em J Hepatol /em 2012; 57:167C185. levels of anti-HBc in serum.11 According to the new method, Yuan et al12 found that among CHB patients, the anti-HBc levels in those who experienced elevated ALT levels were significantly higher than patients with normal levels of ALT. However, further researches proved that baseline of anti-HBc was an independent biomarker for predicting HBeAg seroconversion in CHB patients with therapy of interferon or nucleos(t)ide analogs, regardless of ALT levels. Our pilot study also found that levels of anti-HBc and ALT showed a linear correlation, and baseline levels of anti-HBc could predicate the response to interferon therapy (unpublished data). All results revealed that anti-HBc might be a surrogate parameter in indicating an immune activation against HBV. Despite the quantitative monitoring of anti-HBc has already been utilized for predicating therapeutic response in HBeAg (+) hepatitis patients, you will find no studies investigating the clinical significance of anti-HBc in treatment-naive patients. We hypothesize that anti-HBc levels mirror the immune-activation status of chronic HBV infection. Hence, the aim of this study is to evaluate anti-HBc levels in different phases of natural history with CHB who by no means received antiviral therapy; and the association between anti-HBc and ALT, AST, HBVCDNA, and other biochemical and virological markers in patients with chronic HBV contamination. METHODS Patient Populace Two hundred eleven patients who were prolonged of HBV contamination and never received antiviral therapy were included in the study. Patients were recruited from your Sixth Hospital of Shenyang, Liaoning, China. Eighty-seven patients were HBeAg positive as well as others were HBeAg negative. There were 122 males and 89 females with a median age of 38 years (minimum 18, maximum 65 years). Fifty patients who were HBsAg unfavorable and anti-HBc positive were also recruited as past HBV contamination (PBI) CGP-52411 control group. Patients combined with other viral hepatitis, autoimmune or metabolic liver disease, hepatic dysfunction, or malignancies were excluded as well as ones who received immunosuppressive therapy. Children or adolescents with CHB were also excluded in this study. Patients included were classified into different phases of CHB according to Table ?Table1.1. The criteria were based on the European Association for the Study Rabbit Polyclonal to OPN3 of the Liver clinical practice guidelines. 5 The study was conducted according to the guidelines of the Declaration of Helsinki, and was approved by the local institutional ethics research committee. TABLE 1 Definitions of the Different Phases of Chronic HBV Contamination and Recent HBV Infection Open in a separate windows Serum HBsAg Quantification Serum HBsAg levels were quantified CGP-52411 using the Roche Elecsys HBsAg II assay (Roche Diagnostics, Penzberg, Germany). Quantitative HBsAg levels were tested with a dilution of 1 1:400 and reported in IU/mL, with a dynamic range of 20 to 52,000?IU/mL. If HBsAg levels 52,000?IU/mL, samples were retested with a stepwise dilution of 1 1:4000. Samples with HBsAg levels 20?IU/mL were retested without prior dilution. HBVCDNA Measurement Serum HBVCDNA was measured according to the manufacturer’s instructions (dynamic range 2.0??101C1.7??108?IU/mL) of COBAS AmpliPrep/COBAS TaqMan, Roche Diagnostics, Basel, Switzerland. Samples with a viral weight above the upper limit of the dynamic range were retested at a dilution of 1 1:1000 to obtain a defined level. Anti-HBc CGP-52411 Measurement The serum anti-HBc levels were measured by a newly developed double-sandwich immunoassay (Wantai, Beijing, China) that was calibrated using immunoassay.11 Statistical Analysis Continuous and categorical variables were compared between the groups, using the MannCWhitney test and KruskallCWallis analysis of variance for nonparametric continuous data, and 2/Fisher exact test for categorical data. Correlation of anti-HBc with ALT, HBsAg, and other parameters was carried out using the method of Pearson and Spearman. The significance level was fixed at 0.05. Statistical analyses were performed by SPSS ver. 16.0 (SPSS, Chicago, IL). RESULTS Two hundred eleven treatment-naive HBsAg-positive patients and 50 anti-HBc-positive patients as a control group were included in the study. The distributions of patients were: IT (n?=?38), IC (n?=?49), LR (n?=?69), ENH (n?=?55), and PBI (n?=?50). The baseline characteristics are offered in Table.