恩替卡韦单独或与聚乙二醇干扰素α2a联合使用对慢性乙型肝

StephenW

Comparison of fibrosis regression of entecavir alone or combined with pegylated interferon alpha2a in patients with chronic hepatitis B
Shuyan Chen #  1 , Jialing Zhou #  1 , Xiaoning Wu  1 , Tongtong Meng  1 , Bingqiong Wang  1 , Hui Liu  2 , Tailing Wang  3 , Xinyan Zhao  1 , Yuanyuan Kong  1 , Shanshan Wu  1 , Xiaojuan Ou  1 , Jidong Jia  1 , Yameng Sun  4 , Hong You  5
Affiliations
Affiliations

    1
    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.
    2
    Department of Pathology, Beijing You-an Hospital, Capital Medical University, Beijing, China.
    3
    Department of Pathology, China-Japan Friendship Hospital, Beijing, China.
    4
    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. [email protected].
    5
    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. [email protected].

#
Contributed equally.

    PMID: 33677771 DOI: 10.1007/s12072-021-10162-1

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.

Keywords: Antiviral treatment; HBV DNA; HBeAg loss; HBeAg seroconversion; HBsAg loss; HBsAg seroconversion; Hepatitis B virus infection; Liver fibrosis; Reverse; Virological response.

StephenW

恩替卡韦单独或与聚乙二醇干扰素α2a联合使用对慢性乙型肝炎患者纤维化消退的比较
陈树岩＃1，周嘉陵1＃，吴晓宁1，童彤蒙1，王炳琼1，刘慧2，王泰凌3，赵新彦1，圆圆孔1，吴珊珊1，Xiao小娟1，冀东贾1，孙亚萌4，洪游5
隶属关系
隶属关系

    1个
    首都医科大学附属北京市消化病国家临床研究中心，北京市友谊医院肝硬化转化医学北京市重点实验室肝研究中心，北京西城区永安路95号，100050。
    2个
    首都医科大学附属北京佑安医院病理科，北京
    3
    中日友好医院病理科，北京。
    4
    首都医科大学附属北京消化病国家临床消化研究中心，北京市肝硬化转化医学北京市重点实验室肝病研究中心，北京市西城区永安路95号，100050 [email protected]。
    5
    首都医科大学附属北京市消化病国家临床研究中心，北京市友谊医院肝硬化转化医学北京市重点实验室肝研究中心，北京西城区永安路95号，100050。 [email protected]。

＃
贡献均等。

    PMID：33677771 DOI：10.1007 / s12072-021-10162-1

抽象的

背景和目的：核苷类似物的抗病毒治疗有助于慢性乙型肝炎（CHB）患者的组织学改善和病毒学应答。但是，是否添加聚乙二醇化干扰素α2a（Peg-IFN-α-2a）是否可以帮助额外的临床获益，尤其是在纤维化消退方面仍是未知的。

方法：将经治疗前活检证实为Ishak纤维化评分为2、3或4的慢性乙型肝炎患者随机分配至单独的恩替卡韦（ETV）或ETV加Peg-IFN-α-2a（Peg-IFN-α-2aadd- on）组（比例为1：2）。治疗后第78周进行了肝活检。纤维化消退定义为Ishak纤维化评分降低≥1级或主要以P-I-R评分归类。在基线和每26周评估一次血清HBV DNA水平，而在基线和每52周评估一次HBsAg和HBeAg。

结果：总共218例未接受过治疗的CHB患者被随机分配到单独的ETV或Peg-IFN-α-2a附加治疗组。统计分析中包括155例患者（仅ETV：Peg-IFN-α-2a附加，47：108）。仅ETV的纤维化消退率是68％（32/47），Peg-IFN-α-2a附加组的纤维化消退率是56％（60/108）（p = 0.144）。两组在104周抗病毒治疗过程中表现出相似的病毒抑制趋势（p = 0.132）。单纯ETV组的HBeAg或HBsAg丢失或血清转化率低于Peg-IFN-α-2a附加组，但无统计学意义。

结论：Peg-IFN-α-2a联合治疗比单独的ETV治疗没有产生额外的纤维化消退和病毒学应答。

关键字：抗病毒治疗； HBV DNA； HBeAg丢失； HBeAg血清转化； HBsAg丢失； HBsAg血清转化；乙肝病毒感染；肝纤维化；撤销;病毒学反应。