European Commission approves Biktarvy to treat HIV infection.- Gilead Sciences.

Gilead Sciences, Inc. announced that the European Commission has granted Marketing Authorization for Biktarvy (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF), a guidelines-recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone.

This decision makes BIC/FTC/TAF Gilead’s third FTC/TAF-based STR approved in the European Union in the past three years. In Europe, BIC/FTC/TAF is indicated as a complete regimen for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. No dosage adjustment of BIC/FTC/TAF is required in patients with estimated creatinine clearance (CrCL) greater than or equal to 30 mL per minute. BIC/FTC/TAF has convenient dosing, does not require testing for HLA-B 5701, and has no food intake or baseline viral load or CD4 count restrictions.

Comment: Biktarvy seems likely to attract market share from patients who take Tivicay with Truvada or Descovy due to the convenience of a single-tablet regimen and the renal safety benefit Gilead claims for bictegravir.