title: Low-dose interferon in chronic hepatitis non-A/non-B: effects on quantitative liver function and structure in a randomized, controlled multicenter trial.
abstract: In this randomized, controlled multicenter trial we evaluated the effects of recombinant interferon-alpha 2b on galactose elimination capacity and histological activity index in 88 patients with chronic active hepatitis non-A/non-B. Forty-five patients were randomly assigned to treatment with interferon at 1.5 x 10(6) U three times per for 1 year; 43 patients were assigned to no treatment. A complete response (normalization of alanine aminotransferase) was observed, respectively, in 47% and 5% of the two groups (P < 0.006); 47% of these patients suffered a relapse. Thus 22% of patients had a sustained response. Histological activity decreased significantly in responders (P < 0.04) while the biopsy score did not change significantly in nonresponders. In contrast, galactose elimination capacity--a surrogate marker for survival in chronic active hepatitis--was not affected by response to treatment. None of the parameters evaluated, including hepatitis C virus RNA, was able to predict response or relapse. We conclude that low-dose interferon treatment for 1 year is as effective as the recommended treatment schedule.
authors.affiliation: Department of Clinical Pharmacology, University of Berne.
authors.forename: J
authors.initials: J
authors.lastname: Reichen
authors.forename: M
authors.initials: M
authors.lastname: Solioz
authors.forename: H
authors.initials: H
authors.lastname: Bühler
authors.forename: J J
authors.initials: JJ
authors.lastname: Gonvers
authors.forename: M
authors.initials: M
authors.lastname: Knoblauch
authors.forename: D
authors.initials: D
authors.lastname: Lavanchy
authors.forename: P J
authors.initials: PJ
authors.lastname: Malé
authors.forename: B
authors.initials: B
authors.lastname: Meyer
authors.forename: M
authors.initials: M
authors.lastname: Schmid
authors.forename: L
authors.initials: L
authors.lastname: Bianchi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000378:metabolism; D002908:Chronic Disease; D005260:Female; D005690:Galactose / Q000378:metabolism*; D016174:Hepacivirus / Q000276:immunology / Q000302:isolation & purification; D006508:Hepatitis Antibodies / Q000097:blood; D006526:Hepatitis C / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D018937:Hepatitis C Antibodies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008099:Liver / Q000648:ultrastructure*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D011994:Recombinant Proteins; D013997:Time Factors
chemical_list: D006508:Hepatitis Antibodies; D018937:Hepatitis C Antibodies; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000410:Alanine Transaminase; D005690:Galactose