2010 Volume 58 Issue 4 Pages 153-162
The clinical usefulness of hepatitis B virus (HBV) DNA, RNA, and core related antigen (HBcrAg) assays for predicting the appearance of HBV DNA breakthrough was evaluated and compared in patients with chronic hepatitis B undergoing lamivudine therapy. Methods : Thirty six patients with chronic hepatitis B who received lamivudine therapy for more than 1 year were enrolled. HBV RNA was measured simultaneously with HBV DNA (HBV RNA/DNA) using a real-time detection polymerase chain reaction assay with a preceding step of reverse-transcription. HBV DNA was measured by an HBV AMPLICOR monitor kit. HBcrAg was measured using a chemiluminescence enzyme immunoassay. Results : Sixteen patients (44%) developed HBV DNA breakthrough during the median observation period of 48.4 months (range 7.4-87.8 months). Afterwards, HBV DNA breakthrough was prospected using the three parameters taken 6 months after starting lamivudine therapy. The cut-offlevels for predictions were determined by receiver operating characteristic curves, and were 2.6 log copies/ml for HBV DNA, 3.8 log U/ml for HBV RNA/DNA, and 4.0 log U/ml for HBcrAg. Sensitivity, specificity, and accuracy for predicting HBV DNA breakthrough were 25%, 100%, and 67% respectively for HBV DNA. Similarly, they were 50%, 90%, and 72% for HBV RNA/DNA, and 100%, 40%, and 67% for HBcrAg. Conclusion : Our findings confirm that HBV DNA is useful for identifying patients who are at high risk for HBV breakthrough. HBcrAg is useful for isolating those who are at low risk, and HBV RNA/DNA showed predictive characteristics similar to HBV DNA with higher sensitivity and the highest accuracy.
