Clinical Consequences of Delaying Implementation of Long-Acting Antiretroviral Therapy for People With HIV and Persistent Viremia in the United States.

Abstract

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. 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). 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. 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.