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Medivir AB's Partner Announces Primary Efficacy and Safety Results from Japanese Phase III Clinical Studies

Thursday, 6 Jun 2013 08:00am EDT 

Medivir AB announced that its partner Janssen Pharmaceutical R&D Ireland (Janssen) has presented primary efficacy and safety results from four Japanese phase III clinical studies demonstrating that the use of the investigational NS3/4A protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in patients with genotype 1 hepatitis C, when administered once daily with pegylated interferon and ribavirin. The four studies examined the use of simeprevir in genotype 1 chronic hepatitis C patients who were treatment naive, as well as patients who were non-responders to prior therapy or relapsed following treatment with pegylated interferon with or without ribavirin. The most common adverse events seen in patients receiving simeprevir plus pegylated interferon and ribavirin in CONCERTO-1 were similar to those observed with pegylated interferon and ribavirin alone and were also similar in the other studies (decreased white blood cell count, fever, anemia, decreased neutrophil count, malaise, headache and rash). Treatment discontinuation rates due to an adverse event in CONCERTO-1 were five percent in the simeprevir arm and 8 percent in the placebo arm, four percent in CONCERTO-2, four percent in CONCERTO -3 and one percent in CONCERTO-4. 

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