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Objective To investigate the independent predictive factors for significant liver histological changes (SLHCs) in patients with HBeAg - positive high - viral - load chronic hepatitis B virus (HBV) infection and a normal alanine aminotransferase (ALT) level. Methods A retrospective analysis was performed on the clinical data of 116 previously untreated patients with HBeAg - positive high - viral -load (HBV DNA≥105 copies/ml) chronic HBV infection and a normal ALT level ( <50 U/L) who were hospitalized in Shanghai Public Health Clinical Center Affiliated to Fudan University from June 2013 to August 2015. The definition of SLHCs was inflammation ≥G2 and// or fibrosis ≥S2. The t - test or Mann - Whitney U rank sum test was used for comparison of continuous data between groups, and the chi -square test was used for comparison of categorical data between groups. Univariate and multivariate regression analyses were used to determine independent predictive factors for SLHCs. Results Of all the 116 patients, 47 (40. 5% ) had SLHCs. The multivariate analysis showed that age ( OR =2. 828 , P < 0. 05 ) , ALT ( OR = 1.011, P <0.05) , and gamma - glutamyl transpeptidase ( GGT) ( OR = 1. 089, P <0. 05) were independent predictors for SLHCs in patients with HBeAg - positive high - viral - load chronic HBV infection and a normal ALT level. The patients aged ≤30 years had a significantly lower incidence rate of SLHCs than those aged > 30 years (21.6% vs 49.4% , X2 = 6. 42, P =0. 015 ) , the patients with ALT ≤30 U/L had a significantly lower incidence rate of SLHCs than those with 30 U/L < ALT≤ 50 U/L (17.6% vs 50.0% ,;X2 = 19. 86, P <0.001), and the patients with GGT ≤40 U/L had a significantly lower incidence rate of SLHCs than those with GGT >40 U/L (28. 8% vs 66. 7% , x2 = 28. 63 , P < 0. 001 ) . Conclusion In patients with HBeAg - positive high -viral - load chronic HBV infection and a normal ALT level, those with an age of > 30 years, ALT > 30 U/L, and GGT > 40 U/L tend to develop SLHCs and need liver biopsy. [ABSTRACT FROM AUTHOR]

Chronic hepatitis B (CHB) is one of the major causes of liver cirrhosis and hepatocellular carcinoma. Interferon and nucleos(t)ide analogues can control disease progression. However, they cause very low HBsAg clearance or seroconversion rates and relapse in most patients after treatment withdrawal. In recent years, the further understanding of the interaction between hepatitis B virus (HBV) and host gives birth to a large number of novel drugs that hold promise for successful cure of CHB. This paper reviews several novel drugs against HBV in phase I, II, or III clinical trials, and points out that these novel drugs against HBV have preliminarily indicated a bright future. [ABSTRACT FROM AUTHOR]