Gilead announces FDA approval of Biktarvy combo treatment for HIV-1 infection
Gilead Sciences announced that the U.S. Food and Drug Administration has approved Biktarvy, a once-daily single tablet regimen for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor bictegravir, with the demonstrated safety and efficacy profile of the Descovy dual nucleoside reverse transcriptase inhibitor backbone, and is the smallest INSTI-based triple-therapy STR available, the company stated. Biktarvy has a Boxed Warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B. Additional clinical trials of Biktarvy are ongoing, including a dedicated study in women, as well as a study in adolescents and children living with HIV. Gilead plans to present data from these studies at scientific conferences in 2018.