IMPAACT 2017 (MOCHA) Data Supports European Commission’s Authorization of Vocabria and Rekambys in Adolescents

The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is pleased to announce that data from IMPAACT 2017/MOCHA (More Options for Children and Adolescents) has informed the European Commission’s authorization of ViiV Healthcare’s long-acting injectable Vocabria (cabotegravir long-acting injections) and Johnson and Johnson’s Rekambys (rilpivirine long-acting injections). The authorization expands the adult approvals of long-acting cabotegravir and rilpivirine for HIV treatment to adolescents aged 12 years and older and weighing at least 35 kg who are virologically suppressed. The US Food and Drug Administration (FDA) also previously approved this indication, based on data from IMPAACT 2017/MOCHA.

MOCHA is an ongoing Phase I/II, multi center, open label, non-comparative study to confirm the dose and evaluate the safety, tolerability, acceptability, and pharmacokinetics of oral CAB, long-acting injectable CAB (CAB LA), and long-acting injectable RPV (RPV LA) among up to 155 children and adolescents aged 12 to <18 years with virologically suppressed HIV-1. Participants enrolled across 18 sites in Botswana, South Africa, Thailand, Uganda, and the United States. Follow-up is expected to be completed this year.

Additionally, the IMPAACT 2017/MOCHA team recently published results from Cohort 2 through Week 24 in the Lancet HIV. Overall, participants experienced high virological suppression with no confirmed virological failures (defined as HIV RNA > 200 copies per mL) at Week 24. None of the participants (0/142) experienced drug-related serious adverse events or premature treatment discontinuation due to drug-related adverse events. These results demonstrated that long-acting injectable cabotegravir and long-acting injectable rilpivirine, given to adolescents every 8 weeks, showed no unanticipated safety concerns at 24 weeks.