title: Clinical evaluation of the branched DNA assay for hepatitis B virus DNA detection in patients with chronic hepatitis B lacking hepatitis B e antigen and treated with interferon-alpha.
abstract: The aim of this study was to evaluate the Chiron branched DNA (bDNA) assay for detection of serum hepatitis B virus (HBV) DNA in patients with chronic hepatitis B lacking hepatitis B e antigen (HBeAg) and undergoing interferon (IFN) therapy. Results obtained with the bDNA assay were compared with those obtained using the Abbott liquid hybridization (LH) assay and the polymerase chain reaction (PCR). Serial samples (274) from 34 patients were analysed. Analysis of variance results indicated that bDNA values were more significantly correlated than LH values with both PCR positive/negative results (probability of artifact (Prob > F) = 0.7 and 0.09 for LH and bDNA assays, respectively) and presence/absence of precore mutations (Prob > F = 0.21 and 0.001 for LH and bDNA assays, respectively). Both bDNA and LH results correlated highly with alanine aminotransferase (ALT) values (both had Prob > F values of 0.0) while PCR was not correlated with ALT (Prob > F = 0.05). In 26 evaluable patients, a model based on a generalized Knodell score was used to predict response to IFN therapy, as defined by normalization of ALT values during therapy. This model discriminated well between non-responders and responders. The bDNA results correlated well with the generalized Knodell score, while the LH results did not (Prob > F = 0.04 and 0.19 for the bDNA and LH assays, respectively). In conclusion, the bDNA assay appears to be useful for quantification of HBV DNA levels in HBeAg-negative chronic hepatitis as it correlates with biochemical and histological indications of disease severity as well as with response to IFN therapy.
authors.affiliation: Hôpital de l'Hôtel Dieu, Lyon, France.
authors.forename: F
authors.initials: F
authors.lastname: Habersetzer
authors.forename: F
authors.initials: F
authors.lastname: Zoulim
authors.forename: J F
authors.initials: JF
authors.lastname: Jusot
authors.forename: X
authors.initials: X
authors.lastname: Zhang
authors.forename: M A
authors.initials: MA
authors.lastname: Trabaud
authors.forename: P
authors.initials: P
authors.lastname: Chevallier
authors.forename: M
authors.initials: M
authors.lastname: Chevallier
authors.forename: S N
authors.initials: SN
authors.lastname: Ahmed
authors.forename: M
authors.initials: M
authors.lastname: Sepetjan
authors.forename: L
authors.initials: L
authors.lastname: Comanor
authors.forename: J
authors.initials: J
authors.lastname: Minor
authors.forename: C
authors.initials: C
authors.lastname: Trépo
mesh_terms: D000704:Analysis of Variance; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood*; D005069:Evaluation Studies as Topic; D006513:Hepatitis B e Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000235:genetics* / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D009154:Mutation; D009693:Nucleic Acid Hybridization / Q000379:methods; D016133:Polymerase Chain Reaction / Q000379:methods; D011994:Recombinant Proteins; D016896:Treatment Outcome; D014758:Viral Core Proteins / Q000235:genetics
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D014758:Viral Core Proteins