use this form

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