Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
Different doses of recombinant alpha interferon in the treatment of chronic hepatitis B patients without antibodies against the human immunodeficiency virus.
Abstract:
A total of 24 chronic carriers of HBsAg, HBeAg and hepatitis B virus (HBV)-DNA were included in a controlled trial. The patients were randomly assigned to four groups: Group I (n = 6): control; group II (n = 6): 2.5 MU; group III (n = 6): 5 MU and group IV (n = 6): 10 MU rIFN-alpha/m2 body surface 3 times weekly i.m. during 6 months. At the end of the treatment, all patients under therapy, as well as 4 belonging to the control group, lost HBV-DNA polymerase. HBV-DNA became negative in 3 (50%), 1 (17%), and 2 (33%) patients from groups II, III, and IV, respectively, while all patients from the control group maintained HBV-DNA. At 15 months of follow-up, 6 patients (33%) under therapy (2 from each group) and 1 from the control group remained HBV-DNA-negative. Knodell's index decreased significantly on comparing basal and final liver biopsies among patients in group IV (16.0 +/- 1.9 vs 7.0 +/- 1.9, p less than 0.01), while no changes were observed in the other groups. Five patients (27%) developed anti-IFN antibodies during treatment. In summary, although low doses of rIFN-alpha (2.5-5 MU) had an antiviral effect on HBV replication, only patients treated with 10 MU showed a significant decrease in liver histological activities. In addition, the effectiveness of rIFN-alpha therapy may be negatively influenced by the appearance of anti-IFN antibodies.
Keywords: Adult Biopsy Comparative Study Female Hepatitis B/*THERAPY Hepatitis, Chronic Active/*THERAPY Human *HIV Antibodies Interferon Alfa-2a/*ADMINISTRATION & DOSAGE/THERAPEUTIC USE Interferon Alfa, Recombinant/*ADMINISTRATION & DOSAGE Liver/PATHOLOGY Liver Function Tests Male Random Allocation Support, Non-U.S. Gov't Time Factors CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL
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