Subcutaneous injections of cabotegravir plus rilpivirine long-acting in virally suppressed adults with HIV-1.

ABSTRACT:

Objective

To evaluate subcutaneous anterior abdominal injections of long-acting cabotegravir plus rilpivirine (CAB + RPV LA) in participants with more than 3 years' experience with intramuscular injections in the Phase 3 FLAIR (NCT02938520) study.

Design

Substudy of a phase 3, randomized, open-label, multicenter, noninferiority study.

Methods

Substudy phases included screening/intramuscular gluteal injection, subcutaneous injection [day 1-week (W) 8], and return to gluteal injection (W12-W20). The injection schedule was unchanged from the main study (every 4 weeks). Outcomes included pharmacokinetics, safety, tolerability, efficacy, and patient-reported outcomes.

Results

Overall, 93 participants were enrolled and received subcutaneous injections; 19% were femal

SUBMITTER: D'Amico R 

PROVIDER: S-EPMC12629108 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature