The Potential Role of Simeprevir for the Treatment of Hepatitis C

Cristina del Barrio Gascón; Maria Buti


Future Virology. 2015;10(2):67-75. 

In This Article

SMV for Genotype 4 Patients

SMV has been approved for the treatment of patients with chronic hepatitis C genotype 4 infection in Europe. The multicenter RESTORE study included genotype 4 patients who were treatment-naive, prior relapsers, partial responders or null responders to PEG-IFN/RBV. naive patients and prior relapsers were eligible for RGT criteria that used in the QUEST studies, whereas prior partial and null responders were treated with SMV triple therapy for 12 weeks, followed by PEG-IFN/RBV for 36 additional weeks. In total, 35 naive patients, 22 prior relapsers, 10 prior partial responders and 40 prior null responders were included. Depending on the group, 5–50% of patients had liver cirrhosis. SVR12 by intention to treat was achieved in 83% of naive patients, 86% of relapsers, 60% of partial responders and 40% of null responders. Among naive patients and relapsers, 89 and 91%, respectively, were eligible for 24 weeks of treatment, with SVR rates of 93 and 95%, respectively. In the overall study population, patients with a fibrosis score of F3 or F4 achieved lower SVR rates than those with F1 or F2. The safety profile of SMV was consistent with previous studies in patients with HCV genotype 1.[29]