| Treatment of patients with chronic hepatitis C not responding to interferon with high-dose interferon alpha with or without ribavirin: final results of a prospective randomized trial. Austrian Hepatitis Study Group. | |
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MedLine Citation:
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PMID: 11434597 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To investigate the efficacy of high-dose interferon alpha (IFN-alpha) with or without ribavirin in interferon (IFN) non-responders. STUDY DESIGN: 304 chronic hepatitis C patients received 5 MU IFN-alpha2b (IntronA, Schering-Plough, Kenilworth, NJ, USA) three times a week for 3 months. Non-responders were randomized either to continue with IFN (IFN 5 MU/TIW followed by 10 MU/TIW, each for 3 months) alone (group A: n = 76, m: f = 54: 22, age 45.7 +/- 12 years, 16% cirrhosis, alanine aminotransferase [ALT] 66 +/- 35 U/l) or in combination with ribavirin (approximately 14 mg/kg/day) (group B: n = 81, m: f = 57: 24, age 48.2 +/- 12 years, 17% cirrhosis, ALT 71 +/- 40 U/l). At the end of treatment, patients were followed for 6 months. MAIN OUTCOME MEASURES: Virological response at end of treatment and 6 months thereafter. SETTING: University hospitals and tertiary referral centres. RESULTS: At the end of treatment, eight (10.8%) and 25 (31.3%, P= 0.0066) patients were HCV-RNA negative, and 51 and 39 were HCV-RNA positive, in groups A and B, respectively. There were 17 drop-outs in each group. Six months after treatment, only one patient in group A (1.3%) and seven patients (8.6%, P= 0.06) in group B had normal ALT and undetectable serum HCV-RNA. CONCLUSIONS: A combination of high-dose IFN with ribavirin induces a short-lasting complete response in about one-third of IFN-non-responders. |
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Authors:
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P Ferenci; R Stauber; P Steindl-Munda; M Gschwantler; P Fickert; C Datz; C Müller; F Hackl; W Rainer; T Watkins-Riedel; W Lin; G J Krejs; A Gangl; |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: European journal of gastroenterology & hepatology Volume: 13 ISSN: 0954-691X ISO Abbreviation: Eur J Gastroenterol Hepatol Publication Date: 2001 Jun |
Date Detail:
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Created Date: 2001-07-03 Completed Date: 2001-12-04 Revised Date: 2009-10-16 |
Medline Journal Info:
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Nlm Unique ID: 9000874 Medline TA: Eur J Gastroenterol Hepatol Country: England |
Other Details:
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Languages: eng Pagination: 699-705 Citation Subset: IM |
Affiliation:
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Department of Internal Medicine IV, University of Vienna, Austria. peter.ferenci@akh-wien.ac.at |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antiviral Agents / administration & dosage* Base Sequence Dose-Response Relationship, Drug Drug Therapy, Combination Female Follow-Up Studies Hepatitis C, Chronic / diagnosis, drug therapy* Humans Interferon-alpha / administration & dosage* Interferons / administration & dosage Male Middle Aged Molecular Sequence Data Organization and Administration Polymerase Chain Reaction Probability Prospective Studies RNA, Viral / analysis* Reference Values Ribavirin / administration & dosage* Treatment Failure Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antiviral Agents; 0/Interferon-alpha; 0/RNA, Viral; 36791-04-5/Ribavirin; 9008-11-1/Interferons |
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