title: Pegylated interferon-based treatment in patients with advanced liver disease due to chronic delta hepatitis.
abstract: OBJECTIVE
  The safety and efficacy of interferons in advanced delta hepatitis have not been explored. The aim of this subanalysis of a multicenter clinical trial was to compare the efficacy and safety of 48 weeks of pegylated interferon alpha-2a (180 μg weekly) with or without adefovir (10 mg daily) in patients with chronic delta hepatitis-induced advanced liver disease and in those with non-advanced liver disease.
  
  
  METHODS
  Thirty-one patients with advanced and 27 patients with non-advanced liver disease were assessed. Patients were considered to have advanced liver disease when biopsy disclosed a fibrosis score of ≥4 according to Ishak or when imaging studies were indicative of cirrhosis. Virologic response, defined as achievement of undetectable hepatitis D virus RNA, was assessed at the end of treatment and end of 24 weeks of treatment-free follow-up.
  
  
  RESULTS
  Patients with advanced disease had lower hepatitis D virus RNA levels and platelet counts (p=0.014 and p=0.0015, respectively). End of treatment and end of follow-up virologic responses in patients with advanced vs. non-advanced liver disease were similar (29% vs. 19% and 32% vs 23%). Proportion of adverse events did not differ between groups except that thrombocytopenia was noted more often in the advanced liver disease group. Further, four cases of clinically important adverse events including two cases of hepatic decompensation and one case of tuberculosis reactivation occurred in the advanced liver disease group.
  
  
  CONCLUSIONS
  Pegylated interferon is as effective in patients with advanced liver disease due to chronic delta hepatitis as in patients with non-advanced liver disease, but patients should be monitored closely for clinically important side effects.
authors.affiliation: Ankara University, School of Medicine, Department of Gastroenterology, Ankara, Turkey.
authors.forename: Gökhan
authors.initials: G
authors.lastname: Kabaçam
authors.forename: George N
authors.initials: GN
authors.lastname: Dalekos
authors.forename: Yılmaz
authors.initials: Y
authors.lastname: Çakaloğlu
authors.forename: Kalliopi
authors.initials: K
authors.lastname: Zachou
authors.forename: Thomas
authors.initials: T
authors.lastname: Bock
authors.forename: Andreas
authors.initials: A
authors.lastname: Erhardt
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: Fehmi
authors.initials: F
authors.lastname: Tabak
authors.forename: Kendal
authors.initials: K
authors.lastname: Yalçin
authors.forename: A Mithat
authors.initials: AM
authors.lastname: Bozdayi
authors.forename: Hans P
authors.initials: HP
authors.lastname: Dienes
authors.forename: Hakan
authors.initials: H
authors.lastname: Bozkaya
authors.forename: Michael
authors.initials: M
authors.lastname: Manns
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
authors.forename: Cihan
authors.initials: C
authors.lastname: Yurdaydin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage; D001706:Biopsy; D004305:Dose-Response Relationship, Drug; D019701:Hepatitis D, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D003698:Hepatitis Delta Virus / Q000235:genetics; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008099:Liver / Q000473:pathology*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D012367:RNA, Viral / Q000235:genetics; D011994:Recombinant Proteins / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a