Control study of peginterferon α-2a and entecavir treatment in chronic hepatitis B patients / 中华传染病杂志

ABSTRACT

Objective To observe the efficacy and safety of peginterferon α-2a and entecavir treatment in chronic hepatitis B(CHB)patients with alanine aminotransferase(ALT)＜2×upper limit of normal(ULN)and hepatic inflammatory activity(G)≥2.Methods 0ne hundred CHB patients with ALT＜2×ULN and G≥2 were enrolled in the open-label and control study. Fifty patients were treated with peginterferon α-2a including 34 hepatitis B e antigen(HBeAg)positive cases and the other 50 patients were treated with entecavir including 33 HBeAg positive cases.The patients were evaluated at week 48 of treatment. The data were analyzed using variance test,t test,Wileoxon test and X~2 test. Results Baseline levels of hepatitis B virus(HBV)DNA,ALT, HBeAg, hepatitis B surface antigen(HBsAg)and hepatic histology were comparable in peginterferon a-2a group and entecavir group. At week 48 of treatment, HBV DNA negative rates in the 2 groups were 66.0% and 72.0%,respectively(X~2=0.421,P=0.517);HBV DNA levels decreased(3.08±1.43)lg copy/mL and(3.79±1.36)lg copy/mL, respectively(t=2.544,P=0.013).Five(10%)patients in peginterferon α-2a group achieved HBsAg loss, while only 1(2.0%)in entecavir group(X~2=2.837,P=0.204);three(6%)patients in peginterferon α-2a group achieved HBsAg seroconversion, while no one in entecavir group(X~2=3.093,P=0.242).Fourteen(41.2%)HBeAg positive patients in peginterferon α-2a group achieved HBeAg loss and seroconversion,while 5(15.2%)HBeAg positive patients in entecavir group achieved HBeAg loss and 4 of them(12.1%)obtained HBeAg seroconversion (X~2=5.583,P=0.018;X~2=7.159,P=0.007).Paired liver biopsies before and after treatment were done in 15 patients in peginterferon α-2a group and 14 in entecavir group. Eleven patients in peginterferon α-2a group and 9 in entecavir group achieved necroinflammatory improvement(Knodell score decline ≥2)at week 48 of treatment(X~2=0.277,P=0.599).Concusions CHB patients with ALT＜2×ULN and G≥2 treated with peginterferon α-2a could achieve virological response,serological response and histologic improvement with good safety. HBeAg seroconversion rate in patients treated with pegintert'eron α-2a is much higher than that in patients treated with entecavir.