Two-year efficacy and safety of long-acting cabotegravir and rilpivirine in the SCohoLART study.

BACKGROUND: Long-acting drugs were recently introduced for HIV treatment, so there are no medium-term or long-term data in real-world settings. Aims were to assess the cumulative probability of treatment discontinuation and the proportion of people with HIV (PWH) with HIV RNA less than 50 copies/ml at month 24 among participants switching to cabotegravir (CAB) and rilpivirine (RPV). METHODS: SCohoLART is a single-center, prospective, cohort study enrolling PWH on virological suppression who switched to bimonthly long-acting CAB/RPV.Treatment discontinuation occurred at switch to another regimen for any reason including virological failure; virological failure was defined as HIV RNA at least 50 copies/ml at two consecutive measurements or a single HIV RNA at least 1000 copies/ml. Participants' characteristics were reported as median (interquartile range, IQR) or frequency (%). Cumulative probabilities of TD were estimated by Kaplan-Meier curve. RESULTS: We evaluated 549 participants: 501 (91.3%) were men and median age was 49 (40-56). At the time of switching, median years from HIV diagnosis and of ART were 13.8 (8.7-20.4) and 11.3 (7.9-17.3).During a median follow-up of 24.0 (17.0-26.8) months, 86 PWH experienced treatment discontinuations (15.6%), including 6 (1.1%) for virological failure, 37 (6.7%) for injection site reactions (ISRs) and 17 (3.1%) for lifestyle changes incompatible with administrations. The cumulative probabilities of treatment discontinuation were 10.5% at month 12 and 16.4% at month 24.The proportions of participants with HIV RNA less than 50 copies/ml at months 12 and 24 were 99.0 and 98.6%. CONCLUSION: CAB/RPV demonstrated high virological efficacy over 2 years in a real-world setting; ISRs represented the leading cause of discontinuation.