title: Anti-HDV immunoglobulin M testing in hepatitis delta revisited: correlations with disease activity and response to pegylated interferon-α2a treatment.
abstract: BACKGROUND
  The role of anti-HDV immunoglobulin M (IgM) testing in patients receiving pegylated interferon-α therapy for hepatitis delta is unknown. We performed anti-HDV IgM testing in a well defined cohort of HDV-infected patients who were treated with pegylated interferon-α2a plus adefovir, or either drug alone.
  
  
  METHODS
  Sera from 33 HDV-RNA-positive patients from the international HIDIT-1 trial were available for anti-HDV IgM testing (ETI-DELTA-IGMK-2 assay, DiaSorin, Saluggia, Italy) before therapy, at treatment weeks 24 and 48, and at 24 weeks after the end of treatment.
  
  
  RESULTS
  Anti-HDV IgM tested positive in 31 out of the 33 patients (94%) prior to treatment. HDV IgM levels correlated with histological inflammatory activity (r=0.51, P<0.01) and were higher in patients with alanine aminotransferase and γ-glutamyl transpeptidase levels above the median (P<0.05). Quantitative anti-HDV IgM values declined in patients responding to antiviral therapy, however anti-HDV IgM remained positive after treatment in the majority of virological responders.
  
  
  CONCLUSIONS
  We suggest that anti-HDV IgM testing might give additional useful information to determine disease activity in hepatitis delta and to predict treatment response to antiviral therapy with type I interferons. However, determination of anti-HDV IgM can not substitute HDV RNA testing, which remains the primary virological marker for response to therapy.
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
authors.forename: Ingmar
authors.initials: I
authors.lastname: Mederacke
authors.forename: Cihan
authors.initials: C
authors.lastname: Yurdaydin
authors.forename: George N
authors.initials: GN
authors.lastname: Dalekos
authors.forename: Birgit
authors.initials: B
authors.lastname: Bremer
authors.forename: Andreas
authors.initials: A
authors.lastname: Erhardt
authors.forename: Yilmaz
authors.initials: Y
authors.lastname: Cakaloglu
authors.forename: Kendal
authors.initials: K
authors.lastname: Yalcin
authors.forename: Selim
authors.initials: S
authors.lastname: Gurel
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: Kalliopi
authors.initials: K
authors.lastname: Zachou
authors.forename: Hakan
authors.initials: H
authors.lastname: Bozkaya
authors.forename: Hans Peter
authors.initials: HP
authors.lastname: Dienes
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use; D005260:Female; D006508:Hepatitis Antibodies / Q000097:blood*; D003699:Hepatitis D / Q000188:drug therapy / Q000276:immunology*; D003698:Hepatitis Delta Virus / Q000235:genetics / Q000276:immunology*; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood* / Q000276:immunology; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000627:therapeutic use; D055815:Young Adult; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D000998:Antiviral Agents; D006508:Hepatitis Antibodies; D007075:Immunoglobulin M; D016898:Interferon-alpha; D063065:Organophosphonates; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C053001:adefovir; D005723:gamma-Glutamyltransferase; D000410:Alanine Transaminase; D000225:Adenine; C100416:peginterferon alfa-2a