| Reduced dose and duration of peginterferon alfa-2b and weight-based ribavirin in patients with genotype 2 and 3 chronic hepatitis C. | |
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MedLine Citation:
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PMID: 21237227 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2011-01-13 |
Journal Detail:
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Title: Journal of hepatology Volume: 55 ISSN: 1600-0641 ISO Abbreviation: J. Hepatol. Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-08-19 Completed Date: 2012-01-23 Revised Date: 2012-08-24 |
Medline Journal Info:
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Nlm Unique ID: 8503886 Medline TA: J Hepatol Country: England |
Other Details:
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Languages: eng Pagination: 554-63 Citation Subset: IM |
Copyright Information:
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Copyright © 2011. Published by Elsevier B.V. |
Affiliation:
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Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. manns.michael@mh-hannover.de |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00302081 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Body Weight Drug Therapy, Combination Female Genotype Hepacivirus / genetics* Hepatitis C, Chronic / drug therapy*, ethnology, virology* Humans Intention to Treat Analysis Interferon-alpha / administration & dosage*, adverse effects, therapeutic use Male Middle Aged Polyethylene Glycols / administration & dosage*, adverse effects, therapeutic use RNA, Viral / blood Recombinant Proteins / administration & dosage, adverse effects, therapeutic use Recurrence Ribavirin / administration & dosage*, adverse effects, therapeutic use Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Interferon-alpha; 0/Polyethylene Glycols; 0/RNA, Viral; 0/Recombinant Proteins; 0/peginterferon alfa-2b; 36791-04-5/Ribavirin |
| Comments/Corrections | |
Comment In:
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J Hepatol. 2011 Sep;55(3):505-6
[PMID:
21601599
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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