Boehringer Ingelheim Corporation Announces Full Patient Enrolment for Two of Its Pivotal Phase III Interferon-Free Hepatitis C Clinical Trials
8/15/2013 10:10:21 AM
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Boehringer Ingelheim today announced that enrolment of over 950 treatment naïve genotype-1b patients in the pivotal Phase III interferon-free HCVerso™ 1 and 2 trials is complete.1,2 The trials are investigating the efficacy and safety of Boehringer Ingelheim’s second generation protease inhibitor faldaprevir* and NS5B polymerase inhibitor deleobuvir (BI 207127)*, in combination with ribavirin. HCVerso™ 1 and 2 include difficult-to-treat patient populations such as those who are ineligible for interferon or those with liver cirrhosis. This important developmental milestone coincides with today’s publication of Boehringer Ingelheim’s Phase IIb interferon-free SOUND-C2 study in the New England Journal of Medicine (NEJM).3 SOUND-C2 showed viral cure rates (sustained virological response, SVR) of up to 85% in patients infected with genotype-1b (GT-1b) hepatitis C virus (HCV). SOUND-C2 investigated the efficacy and safety of faldaprevir* and deleobuvir* plus ribavirin in treatment-naïve patients with genotype-1a and 1b HCV, the most common types of HCV globally. The study included patients with liver cirrhosis (9%), who showed similar rates of viral cure as patients without cirrhosis.
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