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. 2025 Jul 22;26(1):1709.
doi: 10.4102/sajhivmed.v26i1.1709. eCollection 2025.

The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans

Rosie Mngqibisa  1 , Yashna Singh  2 , Catherine Orrell  2 , Johan Lombaard  3 , Sandy Griffith  4 , Conn Harrington  4 , Ronald D'Amico  4 , William Spreen  4 , Marty St Clair  4 , Christine Latham  4 , Louise Garside  5 , Rodica Van Solingen-Ristea  6 , Veerle Van Eygen  6 , Fafa Addo Boateng  7 , Herta Crauwels  6 , Prosperity Eneh  8 , Ingrid Eshun-Wilsonova  9
Affiliations

The 96-week outcomes and pharmacokinetics of long-acting cabotegravir plus rilpivirine in South Africans

Rosie Mngqibisa et al. South Afr J HIV Med. .

Abstract

Background: Evaluating long-term efficacy, safety and pharmacokinetics of long-acting cabotegravir + rilpivirine (CAB+RPV LA) in sub-Saharan African populations is important because of the region's unique demographics and antiretroviral therapy resistance patterns.

Objectives: To describe the 96-week efficacy, safety and pharmacokinetics of CAB+RPV LA in South African participants from the pooled FLAIR and ATLAS-2M Phase 3/3b randomised studies.

Method: Primary endpoint: proportion of participants with plasma HIV-1 RNA levels ≥ 50 copies/mL at Week 96. Secondary endpoints: proportion of participants with plasma HIV-1 RNA levels < 50 copies/mL, confirmed virological failure (CVF; two consecutive plasma HIV-1 RNA ≥ 200 copies/mL), adverse events and pharmacokinetics.

Results: Sixty-six participants were included, (CAB+RPV LA, n = 49; current oral antiretroviral regimen [CAR], n = 17). Forty-five (92%) on CAB+RPV LA and 15 (88%) on CAR maintained HIV-1 RNA levels < 50 copies/mL. At Week 96, two participants, one in each arm, had CVF. Ninety per cent on CAB+RPV LA and 76% on CAR of participants experienced an adverse event; six (12%) of which were drug-related (CAB+RPV LA: n = 6). Injection-site reactions were common (78% [Grade 1: 80%; Grade 2: 20%]). CAB and RPV trough plasma concentrations remained above respective in vitro protein-adjusted 90% inhibitory concentrations following all doses.

Conclusion: This subgroup analysis of South African participants demonstrated durable efficacy, acceptable safety profile and pharmacokinetics of injectable CAB+RPV LA up to 96 weeks, consistent with long-term data from other regions and studies.

Keywords: ARV; Africa; Phase 3; adherence; clinical trials; resistance; treatment; viral suppression.

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Conflict of interest statement

R.M., Y.S., J.L. and S.G. have no competing interests to declare. C.O. received honoraria from Johnson & Johnson and Merck Sharp & Dohme in the past 2 years for contributing to expert forum meetings. C.H., R.D., W.S. and M.S.C. are employees of ViiV Healthcare and are stockholders of GlaxoSmithKline. C.L. was an employee of ViiV Healthcare at the time of preparing the article. L.G. is a stockholder of GlaxoSmithKline and an employee of Phastar and was working as a contractor on behalf of ViiV healthcare at the time of the analysis. R.V.S.-R., V.V.E., F.A.B., H.C., P.E. and I.E.-W. are employees of Janssen Pharmaceutical Companies of Johnson & Johnson, and stockholders of Johnson & Johnson.

Figures

FIGURE 1
FIGURE 1
Median (5th and 95th percentile) trough plasma concentration-time (a) CAB and (b) RPV pharmacokinetic profiles following CAB+RPV LA IM Q4W or Q8W: pooled data from South African participants in FLAIR and ATLAS-2M studies.
See this image and copyright information in PMC

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