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Medivir AB's Partner Announces Primary Efficacy and Safety Findings from Phase III Study of Simeprevir in Treatment


Tuesday, 21 May 2013 08:15am EDT 

Medivir AB announced that the Company's Partner Janssen R&D Ireland (Janssen) has presented primary efficacy and safety results from the global phase III PROMISE study. Results demonstrated that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 79% of treatment-experienced genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir was administered once daily with pegylated interferon and ribavirin. In the study, 37% of patients receiving pegylated interferon and ribavirin (placebo) alone achieved SVR12. In the simeprevir arm, on-treatment failure rates were 3% and relapse rates were 19%, compared to 27% and 48% in the placebo arm. All patients had previously relapsed following pegylated interferon-based therapy.