长效卡博替拉韦和利匹韦林的实际使用情况:可检测抗逆转录病毒疗法可行性研究(JABS)的 12 个月结果。

IF 2.8 3区 医学 Q2 INFECTIOUS DISEASES
HIV Medicine Pub Date : 2024-04-21 DOI:10.1111/hiv.13647
M. John, L. Williams, G. Nolan, M. Bonnett, A. Castley, D. Nolan
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引用次数: 0

摘要

方法JABS是一项为期12个月、单中心、单臂、开放标签的IV期研究,对接受治疗的成人HIV-1感染者每2个月肌肉注射一次长效卡博替拉韦600毫克加利匹韦林900毫克。主要终点是12个月内14天给药窗口期内的就诊和注射比例,占处方总剂量的比例。次要终点包括失约比例、口服桥接疗法的使用、停药、病毒学失败、不良事件和参与者报告的结果。结果 在2022年5月注册的60名参与者中,60%的人有一个或多个复杂或脆弱因素,包括缺乏社会支持(50%)、精神健康问题、酗酒或吸毒(30%)、经济困难或不稳定(13%)等。27% 的参与者曾不坚持抗逆转录病毒治疗。在 395 次处方剂量中,97.2% 的注射剂量是在门诊就诊时的正确剂量窗口内注射的。需要两个疗程的短期口服桥接疗法。注射部位反应发生率为 29%,大多数为 1-2 级反应。没有出现病毒学失败、严重不良事件,只有一次因注射而中止研究。基线治疗满意度高,注射的可接受性在第 12 个月时有所提高。有易感因素者与无易感因素者的注射依从性相似。结论长效卡博替拉韦加利匹韦林在澳大利亚不同的临床人群中具有很高的依从性、病毒学抑制维持率、安全性和治疗满意度,与 III 期随机临床试验的结果相当。有易感因素的患者可以在个性化支持下坚持注射。对这一群体采用长效疗法可以提高其对临床治疗的参与度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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.

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来源期刊
HIV Medicine
HIV Medicine 医学-传染病学
CiteScore
5.10
自引率
10.00%
发文量
167
审稿时长
6-12 weeks
期刊介绍: HIV Medicine aims to provide an alternative outlet for publication of international research papers in the field of HIV Medicine, embracing clinical, pharmocological, epidemiological, ethical, preclinical and in vitro studies. In addition, the journal will commission reviews and other feature articles. It will focus on evidence-based medicine as the mainstay of successful management of HIV and AIDS. The journal is specifically aimed at researchers and clinicians with responsibility for treating HIV seropositive patients.
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