FDA backs Gilead's Descovy HIV therapy

5 April 2016

The US Food and Drug Administration has approved Descovy (emtricitabine/tenofovir alafenamide), Gilead Science’s (Nasdaq: GILD) 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 aged 12 and over. It is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

The drug 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.

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