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 pretreatment 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 and 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 instead of prednisolone; 3) group C: an 18-week course of placebo. Clearance 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 months after the end of therapy, the complete response rate was 46% in group 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 response 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 pretreated with prednisolone (59%) than when treated with interferon alone (29%, p=0.084) or untreated (22%, p<0.03). The strongest independent predictor of a response to treatment was prednisolone withdrawal (p<0.05). None of the responders lost hepatitis B surface antigen. Blinded histologic assessment showed a significant improvement, particularly in lobular necroinflammation (p<0.02). These results suggest that prednisolone withdrawal followed by interferon therapy is effective and safe in Chinese patients with chronic active hepatitis B, particularly those with lower pretreatment serum alanine transaminase and hepatitis B virus-DNA levels. (C) Journal of Hepatology.