Biktarvy approved for the treatment of HIV-1 infection
The FDA has approved Biktarvy a once-daily single-tablet regimen for the treatment of HIV-1 infection…
Gilead Sciences, Inc. has announced that the US 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.
BIC/FTC/TAF combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy (emtricitabine 200 mg/tenofovir alafenamide, 25 mg;FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available.
BIC/FTC/TAF 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 <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 BIC/FTC/TAF. No dosage adjustment of BIC/FTC/TAF is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
BIC/FTC/TAF does not require testing for HLA-B 5701, has no food intake requirements, and has no baseline viral load or CD4 count restrictions.According to BIC/FTC/TAF’s Prescribing Information, prior to or when initiating treatment with BIC/FTC/TAF, healthcare providers should test for hepatitis B virus (HBV) infection and renal function, and monitor renal function as clinically appropriate during therapy.