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

  • Drugs in Disease Management
  • Published:
Disease Management & Health Outcomes

Abstract

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A combination of subcutaneous peginterferon plus oral ribavirin has superseded unmodified interferon-α-based therapy for chronic hepatitis C, and is approved for the treatment of treatment-naive patients with chronic hepatitis C and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 α-2a (40kD) [Pegasys®] and peginterferon α-2b (12kD) [PegIntron®], and both have shown significantly higher SVR rates than unmodified interferon-α 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 α-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 α-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 α-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).

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Notes

  1. The use of trade names is for identification purposes only and does not imply endorsement.

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Authors and Affiliations

  1. Wolters Kluwer Health I Adis, Auckland, New Zealand

    Dene Simpson & Monique P. Curran

  2. editorial office of Wolters Kluwer Health, Conshohocken, Pennsylvania, USA

    Dene Simpson & Monique P. Curran

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  1. Dene Simpson
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Correspondence to Dene Simpson.

Additional information

Various sections of the manuscript reviewed by: A. Cargnel, Department of Infectious Diseases, Ospedale ‘Luigi Sacco’, Azienda Ospedaliera — Polo Universitario, Milan, Italy; P. Ferenci, Universiteit Klinik für Innere Medizin IV, AKH, Vienna, Austria; S.K. Herrine, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA; S. Kamal, Liver Disease Center, Harvard Institute of Medicine, Boston, Massachusetts, USA; B.A. Luxon, Department of Internal Medicine, St Louis University Health Sciences Center, St Louis University, St Louis, Missouri, USA; H.J. Worman, Department of Medicine, College of Physicians & Surgeons, Columbia University, New York, New York, USA.

Data Selection

Sources: Medical literature published in any language since 1980 on peginterferon alfa-2a/ribavirin, identified using MEDLINE, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: MEDLINE search terms were ‘hepatitis C’ and (‘guidelines’ or ‘decision-making’ or ‘health-policy’ or ‘managed-care-programmes’ or ‘epidemiology’ or ‘outcome-assessment-health-care’ or ‘clinical-protocols’ or ‘guideline in pt’ or ‘polic* in ti’ or ‘expert panel’ or ‘utilization review’ or ‘algorithms’ or ‘disease management’ or ‘quality of life’) or (‘peginterferon alfa-2a’ or ‘pegylated interferon alfa-2a’ or ‘peg-ifn alfa-2a’) and ‘ribavirin’ and ‘review in pt’. AdisBase search terms were ‘hepatitis-C’ and (‘guideline’ or ‘guideline-utilisation’ or ‘practice-guideline’ or ‘disease-management-programmes’ or ‘treatment-algorithms’ or ‘reviews-on-treatment’ or ‘drug-evaluations’ or ‘epidemiology’ or ‘cost-of-illness’ or ‘pathogenesis’) or (‘peginterferon-alfa-2a’ or ‘pegylated-interferon-alfa-2a’ or ‘peg-ifn alfa-2a’) and ‘ribavirin’ and (‘review’ or ‘clinical-study’). The searches were last updated on October 2, 2006.

Selection: Studies in patients with chronic hepatitis C who received peginterferon-α-2a. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic, pharmacokinetic, pharmacoeconomic, and epidemiological data were also included.

Index terms: Hepatitis C virus, chronic hepatitis C, peginterferon-α-2a, ribavirin, disease management, review on treatment.

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Simpson, D., Curran, M.P. The Role of Peginterferon α-2a (40kD) Plus Ribavirin in the Management of Chronic Hepatitis C Mono-Infection. Dis-Manage-Health-Outcomes 14, 303–320 (2006). https://doi.org/10.2165/00115677-200614050-00005

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