Biktarvy gains European approval

The European Commission has granted marketing authorization for 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.

The Commission's decision makes Biktarvy US biotech major Gilead Sciences’ (Nasdaq: GILD) third FTC/TAF-based STR approved in the European Union in the past three years.

In Europe, Biktarvy 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 Biktarvy is required in patients with estimated creatinine clearance (CrCL) greater than or equal to 30mL per minute. Biktarvy has convenient dosing, does not require testing for HLA-B 5701, and has no food intake or baseline viral load or CD4 count restrictions.