By Ethan Covey
Data from the IMPAACT 2017/MOCHA study support the use of long-acting cabotegravir plus rilpivirine (CAB+RPV; Cabenuva, ViiV Healthcare) among virologically suppressed adolescents, as presented during the “ART nouveau” session at AIDS 2024, in Munich (abstract OAB2606LB).
The cohort from the phase 2/3 MOCHA (More Options for Children and Adolescents) trial performed by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT 2017) included 144 virologically suppressed people between 12 and 15 years of age, enrolled from centers located in Botswana, South Africa, Thailand, Uganda and the United States.
“This cohort is providing this valuable first glimpse in terms of informing both the clinical use of this regimen, as well as the regulatory submissions currently underway by the EMA [European Medicines Agency],” said Aditya Gaur, MD, the director of the Division of HIV Prevention and Treatment, and who oversees the Translational Trials Center at St. Jude Children’s Research Hospital, in Memphis, Tenn.
“The 18 centers from five countries underscore the point that there was good diversity of the participant pool from which we are learning as we reach each of these study milestones,” Dr. Gaur added.
The study participants switched from their pre-study antiretroviral therapy (ART) to at least four weeks of daily oral CAB+RPV followed by CAB-LA (long-acting) plus RPV-LA given intramuscularly in the contralateral gluteus medius at weeks 4 and 8, and then every eight weeks.
Most of the participants (142/144) received at least one injection, and 97% completed their week 48 visit.
Throughout week 48, 37% of participants experienced a drug-related adverse event (AE). However, no drug-related serious AEs occurred. Two grade 3 AEs were reported, both from the same center and both involving an abscess. After week 48, one participant experienced anaphylaxis leading to study drug discontinuation. Through week 48, 34% of participants who received one or more injections reported injection site reactions. Of these, 90% were grade 1, and 89% resolved within seven days.
“To put the abscess and the grade 3 in perspective, these were both culture-negative abscesses,” Dr. Gaur said. “A sterile site abscess is automatically a grade 3 based on the Division of AIDS toxicity table. Neither [patient] was hospitalized [and] both carried on taking the study medications.”
The CAB and RPV trough levels were similar to those in adults, and virologic suppression was maintained in all participants. All 140 participants who responded to a preference questionnaire at week 48 preferred the LA injections to daily oral treatment.
“The key finding is that at year 1—week 48—there is no unexpected safety signal, the PK [pharmacokinetics] is comparable to adults and the participant experience is very good,” Dr. Gaur said. “These are adolescents who have lived most, if not all of, their life with HIV and have been taking daily oral medications,” Dr. Gaur said. “Now [they] have their first year of not having taken oral meds.”
Dr. Guar said the study supports the ongoing use of CAB+RPV in adolescent patients.
“This cohort will continue to teach us as it reaches its next, week 96, milestone,” Dr. Gaur said, adding he hopes “sooner rather than later there will be global access for this long-acting [regimen] for adolescents.”
The study products were provided by Janssen and ViiV Healthcare Ltd.
