BACKGROUND: Long-acting cabotegravir plus rilpivirine is effective and safe HIV treatment in phase III randomised controlled clinical trials. Individuals in the wider community with risk factors for non-adherence who may benefit from this approach have been under-represented in registrational trials. The inJectable Antiretroviral feasiBility Study (JABS) seeks to evaluate the effectiveness of long-acting regimens in a "real world" Australian setting, with inclusion of participants with complex medical needs and social vulnerability, including those with historical non-adherence or non-engagement who receive individualised adherence support through a multidisciplinary program (REACH) embedded within the clinical service.
METHODS: JABS is a 48-week, single centre, single arm, open label study of long-acting cabotegravir 600mg plus rilpivirine 900mg maintenance therapy administered 2-monthly to adults with treated HIV-1. The primary endpoint is the proportion of attendances/delivery of injections within a seven-day dosing window over 12 months. Secondary and exploratory endpoints include proportions of missed/rescheduled appointments, use of oral bridging, discontinuations, virological failures, adverse events, multiple participant related outcomes and changes to service delivery.
RESULTS: Sixty participants were enrolled by May 2022. Median age was 40 years (IQR 36-47); 15% (n=9) female at birth; 51% males and 89% females were born overseas. Complexity/vulnerability factors included social isolation (50%), mental health/AOD issues (30%), and financial instability (13%). Sixteen (27%) received enhanced support through REACH. Of 315 injection doses analysed to date, 97.8% injections were within prescribed windows. Seven doses given outside the dosing window were due to planned (n=4, all work-related) and unplanned (n=3) interruptions. Two oral bridging courses were required. There were 6 discontinuations, due to patient decision (n=3), CNS side-effects during oral lead-in (n=1), positive Hepatitis B serology (n=1), and drug interaction (n=1). There were no virological failures or serious adverse events. Participant experience and service delivery outcomes are presented separately, and updated results will be presented with planned study completion in May 2023.
CONCLUSIONS: Adherence to 2 monthly intramuscular cabotegravir plus rilpivirine in an Australian clinic population is very high, including in those who access individualised adherence support. Real world efficacy and safety is comparable to phase III randomised clinical trials.

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