10:17 AM EST, 11/13/2025 (MT Newswires) -- Gilead Sciences ( GILD ) said Thursday that a phase 3 trial of a single-tablet regimen of bictegravir and lenacapavir in adults with HIV met its primary endpoint of non-inferiority to multi-tablet regimens.

The company said the primary endpoint was the proportion of patients with a viral load of at least 50 copies/mL at week 48, as defined by the US Food and Drug Administration snapshot algorithm. The investigational combination treatment was also "generally well tolerated," Gilead added.

Another phase 3 trial is evaluating the safety and efficacy of switching from Biktarvy to a fixed-dose combination of bictegravir and lenacapavir in virologically suppressed people with HIV-1, with top-line data for primary endpoint expected before year-end, the company said.

Gilead said it plans to use the results of the phase 3 trials for the treatment candidate's regulatory submissions.

Shares of Gilead were up 2.9% in recent trading Thursday.

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