title: Pre-treatment with prednisolone does not improve the efficacy of subsequent alpha interferon therapy in chronic hepatitis C.
abstract: OBJECTIVE
  Alpha interferon administration is quite disappointing as a single therapy in chronic hepatitis C. A brief course of corticosteroid therapy might increase the effectiveness of subsequent alpha interferon administration, but data on this issue are controversial.
  
  
  METHODS
  One hundred and fifty-six consecutive patients with chronic hepatitis C were randomly assigned to be treated blind with tapering doses of oral prednisolone or placebo for 4 weeks. Two weeks after cessation of therapy, patients received alpha interferon (3 MU t.i.w.) for 48 weeks and were followed for 24 additional weeks. Response was defined by the presence of normal alanine aminotransferase (ALT) and negative HCV-RNA in serum.
  
  
  RESULTS
  ALT activity decreased during prednisolone administration and rebounded upon withdrawal in 38% of the patients treated with this drug. Significant changes in serum bilirubin were not observed. HCV-RNA serum concentration tended to increase during prednisolone administration and to decrease upon withdrawal. ALT and HCV-RNA did not change during administration of placebo. At the end of interferon administration, 33% of patients treated with prednisolone and 25% of those treated with placebo presented biochemical and virological response. At the end of post-treatment follow-up, response was maintained in 12% and 13% of patients treated with prednisolone or placebo respectively. Response was not related to ALT or HCV-RNA changes observed during the pre-interferon phase of the study. No adverse events related to prednisolone administration were observed.
  
  
  CONCLUSIONS
  Prednisolone administration and withdrawal induced a rebound in ALT activity and a decrease in HCV-RNA serum concentration in about one third of the patients with chronic hepatitis C. However, these changes did not enhance the effectiveness of subsequent alpha interferon therapy.
authors.affiliation: Institut de Malalties Digestives, Hospital Clinic, IDIBAPS, Universitat de Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Guilera
authors.forename: X
authors.initials: X
authors.lastname: Forns
authors.forename: X
authors.initials: X
authors.lastname: Torras
authors.forename: J
authors.initials: J
authors.lastname: Enríquez
authors.forename: S
authors.initials: S
authors.lastname: Coll
authors.forename: R
authors.initials: R
authors.lastname: Solà
authors.forename: R
authors.initials: R
authors.lastname: Morillas
authors.forename: R
authors.initials: R
authors.lastname: Planas
authors.forename: S
authors.initials: S
authors.lastname: Ampurdanès
authors.forename: M
authors.initials: M
authors.lastname: Soler
authors.forename: J
authors.initials: J
authors.lastname: Costa
authors.forename: J C
authors.initials: JC
authors.lastname: Sáiz
authors.forename: J M
authors.initials: JM
authors.lastname: Sánchez-Tapias
authors.forename: J
authors.initials: J
authors.lastname: Rodés
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000201:enzymology / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D011292:Premedication; D012367:RNA, Viral / Q000097:blood; D017211:Treatment Failure
chemical_list: D000893:Anti-Inflammatory Agents; D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011239:Prednisolone; D000410:Alanine Transaminase