Abstract
Background People with HIV (PWH) with persistent viremia and adherence challenges to oral antiretroviral therapy (ART) can achieve viral suppression (VS) with long-acting cabotegravir/rilpivirine (LA-CAB/RPV). The US guidelines, however, recommend CAB/RPV only in limited situations. We projected the impact of delaying LA-CAB/RPV implementation while awaiting trial data. Methods Using a microsimulation model, we considered 2 approaches for PWH with persistent viremia and intermittent care engagement: daily first-line oral ART or LA-CAB/RPV, both with intensive-support-services (ISS) to maximize adherence. We evaluated 4 CAB/RPV implementation scenarios: (1) Current practice (1% on CAB/RPV); (2) hypothetical Immediate/Delayed complete implementation (100% CAB/RPV after 0–4 year); (3) 2 Post-trial implementation scenarios: Post-one-arm-trial implementation (1-year trial, 5% uptake/year thereafter), Post-randomized-trial implementation (3-year trial, 15% uptake/year thereafter; and (4) Immediate incomplete implementation (1%–20% uptake/year). Outcomes were virologically suppressed person-years (VSPY) and 5-yearmortality. Inputs included cohort size 33,600, initial CD4 count of 150/µL, 6-month-VS from observational data: 23% (oral ART), 65% (LA-CAB/RPV). Results Current practice projects 35 810 VSPY and 17 640 deaths at 5 years. Immediate complete implementation increases VSPY by 26 830 and averts 3980 deaths; Delayed complete implementation produces 5370 fewer VSPY and 800 more deaths/delayed year. Post-one-arm-trial implementation yields 1700 more VSPY and 330 fewer deaths than Current practice; Post-randomized-trial implementation yields 1280 more VSPY and 270 fewer deaths. Immediate incomplete implementation at 3% and 2% uptake/year is similar to Post-one-arm-trial implementation and Post-randomized-trial implementation. Conclusions LA-CAB/RPV for US PWH with persistent viremia and intermittent care engagement would increase VS and decrease mortality. Increased LA-CAB/RPV implementation with ISS should be undertaken while awaiting trial results.
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Pei, P. P., Jones, M., Hu, R., Chen, W., Sax, P. E., Pandya, A., … Freedberg, K. A. (2026). Clinical Consequences of Delaying Implementation of Long-Acting Antiretroviral Therapy for People With HIV and Persistent Viremia in the United States. Clinical Infectious Diseases, 81(6), e591–e599. https://doi.org/10.1093/cid/ciaf428
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