BENEFICIAL EFFECT OF PREDNISOLONE WITHDRAWAL FOLLOWED BY HUMAN LYMPHOBLASTOID INTERFERON ON THE TREATMENT OF CHRONIC TYPE-B HEPATITIS IN ASIANS - A RANDOMIZED CONTROLLED TRIAL

To evaluate the effect of interferon and the benefit of prednisolone p retreatment in Oriental patients with chronic active hepatitis B, 120 male Chinese patients were randomly allocated to receive: 1) group A: a 4-week course of prednisolone followed by 2 weeks of no treatment an d then a 12-week course of human lymphoblastoid interferon, 4 to 6 MU/ m(2) intramuscularly; 2) group B: as group A, but with placebo given i nstead of prednisolone; 3) group C: an 18-week course of placebo. Clea rance of serum hepatitis B virus-DNA and HBeAg (complete response) was achieved in 21% of group A, 5% of group B and none of group C at the end of therapy (A vs B: p=0.054; A vs C: p<0.01). When assessed 12 mon ths after the end of therapy, the complete response rate was 46% in gr oup A, 24% in group B and 25% in group C (p<0.05). Those with baseline alanine transaminase less than or equal to 200 U/l showed a better re sponse to interferon following prednisolone withdrawal (48%) than with interferon therapy alone (20%, p=0.056) and no treatment (9%, p<0.01) . Those with a baseline serum hepatitis B virus-DNA less than or equal to 1000 pg/ml also showed a higher complete response rate when pretre ated with prednisolone (59%) than when treated with interferon alone ( 29%, p=0.084) or untreated (22%, p<0.03). The strongest independent pr edictor of a response to treatment was prednisolone withdrawal (p<0.05 ). None of the responders lost hepatitis B surface antigen. Blinded hi stologic assessment showed a significant improvement, particularly in lobular necroinflammation (p<0.02). These results suggest that prednis olone withdrawal followed by interferon therapy is effective and safe in Chinese patients with chronic active hepatitis B, particularly thos e with lower pretreatment serum alanine transaminase and hepatitis B v irus-DNA levels. (C) Journal of Hepatology.