Editor's note: Drexel University School of Public Health's Dr. Lisa Bowleg and Dr. Seth Welles also commented on the recent FDA approval of Truvada. Read more.
On Monday, July 16, 2012, the U.S. Food and Drug Administration approved Truvada®(emtricitabine and tenofovir disoproxil fumarate), the first drug intended to prevent HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity, a strategy called pre-exposure prophylaxis (PrEP). As part of the approval, Gilead worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use of Truvada for PrEP as part of a comprehensive prevention strategy. Join Dr. M. Keith Rawlings, Director, HIV Medical Affairs, Gilead Sciences as he discusses Truvada, followed by a conversation between Dean Marla J. Gold, MD and Dr. Rawlings.
The FDA approved once-daily oral Truvada, in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. Truvada was originally approved in 2004 in combination with other antiretroviral agents as a treatment of HIV-1 infection in adults.
It is estimated that 1.2 million Americans are currently living with HIV, and, despite the availability of existing prevention tools such as condoms, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year. Nearly one-quarter (23 percent) of new HIV cases occur among women, and more than half (61 percent) occur among men who have sex with men (MSM). In particular, young African American MSM bear a heavy burden of the epidemic, with new HIV cases among this group increasing by nearly 50 percent between 2006 and 2009.
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