Patients with chronic hepatitis C virus (HCV) infection have an increased risk of developing cirrhosis or hepatocellular carcinoma.
Consensus interferon (CIFN) offers sustained clinical efficacy to patients studied in the Western countries.
This randomized, double-blind, controlled trial in 75 Chinese patients with chronic hepatitis C compared treatment with CIFN or placebo to determine whether CIFN had efficacy and safety in Chinese patients similar to that in Western patients.
Patients were randomized to receive CIFN (3 mug or 9 mug) or placebo given subcutaneously 3 times/wk for 24 wk, followed by 24 wk of observation.
Efficacy was assessed by normalization of serum alanine transaminase (ALT) and clearance of serum HCV RNA concentrations to undetectable levels by reverse-transcription polymerase chain reaction.
There was a greater benefit with CIFN 9 mug than with CIFN 3 mug or placebo.
At the end of 24 wk of treatment, the ALT response was 64%, 38.5%, and 8.4% for the 9-mug, 3-mug, and placebo-treated groups, respectively.
After an additional 24 wk of observation, sustained ALT responses were 44%, 23.1%, and 12.5% for the 9-mug, 3-mug, and placebo-treated groups, respectively.
HCV RNA clearance at the end of treatment was 56%, 42.3%, and 4.2% ; and after 24 wk of additional observation, 40%, 11.5%, and 0% for the 9-mug, 3-mug, and placebo-treated groups, respectively.
There were no unexpected adverse reactions to CIFN. (...)
Mots-clés Pascal : Hépatite virale C, Virose, Infection, Chronique, Essai thérapeutique contrôlé, Interféron, Conférence consensus, Randomisation, Etude double insu, Placebo, Etude comparative, Efficacité traitement, Sécurité, Chinois, Résultat, Homme, Monde Ouest, Voie souscutanée, Cytokine, Appareil digestif pathologie, Foie pathologie, Antiviral, Immunomodulateur, Antirétroviral
Mots-clés Pascal anglais : Viral hepatitis C, Viral disease, Infection, Chronic, Controlled therapeutic trial, Interferon, Consensus conference, Randomization, Double blind study, Placebo, Comparative study, Treatment efficiency, Safety, Chinese, Result, Human, Western countries, Subcutaneous administration, Cytokine, Digestive diseases, Hepatic disease, Antiviral, Immunomodulator
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0485499
Code Inist : 002B05C02G. Création : 22/03/2000.