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Medivir AB to Present New Data from Simeprevir Phase III Studies Quest 1 and 2 in Hepatitis C Patients

Tuesday, 23 Apr 2013 06:00am EDT 

Medivir AB announced that data on the investigational protease inhibitor simeprevir (TMC435) for the treatment of genotype 1 hepatitis C patients is to be presented at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL) in Amsterdam, The Netherlands. These primary efficacy and safety results from two global phase III studies demonstrate that use of the investigational protease inhibitor simeprevir led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 80% and 81%, respectively, of treatment-naive genotype 1 chronic hepatitis C adult patients with compensated liver disease, when administered once daily with pegylated interferon and ribavirin. In both studies, 50% of patients receiving pegylated interferon and ribavirin alone achieved SVR12. The QUEST-1 and QUEST-2 data will also be discussed in an official EASL press conference on April 24, 2013. In QUEST-1 and QUEST-2, patients were randomized to receive simeprevir or placebo for 12 weeks plus pegylated interferon and ribavirin for 24 or 36 weeks. In findings related to a secondary endpoint, 85% (QUEST-1) and 91% (QUEST -2) of patients receiving simeprevir were able to shorten therapy with pegylated interferon and ribavirin to 24 weeks due to meeting response-guided therapy (RGT) criteria. Of those patients meeting RGT criteria to stop treatment at 24 weeks, 91% (QUEST-1) and 86% of patients (QUEST-2) achieved SVR12. 

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19 Dec 2014