FDA Approves Gilead’s Bixlenvo, Once-Daily Pill for Virologically Suppressed Adults with HIV

Editor’s Take: Having a once-daily option could greatly impact those taking up to, in some cases, 11 pills per day.

The U.S. FDA approved Gilead Sciences’ Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg) for treatment of HIV in virologically suppressed adults. Bixlenvo becomes the first—and smallest—once-daily single-tablet regimen (STR) for patients on complex regimens unable to take current STRs.

Bixlenvo Explained

In this novel treatment, Gilead’s first-in-class capsid inhibitor lenacapavir combines with bictegravir, an integrase strand transfer inhibitor (INSTI). Bictegravir has a high resistance barrier, while lenacapavir possesses a novel mechanism of action that does not cross-resist other antiretrovirals.

The bictegravir–lenacapavir combination has not yet gained approval from any regulatory authority outside the United States.

“Bixlenvo continues Gilead’s long-term commitment to innovation in HIV.”

Daniel O’Day, Gilead Sciences Chairman and CEO

Bixlenvo does require a two-day initiation dose with Sunlenca (lenacapavir), also a Gilead property. Thereafter, Bixlenvo alone is taken once a day orally.

FDA Looked at Trial Results

The FDA’s approval came from results from two Phase III trials (ARTISTRY-1 and ARTISTRY-2). Included were patients switching from complex multi-tablet regimens, or Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; also Gilead).

In particular, ARTISTRY-1 enrolled the oldest study population to date in a Phase III trial for HIV treatment. The median participant age was 60, with a median treatment duration of 28 years. Participants were taking between two and 11 pills per day, at baseline.

Bixlenvo demonstrated comparable efficacy in maintaining virologic suppression, at week 48, in both trials.

Gilead’s History with HIV

“Bixlenvo continues Gilead’s long-term commitment to innovation in HIV,” Gilead Chairman and CEO Daniel O’Day said. “Bixlenvo offers a novel choice to people with HIV looking to switch or simplify their treatment regimen. Our goal at Gilead is to provide multiple options for HIV treatment and prevention. With a pipeline of potential daily, weekly and longer acting options, today’s approval could be the first of many.”