Posted by Michael Wonder on 26 Jun 2018
European Commission grants marketing authorisation for Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection
25 June 2018 - In clinical trials, Biktarvy demonstrated high efficacy and zero resistance through 48 weeks.
Gilead Sciences today announced that the European Commission has granted marketing authorisation for Biktarvy (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor bictegravir, with the demonstrated safety and efficacy profile of Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF), a guidelines-recommended dual nucleoside reverse transcriptase inhibitor backbone. Today’s decision makes BIC/FTC/TAF Gilead’s third FTC/TAF-based STR approved in the European Union in the past three years.
