FDA Approves Gilead's Once-Daily Combination Pill for Suppressed HIV Patients

The US Food and Drug Administration has approved Gilead Sciences' (GILD) once-daily oral combination pill for the treatment of adults whose HIV infection has already been reduced to undetectable levels, the California-based drugmaker said.

The pill, branded Bixlenvo, combines two of Gilead's existing HIV medicines: bictegravir, the active ingredient in its blockbuster treatment Biktarvy and a widely recommended therapy with a high barrier to resistance; and lenacapavir, a capsid inhibitor that disrupts HIV's replication by targeting the virus's protective shell. Lenacapavir is already marketed as Sunlenca for HIV treatment and as Yeztugo for prevention. Patients are required to take an initial two-day course of Sunlenca before beginning the once-daily Bixlenvo regimen. Gilead said the drug would be available within days of approval.

The wholesale acquisition cost for a 30-day supply is $4,595, according to a company spokesperson.

Approval was based on two late-stage clinical studies in which Bixlenvo demonstrated comparable efficacy to both complex multi-pill regimens and Biktarvy in maintaining viral suppression over 48 weeks. Approximately 5 per cent of people living with HIV in the United States currently take regimens involving more than one tablet daily, according to Jared Baeten, Gilead's head of clinical development for virology.

"The main advantage of this combination is that it potentially offers a simpler option, in terms of pill burden, to patients who might currently be on more complex regimens due to a history of drug-resistant virus," said Monika Shah, an infectious disease specialist at Memorial Sloan Kettering Cancer Center.

Bixlenvo enters a competitive market that includes Merck's (MRK) Idvynso, a once-daily two-drug pill approved in April for certain adults with suppressed HIV-1. The approval forms part of Gilead's multi-year strategy to build out its HIV portfolio around lenacapavir as a cornerstone compound.