Background
Cabotegravir + rilpivirine long-acting (CAB+RPV LA) injectable was FDA approved for treatment experienced, suppressed (viral load [VL] <50 c/mL) people with HIV (PWH) on a monthly (Q1M; 2021) or every 2 months (Q2M; 2022) schedule. We assessed CAB+RPV LA use in a real-world setting over its first 3 years of availability.
Methods
Suppressed adults with HIV switching to CAB+RPV LA (21JAN2021-31DEC2023) were followed through 29FEB2024 in the OPERA Cohort. Among complete initiators (first 2 injections ≤67 days apart), on-time injections (23-37 days after last Q1M injection, 53-67 days after last Q2M injection) and discontinuation (no injection for ≥68 days [Q1M] or ≥128 days [Q2M]) were described. Confirmed virologic failure (CVF; 2 VLs ≥200 c/mL or 1 VL ≥200 c/mL + discontinuation) was assessed among those with ≥1 follow-up VL. Virologic outcomes were assessed overall and stratified by body mass index (BMI) at initiation (<30 vs. ≥30 kg/m2).
Results
There were 2,858 suppressed CAB+RPV LA users (median age: 39 [IQR: 31, 51], 84% male, 42% Black, 30% Hispanic, 55% in the US South, median years since HIV diagnosis: 6 [IQR: 2, 13], 24% with history of an AIDS defining event, 30% with BMI ≥30 kg/m2, median CD4 count: 698 cells/µL [IQR: 519, 912], 78% on an INSTI prior to CAB+RPV LA). Among 2,626 (92%) PWH who completed initiation, median follow-up time was 11 months (IQR: 6, 18; Table) and 2,182 (83%) were on CAB+RPV LA at time of analysis; 83% received their second injection on-time, and all maintenance injections were on-time in 60% of the 2,401 PWH with maintenance injections. Most PWH maintained virologic suppression (95% <50 c/mL at last VL and 83% had no virologic blips [all VLs <50 c/mL]). Of those with 6, 12, and 24-month VLs, virologic suppression was observed in 954/1,015 (94%), 511/538 (95%), and 85/89 (96%), respectively. CVF was observed in 32 (1%) PWH, with 17 CVFs occurring within the first 6 months. Across BMI categories (<30 kg/m2 vs. ≥30 kg/m2), neither virologic suppression <50 c/mL (all VLs: 83% vs. 84%; last VL: 95% vs. 94%) nor CVF (1% vs 1%) differed.
Conclusions
In this large cohort of suppressed CAB+RPV initiators with long-term follow-up, most individuals were able to remain on the regimen and adhere to the dosing schedule over the first 3 years of availability. Suppressed PWH on CAB+RPV LA had favorable virologic outcomes as most maintained VLs <50 c/mL and CVF was infrequent. Further, virologic suppression was maintained regardless of BMI category at initiation.
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