FHI to stop FEM-PrEP study of HIV prevention among heterosexual women

On the heels of Centers for Disease Control (CDC) announcement earlier today that an ongoing study of the use of Gilead's top selling AIDS treatment, Truvada, as a possible form of pre-exposure prophylaxis (PrEP) for HIV prevention in women is being abruptly halted because the, "…trial could not demonstrate efficacy," the AIDS Healthcare Foundation (AHF) renewed its call on Gilead Sciences to slow its fast track pursuit of its application for FDA approval of use of its AIDS drug as a possible form of HIV prevention. AHF notes that disappointing results of a similar earlier study of PrEP in men who have sex with men (MSM) coupled with today's announcement of the failure of women's study—before it was even concluded—indicate officials at Gilead should put the brakes on approval of its top-selling AIDS drug as prevention.

In a `Dear Colleague' letter dated today (April 18, 2011) Kevin A. Fenton, M.D., Ph.D., Director, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention and Jonathan H. Mermin, M.D., M.P.H., Director, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral, Hepatitis, STD, and TB Prevention wrote:

"Today, FHI announced that it will stop the FEM-PrEP study of pre-exposure prophylaxis (PrEP) for HIV prevention among heterosexual women. The decision was made after a regularly scheduled interim review of data by the trial's independent data monitoring committee determined that the trial could not demonstrate efficacy even if it continued to its originally-planned conclusion."

"While the failure of this latest study examining Gilead's use of Truvada as a form of pre-exposure prophylaxis in women is unfortunate, this news, coupled with the disappointing results of a similar earlier study of PrEP in men who have sex with men indicates that officials at Gilead should slow down their fast track pursuit of FDA-approval of use of its AIDS drug Truvada as a possible form of HIV prevention," said AHF President Michael Weinstein. "Clearly Gilead should take the news today of this failed study in women as well as the unacceptable study results in its previous MSM study to heart, delay seeking FDA-approval for use of Truvada as prevention and concentrate on further studies and clinical trials. Relying on the one study conducted in MSM that showed marginal success is simply not acceptable or sufficient for extending the approved use of this drug."

Truvada, a drug compound that consists of Gilead's drugs Viread (tenofovir DF) and Emtriva (emtricitabine), is currently FDA-approved for use as part of antiretroviral therapy combinations for individuals already living with HIV or AIDS. FDA-approval for pre-exposure use as a possible form of HIV prevention for those NOT infected with the virus would be a first for the FDA, and a move that AHF and many other AIDS advocates believe would set a dangerous precedent.

Gilead's likely pursuit of FDA-approval for expanding the use of its best selling $35 per day AIDS drug to include use as a form of HIV prevention comes following a recent and widely-reported study of 2,500 high risk gay men using Truvada which showed a 44% effectiveness rate in preventing HIV transmission.

In 2010, Truvada was Gilead's second-best selling product generating over $2.6 billion in revenue. One analyst told Bloomberg that FDA-approval to prescribe the drug for pre-exposure prophylaxis may add $1 billion to Gilead's sales of Truvada.