title: Efficacy and safety of simeprevir for chronic hepatitis virus C genotype 1 infection: A meta-analysis.
abstract: OBJECTIVE
  To gain a profile of the efficacy and safety of simeprevir-based triple therapy in chronic hepatitis virus C (HCV) genotype 1 infected patients.
  
  
  METHODS
  We searched in Medline, Embase, Cochrane database of systematic reviews and CINAHL for randomized controlled trials (RCTs) without year or language restriction. Eligible studies should evaluate simeprevir plus peginterferon and ribavirin combination therapy for chronic hepatitis C genotype 1 patients, while the standard peginterferon and ribavirin therapy as control group. Results must include the data of achieving sustained virological response (SVR), rapid virological response (RVR), incidence of discontinuation and severe adverse events (SAE).
  
  
  RESULTS
  Six RCTs (2209 patients) were included. The proportion of achieving SVR at 12 weeks after planned end of treatment (SVR12) was significantly higher in the simeprevir group than in the control group (RR=1.69, 95%CI: 1.37-2.08, P<0.001). The results also showed that the RVR rate was significantly higher in the simeprevir group (RR=9.57, 95%CI: 5.82-15.73, P<0.001). The addition of simeprevir was not accompanied with the increased risks of SAE (RR=0.67, 95%CI: 0.47-0.94, P=0.023). The incidence of discontinuation due to adverse events seems a little higher in simeprevir group than in the control group (3.0% vs. 1.1%), though there was no statistical difference (RR=1.26, 95%CI: 0.58-2.74, P=0.566).
  
  
  CONCLUSIONS
  Simeprevir-based triple therapy significantly increase the SVR12 rate and RVR rate without increasing the incidences of SAE and treatment discontinuation due to adverse events. However, further inquiries on the long-term safety of simeprevir are required in future.
authors.affiliation: Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, 247, Beiyuan Road, 250033 Jinan, PR China.
authors.forename: Yundong
authors.initials: Y
authors.lastname: Qu
authors.affiliation: Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, 247, Beiyuan Road, 250033 Jinan, PR China.
authors.forename: Tao
authors.initials: T
authors.lastname: Li
authors.affiliation: Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, 247, Beiyuan Road, 250033 Jinan, PR China. Electronic address: wlsdeygbk@163.com.
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, 247, Beiyuan Road, 250033 Jinan, PR China.
authors.forename: Feng
authors.initials: F
authors.lastname: Liu
authors.affiliation: Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, 247, Beiyuan Road, 250033 Jinan, PR China.
authors.forename: Qian
authors.initials: Q
authors.lastname: Ye
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000069616:Simeprevir / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D000069616:Simeprevir