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Thigh Injections of Cabotegravir plus Rilpivirine in Virally Suppressed Adults With Human Immunodeficiency Virus Type 1: A Substudy of the Phase 3b ATLAS-2M Study
Journal article   Open access   Peer reviewed

Thigh Injections of Cabotegravir plus Rilpivirine in Virally Suppressed Adults With Human Immunodeficiency Virus Type 1: A Substudy of the Phase 3b ATLAS-2M Study

Susan L. Ford, Franco Felizarta, Kelong Han, Kehui Wang, Herta Crauwels, Anna Dari, Mar Masia, Miguel Garcia Deltoro, Olaf Degen, Jonathan B. Angel, …
Clinical infectious diseases, v 81(1), pp 101-112
15 Jul 2025
DOI: https://doi.org/10.1093/cid/ciae620
PMID: 39878031
Featured in Collection :   UN Sustainable Development Goals @ Drexel
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https://doi.org/10.1093/cid/ciae620View
Published, Version of Record (VoR) Open

Abstract

Life Sciences & Biomedicine Science & Technology Immunology Infectious Diseases Microbiology
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 and mixed-effects modeling. Population pharmacokinetic simulations were performed.Results There were 118 participants. In the arm that received injections every 2 months (Q2M), first CAB thigh injection including area under the concentration-time curve and maximum observed concentration (Cmax) and first RPV thigh injection Cmax and all last RPV thigh injection parameters were statistically higher vs gluteal injections (paired comparison). No significant differences occurred with once-monthly (QM) dosing. No participants had HIV-1 RNA >= 50 copies/mL after thigh injections. Overall, 4%-7% of injection site reactions (ISRs) were grade 3. Five participants withdrew due to an ISR or injection intolerability. Overall, 30% preferred thigh vs gluteal injections. Simulations demonstrated the potential for chronic/continuous QM or <= 2 consecutive Q2M thigh injections.Conclusions These data demonstrate the potential use of chronic/continuous QM and rotational/short-term QM or Q2M (<= 4 months of continuous dosing), CAB + RPV long-acting intramuscular thigh administration for HIV-1 treatment. Long-acting (LA) cabotegravir + rilpivirine (CAB + RPV) is indicated for chronic/continuous gluteal intramuscular administration. These data demonstrate the potential for chronic/continuous once-monthly (QM) and rotational/short-term QM or every-2-months CAB + RPV LA intramuscular lateral thigh administration within an established gluteal regimen.

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Collaboration types
Industry collaboration
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Web of Science research areas
Immunology
Infectious Diseases
Microbiology
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