Today, Boehringer Ingelheim announced that the first patients have been enrolled in the company's pivotal Phase III interferon (IFN)-free hepatitis C (HCV) clinical trial programme, HCVerso™. Boehringer Ingelheim's IFN-free investigational polymodal regimen combines faldaprevir (BI 201335), a next wave once-daily protease inhibitor, and BI 207127, a non-nucleoside polymerase inhibitor, plus ribavirin.
The HCVerso™ clinical trial programme includes two Phase III IFN-free clinical trials that will treat approximately 1,000 treatment-naïve HCV genotype-1b (GT-1b) patients. The decision to focus the Phase III trials on this patient group follows positive Phase IIb trial data from the SOUND-C studies, where Boehringer Ingelheim's IFN-free investigational polymodal regimen showed high viral cure rates in patients with GT-1b HCV, the most prevalent type of HCV globally.
New preliminary results from the SOUND-C3 trial show that 100 percent (n=20) of patients with HCV GT-1b achieved sustained virologic response four weeks (SVR4) after completing a 16 week course of treatment. Two patients experienced serious adverse events and two patients discontinued treatment early due to adverse events in SOUND-C3. Four patients in this study had compensated liver cirrhosis (damaged or scarred liver tissue). These data further support the trial design for Boehringer Ingelheim's pivotal HCVerso™ study. Full results from SOUND-C3 are expected in 2013.
"We are proud to announce that the first patients have now been enrolled in our Phase III interferon-free clinical trial programme, HCVerso™," said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. "HCV patients will benefit most from an individualised treatment approach since host genetics, viral genotype and stage of liver disease vary from patient to patient. Our interferon-free investigational polymodal regimen has shown particular promise in treating patients with genotype-1b HCV so we have decided to focus our Phase III trial programme on this population. Our goal is an interferon-free future in the treatment of HCV and ensuring all patients individually receive the most effective treatment for them."
Results from the SOUND-C2 study, which were presented in November 2012 at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), found that up to 85 percent of GT-1b HCV patients treated with different IFN-free regimens of faldaprevir, BI 207127 and ribavirin achieved viral cure at 12 and 24 weeks following treatment completion (SVR12 and SVR24).
Eliminating injectable interferon from treatment regimens is a critical goal in HCV as it can be challenging for patients, due to the long treatment duration and often severe side-effects. Up to 50 percent of patients may not be eligible for treatment with interferon and of those eligible, less than 80 percent of patients with the most common type of chronic HCV, genotype-1, achieve a viral cure with current interferon based triple therapies. The severe side-effects of interferon, including heart failure, sepsis, leukopenia, depression and vision loss, contribute to low medication adherence, ultimately leaving many patients in need uncured. Since 1999, there has been a significant increase in deaths due to chronic HCV, accounting for 15,000 deaths in the United States in 2007 alone.
"More effective and tolerable alternatives to interferon would help patients with their decision to start and to stay on treatment, which is imperative to achieve the ultimate goal of a virologic cure," said lead study investigator Christoph Sarrazin, M.D., Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany. "I'm pleased the trial design includes a diverse population of genotype-1b patients, particularly those with liver cirrhosis, reflecting the types of patients we see every day in clinical practice."