Thigh Injections of Cabotegravir + Rilpivirine in Virally Suppressed Adults With HIV-1: A Substudy of the Phase 3b ATLAS-2M Study.

ABSTRACT:

Background

Cabotegravir + rilpivirine (CAB + RPV) administered via intramuscular gluteal injections is the first complete long-acting regimen for maintaining human immunodeficiency virus type 1 (HIV-1) virologic suppression. We present substudy results on short-term repeat intramuscular CAB + RPV long-acting thigh injections in participants with ≥3 years of experience with gluteal administration during the ATLAS-2M study.

Methods

Substudy phases included screening, thigh injection (day 1-week 16), and return to gluteal injection (week 16-week 24). The injection schedule was unchanged from the main study. Outcomes included pharmacokinetics, safety, tolerability, efficacy, and patient-reported outcomes. Pharmacokinetic parameters were determined using noncompartmental analysis

SUBMITTER: Ford SL 

PROVIDER: S-EPMC12314501 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature