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Tuesday, July 29, 2014

Phase 2 COSMOS Study Results Published in The Lancet Demonstrate Efficacy and Safety of Janssen’s Once-Daily Simeprevir in All Oral 12-Week Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C | Johnson & Johnson

CORK, Ireland (July 28, 2014) -- Results from the Phase 2 COSMOS (Combination OSiMeprevir and sOfosbuvir in HCV genotype 1 infected patientS) clinical study were published July 28 in The Lancet, demonstrating that 92 percent of genotype 1 chronic hepatitis C virus (HCV) adult patients treated with Janssen R&D Ireland’s (Janssen) simeprevir, an NS3/4A protease inhibitor, in combination with sofosbuvir, achieved sustained virologic response 12 weeks after the end of treatment (SVR12), including those patients with compensated cirrhosis and prior null response to treatment with pegylated interferon (PegIFN) and ribavirin (RBV).
According to findings from the study, the all-oral 12-week, interferon-free treatment regimen with simeprevir and sofosbuvir resulted in consistent SVR12 rates regardless of degree of fibrosis, and was an effective and well-tolerated therapeutic regimen in both treatment-naïve and prior null-responder patients.


Phase 2 COSMOS Study Results Published in The Lancet Demonstrate Efficacy and Safety of Janssen’s Once-Daily Simeprevir in All Oral 12-Week Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C | Johnson & Johnson

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