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.

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dc.contributor.affiliationCentre for Infectious Disease Research in Zambia/University of Alabama Birmingham, Lusaka, Zambia.
dc.contributor.affiliationThe Children's Hospital of Philadelphia, Division of General Pediatrics and Global Health Center, Philadelphia, PA, USA.
dc.contributor.affiliationCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
dc.contributor.affiliationThe Children's Hospital of Philadelphia, Division of General Pediatrics and Global Health Center, Philadelphia, PA, USA; University of Pennsylvania Perelman School of Medicine, Departments of Pediatrics and Biostatistics, Epidemiology and Informatics, Philadelphia, PA, USA. Electronic address: lowenthale@chop.edu.
dc.contributor.affiliationFrontier Science Foundation, Amherst, NY, USA.
dc.contributor.affiliationJanssen Research and Development, Beerse, Belgium.
dc.contributor.affiliationKeck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
dc.contributor.affiliationEmory University School of Medicine, Atlanta, GA, USA.
dc.contributor.affiliationNorthwestern University and Lurie Children's Hospital of Chicago, Chicago, IL, USA.
dc.contributor.affiliationUniversity of Pennsylvania School of Nursing, Philadelphia, PA, USA.
dc.contributor.affiliationJohns Hopkins University School of Medicine, Baltimore, MD, USA.
dc.contributor.affiliationSt Jude Children's Research Hospital, Memphis, TN, USA.
dc.contributor.affiliationNational Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS, National Institutes of Health (NIH), Rockville, MD, USA.
dc.contributor.affiliationViiV Healthcare, Madrid, Spain.
dc.contributor.affiliationViiV Healthcare, Research Triangle Park, NC, USA.
dc.contributor.affiliationUniversity of Colorado School of Medicine, Aurora, CO, USA.
dc.contributor.affiliationFHI 360 IMPAACT Operations Center, Durham, NC, USA.
dc.contributor.affiliationCIDRZ
dc.contributor.affiliationCentre for Infectious Disease Research in Zambia (CIDRZ)
dc.contributor.authorLowenthal ED
dc.contributor.authorChapman J
dc.contributor.authorOhrenschall R
dc.contributor.authorCalabrese K
dc.contributor.authorBaltrusaitis K
dc.contributor.authorHeckman B
dc.contributor.authorYin DE
dc.contributor.authorAgwu AL
dc.contributor.authorHarrington C
dc.contributor.authorVan Solingen-Ristea RM
dc.contributor.authorMcCoig CC
dc.contributor.authorAdeyeye A
dc.contributor.authorKneebone J
dc.contributor.authorChounta V
dc.contributor.authorSmith-Anderson C
dc.contributor.authorCamacho-Gonzalez A
dc.contributor.authorD'Angelo J
dc.contributor.authorBearden A
dc.contributor.authorCrauwels H
dc.contributor.authorHuang J
dc.contributor.authorBuisson S
dc.contributor.authorMilligan R
dc.contributor.authorWard S
dc.contributor.authorBolton-Moore C
dc.contributor.authorGaur AH
dc.date.accessioned2025-05-23T11:43:16Z
dc.date.issued2024-Apr
dc.description.abstractBACKGROUND: Long-acting injectable cabotegravir and rilpivirine have demonstrated safety, acceptability, and efficacy in adults living with HIV-1. The IMPAACT 2017 study (MOCHA study) was the first to use these injectable formulations in adolescents (aged 12-17 years) living with HIV-1. Herein, we report acceptability and tolerability outcomes in cohort 1 of the study. METHODS: In this a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study, with continuation of pre-study oral combination antiretroviral treatment (ART), 55 adolescents living with HIV-1 were enrolled to receive sequential doses of either long-acting cabotegravir or rilpivirine and 52 received at least two injections. Participants had a body weight greater than 35 kg and BMI less than 31·5 kg/m FINDINGS: Between March 19, 2019, and Nov 25, 2021, 55 participants were enrolled into cohort 1. Using the six-point face scale, 43 (83%) of participants at week 4 and 38 (73%) at week 8 reported that the injection caused "no hurt" or "hurts little bit", while only a single (2%) participant for each week rated the pain as one of the two highest pain levels. Quality of life was not diminished by the addition of one injectable antiretroviral. In-depth interviews revealed that parents and caregivers in the USA frequently had more hesitancy than adolescents about use of long-acting formulations, but parental acceptance was higher after their children received injections. INTERPRETATION: High acceptability and tolerability of long-acting cabotegravir or rilpivirine injections suggests that these are likely to be favoured treatment options for some adolescents living with HIV. FUNDING: National Institutes of Health and ViiV Healthcare.
dc.identifier.doi10.1016/S2352-3018(23)00301-6
dc.identifier.urihttps://pubs.cidrz.org/handle/123456789/10796
dc.sourceThe lancet. HIV
dc.titleAcceptability 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.

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