含索磷布韦方案治疗基因2型和3型慢性丙型肝炎患者的疗效与安全性：18项随机对照试验的综合分析
Efficacy and safety of sofosbuvir-containing regimens in chronic hepatitis C patients with genotype 2 and 3: a comprehensive analysis of 18 randomized controlled trials.
作者信息
Fan Haozhi, Huang Peng, Tian Ting, Wu Jingjing, Xia Xueshan, Feng Yue, Wang Jie, Yu Rongbin, Zhang Yun, Yue Ming
机构信息
Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, R.P.China.
Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing;Institute of Epidemiology and Microbiology, Huadong Research Institute for Medicine and Biotechnics, Nanjing, R.P.China.
出版信息
J Gastrointestin Liver Dis. 2018 Jun;27(2):159-168. doi: 10.15403/jgld.2014.1121.272.sof.
BACKGROUND AND AIM
Sofosbuvir is a hepatitis C virus (HCV) NS5B polymerase inhibitor. The objective of this study was to explore the efficacy and safety of sofosbuvir for HCV genotype (GT) 2 and 3 infected patients.
METHOD
We searched randomized controlled trials (RCTs) which analyzed the efficacy and safety of sofosbuvir-containing regimens for HCV GT 2/3 infected patients and collected data. The endpoints were sustained virological response 12- and 24-weeks after the cessation of therapy (SVR12 and SVR24), the adverse events (AEs) and the severe adverse events (SAEs).
RESULTS
Eighteen trials comprising 2,975 HCV GT 2/3 infected patients were included. The pooled estimate SVR12, SVR24, AEs and SAEs rates were 84.6% (95% CI: 83.2-86.0), 83.7% (95% CI: 82.0-85.2), 83.8 (95% CI: 82.3-85.3) and 3.9 (95% CI: 3.2-4.8). The SVR12 rate of sofosbuvir-containing regimens for HCV GT 2 infection was higher than that for HCV GT 3 infection (95.7% vs. 80.8%). The sofosbuvir combined with velpatasvir (with or without ribavirin) regimen presented a higher SVR12 rate and lower AEs rate than the sofosbuvir combined with ribavirin (with or without peg-IFN) regimen (94.9% vs. 80.7% for SVR12 rate; 69.3% vs. 87.7% for AEs rate).
CONCLUSIONS
The sofosbuvir-containing regimens in patients with HCV GT 2 infection have better efficacy than in patients with HCV GT 3 infection.
背景与目的
索磷布韦是一种丙型肝炎病毒（HCV）NS5B聚合酶抑制剂。本研究的目的是探讨索磷布韦对丙型肝炎病毒基因2型（GT）和3型感染患者的疗效和安全性。
方法
我们检索了分析含索磷布韦方案对HCV GT 2/3感染患者疗效和安全性的随机对照试验（RCT）并收集数据。终点指标为治疗停止后12周和24周的持续病毒学应答（SVR12和SVR24）、不良事件（AE）和严重不良事件（SAE）。
结果
纳入了18项试验，共2975例HCV GT 2/3感染患者。汇总估计的SVR12、SVR24、AE和SAE发生率分别为84.6%（95%CI：83.2 - 86.0）、83.7%（95%CI：82.0 - 85.2）、83.8（95%CI：82.3 - 85.3）和3.9（95%CI：3.2 - 4.8）。含索磷布韦方案对HCV GT 2感染患者的SVR12率高于HCV GT 3感染患者（95.7%对80.8%）。与索磷布韦联合利巴韦林（含或不含聚乙二醇干扰素）方案相比，索磷布韦联合维帕他韦（含或不含利巴韦林）方案的SVR12率更高，AE发生率更低（SVR12率：94.9%对80.7%；AE发生率：69.3%对87.7%）。
结论
含索磷布韦方案对HCV GT 2感染患者的疗效优于HCV GT 3感染患者。
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