Bictegravir-Lenacapavir Combo Pill Earns FDA Approval in Suppressed HIV

— Combo could offer an alternative for those who can't take existing single-tablet regimens

August 28, 2026

• 2 min read

The FDA approved the combination of bictegravir and lenacapavir (Bixlenvo) for adults with virologically suppressed HIV-1 infection, Gilead Sciences announced Thursday.

The once-daily single tablet contains 75 mg of the integrase strand transfer inhibitor (INSTI) bictegravir and 50 mg of the capsid inhibitor lenacapavir. The treatment is indicated in adults with HIV-1 RNA levels less than 50 copies per mL who are switching from a stable antiretroviral regimen and have no resistance to the two drugs.

Bictegravir-Lenacapavir Combo Pill Earns FDA Approval in Suppressed HIV

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