FDA Clears Once-Daily Two-Drug HIV Pill for Virologically Suppressed Adults

Gilead Sciences announced FDA approval of Bixlenvo, a single tablet combining bictegravir and lenacapavir, for adults with HIV-1 RNA below 50 copies/mL who are switching from a stable regimen. The approval is based on phase III trials showing the combo maintained viral suppression and was noninferior to existing therapies. It offers an alternative for patients with resistance or tolerability issues with current single-tablet regimens.

The approval rests on two phase III trials. In ARTISTRY-1, involving 557 suppressed patients on complex regimens, viral rebound occurred in 0.8% of those switching to the combo versus 1.1% staying on their regimen. ARTISTRY-2 demonstrated noninferiority to Biktarvy, with rebound rates of 1.3% and 1.0% respectively.

Treatment begins with a two-day initiation phase pairing the combo tablet with additional 300-mg lenacapavir doses, then settles into once-daily maintenance. The label prohibits coadministration with dofetilide or strong CYP3A inducers, and the most frequently reported side effects were headache, nausea, and diarrhea. Researchers are also exploring oral lenacapavir in weekly regimens paired with islatravir.