title: Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection.
abstract: OBJECTIVE
  To confirm the findings of pilot studies that interferon alfa is an effective treatment of Europid men with chronic hepatitis B virus infection.
  
  
  METHODS
  Randomised controlled trial of three months treatment with interferon alfa followed by 12 months of observation.
  
  
  METHODS
  Outpatient clinic of a tertiary referral centre.
  
  
  METHODS
  37 Treated men (six anti-HIV positive) and 34 untreated men (nine anti-HIV positive) who met the criteria for the trial. Four controls failed to complete follow up.
  
  
  METHODS
  The treated group received subcutaneous injections of 5-10 MU interferon alfa/m2 daily for five days, then 10 MU/m2 thrice weekly for 11 weeks. Follow up continued at monthly intervals for 12 months. Untreated controls were monitored over the same period.
  
  
  METHODS
  Hepatitis B e antigen and hepatitis B virus DNA state after 15 months of observation.
  
  
  RESULTS
  12 Of the 37 treated patients cleared hepatitis B e antigen and hepatitis B virus DNA, whereas only one of 30 untreated controls seroconverted over the same period--an increased response rate of 29% (95% confidence interval 13% to 45%). The life table estimate of response at 15 months was 35% in treated patients, an increase of 32% above controls (95% confidence interval 16% to 48%). The response rates in groups by predictive pretreatment variables were 12 of 31 anti-HIV negative patients (excess response 34%; 95% confidence interval 14% to 54%), 12 of 26 with chronic active hepatitis before treatment (excess response 46%; 27% to 65%), and 12 of 21 with a pretreatment serum aspartate aminotransferase activity greater than 70 IU/l (excess response 46%; 16% to 76%). The combination of these factors predicted response with a sensitivity of 100% and a specificity of 80%. Four of the 12 responders, who had all been infected for less than two years, also lost hepatitis B surface antigen. Treatment was well tolerated.
  
  
  CONCLUSIONS
  Interferon alfa is effective in the treatment of a proportion of Europid men with chronic hepatitis B virus infection, who might be identified before treatment. Additional strategies are required to improve the rate of response.
authors.affiliation: Academic Department of Medicine, St Mary's Hospital Medical School, London.
authors.forename: M G
authors.initials: MG
authors.lastname: Brook
authors.forename: G
authors.initials: G
authors.lastname: Chan
authors.forename: I
authors.initials: I
authors.lastname: Yap
authors.forename: P
authors.initials: P
authors.lastname: Karayiannis
authors.forename: A M
authors.initials: AM
authors.lastname: Lever
authors.forename: M
authors.initials: M
authors.lastname: Jacyna
authors.forename: J
authors.initials: J
authors.lastname: Main
authors.forename: H C
authors.initials: HC
authors.lastname: Thomas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004797:Enzyme-Linked Immunosorbent Assay; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006513:Hepatitis B e Antigens / Q000032:analysis; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D001613:beta 2-Microglobulin / Q000032:analysis
chemical_list: D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D007370:Interferon Type I; D001613:beta 2-Microglobulin