EC approves Gilead's triple combo HIV therapy

Gilead Sciences Inc. (NASDAQ:GILD) said the European Commission approved an MAA for Biktarvy bictegravir/emtricitabine/tenofovir alafenamide to treat HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.

FDA approved Biktarvy in February to treat HIV-1 infection. The drug's U.S. label includes a boxed warning of severe acute exacerbations of HBV in patients co-infected with HIV-1 and HBV (see "FDA Approves Gilead's Triple Combo HIV Therapy")...