Clinical consequences of delaying implementation of long-acting antiretroviral therapy for people with HIV and persistent viremia in the US.

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). 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 yr); 3) two Post-trial implementation scenarios: Post-one-arm-trial implementation (1yr-trial, 5% uptake/yr thereafter), Post-randomized-trial implementation (3yr-trial, 15% uptake/yr thereafter; 4) Immediate incomplete implementation (1-20% uptake/yr). Outcomes were virologically-suppressed person-years (VSPY) and 5yr-mortality. Inputs included cohort size 33,600, initial CD4 count 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 5yrs. Immediate complete implementation increases VSPY by 26,830 and averts 3,980 deaths; Delayed complete implementation produces 5,370 fewer VSPY and 800 more deaths/delayed year. Post-one-arm-trial implementation yields 1,700 more VSPY and 330 fewer deaths than Current practice; Post-randomized-trial implementation yields 1,280 more VSPY and 270 fewer deaths. Immediate incomplete implementation at 3% and 2% uptake/yr 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 intensive-support-services should be undertaken while awaiting trial results.