Affiliations 

  • 1 Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. Electronic address: manns.michael@mh-hannover.de
  • 2 Department of Medicine I, J.W. Goethe University Hospital, Frankfurt, Germany
  • 3 Dayanand Medical College and Hospital, Ludhiana, Punjab, India
  • 4 Gastroenterology and Hepatology, Sourasky Medical Center, Tel Aviv, Israel
  • 5 Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany
  • 6 Division of Infectious Diseases, Department of Internal Medicine II, University of Wurzburg Medical Center, Wurzburg, Germany
  • 7 Liver Center Hamburg, IFI-Institute, Hamburg, Germany
  • 8 Center for Ambulatory Gastroenterology and Endocrinology, Freiburg, Germany
  • 9 Practice for Gastroenterology and Hepatology, Kiel, Germany
  • 10 Selayang Hospital, Selangor, Malaysia
  • 11 Department of Medicine, Hebrew University-Hadassah Medical Center, Jerusalem, Israel
  • 12 Center for HIV and Hepatogastroenterology, Dusseldorf, Germany
  • 13 Hillel-yaffe Medical Center, Hadera, Israel
  • 14 Warsaw Medical University & Hospital of Infectious Diseases, Warsaw, Poland
  • 15 Institute for Medical Informatics, Biometry and Epidemiology, University of Munich, Munich, Germany
  • 16 Schering-Plough Corporation, Now Merck & Co., Inc., Whitehouse Station, NJ, USA
J. Hepatol., 2011 Sep;55(3):554-563.
PMID: 21237227 DOI: 10.1016/j.jhep.2010.12.024

Abstract

BACKGROUND & AIMS: There is increasing interest in identifying patients with chronic hepatitis C genotype 2 or 3 infection in whom it is possible to lower the burden of therapy while retaining high levels of efficacy.

METHODS: Treatment-naive patients with chronic hepatitis C genotype 2/3 infection were randomized to receive peginterferon alfa-2b (1.5μg/kg/wk) for 24weeks (group A); peginterferon alfa-2b (1.0μg/kg/wk) for 24weeks (group B); or peginterferon alfa-2b (1.5μg/kg/wk) for 16weeks (group C), each in combination with weight-based ribavirin (800-1200mg/d). The study population comprised two cohorts: the Hep-Net cohort enrolled in Germany and an International cohort enrolled at study sites throughout Europe and Asia. The primary end point was sustained virological response (SVR).

RESULTS: The study included 682 patients; 80.2% had genotype 3 infection. In the intent-to-treat population, SVR rates were 66.5%, 64.3%, and 56.6% in groups A, B, and C, and were similar in Asian and white patients. Treatment differences (A vs. B and A vs. C) failed to reach the predefined margin for noninferiority of -10%; and thus groups B and C failed to show noninferiority relative to group A. Among patients with undetectable HCV RNA at week 4, SVR rates were 75.3%, 75.9%, and 72.4%, respectively. Relapse rates were 17.8%, 16.3%, and 29.3%, respectively. Treatment-emergent serious adverse events were highest in group A and lowest in group C, and adverse events leading to discontinuation were similar across treatment arms.

CONCLUSIONS: For patients with chronic hepatitis C genotype 2/3 infection, 24weeks of peginterferon alfa-2b (1.5μg/kg/wk) plus weight-based ribavirin remains a standard-of-care therapy; however, treatment for 16weeks may be considered for patients with undetectable HCV RNA at week 4 of the treatment.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.