A comparative study on the efficacy of different dosage of alpha-interferon treatment in patients with chronic hepatitis B

Kim, Tae Ho; Kim, Chang Whan; Cho, Keun Jong; Han, Sok Won; Cheong, Dae Young; Kim, Jin Il; Choi, Kyu Yong

Abstract

BACKGROUND: Infection with hepatitis B virus has been a major health problem. Chronic viral hepatitis B is the principal cause of chronic liver disease, cirrhosis, and hepatoma. A number of studies have showed that a course of interferon (INF) treatment induces a long-term remission in 20~40% of patients. Compared with the use of lamivudine, INF therapy is followed by delayed clearance of HBsAg and the treatment improves the natural history of chronic hepatitis B. The aim of this study is to evaluate the efficacy of the use of different dosages of alpha-interferon treatment in patients with chronic hepatitis B.
METHODS
We conducted a one-and-a-half year, randomized clinical trial of interferon in 24 Korean chronic hepatitis B patients with a positive HBeAg, and excluded other liver problems with biopsies. The patients were randomly assigned to receive 5 million units (n=10) of interferon-alpha2b and 10 million units (n=14) of interferon-alpha2b three times weekly for 16/24 weeks. Patients were followed for 12 months after the cessation of the therapy, and the patients received a second biopsy.
RESULTS
After treatment with interferon, 29.2% of the patients became negative for HBeAg and the presence of HBV DNA. Fifty percent of the patients showed histological improvement. The differences of the loss of HBeAg, HBV DNA and histological improvement between the two groups were not significant. HBV DNA and ALT were not valuable as predictive variables in treatment efficacy. However, the rate of histological improvement in patients with a low ALT level was higher.
CONCLUSIONS
The administration of different doses of interferon-alpha2b during treatment in patients with chronic hepatitis B did not show a significant difference in efficacy.