CLINICAL RESEARCH UPDATE

by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer

April 23, 2024


Featured Literature:

Lowenthal ED, Chapman J, Ohrenschall R, et al.  Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study.  Lancet HIV.  2024 Apr;11(4):e222-e232.  doi: 10.1016/S2352-3018(23)00301-6.  PMID: 38538161. 

The international More Options for Children and Adolescents (MOCHA) study evaluated long-acting cabotegravir and rilpivirine (LA-CAB, LA-RPV) in adolescents ages 12-17 years. This secondary analysis describes LA-CAB and LA-RPV tolerability and acceptability among participants.  Quantitative data were collected from staff-administered questionnaires; in-depth interviews with U.S.-based participants and parents/caregivers were conducted. 29/53 (55%) participants who completed a questionnaire regarding reasons for switching indicated their primary reason was so they did not have to take daily pills. At week 4, 43/52 (83%) reported the injection did not hurt or hurt a little bit. Themes from in-depth interviews included not having to worry about hiding pills from peers and avoiding the stress of monitoring adolescents’ daily medication-taking. A common concern was the ability to maintain a routine injection schedule, particularly in the event of college relocation. Pre-study disagreements were noted between adolescents and parents/caregivers regarding whether the adolescent should initiate long-acting ART. For parents/caregivers with a higher level of hesitancy, trust in their health care provider was a key factor. Injection location was the most consistent concern among adolescents, however all interviewees indicated they would recommend long-acting formulations to peers. A few noted that more frequent clinic visits could add to the stress related to living with HIV.

Author’s Commentary:

Data from a MOCHA study interim analysis led to the expanded indication for use of long-acting cabotegravir/rilpivirine among virologically suppressed adolescents with HIV.  Results of this secondary analysis help guide implementation for providers and programs that deliver adolescent services by highlighting not only what drives interest in long-acting injectable therapies, but also what factors (e.g., trust in health care providers, the injection environment, and adaptability/flexibility) might be especially important for decision-making and sustainability.  Injection-related symptoms, although common, did not seem to adversely impact quality of life.  In-depth interviews were limited to a small number of U.S. participants, and additional evaluations in other contexts and across diverse sub-populations (such as younger adolescents) are needed to inform how to best support adolescents who opt to start long-acting ART.

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