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.
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/108896
- author
- Verbaan, Hans LU ; Widell, Anders LU ; Bondeson, Lennart LU and Lindgren, Stefan LU
- organization
- publishing date
- 2002
- type
- Contribution to journal
- publication status
- published
- subject
- 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
- 2016-04-01 12:07:18
- date last changed
- 2022-03-28 20:34:28
@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 >/= 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.}},
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.}},
url = {{http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12072596&dopt=Abstract}},
volume = {{14}},
year = {{2002}},
}