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Interferon-α2b Induction Treatment with or Without Ribavirin in Chronic Hepatitis C: A Multicenter, Randomized, Controlled Trial

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Abstract

We aimed to compare the efficacy of interferon-α2b (IFN) induction treatment in combination with ribavirin to IFN induction alone in chronic hepatitis C. In total, 125 patients (66 male, 59 female, mean age: 48 ± 9, range: 21–70) were enrolled and randomized into two arms: In the first, patients received 5 MU/day of IFN for 4 weeks followed by 3 MU/day for the next 4 weeks. Treatment was continued with 3 MU three times a week IFN for an additional 40 weeks. Ribavirin was administered 1000–1200 mg/day according to the body weight for the entire 48-week period. In the second arm, patients received placebo in addition to IFN. Fifty-nine patients were placed in the ribavirin arm and 66 in placebo arm. All patients were genotype 1. At week 48, 24/66 (36%) from the placebo and 31/59 (52%) from the ribavirin group responded (P < 0.05). However, during the 24-week untreated follow-up period, 13/24 (54%) from the placebo, and 8/31 (26%) from the ribavirin group relapsed (P = 0.002.), resulting in a sustained virologic response (SVR) rate of 17% in the placebo and 39% in the ribavirin group (P = 0.005.) In conclusion, IFN induction treatment in combination with ribavirin is superior to IFN induction treatment alone in genotype 1 patients, and the SVR rate of 39% is encouraging.

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Authors and Affiliations

  1. Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Istanbul, Turkey

    Hakan Senturk & Fehmi Tabak

  2. Department of Gastroenterology, Medical Faculty, Ege University, Izmir, Turkey

    Galip Ersoz

  3. Department of Infectious Diseases, Cerrahpasa Medical Faculty, and Medical Department of Gastroenterology, Medical Faculty, Instanbul University, Istanbul, Turkey

    Resat Ozaras & Ali Mert

  4. Hepatology Institute, Ankara University, Ankara, Turkey

    Hakan Bozkaya & Mithat Bozdayi

  5. Ankara, Yuksek Ihtisas Hospital, Ankara, Turkey

    Meral Akdogan

  6. Department of Gastroenterology, Okmeydani Hospital, and Department of Pathology, Cerrahpasa Medical Faculty, Istanbul University, Istanbul, Turkey

    Necati Yenice & Gulsen Ozbay

Authors
  1. Hakan Senturk
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  2. Galip Ersoz
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  3. Resat Ozaras
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  4. Sabahattin Kaymakoglu
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  5. Hakan Bozkaya
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  6. Meral Akdogan
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  7. Ali Mert
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  8. Mithat Bozdayi
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  9. Fehmi Tabak
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  10. Necati Yenice
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  11. Gulsen Ozbay
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Senturk, H., Ersoz, G., Ozaras, R. et al. Interferon-α2b Induction Treatment with or Without Ribavirin in Chronic Hepatitis C: A Multicenter, Randomized, Controlled Trial. Dig Dis Sci 48, 1124–1129 (2003). https://doi.org/10.1023/A:1023725014751

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