FOSTER CITY, Calif. – August 27, 2026

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), a new once-daily single-tablet regimen for adults with virologically suppressed HIV-1 infection. The approval introduces a simplified oral treatment option for patients who are stable on antiretroviral therapy but may be unable to use currently available single-tablet regimens, including people taking complex multi-tablet treatment schedules. Bixlenvo combines bictegravir, an integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a first-in-class HIV capsid inhibitor with a novel mechanism and no cross-resistance to existing antiretroviral classes. The FDA decision expands Gilead’s HIV treatment portfolio and provides another approach for patients seeking to simplify established treatment while maintaining viral suppression.

Bixlenvo Combines Two Complementary HIV Mechanisms

Bixlenvo is designed to target multiple stages of the HIV life cycle by combining two antiretroviral agents with distinct mechanisms of action. Bictegravir inhibits HIV integrase, an enzyme required for viral genetic material to become integrated into the host cell genome, while lenacapavir targets the HIV capsid and acts through multiple stages of the viral life cycle. The combination is particularly relevant for patients with extensive treatment histories or complex regimens because lenacapavir has no cross-resistance with other existing antiretroviral classes, while bictegravir provides a high barrier to resistance. Bixlenvo is indicated as a complete regimen for adults who are virologically suppressed, with HIV-1 RNA below 50 copies/mL, on a stable antiretroviral regimen and without known or suspected resistance to either component. The regimen is intended to replace an existing treatment rather than initiate therapy in patients who have not achieved viral suppression.

Phase 3 ARTISTRY Program Supports FDA Approval

The FDA approval was supported by results from the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, which evaluated adults with virologically suppressed HIV who switched to Bixlenvo from existing treatment regimens. Across the studies, Bixlenvo demonstrated comparable efficacy in maintaining virologic suppression at Week 48 and was generally well tolerated, with no significant new safety concerns identified. ARTISTRY-1 enrolled a particularly treatment-experienced population, with participants taking between two and 11 pills daily at baseline and a median HIV treatment duration of 28 years. Approximately 81% of participants were receiving complex regimens because of antiretroviral resistance, highlighting the population for which treatment simplification may be particularly relevant. Switching to Bixlenvo was also associated with improvements in certain fasting lipid parameters and participant-reported treatment satisfaction, while ARTISTRY-2 found no significant impact on weight.

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Once-Daily Option Expands Treatment Simplification

Bixlenvo becomes the smallest single-tablet regimen (STR) and the first STR specifically positioned for virologically suppressed adults who are unable to take currently available STR options because of treatment complexity or other considerations. The regimen requires a two-day initiation phase using Bixlenvo together with Sunlenca® (lenacapavir), followed from Day 3 onward by one Bixlenvo tablet taken once daily. The most common adverse reactions reported across the ARTISTRY program were headache, nausea and diarrhea. Gilead said the approval reinforces its continued focus on developing HIV therapies that offer different dosing approaches and treatment options for people with evolving clinical needs. While Bixlenvo provides a new oral simplification strategy for virologically suppressed adults, the company continues to develop additional daily, weekly and longer-acting HIV treatment and prevention approaches.

Source:Gilead Sciences,,press relese