ackground : There is no satisfactory method of treatment for chronic active hepatitis caused by hepatitis B virus(CAH-B). Randomized controlled studies on a limited number of patients with CAH-B using alpha interferon or combination with
corticosteroid
showed some promise in reducing or eliminating viral replication. We evaluated the safety and efficacy of prednisolone withdrawal followed by recombinant alpha-Interferon 2b therapy.
Methods : Sixteen patients (treatment group) with CAH-B were injected alpha-Interferon
for 16 weeks after prednisolone tapered for 6 weeks, and compared to 12 controlled patients
(control group). We measured serum aminotransferase activities, HBsAg, Anti-HBs, HBeAg,
Anti-Hbe and HBV-DNA before and after therapy.
Results :
1) Serum levels of AST and ALT were decreased significantly in treatment group (AST:
36±17, ALT: 38±14 IU/L) compared to control group (AST: 188±152, ALT: 272±155 IU/L).
The responses were maintained for 1 year after therpy.
2) The negative conversion rates of HBeAg and HBV-DNA were significantl higher in
treatment group (HBsAg: 50%, HBV-DNA: 87%) than control group (HBeAg: 0%,
HBV-DNA: 14%) after treatment. But there was no significant difference in follow up period
(36 & 43%: 17 & 25%, lyr. After).
3) Loss of HBsAg was not observed in both groups.
4) Mild tolerable side effects were observed; fever (94%), myalgia (75%), headache (19%)
and hair loss (13%).
5) Leukocytopenia (19%) and thrombocytopenia (19%) were transient.
Conclusions : Prednisolone withdrawal followed by recombinant alpha-Interferon 2b therapy
was effective for decreasements of serum aminotransferase activities, for the loss of HBeAg
and HBV-DNA, and relatively safe for patients with CAH-B. But it is necessary for study
with larger number of patients, more prolonged duration of follow up and more strict control
study.
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