2018/02/07

U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection
Feb. 7, 2018 Gilead, HIV
  • 米国FDAがギリアドのビクタルビ(ビクテグラビル、エムトリシタビン、テノフォビル)をHIV-1感染症治療薬として承認。

– In Clinical Trials, Biktarvy Demonstrated High Efficacy, Few Interactions With Other Drugs and a High Barrier to Resistance Through 48 Weeks –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 7, 2018-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available.