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Bixlenvo combines two existing Gilead drugs into a single tablet for adults whose virus is suppressed but who can't use current one-pill options

Gilead $GILD Sciences announced Thursday that the U.S. Food and Drug Administration approved Bixlenvo, a once-daily single-tablet HIV treatment combining bictegravir and lenacapavir, for adults whose virus is already suppressed, including those on complex multi-pill regimens who cannot use existing one-tablet options.

Bixlenvo pairs bictegravir — the active ingredient in Gilead's existing HIV treatment Biktarvy — with lenacapavir, a capsid inhibitor with no cross-resistance to other antiretrovirals. The two drugs target multiple stages of the HIV life cycle through different mechanisms, the company said.

Gilead said the pill represents the first time virologically suppressed adults who cannot take any existing one-tablet option have had a single-tablet regimen to turn to. That population accounts for an estimated 5% or more of people in the U.S. living with HIV, the company told CNBC.