HCV-related advanced fibrosis/cirrhosis: randomized controlled trial of pegylated interferon α-2a and ribavirin

  1. Beat Helbling1,2,
  2. Wolfram Jochum3,
  3. Ivan Stamenic1,
  4. Marina Knöpfli4,
  5. Andreas Cerny4,
  6. J. Borovicka2,
  7. Jean-Jacques Gonvers5,
  8. Martin Wilhelmi1,
  9. Sabine Dinges1,
  10. Beat Müllhaupt1,
  11. Alicia Esteban6,
  12. Beat Meyer-Wyss7,
  13. Eberhard L. Renner1,8,
  14. on behalf of the Swiss Association for the Study of the Liver (SASL)1

Article first published online: 10 JUL 2006

DOI: 10.1111/j.1365-2893.2006.00753.x

Issue

Journal of Viral Hepatitis

Journal of Viral Hepatitis

Volume 13, Issue 11, pages 762–769, November 2006

Additional Information

How to Cite

Helbling, B., Jochum, W., Stamenic, I., Knöpfli, M., Cerny, A., Borovicka, J., Gonvers, J.-J., Wilhelmi, M., Dinges, S., Müllhaupt, B., Esteban, A., Meyer-Wyss, B., Renner, E. L. and on behalf of the Swiss Association for the Study of the Liver (SASL) (2006), HCV-related advanced fibrosis/cirrhosis: randomized controlled trial of pegylated interferon α-2a and ribavirin. Journal of Viral Hepatitis, 13: 762–769. doi: 10.1111/j.1365-2893.2006.00753.x

Author Information

  1. 1

    Division of Gastroenterology and Hepatology, University Hospital, Zurich, Switzerland

  2. 2

    Division of Gastroenterology/Hepatology, Cantonal Hospital, St Gallen, Switzerland

  3. 3

    Department of Pathology, University Hospital, Zurich, Switzerland

  4. 4

    Department of Internal Medicine, Cantonal Hospital, Lugano, Switzerland

  5. 5

    Division of Gastroenterology, University Hospital, Lausanne, Switzerland

  6. 6

    Roche Pharma (Schweiz) AG, Reinach, Switzerland

  7. 7

    Division of Gastroenterology, St Claraspital, Basel, Switzerland

  8. 8

    Section of Hepatology, Department of Internal Medicine, Health Sciences Center, University of Manitoba, Winnipeg, MB, Canada

*Dr Eberhard L. Renner, Department of Internal Medicine/Section of Hepatology, University of Manitoba, John Buhler Research Centre Room 809-715, McDermot Avenue Winnipeg, MB Canada R3A 1R9. E-mail: rennerel@cc.UManitoba.CA

Publication History

  1. Issue published online: 10 JUL 2006
  2. Article first published online: 10 JUL 2006
  3. Received November 2005; accepted for publication February 2006

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Keywords:

  • cirrhosis;
  • controlled clinical trial;
  • hepatitis C;
  • pegylated interferon;
  • ribavirin

Summary.  In patients with hepatitis C virus (HCV)-related advanced fibrosis/cirrhosis, 30% of sustained HCV clearance has been reported with pegylated interferon α-2a (PEG-IFN) alone, but the efficacy and tolerability of the PEG-IFN/ribavirin (RBV) combination remain poorly defined. A total of 124 treatment-naïve patients with biopsy proved HCV-related advanced fibrosis/cirrhosis (Ishak score F4–F6, Child–Pugh score ≤7) were randomized to 48 weeks of PEG-IFN (180 μg sc weekly) and standard dose of RBV (1000/1200 mg po daily, STD) or PEG-IFN (180 μg sc weekly) and low-dose of RBV (600/800 mg po daily, LOW). Sustained virologic response (SVR) rates with PEG-IFN/STD RBV (52%) were higher – albeit not significantly – than that with PEG-IFN/LOW RBV (38%, P = 0.153). In multivariate analysis, genotype 2/3 and a baseline platelet count ≥150 × 109/L were independently associated with SVR. The likelihood of SVR was <7% if viraemia had not declined by ≥2 log or to undetectable levels after 12 weeks. Nine adverse events in the STD RBV and 15 in the LOW RBV group were classified as severe (including two deaths); dose reductions for intolerance were required in 78% and 57% (P = 0.013), and treatment was terminated early in 23% and 27% of patients (P = n.s.). The benefit/risk ratio of treating compensated HCV-cirrhotics with STD PEG-IFN/RBV is favourable.

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