Baseline prognostic factors and statistic model to predict early virological response in lamivudine-treated patients with chronic hepatitis B.

Lamivudine is a potent nucleoside analogue used in treating chronic hepatitis B (CHB). However, resistance to the drug remains a problem. We analyzed all lamivudine recipients in this trial to determine the baseline characteristics and a model to predict early virological response reflecting the long-term effect of lamivudine. In this prospective trial, 230 patients who had not treated with nucleotide analogue with chronic HBV infection were assigned to receive 100 mg of lamivudine once daily for 24 weeks at least. All patients were followed up every 2 week. Cox proportional hazard regression model analyses were employed to evaluate baseline variables and to develop a statistical model. Female (P = 0.042), baseline higher serum aspartate aminotransferase (AST) (P = 0.002), and lower level of HBV-DNA (P = 0.016) were identified to be associated with higher possibility of early virological response. A model was established based on these variables to calculate the risk scores (R) for CHB patients. R > -0.45 suggested early virological response to lamivudine. The model was validated among an independent set of 40 patients. The gender as well as baseline AST and HBV-DNA levels can predict early virological response. The model provides a better tool for response prediction based on the three prognostic factors.