1%, ALT normalized in 64.2% and 81.7% of the patients by the end of 3 and 6 months, respectively. The mean treatment duration was 721 days (24 months), with 48 patients (50.5%) being treated for more than 2 years. The median duration of consolidation therapy was 448 (345-1,678) days. None of the patients lost HBsAg during treatment and the 1-year off-therapy period. Clinical relapse occurred in 43 patients and virologic relapse with normal ALT occurred in additional 12 patients (six cirrhosis). The cumulative off-therapy clinical relapse rate was 45.3% in 1 year with a median duration to relapse of 230 days (79-368 Stem Cells antagonist days). Most relapses (74.4%) occurred

beyond 6 months after stopping ETV therapy (Fig. 1). The baseline and on-treatment features of the patients with or without clinical relapse (relapsers versus nonrelapsers) are compared in Tables 1 and 2. All baseline features were comparable between relapsers and nonrelapsers except that relapsers had a marginally higher baseline HBV DNA (30.6 × 105 or 6.485 log10 versus 9.7 × 105 or 5.986 log10 IU/mL, P = 0.063) and significantly more relapsers (79.1 versus 57.7%, P = 0.027) had a baseline serum HBV DNA >2 × 105 or 5.3 log10 IU/mL, a level determined

by the Youden Index method showing an area under the ROC curve (AUC) AG-014699 chemical structure of 0.611 (95% confidence interval [CI]: 0.498-0.725; P = 0.063). Of the seven patients who had had rtM204 mutations during prior LAM or LdT therapy, one with rtM204I/V mixed mutation relapsed. There was no statistically significant difference between patients with or without prior mutation (P = 0.123) nor between patients with different rtM204 mutations (P = 0.286). There was no significant difference in the duration of consolidation therapy between relapsers and nonrelapsers. The 1-year relapse rate was 39.4% (13 of 33) and 48.4% (30 of 62) in patients with a consolidation therapy >18 months and 12-18 months, respectively (P = 0.402). Using logistic regression analysis, baseline HBV DNA >2 × 105 or

5.3 log10 IU/mL (odds ratio [OR]: 3.934, 95% CI: 1.345-11.508; P = 0.012) was the only significant independent predictor for clinical relapse (Table 3). Of the 31 patients with a baseline serum HBV DNA ≤2 × 105 or 5.3 log10 IU/mL, 29% encountered clinical relapse, as compared to 53.1% of the 64 patients with HBV DNA >2 × 105 or 5.3 log10 IU/mL (log-rank test P = 0.036; Fig. 2). There Protein kinase N1 was no difference between relapsers and nonrelapsers in the magnitude of the decline in the levels of HBsAg and HBV DNA from baseline to 6 months of ETV therapy (P = 0.364 and 0.83, respectively). Of the five patients who achieved HBsAg level reduction >1 log10 during ETV therapy, three relapsed. Logistic regression multivariate analysis in the 56 noncirrhosis patients revealed that both consolidation duration (OR: 0.99, 95% CI: 0.99-0.99; P = 0.034) and baseline HBV-DNA >2 × 105 or 5.3 log10 IU/mL (OR: 14.5, 95% CI: 1.945-108.173; P = 0.009) were independent predictive factors for relapse.