Efficacy, Safety and Retention in Care Among Adolescents and Youth With HIV on Long-Acting Injectable Cabotegravir/Rilpivirine Treatment: Real-World Observational Cohort Outcomes.

Background: Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) can improve adherence among adolescents and youth with HIV (AYHIV). We evaluated LAI CAB/RPV treatment outcomes among AYHIV.

Methods: An observational cohort study of AYHIV <25 years initiated LAI CAB/RPV from October 2021 to June 2024 as a standard of care. Descriptive data included demographics (age, race/ethnicity and gender/sexual orientation), body mass index, HIV history, efficacy (CD4, HIV RNA and resistance), safety and retention in care.

Results: Twenty-five AYHIV (48% cisgender females; median age, 19 years; 64% with perinatally acquired HIV; median body mass index = 25.3 kg/m2; 52% virally suppressed for ≥6 months) received LAI CAB/RPV for a median duration of 11.8 (range, 0.8-31.3) months. Majority (n=24; 96%) initiated monthly LAI CAB/RPV injections, and 19 AYHIV (76%) switched to bimonthly injections. Seven AYHIV (28%) experienced transient viremia episodes (1-5/person; ranges, 48-1100 copies/mL) with most (78%) occurring within the initial 12 months, all episodes resolved at retesting after 3 to 91 days and none resulted in CAB and/or RPV resistance. Injection-associated pain/discomfort was mild to moderate and decreased over time. Grade 2 adverse events were self-resolved and included 3 AYHIV with postinjection adverse reactions and 1 AYHIV with QTc prolongation. Three cisgender female AYHIV became pregnant and continued LAI CAB/RPV. There were no discontinuations, missed or delayed injections. All AYHIV were virally suppressed at the end of the study follow-up.

Conclusions: We report 100% engagement in care and viral suppression among 25 AYHIV on LAI CAB/RPV during study follow-up. More data are needed to evaluate the long-term outcomes and sustainability of LAI CAB/RPV treatment in AYHIV.