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.
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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.