AHF cautions against fast track FDA-approval for expanded use of Gilead’s Truvada

AIDS Healthcare FoundationMay 4 2011

During its quarterly meeting over the weekend, The Board of Directors of the AIDS Healthcare Foundation (AHF) adopted a resolution cautioning Gilead Sciences against seeking fast track FDA-approval for the expanded use of its best selling AIDS treatment, Truvada, as a possible form of pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV. The resolution noted that Gilead's drug,"…has not shown adequate effectiveness to warrant submitting an application for a specific indication from the FDA without further studies."

“…has not shown adequate effectiveness to warrant submitting an application for a specific indication from the FDA without further studies.”

The move by AHF's Board comes on the heels of a CDC announcement of the abrupt halt late last month of an ongoing study in Africa of the use of Gilead's Truvada as a possible form of pre-exposure prophylaxis for HIV prevention in women because the, "…trial could not demonstrate efficacy." The Board action followed earlier news of a prior study involving 2,500 high risk men-who-have-sex-with-men (MSM) that showed a 44% effectiveness rate in preventing HIV transmission among those who took Truvada as form of prevention.

AHF's Board resolution also parallels wide-ranging efforts by AHF staff and advocates urging Gilead to reconsider its pursuit of FDA-approval of Truvada for expanded use as prevention. The full resolution, which was unanimously adopted by all those AIDS Healthcare Foundation Board of Directors who were in attendance Saturday, April 30^th reads:

AIDS Healthcare Foundation Board Resolution

"It is the position of AIDS Healthcare Foundation that current data on pre-exposure prophylaxis (PrEP) with Truvada for the prevention of HIV has not shown adequate effectiveness to warrant submitting an application for a specific indication from the FDA without further studies. AHF recognizes that medical providers currently have the ability to prescribe Truvada for prevention on an off-label basis and does not wish to interfere in the relationship between a doctor and a patient. However, a new indication for Truvada for prevention would open the door to the widespread promotion of this approach without sufficient scientific justification."

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.

For the past several months, AIDS Healthcare Foundation has been leading a public awareness campaign urging Gilead Sciences, Inc., the U.S. Food & Drug Administration (FDA) and other stakeholders to exercise caution in the rush to bring PrEP to the market. The campaign has included an opinion editorial published in the San Jose Mercury News on December 30, 2010 called: Advance on AIDS, or Giving Up on Gay Men?, an e-letter campaign targeting Gilead CEO John Martin and several newspaper ads.