title: Weight-based dosing regimen of peg-interferon α-2b for chronic hepatitis delta: a multicenter Romanian trial.
abstract: BACKGROUND
  Antiviral therapy for chronic hepatitis D (delta) is not yet satisfactory, although it appears to be the only means to alter the progressive natural course of chronic hepatitis D virus (HDV) infection.
  
  
  OBJECTIVE
  To assess safety and efficacy, evaluated by virological, biochemical and histological end-of-treatment (EOT) and end-of-follow-up (EOF) response to peg-interferon α-2b 1.5 µg/kg body weight weekly in a Romanian cohort of naïve patients with chronic hepatitis delta.
  
  
  RESULTS
  49 Caucasian patients (55.1% men, 44.9% females) with a mean age of 37.95 years received study medication; per-protocol population consisted of 36 subjects. Virological EOT response was present in 33.3% and EOF response was maintained in 25% of patients. 50% of study population showed normalization of ALT level at EOT and 25% at EOF. A combined biochemical and virological response was observed in 19.4% of patients at EOT and in 16.7% at EOF. At baseline, the necroinflammation quantified by histological activity index (HAI) score was 9.72 and the mean fibrosis score was 2.03; there was a significant decrease of HAI score to 7.44 (p=0.01) at EOT, but not for fibrosis score (1.33, p=0.37). However, only 8.3% of patients at EOT and 19.4% at EOF had progressive histological disease.
  
  
  CONCLUSIONS
  Treatment with peg-interferon α-2b succeeded in obtaining a negative HVD RNA in 25% of patients after 104 weeks of follow-up, although combined biochemical and virological response was present in only 16.7%. Necroinflammation decreased significantly in treated patients. Longer treatment periods with pegylated interferon or combination regimen peg interferon-nucleotide analogues should be tested in order to increase efficacy.
authors.affiliation: Center for Digestive Diseases and Liver Transplantation, Fundeni Clinical Institute, Bucharest, Romania. drgheorghe@xnet.ro
authors.forename: Liana
authors.initials: L
authors.lastname: Gheorghe
authors.forename: Speranta
authors.initials: S
authors.lastname: Iacob
authors.forename: Iulia
authors.initials: I
authors.lastname: Simionov
authors.forename: Roxana
authors.initials: R
authors.lastname: Vadan
authors.forename: Ileana
authors.initials: I
authors.lastname: Constantinescu
authors.forename: Florin
authors.initials: F
authors.lastname: Caruntu
authors.forename: Ioan
authors.initials: I
authors.lastname: Sporea
authors.forename: Mircea
authors.initials: M
authors.lastname: Grigorescu
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D001835:Body Weight; D016009:Chi-Square Distribution; D054796:Drug Dosage Calculations; D005260:Female; D019701:Hepatitis D, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D003698:Hepatitis Delta Virus / Q000187:drug effects / Q000235:genetics; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012383:Romania; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b