Background:
Cabotegravir+Rilpirivine (CAB+RPV) is the first complete long-acting (LA) antiretroviral regimen approved in the United States for the treatment of HIV for ART-experienced people with undetectable viral load (VL <50 copies/ml). This study examines the utilization and effectiveness of CAB+RPV in real-world settings in the US.
Methods:
All ART-experienced adults with undetectable VL at initiation who received ≥1 documented CAB+RPV injection were identified from electronic health record data within the Trio Health Cohort between February 2021-July 2023. Discontinuation of CAB+RPV was defined as 2 consecutive missed injections or a regimen switch, while confirmed virologic failure (CVF) was defined as 2 consecutive VLs > 200 copies/mL or 1 VL > 200 copies/mL with discontinuation within 4 months of last recorded injection. ARV resistance from HIV genotype results was available for a subset of individuals and was analyzed through Stanford HIVdb algorithm among those with identified CVF.
Results:
The analysis included 278 ART-experienced individuals with undetectable VL who initiated CAB+RPV; initiators were a median of 44 years (IQR: 35-54) of age, predominately male (80%), non-Black (64%), and from the US South (73%). Median follow-up time after first injection was 10 months (IQR 5-13) with median of 5 injections (IQR: 3-7). There were 246 (88%) CAB+RPV initiators who remained on the regimen at end of follow-up; among those who discontinued CAB+RPV, none experienced injection site reaction. Among all initiators, 221 (80%) individuals had ≥1 recorded follow-up VL. Those with no follow-up VLs had median 1 injection (IQR: 1-2). Among individuals with VL data, 213 (96%) had all follow-up VL <200 copies/mL throughout follow-up, with 196 (89%) undetectable at last recorded VL. Only 2 (0.9%) individuals experienced CVF, both of whom discontinued CAB+RPV after one unsuppressed VL. Resistance data prior to initiation was available for 1 individual, who had extensive resistance to NNRTI and NRTI. Genotype results were not recorded for this individual at the time of CVF, and suppression had not been documented on subsequent therapy (DRV/c/FTC/TAF: 3 months).
Conclusions:
Among ART-experienced adults with undetectable VL initiating CAB+RPV, the vast majority continued the regimen and maintained virologic suppression throughout the follow-up period. Additionally, confirmed virologic failure was rare, suggesting high effectiveness of CAB+RPV in real world settings.