Gilead Sciences has received FDA approval for Bixlenvo, a once-daily single tablet HIV treatment for virologically-suppressed adults.
The regimen is a combination of 75 mg bictegravir and 50 mg lenacapavir. Bictegravir is a guideline-recommended integrase strand transfer inhibitor (INSTI) with high barrier resistance, while lenacapavir is a first-in-class capsid inhibitor with no cross-resistance to other antiretrovirals. Bixlenvo will be available even to patients with complex regimens who are unable to take other STRs.
In the phase 3 ARTISTRY-1 and ARTISTRY-2 trials, Bixlenvo was given to virologically-suppressed patients who had previously been on multi-tablet regimens or were taking Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). The drug demonstrated comparable efficacy in maintaining virologic suppression at week 48 and led to no new or significant safety concerns.