Efficacy and safety of simeprevir for chronic hepatitis virus C genotype 1 infection: A meta-analysis.

Background And 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).

Conclusion: 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.