与中国的慢性乙型肝炎和乙型肝炎表面抗原≤1500 IU / mL的连

StephenW

World J Gastroenterol. 2020 Apr 7;26(13):1525-1539. doi: 10.3748/wjg.v26.i13.1525.
Add-on pegylated interferon augments hepatitis B surface antigen clearance vs continuous nucleos(t)ide analog monotherapy in Chinese patients with chronic hepatitis B and hepatitis B surface antigen ≤ 1500 IU/mL: An observational study.
Wu FP1, Yang Y1, Li M1, Liu YX1, Li YP1, Wang WJ1, Shi JJ1, Zhang X1, Jia XL1, Dang SS2.
Author information

1
    Department of Infectious Diseases, the Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710004, Shaanxi Province, China.
2
    Department of Infectious Diseases, the Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710004, Shaanxi Province, China. [email protected].

Abstract
BACKGROUND:

Nucleos(t)ide analog (NA) has shown limited effectiveness against hepatitis B surface antigen (HBsAg) clearance in chronic hepatitis B (CHB) patients.
AIM:

To evaluate the efficacy and safety of add-on peginterferon α-2a (peg-IFN α-2a) to an ongoing NA regimen in CHB patients.
METHODS:

In this observational study, 195 CHB patients with HBsAg ≤ 1500 IU/mL, hepatitis B e antigen (HBeAg)-negative (including HBeAg-negative patients or HBeAg-positive patients who achieved HBeAg-negative after antiviral treatment with NA) and hepatitis B virus-deoxyribonucleic acid < 1.0 × 102 IU/mL after over 1 year of NA therapy were enrolled between November 2015 and December 2018 at the Second Affiliated Hospital of Xi'an Jiaotong University, China. Patients were given the choice between receiving either peg-IFN α-2a add-on therapy to an ongoing NA regimen (add-on group, n = 91) or continuous NA monotherapy (monotherapy group, n = 104) after being informed of the benefits and risks of the peg-IFN α-2a therapy. Total therapy duration of peg-IFN α-2a was 48 wk. All patients were followed-up to week 72 (24 wk after discontinuation of peg-IFN α-2a). The primary endpoint was the proportion of patients with HBsAg clearance at week 72.
RESULTS:

Demographic and baseline characteristics were comparable between the two groups. Intention-to-treatment analysis showed that the HBsAg clearance rate in the add-on group and monotherapy group was 37.4% (34/91) and 1.9% (2/104) at week 72, respectively. The HBsAg seroconversion rate in the add-on group was 29.7% (27/91) at week 72, and no patient in the monotherapy group achieved HBsAg seroconversion at week 72. The HBsAg clearance and seroconversion rates in the add-on group were significantly higher than in the monotherapy group at week 72 (P < 0.001). Younger patients, lower baseline HBsAg concentration, lower HBsAg concentrations at weeks 12 and 24, greater HBsAg decline from baseline to weeks 12 and 24 and the alanine aminotransferase ≥ 2 × upper limit of normal during the first 12 wk of therapy were strong predictors of HBsAg clearance in patients with peg-IFN α-2a add-on treatment. Regarding the safety of the treatment, 4.4% (4/91) of patients in the add-on group discontinued peg-IFN α-2a due to adverse events. No severe adverse events were noted.
CONCLUSION:

Peg-IFN α-2a as an add-on therapy augments HBsAg clearance in HBeAg-negative CHB patients with HBsAg ≤ 1500 IU/mL after over 1 year of NA therapy.

©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
KEYWORDS:

Add-on therapy; Chronic hepatitis B; Hepatitis B surface antigen clearance; Hepatitis B surface antigen seroconversion; Nucleos(t)ide analog; Peginterferon α-2a

PMID:
    32308352
PMCID:
    PMC7152523
DOI:
    10.3748/wjg.v26.i13.1525

StephenW

世界J胃肠病学杂志。 2020年4月7日； 26（13）：1525-1539。 Doi：10.3748 / wjg.v26.i13.1525。
与中国的慢性乙型肝炎和乙型肝炎表面抗原≤1500 IU / mL的连续核苷（t）ide类似物单一疗法相比，添加聚乙二醇化干扰素可提高乙型肝炎表面抗原的清除率：一项观察性研究。
Wu FP1，Yang Y1，Li M1，Liu YX1，Li YP1，Wang WJ1，Shi JJ1，Zhang X1，Jia XL1，Dang SS2。
作者信息

1个
西安交通大学附属第二医院感染科，陕西西安710004
2
西安交通大学附属第二医院感染科，陕西西安710004 [email protected]。

抽象
背景：

核苷类似物（NA）在慢性乙型肝炎（CHB）患者中对乙型肝炎表面抗原（HBsAg）清除的有效性有限。
目标：

为了评估正在进行的NA方案中CHB患者加用聚乙二醇干扰素α-2a（peg-IFNα-2a）的疗效和安全性。
方法：

在这项观察性研究中，有195例HBsAg≤1500 IU / mL的CHB患者，乙型肝炎e抗原（HBeAg）阴性（包括经过抗病毒治疗后达到HBeAg阴性的HBeAg阴性患者或HBeAg阳性患者）和乙型肝炎于2015年11月至2018年12月在中国西安交通大学第二附属医院接受了NA治疗1年以上的病毒-脱氧核糖核酸<1.0×102 IU / mL。在被告知患者接受持续的NA方案接受peg-IFNα-2a附加治疗（附加组，n = 91）或连续NA单一疗法（单一治疗组，n = 104）之间进行选择。 -peg-IFNα-2a治疗的益处和风险。 peg-IFNα-2a的总治疗时间为48周。所有患者均接受随访至第72周（peg-IFNα-2a停用后24周）。主要终点是在第72周时HBsAg清除率的患者比例。
结果：

两组的人口和基线特征相当。治疗意向分析显示，在第72周，附加组和单一治疗组的HBsAg清除率分别为37.4％（34/91）和1.9％（2/104）。附加组中的HBsAg血清转化率在72周时为29.7％（27/91），单药治疗组中没有患者在72周时达到HBsAg血清转化。在附加治疗组中，HBsAg清除率和血清转化率分别为在第72周时显着高于单一疗法组（P <0.001）。年轻的患者，较低的基线HBsAg浓度，第12和24周的HBsAg浓度较低，从基线到第12和24周的HBsAg下降幅度更大以及治疗的前12周内丙氨酸转氨酶≥2×正常上限是HBsAg的强烈预测指标peg-IFNα-2a联合治疗患者的清除率。关于治疗的安全性，附加组中有4.4％（4/91）的患者由于不良事件而中断了peg-IFNα-2a的治疗。没有发现严重的不良事件。
结论：

在超过1年的NA治疗后，Peg-IFNα-2a作为补充治疗可增加HBsAg≤1500 IU / mL的HBeAg阴性CHB患者的HBsAg清除率。

©作者2020。由百世登出版集团有限公司出版。保留所有权利。
关键字：

附加疗法；慢性乙型肝炎；乙肝表面抗原清除率；乙型肝炎表面抗原血清转化；核（t）ide类似物；聚乙二醇干扰素α-2a

PMID：
32308352
PMCID：
PMC7152523
DOI：
10.3748 / wjg.v26.i13.1525

StephenW

https://www.wjgnet.com/1007-9327/full/v26/i13/1525.htm

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