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Peginterferon α-2a (40kD) [Pegasys®] Improves HR-QOL Outcomes Compared with Unmodified Interferon α-2a [Roferon®-A]

In Patients with Chronic Hepatitis C

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Abstract

Background: Use of unmodified interferon α-2a in chronic hepatitis C is associated with impaired health-related quality of life during therapy. Treatment with peginterferon α-2a (40kD) provides an improved sustained response over unmodified interferon α-2a.

Objectives: To compare health-related quality of life during treatment for patients receiving peginterferon α-2a (40kD) [Pegasys®] versus unmodified interferon α-2a [Roferon®].

Design: A randomised, international, multicentre, open-label, parallel group study.

Setting: 36 centres worldwide.

Patients: Interferon-naïve patients (n = 531) with chronic hepatitis C.

Interventions: Peginterferon α-2a (40kD) 180µg once a week (n = 267) for 48 weeks or unmodified interferon α-2a 6 million IU three times a week for 12 weeks followed by 36 weeks of 3 million IU three times a week (n = 264).

Measurements: Fatigue Severity Scale and 36-item Short-Form Health Survey (SF-36).

Results: At weeks 2 and 12, differences favouring peginterferon α-2a (40kD) were seen on seven of eight domains and both summary scores of the SF-36 (p < 0.05 to p < 0.01). At weeks 2, 12 and 24, patients receiving peginterferon α-2a (40kD) had less disabling fatigue (p < 0.01) than those receiving unmodified interferon α-2a.

Conclusion: Treatment with peginterferon α-2a (40kD) is associated with less disabling fatigue and less impairment in patient functioning and well-being during treatment than unmodified interferon α-2a. In addition to safety and efficacy, the impact on health-related quality of life may be an important consideration for physicians when selecting an optimal treatment regimen.

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Acknowledgements

This work was supported by a grant from F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Amy Lin, Neil Wintfeld, and Jesse Green are employees of F. Hoffmann-La Roche. Dr. Eric Yoshida has been an investigator of clinical trials sponsored by Roche-Canada. He has received honoraria for Continuing Medical Education lectures sponsored by Roche-Canada. He has received honoraria for an article on hepatitis C that appeared on a Roche-sponsored website. He has attended Medical Advisory Committee Meetings at Roche-Canada. All other authors have not disclosed any affiliations and/or financial interests with the pharmaceutical industry.

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Authors and Affiliations

  1. Innere Medizin II, Klinikum der Albert-Ludwigs-Universität, Hugstetter Str. 55, Freiburg, 79106, Germany

    Jens Rasenack

  2. Klinikum der J.W. Goethe-Universität, Frankfurt, Germany

    Stefan Zeuzem

  3. Mount Sinai Hospital, Toronto, Ontario, Canada

    S. Victor Feinman

  4. University Health Network - Toronto Western Hospital, Toronto, Ontario, Canada

    E. Jenny Heathcote

  5. Kliniken Der Medizinischen Hochschule, Hannover, Germany

    Michael Manns

  6. University of British Columbia, Vancouver, British Columbia, Canada

    Eric M. Yoshida

  7. University of Calgary, Calgary, Alberta, Canada

    Mark G. Swain

  8. Middlemore Hospital, Auckland, New Zealand

    Edward Gane

  9. Hospital General De Valencia, Valencia, Spain

    Moises Diago

  10. MEDTAP International Inc., Bethesda, Maryland, USA

    Dennis A. Revicki

  11. F. Hoffmann-La Roche Inc., Nutley, New Jersey, USA

    Amy Lin, Neil Wintfeld & Jesse Green

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  1. Jens Rasenack
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  2. Stefan Zeuzem
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Correspondence to Jens Rasenack.

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Rasenack, J., Zeuzem, S., Feinman, S.V. et al. Peginterferon α-2a (40kD) [Pegasys®] Improves HR-QOL Outcomes Compared with Unmodified Interferon α-2a [Roferon®-A]. Pharmacoeconomics 21, 341–349 (2003). https://doi.org/10.2165/00019053-200321050-00005

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