AHF demands FDA reversal on use of Gilead's HIV prevention pill for women

Citing another failed clinical trial in women of the use of Gilead Sciences’ (Nasdaq: GILD) AIDS drug Truvada (emtricitabine and tenofovir disoproxil fumarate), as a form of Pre-exposure Prophylaxis (PrEP) to prevent HIV infection, the USA-based AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS non-profit medical provider, has urged the Food and Drug Administration to remove this indication for use by women citing insufficient data demonstrating the drug’s safety and efficacy.

Last year, the FDA approved the use of Truvada as prevention in certain populations despite modest clinical trial results supporting Gilead’s application for expanded use of its blockbuster AIDS drug, Truvada, as a means of preventing HIV infection in non-infected people (The Pharma Letter July 12, 2012).

During the Conference on Retroviruses and Opportunistic Infections (CROI) taking place in Atlanta, the US National Institutes of Health (NIH) released results of another HIV clinical trial that evaluated two oral antiretroviral prophylaxis regimens and a vaginal microbicide among sexually active women. Compared with the subjects taking placebos, those taking the drug also received no protection. This is the third major study of PrEP in women that failed - following the FEM-PREP study and the VOICE Study (Vaginal and Oral Interventions to Control the Epidemic) - each of which were halted mid-trial after it was determined they were demonstrating no efficacy whatsoever in women trial subjects, the AHF stated.