Gilead Sciences has received FDA approval for Bixlenvo, a once-daily single-tablet regimen for adults with HIV-1 who are virologically suppressed on a stable antiretroviral regimen.
Bixlenvo combines bictegravir 75 mg and lenacapavir 50 mg. Gilead said it is the smallest once-daily single-tablet regimen for HIV and the first such option for most virologically suppressed adults on complex regimens who cannot use currently available single-tablet therapies.
The regimen is indicated to replace a current antiretroviral treatment in adults with HIV-1 RNA below 50 copies per milliliter and no known or suspected resistance to either Bixlenvo component. It is not approved outside the United States.
Bictegravir is an integrase strand transfer inhibitor with a high barrier to resistance. Lenacapavir is a first-in-class capsid inhibitor with a distinct mechanism of action and no cross-resistance to other existing antiretrovirals, according to Gilead.
The approval was based on the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, which evaluated Bixlenvo in virologically suppressed adults switching from complex multi-tablet regimens or from Biktarvy. In both studies, Bixlenvo maintained virologic suppression through Week 48 with efficacy comparable to the prior regimens and was generally well tolerated, Gilead said.
ARTISTRY-1 enrolled a population with a median age of 60 years. Before switching, participants took between two and 11 pills daily, about 40% used antiretroviral therapy more than once a day, and 81% were on complex regimens due to antiretroviral resistance. Participants had received HIV treatment for a median of 28 years.
Switching from multi-tablet treatment to Bixlenvo was associated with improvements in certain fasting lipid measures and patient-reported treatment satisfaction. ARTISTRY-2 found no significant effect on weight after switching.
Treatment begins with a two-day oral initiation regimen of Bixlenvo plus Sunlenca, Gilead’s lenacapavir product. Starting on Day 3, patients take one Bixlenvo tablet daily, with or without food.
The most common adverse reactions were headache, nausea and diarrhea. Bixlenvo is contraindicated with dofetilide and strong CYP3A inducers. The company said healthcare professionals should assess potential drug interactions before and during treatment.
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