FDA approves Gilead's once-daily combination pill for suppressed HIV patients

The US Food and Drug Administration has approved Gilead Sciences' (GILD) Bixlenvo, a once-daily oral combination pill for adults whose HIV infection has already been suppressed to very low levels, the company said.

Bixlenvo combines bictegravir — the cornerstone ingredient of Gilead's blockbuster Biktarvy franchise — with lenacapavir, a capsid inhibitor that disrupts viral replication by targeting the protective shell of the virus. Lenacapavir is already marketed as Sunlenca for HIV treatment and as Yeztugo for prevention. Patients must take an initial two-day loading dose of Sunlenca before beginning the once-daily Bixlenvo regimen. Gilead said the drug would be available within days of approval, at a wholesale acquisition cost of $4,595 for a 30-day supply.

Approval was based on two late-stage trials in which Bixlenvo maintained viral suppression as effectively as either complex multi-pill regimens or Biktarvy over 48 weeks. The drug is aimed in part at the roughly 5 per cent of people living with HIV in the US who currently take regimens involving more than one tablet daily.

"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. Gilead has framed Bixlenvo as part of a multi-year strategy to build out its HIV portfolio around lenacapavir, which has become a linchpin of the company's virology pipeline.