Clinical effect of entecavir antiviral therapy in chronic hepatitis B patients with persistently normal alanine aminotransferase and mild liver histological abnormalities

Objective  To investigate the clinical effect of entecavir antiviral therapy in chronic hepatitis B (CHB) patients with persistently normal alanine aminotransferase (PNALT) and mild liver histological abnormalities. Methods  A retrospective analysis was performed for 181 patients with hepatitis B virus (HBV) infection who were admitted to The First Affiliated Hospital of Guangxi Medical University from January 2008 to January 2018, and according to the baseline ALT level, they were divided into study group (61 patients with PNALT at baseline), control group 1 [62 patients with an ALT level of (1-2)×upper limit of normal (ULN)], and control group 2 (58 patients with an ALT level of > 2×ULN). Entecavir antiviral therapy was given for at least 1 year, and clinical outcome was compared between the three groups. The life-table method was used to calculate the cumulative progression rates and annual incidence rates of virologic response, HBeAg serological response, and virologic breakthrough. An analysis of variance was used for comparison of continuous data between groups, and the SNK method was used for further comparison between two groups; the chi-square test was used for comparison of categorical data between groups. Results  Among the 181 patients enrolled in this study, there were 124 male patients (68.5%) and 80 patients with positive HBeAg (44.2%), with a mean follow-up time of 3.63 years. The three groups had a mean annual incidence rate of virologic response of 74.37%, 71.89%, and 74.21%, respectively (χ2=2.91, P=0.371) and an annual incidence rate of virologic breakthrough of 3.48%, 5.17%, and 2.73%, respectively (χ2=1.72, P=0.097). For the patients with positive HBeAg, the three groups had a mean annual clearance rate of 9.79%, 37.16%, and 38.24%, respectively (χ2=1.37, P=0.01) and a mean annual HBeAg seroconversion rate of 9.10%, 31.35%, and 36.74%, respectively (χ2=5.61, P=0.021); the study group had significantly lower mean annual clearance rate and seroconversion rate of HBeAg than the control groups 1 and 2 (all P Conclusion  CHB patients with PNALT level can obtain satisfactory virologic response after entecavir antiviral therapy, while immunological response needs to be further improved.