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长效注射型卡替拉韦用于 HIV 暴露前预防:HIV 预防领域的变革者?

Long-acting injectable cabotegravir for PrEP: A game-changer in HIV prevention?

机构信息

Université Paris Cité, Paris, France.

Assistance publique - Hôpitaux de Paris, Département des maladies infectieuses, Hôpital Saint Louis et Lariboisière, Paris, France.

出版信息

HIV Med. 2023 Jun;24(6):653-663. doi: 10.1111/hiv.13451. Epub 2022 Dec 5.

Abstract

BACKGROUND

Long-acting injectable cabotegravir (CAB-LA) represents a new additional option for HIV prevention in people at substantial risk of HIV infection that may fill the gaps in pre-exposure prophylaxis (PrEP) uptake, adherence, and retention in users having difficulty with oral PrEP. Data from clinical trials demonstrated that CAB-LA was safe, highly effective, and well-accepted for HIV prevention. However, the occurrence of breakthrough HIV infections despite timely injections, HIV seroconversion timing and patterns, risk of selection and dissemination of resistance-associated mutations to integrase inhibitors, complexity of follow-up, logistical considerations, and its cost effectiveness compared with oral PrEP constitute significant issues for the integration of CAB-LA into clinical routine.

FINDINGS

These concerns need to be addressed before moving forward with large-scale implementation programmes. Pilot and implementation projects are required in the following areas: HIV testing algorithms, patient education, clinic procedures, protocols for switching and discontinuation, efficacy and safety in populations not included in clinical trials, and demedicalization processes. The development of models to increase the uptake of, adherence to, and persistence with and after CAB-LA injections will also be of paramount importance for success. Lessons learned from these projects will increase experience, staff expertise, and organizational and training capacities to support the roll-out of this new agent as part of HIV prevention programmes.

CONCLUSION

CAB-LA has not yet achieved its full potential in HIV prevention, and strong commitment from all stakeholders is required to push CAB-LA as a game-changer in HIV response.

摘要

背景

长效注射用卡替拉韦(CAB-LA)为存在较高 HIV 感染风险的人群提供了一种新的预防 HIV 的额外选择,可能可以填补暴露前预防(PrEP)使用率、依从性和保留率方面的空白,这些人群使用口服 PrEP 存在困难。临床试验数据表明,CAB-LA 用于 HIV 预防是安全、高效且可接受的。然而,尽管及时注射,但仍会发生突破性 HIV 感染;HIV 血清转换的时间和模式;对整合酶抑制剂耐药相关突变的选择和传播风险;随访的复杂性;以及与口服 PrEP 相比的成本效益,这些问题对将 CAB-LA 纳入临床常规构成了重大挑战。

发现

在大规模实施计划之前,需要解决这些问题。需要在以下领域开展试点和实施项目:HIV 检测算法、患者教育、诊所程序、切换和停药方案、临床试验未纳入人群的疗效和安全性,以及去医学化过程。开发增加 CAB-LA 注射的使用率、依从性和持久性的模型,以及在注射后仍能保持使用,对于成功实施也至关重要。从这些项目中吸取的经验教训将提高接受度、员工专业知识以及组织和培训能力,以支持该新药物作为 HIV 预防计划的一部分推出。

结论

CAB-LA 在 HIV 预防方面尚未发挥其全部潜力,需要所有利益相关者的坚定承诺,将 CAB-LA 作为 HIV 应对的变革推动者。

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