23/04/2012 According to new data from the largest Phase II interferon-free trial to date, after only 28 weeks of treatment, almost 82% of hepatitis C patients achieved a viral cure. The results were achieved in patients with two frequent types of hepatitis C, i.e. HCV genotypes-1a CC and -1b, and will be presented at The International Liver CongressTM at the 47th Annual Meeting of the European Association of the Study of the Liver (EASL), in Barcelona on Saturday 21st April.
Hepatitis C is a viral disease caused by the hepatitis C virus (HCV). It mainly affects the liver and is a leading cause of chronic liver disease and liver transplants. Worldwide, around 170 million people suffer from chronic HCV infections, with 3 to 4 million new infections being diagnosed every year. Overall, only around 20 to 45% patients manage to achieve a viral cure during the acute phase of the disease, whilst 20% of the remaining chronically infected patients will develop liver cirrhosis within an average of 20 years, and the mortality rate of HCV patients with liver cirrhosis is 2 to 5% per year.
At present, liver damage caused by HCV is the leading cause of chronic liver disease, leading to liver failure and end-stage liver disease, which is the major reason for liver transplants in the Western world. Therefore, an early viral cure for HCV is vital in order to minimize long-term liver damage.
The phase II trial involved 362 patients, including those patients with advanced liver disease. All participants were administered with the interferon-free combination of two investigational compounds, the once-a-day protease inhibitor BI 201335 and the polymerase inhibitor BI 207127. Both drugs were administered with and without ribavirin and with different lengths of treatments.
The outcome demonstrated that 68% of all participants, including those with the most difficult to treat HCV type genotype-1a non-CC, achieved a viral cure after 28 weeks of treatment. Most significantly, 82% of patients with the most common HCV types in Europe and Asia, i.e. genotypes-1a CC and -1b also achieved a viral cure after 28 weeks of therapy.
The unique findings in patients with the most common HCV types suggest that interferon could potentially be eliminated in future, however, at present interferon still has to be administered with all treatment options.
HCV has a minimum of six distinct genotypes, i.e. different sequences of the virus, which are identified by a number. Patients with HCV genotype-1 (GT1) are known to be the most difficult to cure. Genotypes have more than 50 subtypes, which are identified by a lowercase letter. An individual's own genetic make-up, represented by uppercase letters like CC, non-CC or CT, is another determining factor in whether treatment will be successful.
Leading researcher Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany declared:
"Eliminating interferon from HCV treatment is an urgent need. Releasing patients from the side effects and the lengthy treatment commitment seen with interferon would be a huge advance. Such treatments would minimize the impact on patients' lives, and may encourage them to start and stay on treatment, to achieve the ultimate goal of a virologic cure."
Interferon can have severe side effects, including heart failure, sepsis, leucopenia, which is a decrease of white blood cells and loss of vision.
The results demonstrated that Boehringer Ingelheim's interferon-free combination therapy was generally well tolerated amongst all five participant groups in the SOUND-C2 trial.
Plans of the Phase III clinical trial program are currently underway to further investigate interferon-free combination therapies BI 201335 and BI 207127 efficacy and safety in genotype-1 patients.
Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim declared:
"We very much look forward to the final results from this study, that we hope will be a significant step towards an interferon-free future for patients with HCV. Our commitment to the millions of people around the world who are chronically infected with HCV is to deliver simpler and better tolerated solutions to treatment, including for those with traditionally difficult to cure virus types." |