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Medivir AB Announces First Interim Results from Phase II Study for Oral Regimen of Simeprevir and Sofosbuvir in Prior Null Responder Hepatitis C Patients Jointly Developed with Janssen R&D Ireland


Monday, 4 Mar 2013 09:06am EST 

Medivir AB announced the first interim results from the cohort 1 of a Phase IIa study of the investigational protease inhibitor simeprevir (TMC435) administered once daily with Gilead’s investigational nucleotide inhibitor sofosbuvir (GS-7977) with and without ribavirin for 12 and 24 weeks in genotype 1 prior null-responder hepatitis C patients with mild to moderate fibrosis (METAVIR F0-2). Simeprevir is jointly developed by Medivir AB and Janssen R&D Ireland, an affiliate of the Janssen Pharmaceutical Companies. Cohort 1 of the phase IIa open-label COSMOS study randomized 80 genotype 1 patients into one of four arms including 150 mg of once-daily simeprevir plus 400 mg of sofosbuvir for 24 weeks with or without ribavirin or for 12 weeks with or without ribavirin. Virologic response rates with 150 mg simeprevir (SMV) and 400 mg sofosbuvir (SOF) q.d. with or without ribavirin (RBV). 

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