Systematic Review And Meta-Analysis of Efficacy And Safety of Simeprevir And Sofosbuvir For Hcv Genotype 1 Infection

Abstract

To evaluate the efficacy and safety of the second-wave direct-acting antivirals simeprevir and sofosbuvir in patients with HCV genotype 1 infection through a systematic review and meta-analysis of randomized clinical trials (RCTs). Electronic searches were performed in databases MEDLINE, International Pharmaceutical Abstracts (IPA), Cochrane Library, SCIELO and Scopus. Statistical analyses were executed using the software Review Manager version 5.3. 774 articles were identified, of which 10 RCTs were selected for data extraction and statistical analysis. Simeprevir 100 mg promoted better RVR and SVR24 Resultsthan placebo, and simeprevir 150 mg was superior to placebo for the following outcomes: RVR, SVR12, SVR24, SVR12 rates according to METAVIR score for the subgroups F0-F2, F3 and F4, SVR12 rates according to HCV genotype for both genotype 1a and genotype 1b, SVR12 rates for HCV genotype 1a without baseline Q80K and SVR12 according to IL28B genotype for CC, CT and TT. More viral relapse events were observed in the placebo group, for both evaluated doses. There were no significant differences for all of the evaluated safety outcomes between the simeprevir 100 mg and the placebo groups, and for almost all evaluated safety outcomes between the simeprevir 150 mg and placebo groups. Sofosbuvir promoted better RVR, SVR12 and SVR24 than placebo. There was no difference in the safety of sofosbuvir and placebo groups for the majority of evaluated outcomes. Our meta-analysis indicates promising efficacy and a good safety profile of simeprevir for both evaluated doses. Data concerning sofosbuvir reveal the benefits of this drug in hepatitis C virus genotype 1 treatment, also in safety terms.