Gilead posts phase 3 results for bictegravir/lenacapavir

Gilead Sciences has posted results from trial NCT05502341 on ClinicalTrials.gov, describing the phase 3 comparison of the bictegravir/lenacapavir fixed-dose combination against a stable baseline regimen. The registry entry reports that 0.8 percent of participants assigned to the bictegravir/lenacapavir 75 mg/50 mg combination and 1.1 percent assigned to a stable baseline regimen had HIV-1 RNA of at least 50 copies per mL at week 48, the primary endpoint.

The trial enrolled 689 people with HIV-1 infection. The trial also included a phase 2 portion that compared bictegravir 75 mg plus lenacapavir 25 mg or 50 mg with a stable baseline regimen.

In the phase 2 portion, the week 24 primary endpoint was the same virologic threshold. The posting lists 0 percent for the bictegravir/lenacapavir 25 mg group, 1.9 percent for the bictegravir/lenacapavir 50 mg group, and 0 percent for the stable baseline regimen group; the p value was 1.000.

The ClinicalTrials.gov results posting is not a peer-reviewed paper. The entry does not report safety outcomes or confidence intervals for the phase 3 comparison.