Real‐world use of long‐acting cabotegravir and rilpivirine: 12‐month results of the inJectable Antiretroviral therapy feasiBility Study (JABS)

• Published in: HIV medicine Vol. 25; no. 8; pp. 935 - 945
• Main Authors: John, M., Williams, L., Nolan, G., Bonnett, M., Castley, A., Nolan, D.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-08-2024
• Subjects: adherence; Adult; Adverse events; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antiretroviral agents; Antiretroviral therapy; Australia; Clinical trials; Complexity; Diketopiperazines; Dosage; Drug therapy; Feasibility Studies; Female; Health services; HIV Infections - drug therapy; HIV-1 - drug effects; Humans; injectable ART; Injection; Injections, Intramuscular; long‐acting ART; Male; Medication Adherence - statistics & numerical data; Mental disorders; Middle Aged; Pyridones - administration & dosage; Pyridones - adverse effects; real‐world; Rilpivirine - administration & dosage; Rilpivirine - adverse effects; Rilpivirine - therapeutic use; Therapy; Treatment Outcome; vulnerable populations; Australia; long‐acting ART; real‐world; injectable ART; vulnerable populations; adherence
• ISSN: 1464-2662; 1468-1293; 1468-1293
• DOI: 10.1111/hiv.13647

Objectives
The inJectable Antiretroviral feasiBility Study (JABS) aimed to evaluate the implementation of long‐acting regimens in a ‘real world’ Australian setting, with inclusion of participants with complex medical needs, social vulnerability and/or historical non‐adherence.
Methods
JABS was a 12‐month, single‐centre, single‐arm, open‐label phase IV study of long‐acting cabotegravir 600 mg plus rilpivirine 900 mg administered intramuscularly every 2 months to adults with treated HIV‐1 infection. The primary endpoint was the proportion of attendances and administration of injections within a 14‐day dosing window over 12 months, out of the total prescribed doses. Secondary endpoints included proportions of missed appointments, use of oral bridging, discontinuations, virological failures, adverse events and participant‐reported outcomes. A multidisciplinary adherence programme embedded in the clinical service known as REACH provided support to JABS participants.
Results
Of 60 participants enrolled by May 2022, 60% had one or more complexity or vulnerability factors identified, including absence of social supports (50%), mental health issues, alcohol or drug use (30%) and financial hardship or instability (13%), among others. Twenty‐seven per cent of participants had historical non‐adherence to antiretroviral therapy. Out of 395 prescribed doses, 97.2% of injections were administered within correct dosing windows at clinic visits. Two courses of short‐term oral bridging were required. The rate of injection site reactions was 29%, the majority being grade 1–2. There were no virological failures, no serious adverse events and only one injection‐related study discontinuation. High baseline treatment satisfaction and acceptability of injections increased by month 12. Those with vulnerability factors had similar adherence to injections as those without such factors. Ninety‐eight per cent of the participants who completed 12 months on the study have maintained long‐acting therapy, virological suppression and retention in care.
Conclusions
Long‐acting cabotegravir plus rilpivirine was associated with very high adherence, maintenance of virological suppression, safety and treatment satisfaction in a diverse Australian clinic population, comparable to results of phase III randomized clinical trials. Individuals with vulnerability factors can achieve adherence to injections with individualized support. Long‐acting therapies in this group can increase the subsequent engagement in clinical care.