The Phase III study programme includes treatment naïve patients, including those ineligible for interferon and patients with liver cirrhosis.
The milestone coincides with the New England Journal of Medicine publication of SOUND-C2: one of the largest interferon-free studies in genoytpe-1 HCV published to date, forming the basis of the HCVerso™ trials
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.4
