Efficacy of different doses of 12-month Interferon alfa therapy in patients with HBeAg negative chronic hepatitis B: A randomized trial

Abstract

The best interferon-alfa (IFNα) regimen for HBeAg negative
chronic hepatitis B has not been established yet. We evaluated
the efficacy of three regimens of IFNα in 75 patients with
histologically documented HBeAg negative chronic hepatitis
B, who were randomly allocated to receive IFNα-2b thrice
weekly in a dose of: 3MU for 12 months (Group A, n=25);
5 MU for 6 months and 3 MU for another 6 months (Group
B, n=25); and 3 MU for 6 months and 1 MU for another 6
months (Group C, n=25). Initial biochemical response was
observed in 71% of the 75 patients and initial virological response (undetectable serum HBV DNA by bDNA assay) in
38% of the patients with pre-treatment detectable serum HBV
DNA. The decline of HBV DNA levels at the end of therapy
was significant in group A (P=0.02) or B (P=0.004), but not
in group C. Sustained biochemical and virological response
rates (at 6 months after the end of therapy) were 35% and
22% respectively, without any significant difference among
the three groups. There was a significant improvement in the
grading (P<0.001) and no significant change in the staging
of the post-treatment liver biopsies at 6 months after the end
of therapy compared with the pre-treatment histological findings. In conclusion, a 12-month course of IFNα can induce
sustained biochemical response in about one third and sustained virological response in approximately one fifth of patients with HBeAg negative chronic hepatitis B. A standard
dose of 3 MU IFNα thrice weekly seems to be the most cost
effective therapeutic regimen.
Key words: Interferon alfa, chronic hepatitis B, sustained response,HBV DNA