Early hepatitis B virus DNA suppression can predict virologic response to peginterferon and lamivudine treatment

Background & Aims: We aimed to investigate the early on-treatment HBV DNA response to predict sustained virologic response for peginterferon and lamivudine combination therapy. Methods: Patients recruited in previous clinical trials receiving 32-week peginterferon alfa-2b and 52- to 104-week lamivudine combination treatment were studied. The areas under the receiver operating characteristic curve (ROC) of HBV DNA at different time intervals were analyzed to predict sustained virologic response, which was defined as HBeAg seroconversion and HBV DNA <10,000 copies/mL at 1 year after treatment. Results: Fifty-seven patients had peginterferon started 8 weeks before lamivudine, and 9 patients had the 2 drugs commenced simultaneously. Eighteen (27%) patients developed sustained virologic response. The area under ROC for log HBV DNA to predict sustained virologic response reached 0.80 (95% confidence interval, 0.69-0.91; P < .001) at week 8 and plateaued off at subsequent time intervals. Among the 57 patients started with peginterferon monotherapy during the first 8 weeks, the area under ROC was 0.83 (95% confidence interval, 0.73-0.94; P < .001). Compared with other time intervals, the likelihood ratio for sustained virologic response was highest for HBV DNA <10,000 copies/mL at week 8 (10.35), with a high sensitivity (0.89) and negative predictive value (0.92). Two of 33 (6%) patients who had HBV DNA >= 10,000 copies/mL at week 8 developed sustained virologic response. Conclusions: HBV DNA >= 10,000 copies/mL at week 8 of peginterferon treatment had a low chance of sustained virologic response.