Gilead Sciences announced that the U.S. FDA approved Bixlenvo, a once-daily single-tablet HIV treatment combining bictegravir 75 mg and lenacapavir 50 mg.
The approval applies to adults with HIV-1 whose viral load is already suppressed and who are switching from a stable regimen, provided they have no known or suspected resistance to either component.
Bixlenvo is intended to simplify treatment for patients on complex regimens who cannot use currently available single-tablet options. Gilead describes it as the smallest once-daily single-tablet regimen in this setting.
The approval was supported by two Phase 3 studies showing that Bixlenvo maintained viral suppression comparably to existing multi-pill regimens or Biktarvy after 48 weeks.
Patients must receive an initial two-day dose of Sunlenca, lenacapavir’s existing formulation, before beginning daily Bixlenvo. Safety was generally consistent with the known profiles of the medicines, with no new major concerns reported.
Sources:
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