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The FDA Antiviral Drugs Advisory Committee voted in favor of recommending combination emtricitabine/tenofovir for HIV pre-exposure prophylaxis in those at high-risk for acquiring HIV infection. A final recommendation is expected in June.
“Globally, the number of new HIV infections continues to outpace treatment initiations, so we must continue to find new effective primary HIV prevention strategies,” Connie Celum, MD, MPH, professor of medicine and global health at the University of Washington, told the panel.
The supplemental new drug application was submitted by Gilead, the maker of combination emtricitabine/tenofovir (Truvada). This decision affects HIV-uninfected men who have sex with men, HIV-uninfected partners in serodiscordant couples and other individuals at risk for acquiring HIV through sexual activity.
Jared Baeten
The committee considered data from several studies including PrEP for the prevention of HIV acquisition. However, the principal data came from two studies: the Pre-exposure Prophylaxis Initiative (iPrEx) study and the Partners PrEP study.
As previously reported in Infectious Disease News, the Partners PrEP study included 4,747 serodiscordant couples, of which the HIV-uninfected partner was randomly assigned to tenofovir (Viread, Gilead), combination emtricitabine/tenofovir or placebo.
“In the primary analysis of the Partners PReP study, there was a 67% reduction in HIV acquisition in the tenofovir arm and a 75% reduction in HIV acquisition in the emtricitabine/tenofovir arm,” Jared Baeten, MD, PhD, associate professor of global health at the University of Washington, told the panel.
The iPrEx study included 2,499 individuals who were randomly assigned to combination emtricitabine/tenofovir or placebo. Those who were assigned to emtricitabine/tenofovir had a 44% lower risk of HIV acquisition compared with placebo. Among recipients with a high degree of adherence, there was a 73% in the risk of HIV acquisition. The combination treatment was well-tolerated.
Although the FDA is not required to take the advice of the advisory committee, it usually does.
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