在乙肝e抗原阴性患者的核苷酸（t）ids类似物中加入聚乙二醇

StephenW

Hepatitis B surface antigen and hepatitis B core-related antigen kinetics after adding pegylated-interferon to nucleos(t)ids analogues in hepatitis B e antigen-negative patients
Teresa Broquetas  1 , Montserrat Garcia-Retortillo  1 , Miquel Micó  2 , Lidia Canillas  1 , Marc Puigvehí  1 , Nuria Cañete  1 , Susana Coll  1 , Ana Viu  1 , Juan Jose Hernandez  2 , Xavier Bessa  1 , José A Carrión  1
Affiliations
Affiliations

    1
    Department of Gastroenterology, Liver Section, Hospital del Mar Medical Research Institute, Barcelona 08003, Spain.
    2
    Laboratori de Referencia de Catalunya, El Prat de Llobregat, Barcelona 08820, Spain.

    PMID: 33312431 PMCID: PMC7701972 DOI: 10.4254/wjh.v12.i11.1076

Free PMC article
Abstract

Background: Hepatitis B e antigen-negative chronic hepatitis B patients under nucleos(t)ids analogues (NAs) rarely achieve hepatitis B surface antigen (HBsAg) loss.

Aim: To evaluate if the addition of pegylated interferon (Peg-IFN) could decrease HBsAg and hepatitis B core-related antigen (HBcrAg) levels and increase HBsAg loss rate in patients under NAs therapy.

Methods: Prospective, non-randomized, open-label trial evaluating the combination of Peg-IFN 180 µg/week plus NAs during forty-eight weeks vs NAs in monotherapy. Hepatitis B e antigen-negative non-cirrhotic chronic hepatitis B patients of a tertiary hospital, under NAs therapy for at least 2 years and with undetectable viral load, were eligible. Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus co-infection and liver transplanted patients were excluded. HBsAg and HBcrAg levels (log10 U/mL) were measured at baseline and during ninety-six weeks. HBsAg loss rate was evaluated in both groups. Adverse events were recorded in both groups. The kinetic of HBsAg for each treatment group was evaluated from baseline to weeks 24 and 48 by the slope of the HBsAg decline (log10 IU/mL/week) using a linear regression model.

Results: Sixty-five patients were enrolled, 61% receiving tenofovir and 33% entecavir. Thirty-six (55%) were included in Peg-IFN-NA group and 29 (44%) in NA group. After matching by age and treatment duration, baseline HBsAg levels were comparable between groups (3.1 vs 3.2) (P = 0.25). HBsAg levels at weeks 24, 48 and 96 declined in Peg-IFN-NA group (-0.26, -0.40 and -0.44) and remained stable in NA group (-0.10, -0.10 and -0.10) (P < 0.05). The slope of HBsAg decline in Peg-IFN-NA group (-0.02) was higher than in NA group (-0.00) (P = 0.015). HBcrAg levels did not change. Eight (22%) patients discontinued Peg-IFN due to adverse events. The HBsAg loss was achieved in 3 (8.3%) patients of the Peg-IFN-NA group and 0 (0%) of the NA group.

Conclusion: The addition of Peg-IFN to NAs caused a greater and faster decrease of HBsAg levels compared to NA therapy. Side effects of Peg-IFN can limit its use in clinical practice.

Keywords: Chronic hepatitis B; Hepatitis B core-related antigen; Hepatitis B e antigen-negative; Hepatitis B surface antigen; Nucleos(t)ids analogues; Pegylated-interferon.

©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
Conflict of interest statement

Conflict-of-interest statement: Authors declare no conflict-of-interest.

StephenW

在乙肝e抗原阴性患者的核苷酸（t）ids类似物中加入聚乙二醇干扰素后，乙肝表面抗原和乙肝核心相关抗原的动力学
Teresa Broquetas 1，Montserrat Garcia-Retortillo 1，MiquelMicó2，Lidia Canillas 1，MarcPuigvehí1，NuriaCañete1，Susana Coll 1，Ana Viu 1，Juan Jose Hernandez 2，Xavier Bessa 1，JoséACarrión1
隶属关系
隶属关系

    1个
    德尔玛医院医学研究所肝脏科胃肠病科，西班牙巴塞罗那08003。
    2
    西班牙加泰罗尼亚中央实验室（Laboratori de Referencia de Catalunya），萨尔瓦多普拉特（Lpraregat），西班牙巴塞罗那08820

    PMID：33312431 PMCID：PMC7701972 DOI：10.4254 / wjh.v12.i11.1076

免费PMC文章
抽象

背景：在核糖核酸类似物（NAs）的作用下，慢性乙型肝炎e抗原阴性的乙型肝炎患者很少达到乙型肝炎表面抗原（HBsAg）的丢失。

目的：评估在NAs治疗下患者是否添加聚乙二醇化干扰素（Peg-IFN）可以降低HBsAg和乙型肝炎核心相关抗原（HBcrAg）水平并增加HBsAg丢失率。

方法：一项前瞻性，非随机，开放标签的试验，评估与单一疗法中的NAs相比，Peg-IFN 180μg/周加NA在48周内的组合。三级医院接受NAs治疗且病毒载量无法检测的乙型肝炎e抗原阴性非肝硬化慢性乙型肝炎患者合格。排除丙型肝炎病毒，丁型肝炎病毒或人免疫缺陷病毒合并感染的患者以及肝移植患者。在基线和九十六周内测量HBsAg和HBcrAg水平（log10 U / mL）。两组均评估了HBsAg丢失率。两组均记录不良事件。使用线性回归模型，通过基线至HBsAg下降的斜率（log10 IU / mL /周）评估每个治疗组的HBsAg动力学。

结果：招募了65名患者，其中61％接受替诺福韦和33％恩替卡韦。 Peg-IFN-NA组包括36（55％），NA组包括29（44％）。在按年龄和治疗时间进行匹配之后，各组之间的基线HBsAg水平相当（3.1 vs 3.2）（P = 0.25）。 Peg-IFN-NA组第24、48和96周的HBsAg水平下降（-0.26，-0.40和-0.44），而在NA组则保持稳定（-0.10，-0.10和-0.10）（P <0.05）。 Peg-IFN-NA组（-0.02）的HBsAg下降斜率高于NA组（-0.00）（P = 0.015）。 HBcrAg水平未改变。由于不良事件，有八名（22％）患者停用Peg-IFN。 Peg-IFN-NA组3例（8.3％）和NA组0例（0％）达到HBsAg丢失。

结论：与NA治疗相比，向NAs中添加Peg-IFN导致HBsAg水平更大更快地降低。 Peg-IFN的副作用可能会限制其在临床实践中的使用。

关键字：慢性乙型肝炎；乙型肝炎核心相关抗原；乙型肝炎e抗原阴性；乙型肝炎表面抗原； Nucleos（t）ids类似物；聚乙二醇化干扰素。

©The 2020作者。百世登出版集团有限公司出版。保留所有权利。
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利益冲突声明：作者声明没有利益冲突。

StephenW

https://www.wjgnet.com/1948-5182/full/v12/i11/1076.htm