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

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 interfero n (IFN) therapy. Results obtained with the bDNA assay were compared with th ose obtained using the Abbott liquid hybridization (LH) assay and the polym erase chain reaction (PCR), Serial samples (274) from 34 patients were anal ysed. Analysis of variance results indicated that bDNA values were more sig nificantly correlated than LH values with both PCR positive/negative result s (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 c orrelated 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-responder s and responders. The bDNA results correlated well with the generalized Kno dell 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 h epatitis as it correlates with biochemical and histological indications of disease severity as well as with response to TPN therapy.