Over the next 10-20 years chronic hepatitis C is predicted to become a major burden on the health care system as patients who are currently asymptomatic with relatively mild disease progress to end-stage liver disease and develop hepatocellular carcinoma. Predictions in the USA indicate that there will be a 60% increase in the incidence of cirrhosis, a 68% increase in hepatoma incidence, a 279% increment in incidence of hepatic decompensation, a 528% increase in the need for transplantation, and a 223% increase in liver death rate.

Current treatment of chronic Hepatitis C infection with interferon alpha leads to sustained viral clearance in only 15% of patients. Newer therapeutic regimes such as the "combo" of interferon alpha and ribavirin can lead to up to 30% of patients having a sustained virologic response to therapy. However, even with current combination regimes, at least 70% of patients have no therapeutic benefit. Treatment with interferon alpha and ribavirin leads to significant toxicities. Therefore, there still remains a great need for improved therapeutic modalities.

Progressive hepatic fibrosis and cirrhosis develop in 20% to 30% of patients with chronic hepatitis C (HCV). For those patients who fail to respond to antiviral therapy, there are currently no approved therapeutic options designed to delay or reverse the progression of fibrosis. There is NO vaccine and NO completely effective treatment!