9 Patients who were treated according to the protocol and complet

9 Patients who were treated according to the protocol and completed the follow-up phase were selected for the present study. Patients eligible for the original study had been positive for

HBsAg for more than 6 months, were HBeAg-negative and antibody to HBeAg–positive on two occasions within 2 months before randomization, had two episodes of elevated serum alanine aminotransferase (ALT) levels (>1.5 but ≤10 times the upper limit of normal of the normal range) within 2 months before randomization, and had a serum HBV DNA level >100,000 copies/mL (17,143 IU/mL). Exclusion criteria were as follows: antiviral or immunosuppressive therapy within the previous 6 months; coinfection with hepatitis LDE225 C, hepatitis D, or human immunodeficiency virus; other acquired or inherited causes of liver disease; and preexisting cytopenia or decompensated liver disease. The study was conducted in accordance with the guidelines of the Declaration of Helsinki and the principles

of good clinical practice. All patients gave written, informed consent. Serum HBsAg was quantified in samples taken at the baseline, during the treatment period (weeks 4, 8, 12, 24, 36, and 48), and during follow-up (weeks 60 and 72) with the Architect HBsAg assay (Abbott Laboratories; range = 0.05-250 IU/mL).18 Serum HBV DNA was measured at the same time points with the TaqMan polymerase chain reaction assay [TaqMan HBV assay, Roche Diagnostics; lower limit of quantification = 35 copies/mL (6 IU/mL)]. Aminotransferases were measured locally at find more the time of sampling in accordance with standard procedures. The HBV genotype was assessed with the INNO-LiPA assay (Innogenetics). Liver biopsy was performed in all patients within 1 year before randomization. The necroinflammation grade (range = 0-18) and fibrosis stage (range = 0-6) were assessed with the Ishak scoring system.19 SR, the predefined primary endpoint in the original study, was defined according

to the European Association for the Study of the Liver guidelines as the combined presence of serum HBV DNA levels less than 10,000 copies/mL (1714 IU/mL) and normalization of ALT at the end 上海皓元 of follow-up (week 72).20 The association between the baseline factors and SR was assessed by univariate logistic regression analyses. Predictive values of early on-treatment serum HBsAg levels as well as HBV DNA and ALT levels (weeks 4, 8, and 12) were explored with logistic regression analysis techniques. Discrimination, which is the ability to distinguish patients who will develop SR from those who will not, was quantified by the area under the receiver operating characteristic curve (AUC). The best model fit was assessed by a comparison of the AUC and Akaike’s information criterion (AIC).

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