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在真实环境中建立研究生产线:以埃及病毒性肝炎专业中心丙型肝炎管理为例。

Establishing a research production line in real-life settings: the case of Hepatitis C management in a viral hepatitis specialized Egyptian center.

机构信息

Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.

Tropical Medicine department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

出版信息

Curr Med Res Opin. 2022 Apr;38(4):553-563. doi: 10.1080/03007995.2022.2038489. Epub 2022 Feb 15.

Abstract

Efforts toward eradicating the Hepatitis C virus (HCV) have advanced rapidly, due to the development of direct-acting antivirals (DAAs), especially with the appearance of pan-genotypic combinations. Real-world studies, in particular, have verified the efficacy and safety of DAA combinations documented in registration trials. This review documents the results of using DAA combinations in real-life settings in everyday clinical practice in Egypt, the country with the highest prevalence of HCV. The significant number of treated patients in Egypt, which exceeded four million allowed tremendous data about the results of HCV management in real-life settings for different treatment regimens and disease conditions. DAA combinations have resulted in high sustained virologic response rates (SVR12) and few adverse reactions in real-life settings. SVR12 rates ranged from 90% to 100%, depending on the combination of drugs used, the HCV genotype, and the stage of liver disease. Most adverse reactions reported in real-world settings were mild and resulted in treatment discontinuation in only a minority of cases. Data from real-life studies covered most aspects of HCV management that were lacking after initial approval studies. More research is needed to tailor treatment and produce generic HCV combinations to overcome the residual limitations of the currently available DAAs.

摘要

消除丙型肝炎病毒(HCV)的努力进展迅速,这要归功于直接作用抗病毒药物(DAA)的发展,尤其是出现了泛基因型组合。特别是真实世界研究,验证了在注册试验中记录的 DAA 组合的疗效和安全性。本综述记录了在埃及这个 HCV 流行率最高的国家,在日常临床实践中使用 DAA 组合的结果。在埃及,接受治疗的患者数量众多,超过 400 万,为不同治疗方案和疾病状况下 HCV 管理的真实世界数据提供了巨大的支持。DAA 组合在真实环境中产生了高持续病毒学应答率(SVR12)和很少的不良反应。SVR12 率根据所用药物组合、HCV 基因型和肝病阶段的不同,从 90%到 100%不等。在真实环境中报告的大多数不良反应为轻度,仅少数情况下导致治疗中断。真实世界研究的数据涵盖了 HCV 管理的大多数方面,这些方面在最初批准研究后仍存在缺失。需要进一步的研究来调整治疗方案并生产通用的 HCV 组合,以克服目前可用的 DAA 的残留限制。

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