The U.S. Food and Drug Administration (FDA) has approved Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), a once-daily single-tablet regimen developed by Gilead Sciences for adults living with HIV who are virologically suppressed.

The approval introduces a new treatment option for people who may be unable to use currently available single-tablet regimens, including individuals receiving complex multi-tablet HIV treatment.

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 of action and no cross-resistance with existing antiretroviral classes.

According to Gilead, Bixlenvo is now the company's smallest single-tablet regimen and the first and only single-tablet option specifically indicated for virologically suppressed adults who are unable to take currently available single-tablet regimens.

Evidence supporting the approval

The FDA decision was supported by findings from the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, which evaluated adults with virologically suppressed HIV who switched to Bixlenvo from either complex multi-tablet regimens or Biktarvy.

At Week 48, Bixlenvo demonstrated comparable efficacy in maintaining virologic suppression and was generally well tolerated. The most frequently reported adverse reactions occurring in at least 2% of participants were headache, nausea and diarrhoea.

ARTISTRY-1 included a highly treatment-experienced population, with participants taking between two and 11 pills daily at baseline. The median participant age was 60 years, while the median duration of HIV treatment was 28 years. A substantial proportion had historical antiretroviral resistance, including 67% with nucleoside reverse transcriptase inhibitor resistance.

The study also found that switching from complex multi-tablet regimens to Bixlenvo was associated with improvements in selected fasting lipid parameters and patient-reported treatment satisfaction. ARTISTRY-2 found that switching to Bixlenvo did not significantly affect body weight.

Simplifying complex HIV treatment

Bixlenvo requires a two-day initiation regimen involving Sunlenca® (lenacapavir), after which patients take Bixlenvo orally once daily.

The approval adds another option to Gilead's expanding HIV treatment portfolio and reflects the industry's continuing shift toward simplified and potentially more personalised antiretroviral treatment.

Gilead said the company is continuing to develop HIV treatment and prevention options spanning daily, weekly and longer-acting approaches.

Bixlenvo is currently not approved by regulatory authorities outside the United States.