Efficacy of antiviral/immunomodulatory therapy for naive patients with HBeAg-positive chronic hepatitis B / 中华临床感染病杂志

ABSTRACT

Objective To evaluate the clinical efficacy of interferon(IFN) α-2b,adefovir dipivoxil (ADV),granulocyte-macrophage colony stimulating factor (GM-CSF) and hepatitis B vaccine in the treatment of patients with HBeAg-positive chronic hepatitis B (CHB).Methods Two hundredand forty HBeAg-positive CHB patients admitted in the First Affiliated Hospital,Zhejiang University School of Medicine during November 2013 and December 2015 were retrospectively reviewed.They were randomly assigned to four groups with 60 cases in each group,to receive IFNα-2b (group A),IFNα-2b + ADV (group B),IFNα-2b + ADV + GM-CSF (group C) or IFNoα-2b + ADV + GM-CSF + hepatitis B vaccine (group D) for treatment,respectively.All patients were treated for 48 wks and then followed up for 24 wks.The HBsAg serological response,HBeAg serological response,virological response,biochemical response,histological response and adverse effects were compared among 4 groups.Results After 48-wk treatment,the HBsAg negative conversion rate of group D was significantly higher than that of group A and B (x2 =8.634 and 8.634,both P ＜ 0.01);the seroconversion rate of HBsAg in group D was significantly higher than that in group A and group B (x2 =7.149 and 7.149,both P ＜0.01).The baseline drop rate of HBsAg in group C and D was higher than that in group A (t =4.194 and 4.508,both P ＜0.01).In 24-wk follow-up,HBsAg negative conversion rate was as same as that after 48-wk treatment;the seroconversion rate of HBsAg in group D was significantly higher than that in group A and B (x2 =8.634 and 8.634,both P ＜0.01).The baseline drop rate of HBsAg in group C and group D was higher than that in group A (t =4.546 and 4.969,both P ＜0.01).After 48-wk treatment,the HBeAg negative conversion rate in group D was significantly higher than that in group A (x2 =8.792,P ＜ 0.01);the HBeAg seroconversion rate of group C and D was higher than that of group A (x2 =7.064 and 10.159,P ＜0.01).In 24-wk follow-up,the HBeAg negative conversion rate in group C and D was higher than that in group A (x2 =10.159 and 13.713,P ＜0.01);the HBeAg negative conversion rate in group D was higher than that in group B (x2 =8.155,P ＜0.01);the seroconversion rate of HBeAg in group C and D was higher than that in group A (x2 =10.506 and 12.857,P ＜ 0.01).After 48-wk treatment,the negative rate of HBV DNA in group B,C and D was significantly higher than that in group A (x2 =12.452,17.062 and 20.670,all P ＜0.01).In the 24-wk follow-up,the negative rate of HBV DNA in group B,C and D was also significantly higher than that in group A (x2 =21.121,26.880 and 33.611,all P ＜ 0.01).After 48-wk treatment,the alanine aminotransferase (ALT) normalization rate of the group of C and D was significantly higher than that in group A (x2 =8.711 and 8.711,both P ＜0.01).In the 24-wk follow-up,the ALT normalization rate in group C and D was significantly higher than that in group A (x2 =8.076 and 9.624,P ＜0.01).After 48-wk treatment,the improvement rate of inflammation or fibrosis in the group of A,B and C was significantly higher than that in the group A (x2 =8.543,13.348 and 16.205,all P ＜ 0.01).There were no half-way withdrawal and no serious adverse reactions.The main adverse reactions were fever,headache and fatigue,and no significant difference of above reaction was observed among 4 groups (P ＞ 0.05).Conclusion The new anti-virus/immunoregulation therapy containing IFNα-2b + ADV + GM-CSF + hepatitis B vaccine has a better therapeutic effect for patients with HBeAg-positive CHB.