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- Title
Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C.
- Authors
Rasenack, Jens; Zeuzem, Stefan; Feinman, S Victor; Heathcote, E Jenny; Manns, Michael; Yoshida, Eric M; Swain, Mark G; Gane, Edward; Diago, Moises; Revicki, Dennis A; Lin, Amy; Wintfeld, Neil; Green, Jesse
- Abstract
<bold>Background: </bold>Use of unmodified interferon alpha-2a in chronic hepatitis C is associated with impaired health-related quality of life during therapy. Treatment with peginterferon alpha-2a (40kD) provides an improved sustained response over unmodified interferon alpha-2a.<bold>Objectives: </bold>To compare health-related quality of life during treatment for patients receiving peginterferon alpha-2a (40kD) [Pegasys] versus unmodified interferon alpha-2a [Roferon].<bold>Design: </bold>A randomised, international, multicentre, open-label, parallel group study.<bold>Setting: </bold>36 centres worldwide.<bold>Patients: </bold>Interferon-naïve patients (n = 531) with chronic hepatitis C.<bold>Interventions: </bold>Peginterferon alpha-2a (40kD) 180 mirog once a week (n = 267) for 48 weeks or unmodified interferon alpha-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).<bold>Measurements: </bold>Fatigue Severity Scale and 36-item Short-Form Health Survey (SF-36).<bold>Results: </bold>At weeks 2 and 12, differences favouring peginterferon alpha-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 alpha-2a (40kD) had less disabling fatigue (p < 0.01) than those receiving unmodified interferon alpha-2a.<bold>Conclusion: </bold>Treatment with peginterferon alpha-2a (40kD) is associated with less disabling fatigue and less impairment in patient functioning and well-being during treatment than unmodified interferon alpha-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.
- Subjects
THERAPEUTIC use of proteins; ANTIVIRAL agents; CLINICAL trials; COMPARATIVE studies; HEALTH status indicators; HEALTH surveys; RESEARCH methodology; MEDICAL cooperation; POLYETHYLENE glycol; QUALITY of life; QUESTIONNAIRES; RECOMBINANT proteins; RESEARCH; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; CHRONIC hepatitis C; PSYCHOLOGY
- Publication
PharmacoEconomics, 2003, Vol 21, Issue 5, p341
- ISSN
1170-7690
- Publication type
journal article
- DOI
10.2165/00019053-200321050-00005