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U.S. FDA Approves Gilead’s Bixlenvo™, A New Once-Daily Single Tablet Option For Virologically Suppressed Adults With HIV, Including Those On Complex Regimens
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August 27, 2026
U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens
– Novel Daily Oral Tablet Combines Bictegravir, a Guideline-Recommended INSTI with a High Barrier to Resistance, with Lenacapavir, a First-in-Class Capsid Inhibitor with No Cross-Resistance to Other Existing Antiretrovirals –
– Bixlenvo Now the Smallest STR; First and Only STR for Most People on Complex HIV Treatment Regimens –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved 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 the Phase 3 ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, with datapresented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026).
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