Efficacy and safety of simeprevir with PegIFN/ribavirin in naive or experienced patients infected with chronic HCV genotype 4
Faculty of Medicine and Health Sciences
Journal of hepatology. - Amsterdam
, p. 1047-1055
University of Antwerp
Background & Aims: Simeprevir (SMV) is a once-daily (QD), oral hepatitis C virus (HCV) NS3/4A protease inhibitor approved for treatment of genotype (GT) 1 and GT4 infection. This Phase III, open-label, single-arm study (RESTORE; NCT01567735) evaluated efficacy/safety of SMV with peginterferon-alpha-2a/ribavirin (PR) in patients with chronic HCV GT4 infection. Methods: 107 patients were included. Treatment-naive (n = 35) and prior relapse patients (n = 22) received SMV 150 mg QD + PR (12 weeks), followed by PR alone (12 or 36 weeks, response-guided [HCV RNA < 25 IU/ml detectable/undetectable at week 4 and < 25 IU/ml undetectable at week 12]). Prior non-responders (partial, n = 10; null, n = 40) received SMV/PR (12 weeks), followed by PR for 36 weeks. The primary endpoint was sustained virologic response 12 weeks after end of treatment (SVR12). Results: Median age: 49.0 years; 28.0% Black/African; 7.5% IL28B CC; 28.8% METAVIR F4. Overall, 65.4% (70/107) of patients achieved SVR12 (82.9% [29/35] treatment-naive; 86.4% [19/22] prior relapsers; 60.0% [6/10] prior partial responders; 40.0% [16/40] prior null responders). In treatment-naive and prior relapser patients fulfilling response-guided criteria for 24 weeks of treatment (88.6% [31/35] and 90.9% [20/22]), SVR12 rates were high: 93.5% [29/31] and 95.0% [19/20], respectively. Overall on-treatment failure and relapse rates were 23.4% (25/107) and 14.6% (12/82), respectively. Adverse events ( AEs) were mainly grade 1/2; serious AEs were infrequent (4.7%) and considered unrelated to SMV. Conclusions: Efficacy and safety of SMV 150 mg QD for 12 weeks with PR in treatment-naive or -experienced patients with chronic HCV GT4 infection were in line with previous reports for HCV GT1 infection. (C) 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.