FDA Approves Truvada for HIV Infection Prevention

Gilead Sciences announced that the FDA has approved Truvada (emtricitabine and tenofovir disoproxil fumarate tablets), for pre-exposure prophylaxis (PrEP) in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. This approval was based on data from two large placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx) and Partners PrEP that found that Truvada reduced the risk of acquiring HIV infection by 42% and 75%, respectively.

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. Gilead has developed FDA-approved materials to educate and inform healthcare providers and uninfected individuals about Truvada for PrEP.

 
These materials highlight the importance of strict adherence to the dosing regimen, emphasize that Truvada must be considered as only one part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection, and convey that Truvada for PrEP should only be used in individuals who are confirmed HIV negative. HIV-1 screening should be repeated at least every three months while taking Truvada for PrEP.

Truvada is already approved for the treatment of HIV-1 infection in combination with other antiretroviral agents.

For more information call (800) GILEAD-5 or visit www.gilead.com.