title: Treatment of chronic hepatitis delta with pegylated interferon-alpha2b.
abstract: OBJECTIVE
  Chronic hepatitis D is difficult to treat. The present pilot study investigated the efficacy and tolerability of pegylated (PEG)-interferon (IFN)-alpha2b in chronic hepatitis D.
  
  
  METHODS
  Twelve patients with chronic hepatitis D were prospectively treated with 1.5 microg/kg PEG-IFN-alpha2b for 48 weeks and followed for 24 weeks. Sustained response (SR) was defined as undetectable hepatitis delta virus (HDV) RNA by reverse transcriptase-polymerase chain reaction and normalization of alanine aminotransferase (ALT) at 6 months after treatment. Investigations included HDV RNA kinetics, determination of hepatitis B virus (HBV) and HDV genotypes and histological evaluation.
  
  
  RESULTS
  An SR was achieved in two out of 12 of patients (17%). The negative predictive value of a less than 3 log HDV RNA decrease at month 6 was 100%. The positive predictive value of a more than 3 log HDV RNA decrease at month 6 was 67%. A marked ALT reduction at the end of treatment was observed in responders and nonresponders. Ishak histological score was comparable at baseline and significantly improved in responders compared with nonresponders at the end of follow-up (13.5 vs. 8.0; P<0.02).
  
  
  CONCLUSIONS
  The present study indicates that PEG-IFN-alpha2b is a promising treatment option in chronic hepatitis D. Nonresponders could be identified by a less than 3 log decrease of HDV RNA at 6 months of treatment.
authors.affiliation: Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany. erhardt@uni-duesseldorf.de
authors.forename: Andreas
authors.initials: A
authors.lastname: Erhardt
authors.forename: Wolfram
authors.initials: W
authors.lastname: Gerlich
authors.forename: Christine
authors.initials: C
authors.lastname: Starke
authors.forename: Ulrike
authors.initials: U
authors.lastname: Wend
authors.forename: Andreas
authors.initials: A
authors.lastname: Donner
authors.forename: Abdurrahman
authors.initials: A
authors.lastname: Sagir
authors.forename: Tobias
authors.initials: T
authors.lastname: Heintges
authors.forename: Dieter
authors.initials: D
authors.lastname: Häussinger
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D016679:Genome, Viral; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D019701:Hepatitis D, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D003698:Hepatitis Delta Virus / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols; D011994:Recombinant Proteins
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b