Week 24 interim analysis of peginterferon α-2a in HBeAg positive chronic hepatitis B patients with alanine aminotransferase＜2× upper limit of normal / 中华传染病杂志

ABSTRACT

Objective To compare the efficacy of peginterferon (Peg-IFN) α-2a in HBeAg positive chronic hepatitis B (CHB) patients with mildly elevated alanine aminotransferase (ALT) level [ALT＜2× upper limit of normal (ULN)] and active hepatic inflammation(G≥2).Methods Fiftyfive HBeAg positive CHB patients with mildly elevated ALT (＜2×ULN) and active hepatic inflammation (G≥2) were enrolled in this randomized,open-label,controlled study.These patients were treated with either Peg-IFN α-2a 180 μg once weekly (n=27) or entecavir 0.5 mg once daily (n=28) for 48 weeks.The data were analyzed using chi-square test and t test.Results After 24 weeks of treatment,8 cases (29.6%) achieved HBeAg loss and 6 cases (22.2%) achieved HBeAg seroconversion in Peg-IFN α-2a group while none in entecavir group (χ2=9.71,P＜0.01;χ2=6.98,P＜0.0 1).Besides,two patients (7.4%) in Peg-IFN α-2a group achieved HBsAg loss.Compared with baseline level,the mean HBeAg titer at week 24 decreased (1 179.8±582.6) PEIU/mL in Peg-IFN α-2a group and (441.5±258.8) PEIU/mL in entecavir group (t=2.66,P=0.01),respectively.At week 24,the serum HBV DNA reduction in entecavir group was more dramatic than that in Peg-IFN α-2a group [(4.520±0.694) lg copy/mL vs.(3.520±1.442) lg copy/mL,t=2.45,P=0.029].In PegIFN α-2a group,the rate of HBeAg loss in patients with G=3 was higher than that in patients with G=2 (χ2=4.23,P=0.041).Conclusions Twenty-four-week treatment with Peg-IFN α-2a is more effective in term of HBeAg loss,HBeAg seroconversion and HBeAg titer reduction than entecavir,while entecavir is more effective in term of serum HBV DNA reduction.Patients with higher baseline hepatic inflammatory activity scores are more possible to achieve HBeAg loss when treated with Peg-IFN α-2a.