What is the role of simeprevir (Olysio) in the treatment of hepatitis C (hep C) infection?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Simeprevir (Olysio) was FDA approved in November 2013. The QUEST 1 and QUEST 2 phase 3 trials assessed the efficacy of simeprevir in 785 adult, treatment-naïve patients with chronic HCV genotype 1. Results showed that 80% and 81% of patients treated with simeprevir (plus PEG-IFN alfa and ribavirin) achieved SVR at 12 weeks (SVR12) compared with the PEG-IFN alfa and ribavirin control groups (50%). [102]

In the PROMISE study, 393 patients who had previous relapse after completing HCV treatment with PEG-IFN and ribavirin, were randomized to receive either 150 mg of once-daily simeprevir for 12 weeks plus PEG-IFN and ribavirin for 24 or 48 weeks based on response guided treatment criteria (simeprevir group) or PEG-IFN and ribavirin alone for 48 weeks (control group). In this study, the SVR12 was 79% in the simeprevir treatment group compared to 37% with PEG-IFN and ribavirin alone. [102]

The presence of the Q80K HCV genotype (GT) 1a polymorphism (commonly found in GT1a patients in the United States) at baseline had a substantial negative impact on the efficacy of simeprevir. In the pooled trials, the differences in SVR12 rates in GT1a patients with the Q80K polymorphism were not statistically significant between the treatment (58%) and control (55%) groups. [103] In the HPC3007 trial of HCV, the SVR12 rates for those with the Q80K polymorphism were 47% in the treatment group and 30% in the control group. [103]

Simeprevir was approved by the FDA for the treatment of HCV genotype 4 monoinfected and HCV/human immunodeficiency virus (HIV)-coinfected patients as a component of a combination antiviral treatment regimen that includes PEG-IFN and ribavirin. [104] The open-label, single-arm study (RESTORE) included 107 patients with HCV GT4 infection. Treatment included simeprevir 150 mg once daily plus PEG-IFN and ribavirin for 12 weeks, followed by PEG-IFN and ribavirin alone (12 or 36 weeks, response guided). Overall, 65.4% of patients achieved SVR12 (82.9% treatment naïve; 86.4% prior relapsers; 60% prior partial responders; 40% prior null responders). In treatment-naïve and prior relapser patients fulfilling response-guided criteria for 24 weeks of treatment (88.6% and 90.9%), SVR12 rates were high: 93.5% and 95.0%, respectively. These results were similar to previous reports for HCV GT1. [104] As discussed later, simeprevir is used in combination with other agents for the treatment of HCV infection.

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