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High sustained response rate in patients with histologically mild (low grade and stage) chronic hepatitis C infection. A randomized, double blind, placebo controlled trial of interferon alpha-2b with and without ribavirin.

Verbaan, Hans LU ; Widell, Anders LU ; Bondeson, Lennart LU and Lindgren, Stefan LU (2002) In European Journal of Gastroenterology and Hepathology 14(6). p.627-633
Abstract
OBJECTIVE : To evaluate the efficacy and safety of therapy for patients with histologically mild hepatitis C virus (HCV) liver disease. DESIGN : A randomized, double blind, placebo controlled trial of interferon alpha-2b with or without ribavirin. SETTING : Regional and university hospitals. PARTICIPANTS : One hundred and sixteen treatment naive patients with mild chronic HCV infection. Mild HCV infection was defined according to Knodell as a grade score of >/= 1 and </= 6 and a stage score of </= 1. INTERVENTIONS : Interferon alpha-2b (3 MU three times weekly) for 52 weeks in combination with either ribavirin or a matched placebo. MAIN OUTCOME MEASURES : The study endpoint was the absence of HCV RNA in plasma and liver tissue 26... (More)
OBJECTIVE : To evaluate the efficacy and safety of therapy for patients with histologically mild hepatitis C virus (HCV) liver disease. DESIGN : A randomized, double blind, placebo controlled trial of interferon alpha-2b with or without ribavirin. SETTING : Regional and university hospitals. PARTICIPANTS : One hundred and sixteen treatment naive patients with mild chronic HCV infection. Mild HCV infection was defined according to Knodell as a grade score of >/= 1 and </= 6 and a stage score of </= 1. INTERVENTIONS : Interferon alpha-2b (3 MU three times weekly) for 52 weeks in combination with either ribavirin or a matched placebo. MAIN OUTCOME MEASURES : The study endpoint was the absence of HCV RNA in plasma and liver tissue 26 weeks post-treatment. In addition, liver histology was compared pre- and post-treatment. RESULTS : Combination therapy was superior to interferon monotherapy, with a virological sustained response rate of 54% (31/57) and 20% (12/59), respectively, in both serum and liver tissue (P = 0.001). The sustained response rate was higher with combination therapy than monotherapy both in genotype non-1 (81% vs 36%) and in genotype 1 (28% vs 4%). There was a significant improvement in mean grade score in all sustained responders, irrespective of treatment arm. CONCLUSION : Combination therapy with interferon and ribavirin was safe and as effective in patients with histologically mild HCV infection as previously reported for more advanced disease. (Less)
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author
organization
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type
Contribution to journal
publication status
published
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in
European Journal of Gastroenterology and Hepathology
volume
14
issue
6
pages
627 - 633
publisher
Lippincott Williams & Wilkins
external identifiers
  • pmid:12072596
  • wos:000176938400007
  • scopus:0036089296
ISSN
1473-5687
language
English
LU publication?
yes
id
329985c6-5312-43fe-9cb7-931c7f30b8bf (old id 108896)
alternative location
http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12072596&dopt=Abstract
date added to LUP
2007-07-27 12:20:22
date last changed
2017-01-01 04:51:19
@article{329985c6-5312-43fe-9cb7-931c7f30b8bf,
  abstract     = {OBJECTIVE : To evaluate the efficacy and safety of therapy for patients with histologically mild hepatitis C virus (HCV) liver disease. DESIGN : A randomized, double blind, placebo controlled trial of interferon alpha-2b with or without ribavirin. SETTING : Regional and university hospitals. PARTICIPANTS : One hundred and sixteen treatment naive patients with mild chronic HCV infection. Mild HCV infection was defined according to Knodell as a grade score of &gt;/= 1 and &lt;/= 6 and a stage score of &lt;/= 1. INTERVENTIONS : Interferon alpha-2b (3 MU three times weekly) for 52 weeks in combination with either ribavirin or a matched placebo. MAIN OUTCOME MEASURES : The study endpoint was the absence of HCV RNA in plasma and liver tissue 26 weeks post-treatment. In addition, liver histology was compared pre- and post-treatment. RESULTS : Combination therapy was superior to interferon monotherapy, with a virological sustained response rate of 54% (31/57) and 20% (12/59), respectively, in both serum and liver tissue (P = 0.001). The sustained response rate was higher with combination therapy than monotherapy both in genotype non-1 (81% vs 36%) and in genotype 1 (28% vs 4%). There was a significant improvement in mean grade score in all sustained responders, irrespective of treatment arm. CONCLUSION : Combination therapy with interferon and ribavirin was safe and as effective in patients with histologically mild HCV infection as previously reported for more advanced disease.},
  author       = {Verbaan, Hans and Widell, Anders and Bondeson, Lennart and Lindgren, Stefan},
  issn         = {1473-5687},
  language     = {eng},
  number       = {6},
  pages        = {627--633},
  publisher    = {Lippincott Williams & Wilkins},
  series       = {European Journal of Gastroenterology and Hepathology},
  title        = {High sustained response rate in patients with histologically mild (low grade and stage) chronic hepatitis C infection. A randomized, double blind, placebo controlled trial of interferon alpha-2b with and without ribavirin.},
  volume       = {14},
  year         = {2002},
}