Low-dose interferon in chronic hepatitis non-A/non-B: effects on quantitative liver function and structure in a randomized, controlled multicenter trial.
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.
Reichen
J
J
Department of Clinical Pharmacology, University of Berne.
Solioz
M
M
Bühler
H
H
Gonvers
J J
JJ
Knoblauch
M
M
Lavanchy
D
D
Malé
P J
PJ
Meyer
B
B
Schmid
M
M
Bianchi
L
L
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
D006508:Hepatitis Antibodies; D018937:Hepatitis C Antibodies; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000410:Alanine Transaminase; D005690:Galactose