FDA Panel Considers HIV Drug for New Use



UNITED STATES:   “FDA Panel Considers HIV Drug for New Use”
Wall Street Journal     (05.06.12):: Jennifer Corbett Dooren

On Thursday, a Food and Drug Administration advisory panel will consider whether to recommend that FDA approve the first drug for high-risk but healthy people to take to prevent HIV infection. Truvada, made by Gilead Sciences Inc., is already one of the most widely used drugs to treat HIV infection. Gilead has submitted data from two large clinical trials to support marketing Truvada as pre-exposure prophylaxis (PrEP).

Gilead submitted one study involving about 2,500 at-risk gay and bisexual men that found the drug, in addition to other prevention measures like condom use, reduced their HIV infection risk by 44 percent. In another involving about 4,800 serodiscordant heterosexual couples, HIV infection risk was cut 73 percent among HIV-negative partners taking Truvada, interim data showed. But a study among some 2,000 women was stopped last year after it was determined it was unlikely to show whether Truvada helped prevent infection among them.

The AIDS Healthcare Foundation filed a petition in March urging FDA to reject the application, saying PrEP data are not strong enough. AHF also cited worries over side-effects, the drug’s $14,000-a-year cost, and adherence problems. However, the prevention advocacy group AVAC is among 14 organizations calling for FDA’s approval.

Dr. Rodney Wright, AHF’s board chair, said he is concerned about “a blanket approval” of Truvada for PrEP and the lack of data for it among women. Wright and other physicians already prescribe Truvada as PrEP on a limited basis, including for serodiscordant couples wishing to have children. CDC last year released interim PrEP guidelines for certain men who have sex with men, and it is weighing similar guidance for heterosexuals.

“PrEP will be the most beneficial for people at very high risk of HIV infection,” but strict adherence to the daily regimen is essential, said Jonathan Mermin, director of CDC’s Division of HIV/AIDS Prevention.