Author(s): Tamori A, Yoshida K, Kurai O, Kioka K, Hai H,
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Abstract AIM: Simeprevir (SMV) is a potent, macrocyclic hepatitis C virus (HCV) non-structural (NS)3/4A protease inhibitor. This prospective study compared the efficacy and safety of SMV in combination with peginterferon α-2a + ribavirin, (P2aR) and with peginterferon α-2b + ribavirin (P2bR), in Japanese patients with HCV genotype 1b infection. METHODS: HCV genotype 1b patients were randomly assigned to receive SMV (100 mg QD) with P2aR for 12 weeks, then P2aR alone for 12 or 36 weeks; or SMV (100 mg QD) with P2bR for 12 weeks, then P2bR alone for 12 or 36 weeks. The primary endpoint was a sustained virologic response 24 weeks after completing treatment (SVR24). RESULTS: In total, 151 patients were randomly assigned to the P2aR (n = 76) or P2bR group (n = 75). Six patients dropped out. SVR24 was achieved in 55 (75.3\%) of 73 P2aR patients and 55 (76.4\%) of 72 P2bR patients. There was no difference in the rate of SVR24 between the two groups (p = 0.88). No differences in the proportion of patients who became HCV RNA-negative were detected between the P2aR and P2bR groups. The two groups had comparable numbers of adverse events, which led to the discontinuation of treatment in 9.6\% and 8.3\% of participants in the P2aR and P2bR groups, respectively. CONCLUSIONS: Peginterferon α-2a or α-2b in combination with SMV + ribavirin therapy showed identical antiviral effects in patients with chronic hepatitis C. Also, the incidence of adverse events was identical for both regimens. This article is protected by copyright. All rights reserved.
This article was published in Hepatol Res
and referenced in General Medicine: Open Access