Department of Clinical Immunology, Royal Perth Hospital, Perth, Western Australia, Australia.
Immunology, PathWest, Murdoch, Western Australia, Australia.
HIV Med. 2024 Aug;25(8):935-945. doi: 10.1111/hiv.13647. Epub 2024 Apr 21.
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.
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.
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.
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.
长效抗逆转录病毒可行性研究（JABS）旨在评估长效方案在澳大利亚“真实世界”环境中的实施情况，纳入具有复杂医疗需求、社会脆弱性和/或既往不依从的参与者。
JABS 是一项为期 12 个月、单中心、单臂、开放性、四期研究，对接受过治疗的 HIV-1 感染成人每 2 个月肌内注射 600mg 卡替拉韦和 900mg 利匹韦林，评估长效 cabotegravir 600mg 加 rilpivirine 900mg 的实施情况。主要终点是在 12 个月内，14 天给药窗口内的注射次数占总规定剂量的比例。次要终点包括错过预约的比例、口服桥接的使用、停药、病毒学失败、不良事件和参与者报告的结果。REACH 是一项嵌入临床服务的多学科依从性计划，为 JABS 参与者提供支持。
截至 2022 年 5 月，共纳入 60 名参与者，其中 60%有一个或多个复杂或脆弱因素，包括缺乏社会支持（50%）、心理健康问题、酒精或药物使用（30%）和经济困难或不稳定（13%）等。27%的参与者既往抗逆转录病毒治疗不依从。在 395 个规定剂量中，97.2%的注射在就诊时在正确的剂量窗口内进行。需要进行两疗程短期口服桥接。注射部位反应的发生率为 29%，大多数为 1-2 级。无病毒学失败、无严重不良事件，仅 1 例因与注射相关的研究停药。治疗满意度和对注射的接受度基线较高，到第 12 个月时有所增加。有脆弱因素的参与者与无此类因素的参与者的注射依从性相似。98%完成 12 个月研究的参与者维持长效治疗、病毒学抑制和保留在护理中。
长效卡替拉韦加利匹韦林与澳大利亚临床人群非常高的依从性、维持病毒学抑制、安全性和治疗满意度相关，与 III 期随机临床试验结果相当。有脆弱因素的个体可以通过个体化支持实现对注射的依从性。在该人群中使用长效治疗可以增加随后对临床护理的参与。
