FDA approves Gilead’s Bixlenvo, smallest single-tablet option for virologically suppressed HIV patients

Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg) is now the smallest single-tablet regimen (STR) available for HIV treatment and the first and only STR option available to virologically suppressed people with HIV who are on complex regimens and unable to take current STRs, according to a Gilead Sciences news release.

This therapy is a combination of bictegravir, an integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a capsid inhibitor, which means it can target multiple stages of the HIV life cycle.

The approval was made using the results of the phase 3 ARTISTRY-1 and ARTISTRY-2 trials. Both trials enrolled virologically suppressed adults, some switching from complex multi-tablet regimens and others from Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). At Week 48, Bixlenvo maintained viral suppression at Week 48 comparable with prior therapy. ARTISTRY-1 enrolled the oldest population in a phase 3 HIV-1 treatment registrational trial to date, with a median age of 60 and a median treatment history of 28 years.

At baseline, participants were taking between two and 11 pills a day, and 81% were on a complex regimen because of drug resistance. Switching those patients to Bixlenvo was associated with improvements in certain fasting lipid measures and in participant-reported treatment satisfaction. ARTISTRY-2 found no significant impact on weight after the switch.

“Bixlenvo offers a new once-daily STR designed for the evolving needs of people with HIV,” Chloe Orkin, M.D., lead primary investigator for ARTISTRY-1 and Clinical Professor of Infection and Inequities at Queen Mary University of London, said in the news release. “The approval is a significant advancement in HIV treatment, especially for individuals unable to benefit from guideline-recommended STRs due to challenges like pre-existing resistance or tolerability. It expands tailored, simplified dosing to people whose needs were not fully met by existing single-tablet therapies."

• Switching to Bixlenvo starts with a two-day initiation dose, followed by once-daily Bixlenvo alone starting Day 3 and continuing indefinitely:
• Day 1: one Bixlenvo tablet plus two tablets of Sunlenca (lenacapavir), a 600 mg dose
• Day 2: the same combination repeated
• Day 3 and daily thereafter: one Bixlenvo tablet alone

Tablets can be taken with or without food and missed initiation doses should be taken as soon as possible. Patients should not take both Day 1 and Day 2 Sunlenca doses on the same day. If more than seven days pass since a maintenance dose, the initiation regimen restarts. The most common adverse reactions in trials, each reported in at least 2% of participants, were headache, nausea and diarrhea, with no significant or new safety concerns identified.

Approximately 1.1 million people were living with diagnosed HIV in the United States at the end of 2024, and 69% had achieved viral suppression that year, according to the Centers for Disease Control and Prevention. Bictegravir and lenacapavir in combination are not approved outside the United States.

The list price of Bixlenvo is currently $4,595 for a 30-day supply.

“Bixlenvo continues Gilead's long-term commitment to innovation in HIV. Bringing together bictegravir with our first-in-class capsid inhibitor, lenacapavir, Bixlenvo offers a novel choice to people with HIV looking to switch or simplify their treatment regimen,” said Daniel O’Day, chairman and chief executive officer of Gilead Sciences, in the news release. “Our goal at Gilead is to provide multiple options for HIV treatment and prevention and with a pipeline of potential daily, weekly and longer-acting options, today’s approval could be the first of many in the years ahead.”