在资源有限的环境中有效地批准两种新的艾滋病毒预防干预措施:来自津巴布韦的经验

IF 2.3 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Caroline Murombedzi, Libert Chirinda, Gift T. Chareka, Z. Mike Chirenje, Nyaradzo M. Mgodi
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引用次数: 0

摘要

尽管在艾滋病毒治疗和预防方面取得了重大进展,但艾滋病毒的全球负担仍然高得令人无法接受。迫切需要扩大包括暴露前预防(PrEP)在内的全面艾滋病毒预防战略。如果定期服用口服PrEP,在预防感染艾滋病毒方面非常有效,但这对一些高危人群来说仍然是一个挑战。因此,有必要采取其他艾滋病毒预防措施。最近完成的临床试验表明,达匹维林阴道环(DVR)和长效注射卡博特重力韦(CAB-LA)是一种安全有效的新型生物医学干预措施,可用于艾滋病毒暴露前预防。有效干预措施的及时推出和可扩展性取决于国家药品监管机构(NMRAs)的注册程序。津巴布韦药品管理局(MCAZ)是全球第一个于2021年7月批准DVR的国家药品管理局,也是非洲第一个于2022年7月批准CAB-LA用于艾滋病毒预防的国家药品管理局。MCAZ对DVR和CAB-LA的监管审查过程分别耗时4.5个月和5.5个月。MCAZ是一个资源有限的监管机构,它对这两种干预措施进行了有效的审查,为缩短完成临床开发过程和基本药物注册之间的时间间隔提供了重要经验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe
The global burden of HIV remains unacceptably high despite significant progress made in HIV treatment and prevention. There is an urgent need to scale up the comprehensive HIV prevention strategies that include pre-exposure prophylaxis (PrEP). Oral PrEP is highly effective in preventing HIV acquisition when taken regularly, but this remains a challenge for some at-risk individuals. Therefore, there is a need for other HIV prevention options. The dapivirine vaginal ring (DVR) and long-acting injectable cabotegravir (CAB-LA) are novel biomedical interventions that are safe and efficacious for HIV pre-exposure prophylaxis, as demonstrated in recently completed clinical trials. Timely roll-out and scalability of efficacious interventions depend on the registration process with the national medicine regulatory authorities (NMRAs). The Medicines Control Authority of Zimbabwe (MCAZ) was the first NMRA globally to approve the DVR in July 2021 and the first in Africa to approve CAB-LA for HIV prevention in July 2022. The regulatory review process for DVR and CAB-LA by MCAZ took 4.5 and 5.5 months, respectively. This efficient review process of the two interventions by MCAZ, a regulatory body in a resource-limited setting, provides important lessons to shorten timelines between the completion of the clinical development process and the registration of essential medicines.
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