U.S. Food and Drug Administration approves Descovy (emtricitabine, tenofovir alafenamide), Gilead’s third TAF-based HIV therapy

4 April 2016 - Gilead Sciences, Inc. today announced that the U.S. FDA has approved Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV.

Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Descovy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B. See below for important safety information.

For more details, go to: http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2153927

Michael Wonder

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Michael Wonder