Pegylated interferon combined with entecavir in treatment of HBeAg positive chronic hepatitis B / 中华全科医师杂志

ABSTRACT

Objective To evaluate the efficacy of pegylated interferon α-2a and entecavir (ETV) combination therapy for patients with HBeAg positive chronic hepatitis B (CHB).Methods Fifty eight HBeAg positive CHB patients were assigned to two groups29 patients received ETV 0.5 mg daily for 72 weeks (ETV group) and 29 patients received ETV and pegylated interferon α-2a 180 μg weekly for 48 weeks followed by ETV alone for 24 weeks (combination group).Serum samples were collected from all patients every 12 weeks for assessment of biochemical,virological and serological responses to treatment.Results Fifty four patients completed the 72-week study,including 28 in ETV group and 26 in combination group.There were no significant differences in week 24,week 48 and week 72 of ALT normalization [72％ (21/29)vs.93％ (27/29),x2 =2.104;90％ (26/29) vs.97％ (28/29),x2 =0.269;90％ (26/29) vs.97％ (28/29),x2 =0.269],HBV DNA undetectable rate [31％ (8/26) vs.46％ (13/28),x2 =1.391;62％ (16/26) vs.57％ (16/28),x2 =0.108;77％ (20/26) vs.75％ (21/28),x2 =0.027],HBeAg loss rate[12％(3/26) vs.25％ (7/28),x2 =0.850;31％ (8/26) vs.32％ (9/28),x2 =0.012;46％ (12/26) vs.36％(10/28),x2 =0.609] and HBsAg levels (log10 IU/ml) (3.63 ± 0.45 vs.3.36 ± 1.18,t =-1.066;3.45 ±0.43 vs.3.23 ± 1.15,t =-0.915;3.36 ± 0.58 vs.2.88 ± 1.28,t =-1.762) between two regimens (all P ＞ 0.05).Among 58 patients,15 were HBeAg and anti-HBe double-positive (26％)and 43 were HBeAg mono-positive patients.The baseline HBV DNA level [(5.07 ± 1.50) vs.(6.40 ± 1.47) log10 IU/ml,t =2.858,P ＜ 0.05] and HBeAg titer [14 (4-45) vs.732 (296-1 012) S/CO,Z =-5.031,P =0.05] in double-positive patients were lower than those in mono-positive patients.The HBV DNA undetectable rate of double-positive patients was significantly higher than that of mono-positive patients in 24 weeks [10/15 vs.26％ (10/39),x2 =7.819,P ＜0.05] and 72 weeks [15/15 vs.69％ (27/39),x2 =4.287,P =0.05].The HBeAg loss rate of double-positive patients was higher than that of mono-positive patients in 12 weeks [6/15 vs.10％ (4/39),x2 =4.533,P =0.05] and 48 weeks [9/15 vs.26％ (10/39),x2 =5.608,P =0.018].This tendency was more significant in the combination therapy group,but the difference was not statistically significant.(5/6 vs.4/9,P =0.065).Conclusions Compared with Entecavir monotherapy,entecavir combined with interferon may not improve the therapeutic effect in HBeAg positive chronic hepatitis B patients.However,the therapeutic response of HBeAg/anti-HBe double-positive patients may better than that of HBeAg mono-positive patients.