Research Summary

Is Long-Acting Injectable Cabotegravir–Rilpivirine Acceptable and Tolerable in Adolescents With HIV-1?

Anthony Calabro, MA

Key Highlights

  • Nearly all adolescents preferred injectable cabotegravir–rilpivirine over daily oral antiretroviral therapy through 48 weeks.
  • Injection-related pain was more commonly reported with rilpivirine than with cabotegravir.
  • Health-related quality of life remained high and stable throughout treatment.
  • Adolescents and caregivers reported reduced treatment-related stress with injectable therapy.

Long-acting injectable cabotegravir–rilpivirine was highly acceptable and well tolerated among adolescents with HIV-1 over 48 weeks of treatment, according to results from the IMPAACT 2017/MOCHA trial published in The Lancet HIV. The study provides the first detailed patient-reported data on the acceptability and tolerability of this maintenance regimen in adolescents across diverse global settings.

Cabotegravir–rilpivirine is currently the only long-acting intramuscular antiretroviral regimen recommended for maintenance of virological suppression in adults with HIV-1. However, data on adolescents have been limited, despite known challenges with adherence to daily oral therapy in this age group. Investigators designed this trial to assess whether adolescents would find the injectable regimen acceptable and tolerable over nearly 1 year of use.

The phase 1/2, multicenter, open-label, non-comparative trial enrolled adolescents weighing at least 35 kg at 18 sites in Botswana, South Africa, Thailand, Uganda, and the United States. Participants received long-acting intramuscular cabotegravir and rilpivirine and were followed for 48 weeks. Acceptability and tolerability were assessed using participant-reported pain scores, treatment preference, quality-of-life measures, satisfaction questionnaires, and qualitative interviews in a subset of US participants.

Study Findings

A total of 144 adolescents completed study questionnaires, and 140 participants completed 48 weeks of treatment. The cohort was evenly split by sex, with 49% men and 51% women. Across all assessed timepoints, preference for injectable therapy was consistently high. At weeks 8, 24, and 48, 97%, 99%, and 100% of participants, respectively, reported preferring intramuscular injections over oral antiretroviral therapy.

Injection-related pain was more frequently reported with intramuscular rilpivirine than with cabotegravir. Reports of pain greater than “hurts a little bit” ranged from 51% to 62% for rilpivirine across timepoints, compared with 12% to 14% for cabotegravir. Despite this difference, the overall acceptability of the injectable regimen remained high.

Health-related quality of life, measured using the Pediatric Quality of Life Inventory, was high at baseline and remained stable through week 48. Median overall scores were 94.6 at baseline and 93.5 at 48 weeks. Among the 19 US participants who completed the Medication Satisfaction Questionnaire for Teens, all reported greater satisfaction with the injectable regimen than with their previous oral therapy.

Qualitative interviews with 8 adolescents and 3 parents or caregivers highlighted reduced stress and conflict related to medication adherence after transitioning to injectable treatment.

Clinical Implications

According to the study authors, the sustained preference for and satisfaction with long-acting injectable cabotegravir–rilpivirine suggest that this approach may be a well-received maintenance option for adolescents with HIV-1 across varied geographic and cultural settings.

Expert Commentary

“Acceptability and tolerability of intramuscular cabotegravir–rilpivirine remained high through to 48 weeks of treatment, suggesting that this long-acting intramuscular treatment approach is well received by diverse populations of adolescents with HIV across multiple settings,” the researchers concluded.

Reference
Lowenthal ED, Chapman J, Baltrusaitis K, et al. Acceptability and tolerability of long-acting injectable cabotegravir–rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial. Lancet HIV. 2026;13(2):eXXX–eXXX. doi:10.1016/S2352-3018(25)00XXX-X