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Study population
A total of 1,521 consecutive chronic HBV infection patients who underwent liver biopsies and routine laboratory tests at Shanghai Public Health Clinical Center between May 2008 and January 2016 were retrospectively screened for inclusion in the study. Chronic HBV infection was defined as the persistent presence of serum HBV surface antigen (HBsAg) for more than 6 months (Sarin et al., 2016). The included subjects were treatment-naive patients with PNALT levels defined as normal ALT (≤40 IU/L) measured on at least three occasions at intervals of more than 2 months apart over a period of 12 or more months before liver biopsy. Patients with the following conditions were excluded from this study: significant alcohol consumption (>20 g/day) (132 patients); accompanied by non-alcoholic fatty liver disease (136 patients); accompanied by autoimmune liver disease (54 patients); co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency virus (106 patients); prior or current antiviral treatment (252 patients); and ALT>40 IU/L (449 patients). Finally, 392 treatment-naive chronic HBV infection patients with PNALT levels were included. Among the 392 eligible patients, 291 patients had HNALT levels (defined as 0.5 ULN<ALT≤1 ULN measured on at least three occasions at intervals of more than 2 months apart over a period of 12 or more months before liver biopsy), and 101 patients had LNALT levels (defined as ALT≤0.5 ULN measured on at least three occasions at intervals of more than 2 months apart over a period of 12 or more months before liver biopsy) (Sarin et al., 2016). In this study, the ULN of ALT is 40 IU/L.
Baseline characteristics of enrolled patients
Table 1.
Table 1. Baseline characteristics of enrolled patients.
392 chronic HBV infection patients were enrolled, and baseline characteristics were summarized in Table 1. The majority of enrolled patients were male (209, 53.3%), HBeAg positive (231, 58.9%) and middle-aged [36 (30-42) years]. Median HBV DNA, ALT, AST, ALP, GGT, total bilirubin, albumin, globulin, and WBC were 4.8 log10 copies/ml (IQR=3.6-7.2), 27 IU/L (IQR=20-33), 24 IU/L (IQR=21-29), 70 IU/L (IQR=59-85), 18 IU/L (IQR=13-28), 12 μmol/L (IQR=10-17), 44 g/L (IQR=41-47), 29 g/L (IQR=27-32), and 5.3×109/L (IQR=4.5-6.4), respectively. Mean platelet count was 178×109/L. Among 392 enrolled patients, 106 patients (27%) had significant liver inflammation, 119 patients (30.4%) had significant liver fibrosis, and 126 patients (32.1%) had SLHC.
Among 392 enrolled patients, 291 (74.2%) had HNALT and 101 (25.8%) had LNALT. The HNALT patients had significantly higher age (37 vs. 34 years, p=0.003), proportion of male (60.8% vs. 31.7%, p<0.001), ALT (30 vs. 16 IU/L, p<0.001), AST (26 vs. 20 IU/L, p<0.001), ALP (73 vs. 64 IU/L, p<0.001), GGT (19 vs. 14 IU/L, p<0.001), proportion of significant liver inflammation (30.9% vs. 15.8%, p=0.003), proportion of significant liver fibrosis (35.7% vs. 14.9%, p<0.001), and proportion of SLHC (36.4% vs. 19.8%, p=0.002) compared with LNALT patients. No significant statistical differences were seen in the proportion of HBeAg positive, HBV DNA, total bilirubin, albumin, globulin, WBC, and platelet count between HNALT group and LNALT group.
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