title: Beneficial effect of prednisolone withdrawal followed by human lymphoblastoid interferon on the treatment of chronic type B hepatitis in Asians: a randomized controlled trial.
abstract: 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/m2 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 < or = 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 < or = 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.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Department of Pathology, Chang Gung Memorial Hospital, Taipei, Taiwan.
authors.forename: Y F
authors.initials: YF
authors.lastname: Liaw
authors.forename: S M
authors.initials: SM
authors.lastname: Lin
authors.forename: T J
authors.initials: TJ
authors.lastname: Chen
authors.forename: R N
authors.initials: RN
authors.lastname: Chien
authors.forename: I S
authors.initials: IS
authors.lastname: Sheen
authors.forename: C M
authors.initials: CM
authors.lastname: Chu
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D004279:DNA, Viral / Q000032:analysis; D004359:Drug Therapy, Combination; D005006:Ethnicity; D006509:Hepatitis B / Q000628:therapy*; D006515:Hepatitis B virus / Q000235:genetics; D006521:Hepatitis, Chronic / Q000628:therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D011239:Prednisolone / Q000008:administration & dosage*
chemical_list: D004279:DNA, Viral; D016898:Interferon-alpha; D011239:Prednisolone; D000410:Alanine Transaminase