Gilead Sciences, Inc has announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in theUnited States.
Eventually, if the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP. The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP, sponsored by the U.S. National Institutes of Health (NIH) and the University of Washington. Several other clinical studies support the use of Truvada for HIV risk reduction.
The data from these large-scale clinical trials suggest that Truvada may have a role to play in meeting the urgent public health need to reduce new HIV infections. Gileadis proud to have played a part in helping to define the use of Truvada as a potential new prevention tool. Truvada is not currently indicated to reduce the risk of HIV infection.
According to current Centers for Disease Control and Prevention (CDC) data, each year some 50,000 people are newly infected with HIV in the United States. Despite extensive efforts to prevent infections using existing interventions, the HIV incidence rate has remained steady for many years. More than half of new infections (61 percent) occur among men who have sex with men, and nearly a quarter (23 percent) occur among women.