Efficacy Of PegIFN-? In The Treatment Of HBeAg-negative CHB With Normal Or Mild Elevated ALT And METAVIR Scores?G2S2

Background: Hepatitis B virus is the most important risk factor of liver cirrhosis and hepatocellular carcinoma.Chronic hepatitis B has brought significant health and economic burdens,especially in the Asia-Pacific region.More and more clinical and basic studies have shown that the proportion of HBeAg-negative chronic hepatitis B in HBV-infected chronic viral hepatitis increased year by year.At present,clinical treatment is mainly based on alanine aminotransferase ? 2 times the upper limit of normal value and more and more data show that there are some HBeAg-negative patients with normal or mildly elevated ALT exist moderate to severe inflammation or fibrosis of the liver lesions.Pegylated interferon ? is an antiviral drug with both immunoregulatory and antiviral effects.The available data suggest that pegylated interferon ? has a strong antiviral activity against HBeAg-positive or HBeAg-negative chronic hepatitis B patients.However,there is few research discussing the efficacy of pegylated interferon ? in the treatment of HBeAg-negative chronic hepatitis B with normal or mild elevated ALT and pathology confirmed the presence of moderate to severe liver lesions and the predictors of responses.Objective: To investigate the efficacy and predictors of pegylated interferon ? in HBeAg-negative chronic hepatitis B with normal or mild elevated and METAVIR scores ? G2S2.Methods: HBeAg-negative chronic hepatitis B Patients with normal or mild elevated and METAVIR scores of ?G2S2 were treated with pegylated interferon ? for 48 weeks,and the biochemistry,virology,serology,Liver stiffness measurement and other information of were retrospectively analyzed.Results:(1)According to the criteria,49 HBeAg-negative CHB patients with normal or mild elevated ALT were enrolled in this study.The average age was 37.62 ± 10.12 years,including 24 males and 18 females.There are 14 patients with undetectable HBV DNA levels before treatment,and the other 28 patients with detectable HBV DNA before treatment.(2)During the course of treatment,the level of ALT was fluctuantly increased and reached the highest level at 48 weeks.The difference between the baseline ALT and 48 week's ALT was statistically significant(P <0.05).The level of serum HBV DNA decreased gradually and the baseline HBV DNA was significantly higher than that of the every follow-up point(P<0.05).HBsAg titer decreased gradually.The difference between the baseline HBsAg titer and every follow-up point HBsAg titer was statistically significant(P<0.05).The difference between each follow-up point HBsAg titer was statistically significant(P<0.05).LSM was fluctuantly decreased,the difference between baseline LSM and 12 week's LSM,36 week's LSM were statistically significant(P<0.05).(3)At the end of 48 weeks,the HBsAg titer of 14 patients with undetectable HBV DNA levels before treatment decreased from(2.74 ± 1.03)log10IU / m L to(1.79 ± 1.69)log10IU / m L.There were 4 patients who's HBsAg titer <100IU/ml,accounting for 28.57%(4/14).One patient had HBsAg clearance,and the complete response rate was 7.14%(1/14).(4)During the course of treatment,the level of ALT was fluctuantly increased,the level of increasing and decline were not statistically significant(P>0.05).The HBsAg titer decreased gradually and the level of decline after 24 weeks was statistically significant(P<0.05).The LSM increased gradually and the increasing level was not statistically significant(P>0.05).(5)At the end of 48 weeks,22 of 28 patients with detectable HBV DNA before treatment had serum HBV DNA lower than the detection limit,the virologic response rate was 78.60%(22/28)and the primary nonresponse rate plus partial virological response rate was 17.90%(5/28).Six patients had HBsAg titer <100IU/ ml,accounting for 21.43%(6/28).One patient had HBsAg clearance and the complete response rate was 3.57%(1/28).(6)During the course of treatment,the ALT level in the virological response group increased at 12 weeks and decreased gradually after that,the level of increasing and decline were not statistically significant(P>0.05).Serum HBV DNA level decreased gradually,the difference between baseline serum HBV DNA level and 12 week's,24 week's,36 week's,48 week's serum HBV DNA level were statistically significant(P<0.05).HBsAg titer decreased gradually and the level of decline after 24 weeks was statistically significant(P<0.05).LSM was fluctuantly decreased,the difference between baseline LSM and 12 week's LSM,24week's LSM,36 week's LSM were statistically significant(P<0.05).The virological response group and nonresponse group had no significant difference in age,sex,family history,baseline ALT,baseline HBV DNA,baseline HBsAg,baseline LSM and on-treatment of ALT,HBV DNA,HBsAg and LSM(P>0.05).(7)Multivariate logistic regression analysis showed that there was no factor in predicting the virologic response at 48 weeks(P>0.05).Conclusion: 1.The pegylated interferon ? has a high antiviral effect on HBeAg-negative CHB patients with normal or mild elevated ALT and METAVIR scores ? G2S2 at 48 weeks and the virological response rate was 78.60% same as HBeAg-negative CHB patients with ALT ? 2ULN;2.The pegylated interferon ? significantly reduced HBsAg titers in HBeAg-negative CHB patients with undetectable baseline HBV DNA and normal or slightly elevated ALT,METAVIR scores ? G2S2,especially after 24 weeks' treatment.