On November 7th Boehringer Ingelheim announced results from a pre-specified interim evaluation of a Phase IIb investigation (SOUND-C2). The data demonstrated that the combination of the protease inhibitor BI 201335 and the polymerase inhibitor BI 207127, two oral direct acting hepatitis C virus (HCV) compounds, with and without ribavirin (RBV), resulted in successful virological response rates in previously untreated (treatment-naive) patients with the most difficult to treat genotype-1 (GT1) HCV at week 12.
SVR12 was achieved in 59% of participants in the investigation’s shortest treatment period (16weeks). Treatment with interferon was not included in any of the five study groups. On Nov. 7th the results were presented at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA.
Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany and Chief researcher of the investigation, explained:
“Results from the interim analysis of SOUND-C2 look promising. They highlight the potential of BI 201335 plus BI 207127 to lessen the burden of existing treatments for a large portion of patients by offering a potential treatment option without the inclusion of interferon.”
For numerous patients interferon in hepatitis C treatment is challenging because of suboptimal response rates, severe adverse effects or contraindications and durations of treatment.
Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim, said:
“We very much look forward to the final results from the SOUND-C2 study. The development of an oral interferon-free direct-acting antiviral regimen underlines Boehringer Ingelheim’s goal of eliminating interferon from HCV treatment and a commitment to deliver innovative novel treatments in virology. At AASLD we will also present further data from anti-HCV portfolio that demonstrates our dedication to meet the real-world challenges of HCV patients globally, including patient populations with traditionally difficult to treat virus types.”
The researchers found that at week 12 all five treatment groups of the interferon-free oral combination treatment of BI 201335/BI 207127/RBVh showed high virologic response rates, defined by measuring the level of HCV RNA in patient blood:
- At week 12, viral response was achieved by 57% of participants who received BI 201335 QD together with BI 207127 TID without RBV.
- SVR12, which is believed to be highly predictive of SVR and cure of the infection, was achieved in 59% of participants after 16 weeks of treatment.
- 70-76% of participants who received BI 201335 once daily (QD) together with BI 207127 three times daily (TID) or twice daily (BID) with RBV achieved undetectable HCV RNA at week 12, with 13-21% of participants developing a viral load breakthrough during treatment.
The tolerability and safety profile was similar to other direct acting antiviral regimens.
About Hepatitis C Virus
Hepatitis C Virus is an infectious disease that primarily affects the liver. It is the leading cause of liver transplant and chronic liver disease. It has been estimated that approximately 175 million individuals across the world are chronically infected with the virus, with 3-4 million new individuals infected each year. Roughly 20-45% of individuals clear HCV in the acute phase, however, 20% of those who remain chronically infected will develop liver disease (cirrhosis) within an average of two decades. After the cirrhosis has the developed the mortality rate is 2-5% each year. At present In the Western world cirrhosis caused by HCV represents the major cause for liver transplantation.
Written by Grace Rattue