EMA’s CHMP recommended approval of Biktarvy bictegravir/emtricitabine/tenofovir alafenamide from Gilead Sciences Inc. (NASDAQ:GILD) to treat HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. The company expects a final decision from the European Commission in mid-2018.
In February, FDA approved the combo to treat HIV infection in adults with no prior history of antiretroviral treatment or as a replacement in virologically suppressed adults on a stable regimen for at least three months with no history of treatment failure or resistance to Biktarvy's individual components. 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 BioCentury Extra, Feb. 7).
Biktarvy is a single-tablet, fixed-dose combination of bictegravir (GS-9883), an integrase strand transfer inhibitor (INSTI); emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI); and tenofovir alafenamide, a prodrug of the NRTI tenofovir.