Research & Development
US FDA Grants Gilead Approval for Biktarvy for Treatment of HIV-1 Infection
9 February 2018 - - Foster City, California-based global research-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) has received US Food and Drug Administration approval of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen for the treatment of HIV-1 infection, the company said.
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 backbone, and is the smallest INSTI-based triple-therapy STR available.
Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA