Content area
Full text
The FDA has approved combination emtricitabine plus tenofovir disproxil fumarate, combined with safer sex practices, to reduce the risk of acquiring HIV infection in adults at high risk for HIV.
The combination pill (Truvada, Gilead) is the first agent to be approved for pre-exposure prophylaxis (PrEP), according to a Gilead press release. Gilead will continue to work with the FDA to develop a Risk Evaluation and Mitigation Strategy.
"This approval is a major milestone in our 30-year fight against AIDS," Robert M. Grant, MD, MPH, Betty Jean and Hiro Ogawa Endowed Investigator at the Gladstone Institute of Virology and Immunology at the University of California, San Francisco, said in a press release. "The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world."
Data from two large placebo- controlled trials, the Pre- Exposure Prophylaxis Initiative (iPrEx) trial, which was led by Grant, and the Partners PrEP trial, were the basis of the FDA's decision. In the iPrEx trial, the drug reduced the risk of acquiring HIV by 42%, and in the Partners PrEP trial, the drug reduced the risk of acquiring...