Document Detail

Reduced dose and duration of peginterferon alfa-2b and weight-based ribavirin in patients with genotype 2 and 3 chronic hepatitis C.
MedLine Citation:
PMID:  21237227     Owner:  NLM     Status:  MEDLINE    
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.
Michael Manns; Stefan Zeuzem; Ajit Sood; Yoav Lurie; Markus Cornberg; Hartwig Klinker; Peter Buggisch; Martin Rössle; Holger Hinrichsen; Ismail Merican; Yaron Ilan; Stefan Mauss; Saif Abu-Mouch; Andryes Horban; Thomas H Müller; Christoph Welsch; Rongdean Chen; Rab Faruqi; Lisa D Pedicone; Heiner Wedemeyer
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2011-01-13
Journal Detail:
Title:  Journal of hepatology     Volume:  55     ISSN:  1600-0641     ISO Abbreviation:  J. Hepatol.     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-08-19     Completed Date:  2012-01-23     Revised Date:  2012-08-24    
Medline Journal Info:
Nlm Unique ID:  8503886     Medline TA:  J Hepatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  554-63     Citation Subset:  IM    
Copyright Information:
Copyright © 2011. Published by Elsevier B.V.
Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
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MeSH Terms
Body Weight
Drug Therapy, Combination
Hepacivirus / genetics*
Hepatitis C, Chronic / drug therapy*,  ethnology,  virology*
Intention to Treat Analysis
Interferon-alpha / administration & dosage*,  adverse effects,  therapeutic use
Middle Aged
Polyethylene Glycols / administration & dosage*,  adverse effects,  therapeutic use
RNA, Viral / blood
Recombinant Proteins / administration & dosage,  adverse effects,  therapeutic use
Ribavirin / administration & dosage*,  adverse effects,  therapeutic use
Time Factors
Reg. No./Substance:
0/Interferon-alpha; 0/Polyethylene Glycols; 0/RNA, Viral; 0/Recombinant Proteins; 0/peginterferon alfa-2b; 36791-04-5/Ribavirin
Comment In:
J Hepatol. 2011 Sep;55(3):505-6   [PMID:  21601599 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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