Biktarvy approved for the treatment of HIV-1 infection

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.

“In clinical trials through 48 weeks, no patients taking the regimen of bictegravir plus FTC/TAF developed treatment-emergent resistance, results that were observed both in people new to therapy and those who were virologically suppressed and chose to switch regimens.” said Dr Paul Sax, Clinical Director of the Division of Infectious Diseases at Brigham and Women’s Hospital, Boston, Professor of Medicine at Harvard Medical School and a lead clinical trial investigator.  “In addition, the clinical data show that the regimen’s antiviral efficacy, tolerability profile and limited drug interactions offer an effective new treatment option for a range of people living with HIV.”


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