Boehringer Ingelheim completes patient enrolment of two pivotal Phase III interferon-free hepatitis C clinical trials

Published on August 15, 2013 at 6:10 AM · No Comments

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

“We are proud to announce the completion of patient recruitment in two of our pivotal HCVerso™ trials. This is an important step towards our goal of delivering an effective and well tolerated cure that will enable patients and doctors to consider an individualised approach for interferon-free HCV therapy,” said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. “The publication of the SOUND-C2 study in the NEJM as well as the speedy recruitment into our pivotal trials provide an indication of the high relevance of interferon-free regimens for the future treatment of HCV. We look forward to the first Phase III results of faldaprevir*, deleobuvir* plus ribavirin in 2014 and the opportunity to explore wider patient populations in the future.” 

Results from the Phase IIb SOUND-C3 study were also recently presented at the APASL Liver Meeting in Singapore. This follow-up study to SOUND-C2 aimed to further optimise the dosing regimen containing faldaprevir* and deleobuvir* plus ribavirin in treatment-naïve patients (including patients with cirrhosis and those who could not tolerate interferon). SVR rates of 95% were observed in GT-1b infected patients after 16 weeks of treatment.5 The regimen tested in the SOUND-C3 study is now under Phase III evaluation in the HCVerso™ 1 and 2 trials.

Overall tolerability in the SOUND-C trials was good. In the dose-finding study SOUND-C2, 44 of the 362 patients included in the analysis discontinued due to adverse events. 3 In SOUND-C3, mild rash and nausea were the most common side-effects. Adverse events of a moderate or higher intensity were rare, with anemia (16%), fatigue (9%), vomiting (9%) and nausea (9%) being the most frequent adverse events.5

The decision to focus on GT-1b in HCVerso™1 and 2 was based on the higher efficacy seen in this population compared to GT-1a infected patients in the SOUND-C studies (SVR12 in GT-1a patients in SOUND-C2 and SOUND-C3: 58/148 and 2/11 of patients, respectively).3

As part of Boehringer Ingelheim’s long-term commitment to hepatitis C, the company is also evaluating other combinations of investigational hepatitis C compounds that work in different ways. Boehringer Ingelheim’s recent collaboration with Presidio Pharmaceuticals, Inc. for a Phase II clinical study investigating an interferon-free, all-oral combination in GT-1a is part of the company’s continued exploration to discover and develop innovative options for the treatment of HCV.

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