title: Treatment of chronic hepatitis D patients with pegylated interferon: a real-world experience.
abstract: BACKGROUND
  Published experience of treating chronic hepatitis D patients with pegylated interferon (PEG-IFN)-α is limited. The aim of this study was to determine the efficacy of 48 weeks of treatment with PEG-IFN in naive patients outside the clinical trial setting, in the real world.
  
  
  METHODS
  Patients with chronic hepatitis D were treated with PEG-IFN. The primary end points were sustained clearance of HDV RNA and normal alanine aminotransferase (ALT) at 24 weeks post-treatment.
  
  
  RESULTS
  The total number of patients treated with PEG-IFN was 104; 91 males, mean age ±SD 30.1 ±10.0 years (range 15-55). Cirrhosis was present in 41 patients. With an intention-to-treat analysis, end of treatment virological response (ETR) was achieved in 44 (42.3%), normalization of ALT in 38 (35%) and a combined response in 23 (22.1%) patients. Sustained virological response (SVR) at 24 weeks post-treatment was seen in 24 (23.1%) patients each for the virological and biochemical responses and in 13 (12.5%) as combined response. Both ETR and SVR were associated with a negative HDV RNA at 24 weeks of treatment (P=0.001 and P=0.000, respectively). Detectable HDV RNA at this point had a positive predictive value of 0.95 (range 0.85-0.99) for detectable RNA at 6 months post-treatment. End of treatment biological response, that is, normal ALT at the end of treatment was also a predictor of ETR and SVR (P=0.004 and P=0.041, respectively).
  
  
  CONCLUSIONS
  Treatment with PEG-IFN for hepatitis D is of limited efficacy. Detectable HDV RNA at 24 weeks of treatment is a predictor for a failed SVR.
authors.affiliation: Department of Medicine, The Aga Khan University Hospital, Karachi, Pakistan. drzabbas@gmail.com.
authors.forename: Zaigham
authors.initials: Z
authors.lastname: Abbas
authors.forename: Mohammad S
authors.initials: MS
authors.lastname: Memon
authors.forename: Hammad
authors.initials: H
authors.lastname: Mithani
authors.forename: Wasim
authors.initials: W
authors.lastname: Jafri
authors.forename: Saeed
authors.initials: S
authors.lastname: Hamid
mesh_terms: D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D019701:Hepatitis D, Chronic / Q000188:drug therapy* / Q000821:virology*; D003698:Hepatitis Delta Virus / Q000187:drug effects*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000494:pharmacology / Q000627:therapeutic use; D007372:Interferons / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000494:pharmacology / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000494:pharmacology / Q000627:therapeutic use; D012307:Risk Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D007372:Interferons; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a