Cui Xianghua, Kong Yuanyuan, Jia Jidong
Liver Research Center, Being Friendship Hospital, Capital Medical Univers, China.
Clinical Epidemiology and EBM Unit, Being Friendship Hospital, Capital Medical Univers, China.
Rev Esp Enferm Dig. 2015 Oct;107(10):591-7. doi: 10.17235/reed.2015.3840/2015.
A simeprevir (SMV)-based regimen has shown promising results in treating chronic hepatitis C virus (HCV) infection. This meta-analysis aimed to assess the efficacy and safety of simeprevir for treating HCV genotype 1 infection.
MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched, along with the reference lists of retrieved articles. The meta-analysis only included randomized controlled trials (RCTs) that compared the efficacy and safety of addition of SMV to peginterferon (PegIFN) and ribavirin (RBV) (triple regimen) with PegIFN/RBV alone (dual regimen) in treating chronic HCV genotype 1 infection.
A total of seven RCTs involving 2,301 patients were included. The triple regimen had a higher pooled sustained virologic response (SVR) rate [odds ratio (OR) = 4.57; 95% confidence interval (CI): 3.34-6.27; p < 0.001)] and lower pooled relapse rate [relative risk (RR) = 0.41; 95% CI: 0.33-0.50; p < 0.001] than the dual regimen had. The pooled incidence of adverse events (AEs) was comparable between the two regimens (RR = 1.01; 95% CI: 0.99-1.03; p = 0.339), whereas the incidence of serious AEs in the triple regimen was lower (RR = 0.7; 95% CI: 0.50-0.98; p < 0.05).
The meta-analysis demonstrates that the addition of SMV to pegIFN and RBV is effective and well-tolerated in treating chronic HCV genotype 1 infection, with a low incidence of AEs.
基于西米普明（SMV）的治疗方案在治疗慢性丙型肝炎病毒（HCV）感染方面已显示出有前景的结果。本荟萃分析旨在评估西米普明治疗HCV 1型感染的疗效和安全性。
检索了MEDLINE、EMBASE和Cochrane对照试验中央注册库，以及检索文章的参考文献列表。该荟萃分析仅纳入了随机对照试验（RCT），这些试验比较了在治疗慢性HCV 1型感染时，将SMV添加到聚乙二醇干扰素（PegIFN）和利巴韦林（RBV）（三联疗法）与单独使用PegIFN/RBV（双联疗法）的疗效和安全性。
共纳入7项涉及2301例患者的RCT。与双联疗法相比，三联疗法具有更高的合并持续病毒学应答（SVR）率[优势比（OR）=4.57；95%置信区间（CI）：3.34 - 6.27；p<0.001]和更低的合并复发率[相对风险（RR）=0.41；95%CI：0.33 - 0.50；p<0.001]。两种疗法的不良事件（AE）合并发生率相当（RR = 1.01；95%CI：0.99 - 1.03；p = 0.339），而三联疗法中严重AE的发生率较低（RR = 0.7；95%CI：0.50 - 0.98；p<0.05）。
该荟萃分析表明，在PegIFN和RBV中添加SMV治疗慢性HCV 1型感染有效且耐受性良好，AE发生率较低。
