The safety and efficacy of simeprevir inclusion into standard regimens of HCV therapy (PEG-IFNα and ribavirin) was assessed in two randomized controlled trials (QUEST-1, PEG-IFNα2a; QUEST-2, PEG-IFNα2a or 2b). Patients with genotype 1 HCV infection tolerated simeprevir well, with 80–81% reaching a sustained virologic response at 12 weeks compared with 50% of patients receiving standard therapy with placebo. The incidence and severity of adverse events was similar in the simeprevir and placebo groups.
References
Jacobson, I. M. et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 10.1016/S0140-6736(14)60494-3
Manns, M. et al. Simprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 10.1016/S0140-6736(14)60538-9
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Simeprevir inclusion in PEG-IFN plus ribavirin regimen for hepatitis C is safe and effective. Nat Rev Gastroenterol Hepatol 11, 454 (2014). https://doi.org/10.1038/nrgastro.2014.110
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DOI: https://doi.org/10.1038/nrgastro.2014.110
