| Comparison of high initial and fixed-dose regimens of interferon-alpha2a in chronic hepatitis C: a randomized controlled trial. French Multicenter Interferon Study Group. | |
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MedLine Citation:
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PMID: 9493517 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The efficacy of a high-dose de-escalating treatment regimen versus the standard, fixed-treatment regimen of interferon-alpha2a (IFN; Roferon-A) in chronic hepatitis C was evaluated in 291 patients who had elevated alanine aminotransferase (ALT) levels, for at least 6 months prior to the study, and histologically proven chronic hepatitis. Patients were randomized into two groups: 142 patients received IFN at a fixed dose (3 million international units (MIU) three times a week for 6 months) and 149 patients received 6 MIU three times a week for 3 months followed by 3 MIU three times a week for the next 3 months. The groups did not differ significantly with respect to age, gender or percentage of patients with cirrhosis. Response was evaluated by monitoring ALT levels monthly during treatment and during the 6 months post-treatment follow-up. Sixty-one per cent and 66% of the patients in the fixed and de-escalating treatment groups had a primary response (serum ALT normalization) during the treatment period; sustained-response rates at the end of follow-up were 20% and 29%, respectively (not significant). In non-cirrhotic patients, a primary response was recorded in 65% and 70% of the patients in the fixed and de-escalating groups; sustained-response rates were 22% and 33%, respectively. Overall, 62% of patients with a sustained response showed histological improvement. In univariate analysis, patients with sustained response tended to be non-cirrhotic and had lower initial serum gamma-glutamyl transpeptidase and ferritin levels. Multivariate analysis indicated that only ALT activity assessed at month 1 (P < 0.01) was a significant predictor of sustained response. These findings suggest that although the difference in the response rates between the de-escalating (6 MIU three times a week for 3 months; 3 MIU three times a week for 3 months) and fixed (3 MIU three times a week for 6 months) treatment regimens did not reach statistical significance, there was a clear trend towards higher response with the 6 MIU induction dose in patients without cirrhosis. |
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Authors:
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D Ouzan; G Babany; D Valla; P Opolon |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of viral hepatitis Volume: 5 ISSN: 1352-0504 ISO Abbreviation: J. Viral Hepat. Publication Date: 1998 Jan |
Date Detail:
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Created Date: 1998-04-13 Completed Date: 1998-04-13 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9435672 Medline TA: J Viral Hepat Country: ENGLAND |
Other Details:
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Languages: eng Pagination: 53-9 Citation Subset: IM |
Affiliation:
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Institut Arnault-Tzanck, Saint-Laurent-du-Var, France. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Alanine Transaminase / analysis, blood, metabolism* Antiviral Agents / administration & dosage*, therapeutic use* Biopsy Female Ferritins / analysis, blood, metabolism Hepatitis C, Chronic / blood, drug therapy*, metabolism Humans Interferon Alfa-2a / administration & dosage*, therapeutic use* Liver / pathology Liver Cirrhosis / complications, metabolism, virology Male Middle Aged Multivariate Analysis Predictive Value of Tests Prospective Studies gamma-Glutamyltransferase / analysis, blood, metabolism |
| Chemical | |
Reg. No./Substance:
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0/Antiviral Agents; 76543-88-9/Interferon Alfa-2a; 9007-73-2/Ferritins; EC 2.3.2.2/gamma-Glutamyltransferase; EC 2.6.1.2/Alanine Transaminase |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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