title: Prednisone withdrawal followed by recombinant alpha interferon in the treatment of chronic type B hepatitis. A randomized, controlled trial.
abstract: OBJECTIVE
  To determine the efficacy of a short course of prednisone followed by recombinant interferon treatment in patients with chronic type B hepatitis.
  
  
  METHODS
  Randomized, controlled trial with a 5-month treatment phase and a 9-month observation period after treatment.
  
  
  METHODS
  Two referral-based university-affiliated medical centers.
  
  
  METHODS
  Thirty-nine clinically stable patients with chronic type B hepatitis, all of whom were positive for hepatitis B antigen, hepatitis B virus-associated-DNA (HBV-DNA), and DNA polymerase for at least 6 months before entry. Patients included 20 heterosexuals and 19 male homosexuals.
  
  
  METHODS
  Eighteen patients were treated with a 6-week tapered regimen of prednisone, followed by 90 days treatment with recombinant interferon alpha-2b; 21 patients were untreated controls. Paired liver biopsy specimens of 27 patients (pretreatment and 9 months after treatment) were blindly evaluated.
  
  
  RESULTS
  Nine treated patients had a sustained loss of HBV-DNA. In addition, eight treated patients lost hepatitis B e antigen and four became negative for hepatitis B surface antigen (HBsAg). When compared with controls the differences were statistically significant for clearance of HBV-DNA and HBsAg (P = 0.035 and 0.037, respectively). Treated patients who had a sustained loss of HBV-DNA had higher initial alanine aminotransferase lower initial DNA and DNA polymerase levels, and were more frequently heterosexual. Patients who responded to treatment with the disappearance of hepatitis B e antigen and HBV-DNA had normal liver function tests and markedly improved liver histology during follow-up.
  
  
  CONCLUSIONS
  The immunologic priming provided by a short course of prednisone used with alpha interferon may be an effective treatment for selected patients with chronic type B hepatitis.
authors.affiliation: Veterans Administration Medical Center, St. Louis, Missouri.
authors.forename: R P
authors.initials: RP
authors.lastname: Perrillo
authors.forename: F G
authors.initials: FG
authors.lastname: Regenstein
authors.forename: M G
authors.initials: MG
authors.lastname: Peters
authors.forename: K
authors.initials: K
authors.lastname: DeSchryver-Kecskemeti
authors.forename: C J
authors.initials: CJ
authors.lastname: Bodicky
authors.forename: C R
authors.initials: CR
authors.lastname: Campbell
authors.forename: M C
authors.initials: MC
authors.lastname: Kuhns
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D004259:DNA-Directed DNA Polymerase / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D006509:Hepatitis B / Q000382:microbiology / Q000473:pathology / Q000628:therapy*; D006515:Hepatitis B virus / Q000302:isolation & purification; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D011897:Random Allocation; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D007370:Interferon Type I; D011994:Recombinant Proteins; D000410:Alanine Transaminase; D004259:DNA-Directed DNA Polymerase; D011241:Prednisone