Gilead’s Biktarvy Won FDA Approval For The Treatment Of HIV-1 Infection In Adults

U.S. FDA gave green signal to Gilead’s Biktarvy

Company: Gilead

Dosage Form: Tablet

Specific Treatments: HIV-1 infection in adults

Therapeutic Areas: Infections and Infectious Diseases



General information about Biktarvy

Biktarvy is a once daily single tablet regimen combining 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.

Biktarvy is specifically 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 <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

Biktarvy is supplied as a tablet for oral administration. The recommended dose is one tablet once daily with or without food.