Interferon alfa (IFN-alpha) is the primary treatment for chronic hepatitis B. The standard duration of IFN-alpha therapy is considered 16 weeks ; however, the optimal treatment length is still poorly defined.
We evaluated the efficacy and acceptability of prolonged IFN-alpha treatment in patients with chronic hepatitis B. To investigate whether treatment prolongation could enhance the rate of hepatitis B e antigen (HBeAg) seroconversion, we conducted a prospective, controlled, multicenter trial in which all patients were treated with a standard regimen of 10 million units IFN-alpha 3 times per week over 16 weeks.
Patients who were still HBeAg-positive after 16 weeks of therapy were randomized to prolongation of the identical regimen up to 32 weeks (prolonged therapy) or discontinuation of treatment (standard therapy).
Among the 162 patients who entered the study, 27 (17%) were HBeAg-negative after the first 16 weeks of treatment, and 118 were randomized to standard or prolonged therapy.
After randomization, a response (HBeAg seroconversion and sustained hepatitis B virus [HBV]-DNA negativity) was observed in 7 of the 57 (12%) patients assigned to standard therapy versus 17 of the 61 (28%) patients assigned to prolonged therapy (P=04).
A low level of viral replication after 16 weeks of treatment, as indicated by serum HBV-DNA values under 10 pg/mL, was found to be the only independent predictor of response (52% vs. 0% ; P<. 001) during prolonged therapy. (...)
Mots-clés Pascal : Hépatite virale B, Virose, Infection, Chronique, Randomisation, Interféron alpha, Essai thérapeutique contrôlé, Chimiothérapie, Efficacité traitement, Prolongé, Evaluation, Europe, Homme, Appareil digestif pathologie, Foie pathologie, Antiviral, Immunothérapie, antirétroviral
Mots-clés Pascal anglais : Viral hepatitis B, Viral disease, Infection, Chronic, Randomization, Alpha interferon, Controlled therapeutic trial, Chemotherapy, Treatment efficiency, Prolonged, Evaluation, Europe, Human, Digestive diseases, Hepatic disease, Antiviral, Immunotherapy
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0431200
Code Inist : 002B05C02G. Création : 22/03/2000.