March 9, 2012
Ahead of a Food and Drug Administration expert panel review in May, AIDS advocacy groups are weighing in on Gilead Sciences' request that its HIV drug Truvada (emtricitabine and tenofovir) be approved for pre-exposure prophylaxis (PrEP) against the virus.
The Los Angeles-based AIDS Healthcare Foundation has petitioned FDA on the grounds that studies show Truvada is only partially effective at PrEP. Since the combination drug must be taken every day, protection will diminish if -- as is common in everyday life -- a dose is missed, said AHF. "People who take PrEP even haphazardly will consider themselves protected" and could forgo preventive measures like condoms, said Tom Myers, the group's general counsel.
"Any approach that relies on adherence for people who don't have a disease is going to fail," AHF President Michael Weinstein said Thursday. AHF estimates the cost of Truvada as PrEP at $14,000 per patient per year.
In January, a coalition of 25 health organizations contacted FDA and expressed their support for the Truvada application.
Data from a PrEP trial involving 4,758 heterosexual couples in Kenya and Uganda presented this week in Seattle at the 19th Conference on Retroviruses and Opportunistic Infections found 82 transmissions: 17 among those treated with tenofovir, 13 among those given Truvada, and 52 among the placebo group.
An FDA decision on the Truvada application is expected by June 15.