Single-Tablet Bictegravir-Lenacapavir Noninferior to Complex Regimens for HIV-1

MONDAY, March 9, 2026 (HealthDay News) -- For patients with HIV-1 with virologic suppression on complex multipill regimens, the bictegravir-lenacapavir single-tablet regimen (STR) is noninferior to complex regimens, according to a study published online Feb. 25 in The Lancet.Chloe Orkin, M.D., from Queen Mary University of London, and colleagues conducted a randomized, noninferiority phase 3 trial involving people with HIV-1 with virologic suppression on complex regimens. Participants were randomly assigned to switch to once-daily oral bictegravir-lenacapavir 75-mg/50-mg STRs or a continued complex regimen (371 and 186, respectively).The researchers found an HIV-1 RNA viral load of 50 copies/mL or higher in three and two participants receiving bictegravir-lenacapavir and a complex regimen, respectively, at week 48 (both 1 percent; difference −0.3 percent [95.002 percent confidence interval, −2.3 to 1.8], meeting the noninferiority margin). There was no resistance. The groups had similar adverse event rates. Due to adverse events, six and one (2 and 1 percent) participants discontinued bictegravir-lenacapavir and their complex regimen, respectively. Five deaths occurred in the bictegravir–lenacapavir group, none of which were related to the study drug. After switching to bictegravir-lenacapavir, participants reported increased treatment satisfaction."This STR could present the first opportunity to optimize treatment while maintaining virological suppression in people taking complex regimens who have not benefited from available STRs due to antiretroviral resistance or other reasons," the authors write.Several authors disclosed ties to biopharmaceutical companies, including Gilead Sciences, which manufactures bictegravir-lenacapavir and funded the study.Abstract/Full Text.Sign up for our weekly HealthDay newsletter

Single-Tablet Bictegravir-Lenacapavir Noninferior to Complex Regimens for HIV-1

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