Subcutaneous Lenacapavir in People With Multidrug-Resistant HIV-1: 156 Week Results of the CAPELLA Study.

ABSTRACT:

Background

Lenacapavir is a twice-yearly HIV-1 capsid inhibitor approved, in combination with other antiretrovirals, for the treatment of heavily treatment-experienced people with multidrug-resistant HIV, based on the Phase 2/3 CAPELLA study. Here, we report week 156 efficacy and safety results.

Methods

In CAPELLA (NCT04150068), participants received 2-week oral lenacapavir lead-in doses, followed by subcutaneous lenacapavir every 6 months, combined with an investigator-selected optimized background regimen. Endpoints included virologic outcomes, CD4 cell count trends, adverse events, and treatment-emergent resistance.

Results

CAPELLA enrolled 72 participants: 25% female; 38% Black; median age, 52 years; CD4 cell count <200 cells/μL, 64% (<50 cells/μL, 22%). At week 1

SUBMITTER: Ogbuagu O 

PROVIDER: S-EPMC12740718 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature