The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed.
Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs.
This novel HIV treatment pairs bictegravir, a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that has a novel mechanism of action with no cross-resistance to other antiretrovirals.
The FDA approval is based on results from phase 3 trials, with data presented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026). The trials evaluated Bixlenvo in adults with HIV who are virologically suppressed, including those who switched from complex multi-tablet regimens or from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg).
