Overview
- The U.S. regulator cleared Bixlenvo in late August 2026 as a once‑daily single‑tablet option for adults with HIV whose virus is already suppressed but who cannot use current single‑tablet regimens.
- Bixlenvo combines bictegravir, a guideline‑recommended integrase inhibitor, with lenacapavir, a first‑in‑class capsid inhibitor, and requires a two‑day lenacapavir initiation dose followed by one tablet daily.
- Approval rested on the Phase 3 ARTISTRY‑1 and ARTISTRY‑2 trials, which showed the combo maintained viral suppression through 48 weeks and produced no new safety signals.
- The most common side effects were headache, nausea, and diarrhea, and the label restricts use with certain drugs such as strong CYP3A inducers and dofetilide.
- Gilead set a $4,595 list price for a 30‑day supply, says uninsured patients may get free access through a patient assistance program, and presents the pill as part of a broader lenacapavir strategy to simplify care for older and treatment‑experienced people who take many pills.