Roche, InterMune, Inc and Pharmasset announced the first results from their innovative, interferon-free regimen for the treatment of patients chronically infected with the hepatitis C virus (HCV). The study combined two oral, direct acting antivirals (DAAs), R7227 (also known as ITMN-191) and R7128, for the first time in patients. Results showed that the combination was safe and well tolerated over the 14 days of dosing, and that reductions in levels of HCV were significant - dropping below the detectable limit in a large number of patients.

Results of the Inform-1 study were presented during the late-breaker session today at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen.

The trial, conducted in centres in New Zealand and Australia, is the first to investigate the combination of two oral antiviral medicines in the absence of weekly injections of interferon, or ribavirin. The results demonstrate for the first time that an oral protease inhibitor and an oral nucleoside polymerase inhibitor can be safely and effectively combined, and thus have the potential to be developed into a new treatment regimen for hepatitis C patients. Roche is developing R7227, a protease inhibitor, with InterMune, and R7128, a nucleoside polymerase inhibitor, with Pharmasset.

Further studies will test the activity and safety of the combination of R7227 and R7128 with and without interferon and/or ribavirin. The current standard of care for HCV is a combination of pegylated interferon plus ribavirin, which delivers overall cure rates of 50 to 60 per cent.

"These are exciting times in our fight against hepatitis C, and the investigation of the innovative oral treatment regimen in INFORM-1, if validated in further study, may radically change future treatment strategies in our patients with chronic HCV infection," said Edward Gane, associate professor, University of Auckland and Director, Auckland Clinical Studies Limited. "The initial results from this study of the R7227/R7128 combination raise hopes that we can deliver an interferon-based treatment regimen that is more potent and shorter in duration than options currently available or in development - as well as the possibility of an interferon-free treatment regimen."

R7227 is a potent, macrocyclic inhibitor of HCV NS3/4A protease activity, and has produced multi-log10 reductions in levels of HCV levels in chronic HCV patients, when administered for 14 days as monotherapy and when combined with Pegasys and Copegus. R7128, a cytidine nucleoside analog inhibitor of HCV RNA polymerase, is being developed for the treatment of chronic HCV infection.

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections.