Gilead Sciences has secured US regulatory approval for Bixlenvo (bictegravir 75 mg plus lenacapavir 50 mg), a once-daily two-drug single-tablet regimen for virologically suppressed adults with HIV-1, including those switching from complex multi-tablet backgrounds, making it the smallest daily single-tablet option in the HIV-1 field and the first such regimen validated in complex-regimen-experienced patients.

The approval rests on the Phase III ARTISTRY-1 and ARTISTRY-2 trials enrolling 1,134 participants, where Bixlenvo met non-inferiority versus both a complex multi-tablet regimen and Gilead's own three-drug Biktarvy at week 48: viral rebound (HIV-1 RNA ≥50 copies/mL) occurred in 0.8% versus 1.1% in ARTISTRY-1, and 1.3% versus 1.0% in ARTISTRY-2, translating to 98.7% to 99.2% sustained viral suppression, stable CD4 counts, and no treatment-emergent resistance except one isolated integrase substitution without phenotypic resistance.

Bixlenvo pairs a high-barrier integrase strand transfer inhibitor with a first-in-class capsid inhibitor that carries no cross-resistance to other antiretroviral classes, allowing Gilead to retire tenofovir and emtricitabine from the backbone and shrink the pill footprint for an ageing, comorbidity-heavy HIV population.