A CLINICAL-EVALUATION OF A NEW METHOD FOR HBV DNA QUANTITATION IN PATIENTS WITH CHRONIC HEPATITIS-B

Selection of HBsAg-positive patients for antiviral therapy requires an estimation of disease activity and viral replication. Serum transamin ases and histological analysis are commonly used to assess disease act ivity, and viral replication is assessed by serological testing of HBe Ag and serum hepatitis B virus (HBV) DNA. Dot blot hybridisation may b e insufficiently sensitive to corroborate low-grade replication in pat ients with active hepatitis, and polymerase chain reaction (PCR) may b e testing too sensitive for this role. Theoretically an assay of inter mediate sensitivity is therefore required. Our aim was to evaluate whe ther the branched chain DNA (bDNA) assay would fulfil this function. S eventy-one HBsAg-positive patients were tested for HBV DNA by the bDNA assay; 64 were also tested by dot blot hybridisation and, when approp riate, also by PCR. Thirty-seven (52%) patients were positive for HBV DNA by the bDNA assay. HBV DNA was detected in the majority (21/28; 75 %) of HBeAg-positive patients but also in 14 of 36 (39%) anti-HBe-posi tive patients. HBV DNA was detected by the bDNA assay in 20 of 48 (42% ) patients negative for HBV DNA by dot blot hybridisation assay. All p atients positive for HBV DNA by dot blot hybridisation were also posit ive by the bDNA assay. Sixteen of twenty-five (64%) patients negative for HBV DNA by the bDNA assay were positive for HBV DNA by PCR. The bD NA assay is a sensitive and reliable method for the detection of HBV D NA. As nucleoside analogue therapy becomes more widely available, the assay should provide a useful tool for the selection for and monitorin g of patients on antiviral therapy. (C) 1996 Wiley-Liss, Inc.