Medivir: Phase II IMPACT Study Initiated to Evaluate Simeprevir in Combination with Sofosbuvir and Daclatasvir to Treat Genotype 1 and 4 Hepatitis C Patients

HUDDINGE, Sweden I October 10, 2014 I Medivir AB (STO:MVIR-B) today announces that its partner Janssen recently initiated patient enrolment in a phase II study called IMPACT. This study evaluates the efficacy, safety and pharmacokinetics of the NS3/4A protease inhibitor simeprevir administered once daily in combination with Gilead’s nucleotide inhibitor sofosbuvir and Bristol-Myers Squibb’s (BMS) NS5A replication complex inhibitor daclatasvir. The study includes treatment-naïve and treatment-experienced patients with hepatitis C genotype 1 and 4 infection and decompensated liver disease.

In the phase II, open label IMPACT study, patients will receive the once-daily combination of simeprevir 150 mg, sofosbuvir 400 mg and daclatasvir 60 mg, for 12 weeks. The primary efficacy endpoint in the study is the proportion of patients achieving sustained virologic response 12 weeks after the end of treatment (SVR12). The IMPACT study represents the first phase II study of the combination of simeprevir, sofosbuvir and daclatasvir in a regimen without pegylated interferon and ribavirin.

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