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
Abstract
Background: Long-acting cabotegravir and rilpivirine is the first intramuscular injectable antiretroviral treatment regimen recommended for maintenance of virological suppression in adults living with HIV-1. We report acceptability and tolerability outcomes in adolescents during 48 weeks of treatment with this regimen.
Methods: In this analysis of the phase 1/2, multicentre, open-label, non-comparative trial conducted at 18 sites across Botswana, South Africa, Thailand, Uganda, and the USA, 144 adolescents (weight ≥35 kg) with HIV-1 were enrolled to receive long-acting intramuscular cabotegravir and rilpivirine and 140 completed 48 weeks of treatment. Participant-reported acceptability and tolerability outcomes were a Faces Scale assessment of pain at each injection, preferred treatment method, and Quality of Life Inventory (PedsQL) at baseline and across 48 weeks of treatment for participants in Botswana, South Africa, Thailand, Uganda, and the USA. USA-based participants completed a Medication Satisfaction Questionnaire (SMSQc-Teen; after week 24), assessing their satisfaction with the all-intramuscular versus their previous oral regimen. A subset of eight adolescents and three parents or caregivers in the USA underwent in-depth interviews after a minimum of 24 weeks on study. This study is registered with ClinicalTrials.gov, NCT03497676.
Findings: Between July 26, 2021, and Aug 27, 2022, 44 of 55 adolescents who participated in cohort 1 and 100 of 115 screened study-naive…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 144 participants or records.
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