August 28, 2013

Medivir Announces Interim Results from Cohort 2 of the COSMOS Study Evaluating Simeprevir and Sofosbuvir in HCV Patients with METAVIR Scores F3-F4

blogger_HCVRegulatory news:

Medivir AB (OMX: MVIR) (STO:MVIR-B) today announced interim results from the second Cohort in the ongoing COSMOS study evaluating a once daily combination of simeprevir and sofosbuvir in hard to cure hepatitis C (HCV) patients.

SVR4 results from the 12 week arms of Cohort 2 including treatment naïve or previous null responder HCV patients all with METAVIR score F3-F4 were reported. Treatment for 12 weeks with simeprevir and sofosbuvir with or without ribavirin led to SVR4 rates of 96% and 100% respectively.

Interim results from Cohort 1 of the COSMOS study which include only prior null responder HCV patients (METAVIR F0-F2) have been reported earlier and demonstrated SVR8 rates of 96% and 93% after 12 weeks treatment simeprevir and sofosbuvir with and without ribavirin respectively.

“The high SVR rates seen in genotype 1 prior null responders and treatment-naïve patients with advanced liver disease in the COSMOS study and the safety profile of the combination are highly encouraging. We look forward to the final results of this study in difficult to cure patients.” says Charlotte Edenius EVP Development Medivir AB.

COSMOS - Study Design

COSMOS is a randomized open label phase IIa clinical trial evaluating a once-daily combination of the HCV protease inhibitor simeprevir and the nucleotide sofosbuvir with and without ribavirin (RBV) for 12 and 24 weeks. Cohort 1 (n=80) evaluates prior null responder genotype 1 hepatitis C (HCV) patients with METAVIR scores F0-F2 and Cohort 2 (n=87) evaluates prior null responder and treatment-naïve genotype 1 hepatitis C patients with METAVIR scores F3-F4. The METAVIR score is used to quantify the degree of inflammation and fibrosis of the liver. Liver fibrosis is scored on a four-point scale.

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