恩替卡韦单药与聚乙二醇干扰素α-2a 联合治疗慢性乙型肝炎患者的纤维化消退比较。

Comparison of fibrosis regression of entecavir alone or combined with pegylated interferon alpha2a in patients with chronic hepatitis B.

机构信息

Liver Research Center, Beijing Key Laboratory of Translational Medicine On Liver Cirrhosis, Beijing Friendship Hospital, National Clinical Research Center of Digestive Diseases, Capital Medical University, 95 Yong-an Road, Xi-Cheng District, Beijing, 100050, China.

Department of Pathology, Beijing You-an Hospital, Capital Medical University, Beijing, China.

出版信息

Hepatol Int. 2021 Jun;15(3):611-620. doi: 10.1007/s12072-021-10162-1. Epub 2021 Mar 7.

DOI:10.1007/s12072-021-10162-1

PMID:33677771

Abstract

BACKGROUND AND AIMS

Antiviral treatment with necleos(t)ide analogues contributes to histological improvement and virologic response in chronic hepatitis B (CHB) patients. However, whether adding pegylated interferon alpha2a (Peg-IFN-α-2a) can help additional clinical benefit, particularly on fibrosis regression was still unknown.

METHODS

Chronic hepatitis B patients with pre-treatment biopsy-proven Ishak fibrosis score 2, 3 or 4 were randomly assigned to entecavir (ETV) alone or ETV plus Peg-IFN-α-2a (Peg-IFN-α-2a add-on) group (1:2 ratio). Post-treatment liver biopsy was performed at week 78. Fibrosis regression was defined as decrease in Ishak fibrosis score by ≥ 1 stage or predominantly regressive categorized by P-I-R score. Serum HBV DNA levels were assessed at baseline and every 26 weeks, while HBsAg and HBeAg were evaluated at baseline and every 52 weeks.

RESULTS

A total of 218 treatment-naive CHB patients were randomly assigned to ETV alone or Peg-IFN-α-2a add-on group. Totals of 155 patients (ETV alone: Peg-IFN-α-2a add-on, 47:108) were included in statistical analysis. Fibrosis regression rates were 68% (32/47) in the ETV alone and 56% (60/108) in Peg-IFN-α-2a add-on group (p = 0.144). Both groups showed a similar trend of virological suppression during the process of 104-week antiviral therapy (p = 0.132). HBeAg or HBsAg loss or seroconversion rates in the ETV alone group were lower than Peg-IFN-α-2a add-on group though without statistical significance.

CONCLUSIONS

Peg-IFN-α-2a add-on therapy did not yield additional fibrosis regression and virologic response than ETV alone therapy.

摘要

背景和目的

核苷（酸）类似物抗病毒治疗可改善慢性乙型肝炎（CHB）患者的组织学和病毒学应答。然而，加用聚乙二醇干扰素 α2a（Peg-IFN-α-2a）是否能带来额外的临床获益，尤其是在肝纤维化逆转方面，目前仍不清楚。

方法

对治疗前肝活检证实为 Ishak 纤维化评分 2、3 或 4 的慢性乙型肝炎患者进行随机分组，分别接受恩替卡韦（ETV）单药治疗或 ETV 联合 Peg-IFN-α-2a（Peg-IFN-α-2a 加用）治疗（1:2 比例）。治疗 78 周时进行肝活检。纤维化缓解定义为 Ishak 纤维化评分降低≥1 级或按 P-I-R 评分主要为逆转。基线和每 26 周评估血清 HBV DNA 水平，基线和每 52 周评估 HBsAg 和 HBeAg。

结果

共纳入 218 例初治 CHB 患者，随机分配至 ETV 单药或 Peg-IFN-α-2a 加用组。共有 155 例患者（ETV 单药组：Peg-IFN-α-2a 加用组，47:108）纳入统计分析。ETV 单药组的纤维化缓解率为 68%（32/47），Peg-IFN-α-2a 加用组为 56%（60/108）（p=0.144）。两组在 104 周抗病毒治疗过程中均显示出类似的病毒学抑制趋势（p=0.132）。尽管 ETV 单药组的 HBeAg 或 HBsAg 丢失或血清学转换率低于 Peg-IFN-α-2a 加用组，但无统计学意义。