The Role of Peginterferon alpha-2a (40kD) Plus Ribavirin in the Management of Chronic Hepatitis C Mono-Infection

Although the incidence of new hepatitis C virus (HCV) infections may be declining, the prevalence of the diagnosed and treated chronic infection is set to increase over the next 2 decades because of the emergence of hepatic complications of the disease and the increased public awareness of hepatitis C and its transmission, which will prompt diagnosis and treatment of already infected individuals. Increased management costs and demands on support services are inevitable. As well as the costs of medical management of the disease and its complications, there are costs associated with the social, economic, and health-related quality-of-life (HR-QOL) issues for patients. Careful resource planning will be required, as the costs of not treating the disease are substantial. Patients with chronic hepatitis C experience a reduced HR-QOL, which is improved by the achievement of a sustained viral response (SVR; HCV RNA undetectable in serum) to treatment. Because adverse events associated with interferon-based regimens also impair the patient's HR-QOL (during treatment), avoiding unnecessary or prolonged treatment is important. Identification of likely responders to treatment and treating patients for the minimum period of time with the best tolerated and most efficacious drugs could improve compliance and treatment outcomes and contribute to the effective use of available resources. A combination of subcutaneous peginterferon plus oral ribavirin has superseded unmodified interferon-alpha-based therapy for chronic hepatitis C, and is approved for the treatment of treatment-naive patients with chronic hepatitis C and compensated liver disease. Two peginterferons are available, peginterferon alpha-2a (40kD) [Pegasys(R)] and peginterferon alpha-2b (12kD) [PegIntron(R)], and both have shown significantly higher SVR rates than unmodified interferon-alpha when each was administered with ribavirin. There have been no head-to-head comparisons of these two agents in clinical trials. There are data from a study of peginterferon alpha-2a (40kD) plus ribavirin supporting the treatment of patients with chronic hepatitis C and persistently normal ALT activity. Achievement of an SVR with the peginterferon alpha-2a (40kD) combination was associated with an improvement in the HR-QOL of patients regardless of ALT activity. The efficacy and HR-QOL benefits of peginterferon alpha-2a (40kD) plus ribavirin for chronic hepatitis C may outweigh the increased acquisition costs of the drug, and this combination is estimated to be cost effective compared with unmodified interferon-based regimens (or no treatment in patients with chronic hepatitis C and persistently normal ALT activity).