Efficacy of 104-week sequential therapy with telbivudine or entecavir in HBeAg-positive chronic hepatitis B patients with suboptimal responses to 24-week therapy with pegylated interferon-α-2a
10.3760/cma.j.issn.1007-3418.2016.04.001
- VernacularTitle:聚乙二醇干扰素α-2a治疗HBeAg阳性慢性乙型肝炎24周应答不佳患者序贯替比夫定及恩替卡韦104周疗效观察
- Author:
Xiaodan LUO
1
;
Xiaoping CHEN
;
Ren CHEN
;
Xuefu CHEN
;
Jing HUANG
Author Information
1. 广东省医学科学院广东省人民医院感染科
- Keywords:
Hepatitis B,chronic;
Interferon;
Telbivudine;
Suboptimal responses
- From:
Chinese Journal of Hepatology
2016;24(4):241-245
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the efficacy and safety of 104-week sequential therapy with telbivudine or entecavir in HBeAg-positive chronic hepatitis B (CHB) patients with suboptimal responses to 24-week pegylated interferon-α-2a (PEG-IFN-α-2a) therapy.Methods A total of 130 HBeAg-positive CHB patients with HBV DNA ≥ 5.0 lg IU/ml and a reduction in HBsAg quantitation ＜ 1 lg IU/ml compared with baseline who received PEG-IFN-α-2a therapy for 24 weeks were enrolled and randomly divided into telbivudine group and entecavir group,and 5 of them were lost.HBeAg clearance rate and seroconversion rate,HBV DNA clearance rate,safety,and drug resistance rate at week 104 were observed.The t-test,chi-square test,or multivariate Cox regression analysis were used for statistical analysis of different types of data.Results At week 104 of treatment,HBV DNA clearance rate showed no significant difference between the telbivudine group and entecavir group (P =0.363),and the telbivudine group had significantly higher HBeAg clearance rate and HBeAg seroconversion rate than the entecavir group (HBeAg clearance rate:61.29％ vs 23.81％,P ＜ 0.01;HBeAg seroconversion rate:51.61％ vs 19.05％,P ＜ 0.01).Male sex and telbivudine therapy were baseline predictors of HBeAg seroconversion.The multivariate Cox regression analysis (Forward LR,a =0.05) showed that the presence or absence of HBeAg seroconversion at week 104 was significantly associated with male sex (HR =4.917),a reduction in HBsAg ＞ 0.5 lg IU/ml at week 12 of treatment compared baseline (HR =3.514),and a reduction in HBeAg ＞ 1 lg COI at week 12 of treatment compared baseline (HR =8.651).Conclusion In HBeAg-positive CHB patients with suboptimal responses to 24-week PEG-IFNα-2a therapy,the sequential therapy with telbivudine helps achieve better HBeAg clearance rate and seroconversion rate compared with the sequential therapy with entecavir and can be used as a therapeutic regimen for such patients.A reduction in HBeAg ＞ 1 lg COI at week 12 of treatment compared baseline can be used as a predictive factor for HBeAg seroconversion at week 104.
