Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir and rilpivirine in virologically suppressed adolescents with HIV. The study enrolled 139 adolescents who initially received oral formulations before transitioning to intramuscular injections every eight weeks. At 24 weeks, no serious drug-related adverse events or treatment discontinuations occurred, with 10.8% of participants experiencing grade 3 or higher adverse events and 30% reporting mild injection site reactions. Drug concentrations remained above therapeutic thresholds, and virological suppression was maintained without confirmed failures. These findings align with adult data from FLAIR, ATLAS, and ATLAS-2M studies, reinforcing the regimen’s safety and efficacy for adolescents. The high adherence rates and positive reception indicate a strong preference for this fully injectable regimen. While ongoing studies are evaluating its use in younger children, integrating long-acting therapies into healthcare systems remains a key consideration for broader implementation.