Serum assay Analyses of liver function, renal function selleck chemicals llc and creatine kinase level were performed at baseline and at week 2, 4, 8, 12, 16, 24, 32, 36, 48 and 52 of LDT therapy using the Automatic Biochemistry analyzer (Hitachi 7600). HBsAg, HBeAg, anti-HBc, anti-HBe and anti-HBs were quantified using radioimmunoassay (Abbott Laboratories Ltd.). HBV DNA was measured using the Amplicor HBV Test (Roche Diagnostics, Basel, Switzerland) with a detection limit of 300 copies/mL. LTD-associated mutations were assessed by direct sequencing. Statistical analysis Quantitative data were presented as mean �� SD, categorical data were presented as counts and percentages, and HBV DNA levels were presented as log transformation. Data were analyzed using the SPSS software package version 13.0 (SPSS Inc.

, Chicago, IL, USA). Pearson chi-square or Fisher exact tests were used for categorical variables. In all cases, P values less than 0.05 were considered statistically significant. RESULTS Patients Baseline characteristics for all 80 HBeAg-positive CHB patients are presented in Table Table1.1. In the high baseline ALT CHB patient group, patients consisted of 29 males and 11 females, with ages ranging from 21 to 38 years (28.12 �� 3.71 years). Baseline data are as follows: the median level of serum HBV DNA was 7.78 �� 107 copies/mL (range: 4.67 �� 105-8.58 �� 109 copies/mL), the median ALT level was 658.0 IU/L (range: 513.0-978.0 IU/L). Table 1 Patient baseline characteristics Virological response By week 52, the mean decrease in HBV DNA level compared with baseline was 7.

03 log10 copies/mL in the high baseline ALT group and 6.17 log10 copies/mL in the control group, respectively (P Dacomitinib < 0.05). The proportion of patients in whom serum HBV DNA levels were undetectable by polymerase chain reaction assay was greater in the high baseline ALT group than in the control group (72.5% vs 60%, P < 0.05) as indicated in Table Table22. Table 2 Efficacy and safety at week 52 n (%) Serological response At week 52, 45.0% of HBeAg-positive CHB patients in the high baseline ALT group and 27.5% (P < 0.05) of controls became HBeAg-negative, and 37.5% of those in the high baseline group and 22.5% of those in the control group had HBeAg seroconversion (P < 0.05). Moreover, in the high baseline group, 4 out of 40 patients (10%) became HBsAg-negative and 3 (7.5%) of them seroconverted (became HBsAb-positive). Only 1 patient in the control group became HBsAg-negative, but had no seroconversion (Table (Table22). Biochemical response At week 52, ALT normalization was achieved for 30 of the 40 patients (75.0%) in the high baseline ALT group and 31 of 40 patients (77.5%) in the control group (P > 0.05).