OBJECTIVES: 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).  METHODS: 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.  RESULTS: