Shen Chao, Fan Haozhi, Ge Zhijun, Cai Weihua, Shao Jianguo, Dong Chen, Xue Hong, Fu Zuqiang, Li Jun, Zhang Yun, Yue Ming
Key Laboratory of Infectious Diseases, Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China.
Department of Information, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Front Med (Lausanne). 2020 Dec 3;7:592472. doi: 10.3389/fmed.2020.592472. eCollection 2020.
Since a greater number of hepatitis C virus (HCV) patients have access to direct-acting antiviral (DAA) based therapies, the number of patients not properly responding to prior DAA regimens is increasing. The objective of this comprehensive analysis was to assess the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in HCV patients who experienced previous DAA therapy failures. Bibliographic databases were systematically searched for relevant articles published by November 2020. The main endpoints were sustained viral response after 12 weeks (SVR12), adverse events (AEs; any grade) and severe adverse events (SAEs). Publication bias assessment was performed using funnel plots and the Egger's test. Fourteen studies consisting of a total of 1,294 subjects were included in this study and the pooled estimate of SVR12, AEs and SAEs rates were 96.8% (95%CI: 95.1-98.2), 47.1% (95%CI: 26.0-69.3), and 1.8% (95%CI: 0.7-3.4), respectively. Subgroup analysis showed that pooled SVR12 rates were 97.9% (95%CI: 96.7-98.9) for Japan and 91.1% (95%CI: 87.3-94.3) for the United States; 95.8% (95%CI: 93.9-97.4) for genotype (GT)1 and 100.0% (95%CI: 99.6-100.0) for GT2; 95.3% (95%CI: 92.4-97.2) for cirrhosis and 96.3% (95%CI: 94.2-97.7) for non-cirrhosis cases. There was no publication bias included this study. This comprehensive analysis revealed that GLE/PIB is an effective and secure retreatment option for patients who did not optimally respond to DAA treatment, especially the Asian population with GT1-2.
由于越来越多的丙型肝炎病毒（HCV）患者能够接受基于直接抗病毒药物（DAA）的治疗，对先前DAA治疗方案反应不佳的患者数量正在增加。这项综合分析的目的是评估格卡瑞韦/哌仑他韦（GLE/PIB）在先前DAA治疗失败的HCV患者中的疗效和安全性。系统检索了截至2020年11月发表的相关文献数据库。主要终点为12周后持续病毒学应答（SVR12）、不良事件（AE；任何级别）和严重不良事件（SAE）。使用漏斗图和Egger检验进行发表偏倚评估。本研究纳入了14项研究，共1294名受试者，SVR12、AE和SAE发生率的合并估计值分别为96.8%（95%CI：95.1-98.2）、47.1%（95%CI：26.0-69.3）和1.8%（95%CI：0.7-3.4）。亚组分析显示，日本的SVR12合并率为97.9%（95%CI：96.7-98.9），美国为91.1%（95%CI：87.3-94.3）；基因1型（GT）为95.8%（95%CI：93.9-97.4），GT2型为100.0%（95%CI：99.6-100.0）；肝硬化患者为95.3%（95%CI：92.4-97.2），非肝硬化患者为96.3%（95%CI：94.2-97.7）此研究不存在发表偏倚。这项综合分析表明，对于对DAA治疗反应不佳的患者，尤其是GT1-2型的亚洲人群，GLE/PIB是一种有效且安全的再治疗选择。
