A randomized trial of 24- vs. 48-week courses of PEG interferon α-2b plus ribavirin for genotype-1b-infected chronic hepatitis C patients: a pilot study in Taiwan

Authors

  • Ming-Lung Yu,

    1. Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan,
    2. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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  • Chia-Yen Dai,

    1. Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan,
    2. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
    3. Department of Occupational Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, Taiwan
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  • Zu-Yau Lin,

    1. Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan,
    2. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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  • Li-Po Lee,

    1. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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  • Nei-Jen Hou,

    1. Department of Occupational Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, Taiwan
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  • Ming-Yen Hsieh,

    1. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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  • Shinn-Cherng Chen,

    1. Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan,
    2. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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  • Ming-Yuh Hsieh,

    1. Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan,
    2. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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  • Liang-Yen Wang,

    1. Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan,
    2. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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  • Wen-Yu Chang,

    1. Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan,
    2. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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  • Wan-Long Chuang

    1. Hepatobiliary Division, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan,
    2. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan,
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Wan-Long Chuang, MD, PhD,
Hepatobiliary Division,
Department of Internal Medicine,
Kaohsiung Medical University Hospital,
No. 100,
Tzyou 1st Rd,
Kaohsiung 807,
Taiwan
Tel: +886-7-3208282
Fax: +886-7-3123955
e-mail: fishya@ms14.hinet.net; d780178@kmu.edu.tw

Abstract

Abstract: Background: To assess the efficacy of 24- or 48-week peginterferon/ribavirin treatment of Taiwanese patients with chronic hepatitis C virus genotype-1b (HCV-1b) infection, and to identify subgroups of patients in whom the 48-week treatment has benefits. Methods: We assigned 60 patients receiving peginterferon-α-2b (80–100 mcg/week) plus ribavirin (1000–1200 mg/day), depending on body weight, for 24 or 48 weeks, with a 3:1 randomization ratio. Results: The sustained virological response (SVR) rate was significantly higher in the 48-week (80.0%, 12/15) than in the 24-week group (48.9%, 22/45, P<0.05). The 60 patients were classified into two subgroups according to the presence of unfavorable baseline predictors: viral loads ≥400 000 IU/ml or a hepatic fibrosis score of 3–4. In 19 patients without an unfavorable predictor, the SVR rate was comparable in the 24-week (78.6%) and 48-week (75.0%) groups; in patients with either unfavorable predictors, the SVR rate was significantly higher in the 48-week (81.1%, 9/11) than in the 24-week group (36.7%, 11/30, P=0.015). The discontinuation rate was significantly higher in the 48-week (20.0%, 3/15) than in the 24-week group (2.2%, 1/45, P<0.05). Conclusion: A 48-week course of peginterferon-α-2b/ribavirin was more effective than a 24-week course in Taiwanese HCV-1b patients, mainly in those with high viral loads and/or advanced hepatic fibrosis.

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