An estimated 160 million people are chronically infected with Hepatitis C virus (HCV) worldwide . Approximately 9 million have HCV infection in Europe, with greater prevalence in the southern and eastern regions.
While the incidence of new cases is low, few patients exposed to the virus spontaneously clear the infection, so exposure typically results in chronic infection that will continue indefinitely. Many chronically infected patients do not know that they have been infected with HCV, as infection is largely asymptomatic.
Though chronic HCV infection does not always cause serious health consequences, patients are at greater risk for development of cirrhosis, liver failure, and hepatocellular carcinoma (HCC), all of which are associated with high morbidity and mortality.
HCV infection is the most common indication for liver transplantation in Europe, and HCV infection of the transplanted liver is common.
HCV was estimated to have caused more than 86,000 deaths in Europe in 2002, a figure expected to increase as the patient population reaches the age at which long-term consequences of chronic infection typically manifest.
The goal of treatment for HCV is sustained virologic response (SVR), when the virus cannot be detected in the blood six months after the end of treatment. Patients who achieve SVR are at much lower risk for cirrhosis and HCC than those who do not achieve virological cure. However, treatment with pegylated interferon and ribavirin is often unsuccessful, and is associated with adverse events and patient burden during the course of treatment.
Newly developed treatments for HCV infection are expected to dramatically increase the rate of SVR, and determining whether novel treatments are cost effective requires an assessment of the burden of HCV infection, including the economic impact as well as any impairment of quality of life.