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[关于基于博赛泼维与特拉泼维的慢性丙型肝炎三联疗法的专家意见]

[Expert opinion on boceprevir- and telaprevir-based triple therapies of chronic hepatitis C].

作者信息

Sarrazin C, Berg T, Cornberg M, Dollinger M, Ferenci P, Hinrichsen H, Klinker H, Kraus M, Manns M, Mauss S, Peck-Radosavljevic M, Schmidt H, Spengler U, Wedemeyer H, Wirth S, Zeuzem S

机构信息

Klinikum der Goethe-Universität, Medizinische Klinik 1, Frankfurt am Main.

出版信息

Z Gastroenterol. 2012 Jan;50(1):57-72. doi: 10.1055/s-0031-1282015. Epub 2012 Jan 5.

DOI:10.1055/s-0031-1282015
PMID:22222799
Abstract

With the approval of boceprevir and telaprevir the standard treatment of chronic hepatitis C virus (HCV) genotype 1 infection will be the triple therapy of a HCV protease inhibitor together with pegylated interferon alfa and ribavirin. In clinical studies a significant increase of sustained virological response rates from 38 - 44 % to 63 - 75 % for treatment-naïve and from 17 - 21 % to 59 - 66 % in treatment-experienced patients in comparison to the dual combination therapy with pegylated interferon alfa and ribavirin alone has been demonstrated. In addition, a large number of treatment-naïve patients and relapsers benefit from shorten treatment durations to 24 - 28 weeks. However, important differences exist between the administration of boceprevir and telaprevir in terms of a pegylated interferon alfa/ribavirin lead-in phase, the duration of dosing of the protease inhibitor, the overall treatment duration, HCV RNA measurements for response guided treatment durations and stopping rules. Furthermore, triple therapies with boceprevir and telaprevir may be associated with selection of resistant viral variants, new adverse events and clinically relevant drug-drug interactions. The present review gives an overview on the results of underlying clinical studies together with a guideline for the practical management of boceprevir- and telaprevir-based triple therapies.

摘要

随着博赛匹韦和特拉匹韦的获批,慢性丙型肝炎病毒(HCV)1型感染的标准治疗将是HCV蛋白酶抑制剂与聚乙二醇化干扰素α和利巴韦林的三联疗法。在临床研究中,与单独使用聚乙二醇化干扰素α和利巴韦林的双联疗法相比,初治患者的持续病毒学应答率从38%-44%显著提高到63%-75%,经治患者从17%-21%显著提高到59%-66%。此外,大量初治患者和复发患者受益于治疗疗程缩短至24-28周。然而,在聚乙二醇化干扰素α/利巴韦林导入期、蛋白酶抑制剂给药持续时间、总治疗持续时间、用于指导治疗持续时间和停药规则的HCV RNA测量方面,博赛匹韦和特拉匹韦的给药存在重要差异。此外,博赛匹韦和特拉匹韦的三联疗法可能与耐药病毒变异体的选择、新的不良事件以及具有临床意义的药物相互作用有关。本综述概述了相关临床研究结果,并给出了基于博赛匹韦和特拉匹韦的三联疗法实际管理的指南。

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