| Maintenance peginterferon therapy and other factors associated with hepatocellular carcinoma in patients with advanced hepatitis C. | |
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MedLine Citation:
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PMID: 21129375 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND & AIMS: Interferon reportedly decreases the incidence of hepatocellular carcinoma (HCC) in patients with chronic hepatitis C. The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial showed that 4 years of maintenance therapy with pegylated interferon (peginterferon) does not reduce liver disease progression. We investigated whether peginterferon decreases the incidence of HCC in the HALT-C cohort over a longer posttreatment follow-up period. METHODS: The study included 1048 patients with chronic hepatitis C (Ishak fibrosis scores ≥ 3) who did not have a sustained virologic response (SVR) to therapy. They were randomly assigned to groups given a half-dose of peginterferon or no treatment (controls) for 3.5 years and followed up for a median of 6.1 (maximum, 8.7) years. RESULTS: Eighty-eight patients developed HCC (68 definite, 20 presumed): 37 of 515 who were given peginterferon (7.2%) and 51 of 533 controls (9.6%; P = .24). There was a significantly lower incidence of HCC among patients given peginterferon therapy who had cirrhosis, but not fibrosis, based on analysis of baseline biopsy samples. After 7 years, the cumulative incidences of HCC in treated and control patients with cirrhosis were 7.8% and 24.2%, respectively (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.24-0.83); in treated and control patients with fibrosis, incidences were 8.3% and 6.8%, respectively (HR, 1.44; 95% CI, 0.77-2.69). Treated patients with a ≥ 2-point decrease in the histologic activity index, based on a follow-up biopsy, had a lower incidence of HCC than those with unchanged or increased scores (2.9% vs 9.4%; P = .03). CONCLUSIONS: Extended analysis of the HALT-C cohort showed that long-term peginterferon therapy does not reduce the incidence of HCC among patients with advanced hepatitis C who did not achieve SVRs. Patients with cirrhosis who received peginterferon treatment had a lower risk of HCC than controls. |
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Authors:
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Anna S Lok; James E Everhart; Elizabeth C Wright; Adrian M Di Bisceglie; Hae-Young Kim; Richard K Sterling; Gregory T Everson; Karen L Lindsay; William M Lee; Herbert L Bonkovsky; Jules L Dienstag; Marc G Ghany; Chihiro Morishima; Timothy R Morgan; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural Date: 2010-12-01 |
Journal Detail:
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Title: Gastroenterology Volume: 140 ISSN: 1528-0012 ISO Abbreviation: Gastroenterology Publication Date: 2011 Mar |
Date Detail:
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Created Date: 2011-03-07 Completed Date: 2011-05-09 Revised Date: 2013-05-27 |
Medline Journal Info:
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Nlm Unique ID: 0374630 Medline TA: Gastroenterology Country: United States |
Other Details:
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Languages: eng Pagination: 840-9; quiz e12 Citation Subset: AIM; IM |
Copyright Information:
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Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan 48109, USA. aslok@umich.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00006164 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Antiviral Agents / administration & dosage* Biopsy Carcinoma, Hepatocellular / epidemiology, prevention & control*, virology Disease Progression Drug Administration Schedule Female Hepacivirus / genetics Hepatitis C, Chronic / complications, diagnosis, drug therapy*, epidemiology Humans Incidence Interferon-alpha / administration & dosage* Kaplan-Meier Estimate Liver Cirrhosis / diagnosis, drug therapy*, epidemiology, virology Liver Neoplasms / epidemiology, prevention & control*, virology Male Middle Aged Polyethylene Glycols / administration & dosage* Proportional Hazards Models RNA, Viral / blood Recombinant Proteins Risk Assessment Risk Factors Time Factors Treatment Outcome United States / epidemiology Viral Load |
| Grant Support | |
ID/Acronym/Agency:
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1 UL1 RR 025780-01/RR/NCRR NIH HHS; 1 UL1 RR024986/RR/NCRR NIH HHS; 1 UL1 RR025758-01/RR/NCRR NIH HHS; M01RR-00042/RR/NCRR NIH HHS; M01RR-00043/RR/NCRR NIH HHS; M01RR-00051/RR/NCRR NIH HHS; M01RR-00065/RR/NCRR NIH HHS; M01RR-00633/RR/NCRR NIH HHS; M01RR-00827/RR/NCRR NIH HHS; M01RR-01066/RR/NCRR NIH HHS; M01RR-06192/RR/NCRR NIH HHS; N01 DK092323/DK/NIDDK NIH HHS; N01-DK-9-2318/DK/NIDDK NIH HHS; N01-DK-9-2319/DK/NIDDK NIH HHS; N01-DK-9-2320/DK/NIDDK NIH HHS; N01-DK-9-2321/DK/NIDDK NIH HHS; N01-DK-9-2322/DK/NIDDK NIH HHS; N01-DK-9-2323/DK/NIDDK NIH HHS; N01-DK-9-2324/DK/NIDDK NIH HHS; N01-DK-9-2325/DK/NIDDK NIH HHS; N01-DK-9-2326/DK/NIDDK NIH HHS; N01-DK-9-2327/DK/NIDDK NIH HHS; N01-DK-9-2328/DK/NIDDK NIH HHS; RR024982-01/RR/NCRR NIH HHS; UL1 RR024986-02/RR/NCRR NIH HHS; UL1 RR024986-03/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antiviral Agents; 0/Interferon-alpha; 0/Polyethylene Glycols; 0/RNA, Viral; 0/Recombinant Proteins; 0/peginterferon alfa-2a; 76543-88-9/interferon alfa-2a |
| Comments/Corrections | |
Comment In:
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J Hepatol. 2012 Jan;56(1):276-8
[PMID:
21782763
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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