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Digestive Diseases and Sciences

, Volume 41, Supplement 12, pp 103S–108S | Cite as

Dose increase augments response rate to interferon-α in chronic hepatitis C

  • Peter Ferenci
  • Rudolf Stauber
  • Albert Propst
  • Richard Fiedler
  • Christian Müller
  • Michael Gschwantler
  • Kurt Schütze
  • Christian Datz
  • Gerd Judmaier
  • Wolfgang Vogel
  • Günther J. Krejs
  • Alfred Gangl
Article

Abstract

Approximately 50% of patients with chronic hepatitis C respond to treatment with interferon-α. The aim of this randomized controlled trial was to evaluate whether an increase in dose of interferon-α augments response rate. One hundred thirty-eight patients with newly diagnosed chronic hepatitis C received a three-month course of 3 MU IFN-α2b administered every two days. All patients were anti-HCV and HCV-RNA (PCR) positive. Prior to treatment, a liver biopsy was performed. Complete response was defined by normal serum ALT concentrations and disappearance of HCV-RNA. After three months, 60 nonresponders were randomized (stratified according to histology) either to continue 3 MU interferon-α2b every two days for another six months (group A, total dose: 410 MU) or to receive increasing doses of interferon-α2b (6 MU every two days for three months, followed by 10 MU every two days for three months) (group B, total dose: 870 MU). Serum ALT concentrations were measured monthly and HCV-RNA at three-month intervals. Liver biopsy was repeated six months after end of treatment. Pretreatment characteristics of the randomized patients were: group A:N=30; male/female: 20/10; age: 54±10 years; CPH 9, CAH 8, cirrhosis 13; mean ALT 108±98 units/liter; group B:N=30; male/female: 21/9; age: 57±15 years; CPH 10, CAH 9, cirrhosis 11; mean ALT 90±40 units/liter. At the end of treatment six patients in group B but none in group A became responders [P=0.011 (Fisher's exact test), intent-to-treat analysis]. All six responders were noncirrhotics. High-dose interferon was not tolerated by six patients in group B. Noncompliance resulted in five dropouts in group A and one in group B. During the six-month follow-up, four of the six responders relapsed. A patient in group A with increased serum ALT concentration but negative HCV-RNA at the end of treatment became a full responder after six months. Of nonresponders to 3 MU interferon α2b every two days for three months, 20% responded to higher interferon doses, but none to continued standard dose. Prolonged treatment with interferon may be necessary to obtain a sustained response. However, treatment with higher-dose interferon was not tolerated in 20% of the patients.

Key words

interferon-α2b chronic hepatitis C dose-response response rate 

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Copyright information

© Plenum Publishing Corporation 1996

Authors and Affiliations

  • Peter Ferenci
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Rudolf Stauber
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Albert Propst
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Richard Fiedler
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Christian Müller
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Michael Gschwantler
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Kurt Schütze
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Christian Datz
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Gerd Judmaier
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Wolfgang Vogel
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Günther J. Krejs
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  • Alfred Gangl
    • 1
    • 2
    • 3
    • 4
    • 5
    • 6
  1. 1.From the Department of Internal Medicine IV, Gastroenterology and HepatologyUniversity of ViennaViennaAustria
  2. 2.Department of Internal MedicineUniversity of GrazGrazAustria
  3. 3.Department of Internal MedicineUniversity of InnsbruckInnsbruckAustria
  4. 4.Department of Internal Medicine IVRudolfsspitalViennaAustria
  5. 5.Department of Internal Medicine IHanuschspitalViennaAustria
  6. 6.Department of Internal MedicineHospital SalzburgSalzburgAustria

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