聚乙二醇干扰素-α联合富马酸替诺福韦酯治疗乙型肝炎e抗原

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J Infect Chemother

. 2020 Aug 3;S1341-321X(20)30218-X.
doi: 10.1016/j.jiac.2020.07.005. Online ahead of print.
A randomized controlled trial of pegylated interferon-alpha with tenofovir disoproxil fumarate for hepatitis B e antigen-negative chronic hepatitis B: A 48-week follow-up study
Mnasour Bahardoust  1 , Marjan Mokhtare  2 , Mitra Barati  3 , Zahra Bagheri-Hosseinabadi  4 , Arman Karimi Behnagh  5 , Hossein Keyvani  6 , Shahram Agah  7
Affiliations
Affiliations

    1
    Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
    2
    Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.
    3
    Pediatric Infectious Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran.
    4
    Department of Clinical Biochemistry, Faculty of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.
    5
    Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
    6
    Department of Virology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
    7
    Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: [email protected].

    PMID: 32762882 DOI: 10.1016/j.jiac.2020.07.005

Abstract

Background: Recent studies report incongruent finds regarding the addition of pegylated interferon -alpha (Peg- IFNα) to nucleos(t)ide analogues. This study was designed to compare the efficacy of Peg- IFNα and tenofovir disoproxil fumarate (TDF) combination therapy with each of the treatments separately.

Methods: In this open-label, randomized clinical trial, treatment-naive hepatitis B e antigen (HBeAg)-negative patients were randomly assigned to three treatment groups: Group A: Peg- IFNα (180 mcg/week) with TDF (300 mg/day); Group B: TDF (300 mg/day); and Group C: Peg- IFNα (180 mcg/week). The intervention spanned 48 weeks and patients were followed up every 12 weeks. The primary end-point was HBV DNA load <20 IU/mL.

Results: Groups A, B and C each comprised of 22, 23 and 22 patients, respectively. The number of patients with HBV DNA suppression in group A was significantly higher compared to groups B and C (P = 0.034). No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082). At week 48, combination therapy was significantly more effective in suppressing HBV DNA concentration to below the level of detection than TDF monotherapy (OR = 2.1, 95%CI: 1.18-4.15; P = 0.034). Furthermore, a comparison between monotherapy arms revealed that both interventions had similar effects on the overall outcome (OR = 1.24, 95%CI: 1.02-5.8; P = 0.062).

Conclusion: A Peg- IFNα and TDF combination therapy resulted in improved virologic response and was safe in HBeAg negative patients. Monotherapy with Peg-IFNα or TDF procured limited benefits in comparison.

Trial registration: This study was registered in the Iranian Registry of Clinical Trials (IRCT20181113041635N1).

Keywords: Efficacy; Hepatitis B virus; Peg-interferon –alpha; Safety; Tenofovir; Therapy.

Copyright © 2020 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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感染化学杂志

。 2020年8月3日; S1341-321X（20）30218-X。
doi：10.1016 / j.jiac.2020.07.005。在线印刷。
聚乙二醇干扰素-α联合富马酸替诺福韦酯治疗乙型肝炎e抗原阴性慢性乙型肝炎的随机对照试验：一项48周的随访研究
Mnasour Bahardoust 1，Marjan Mokhtare 2，Mitra Barati 3，Zahra Bagheri-Hosseinabadi 4，Arman Karimi Behnagh 5，Hossein Keyvani 6，Shahram Agah 7
隶属关系
隶属关系

    1个
    伊朗医科大学结直肠研究中心，伊朗德黑兰；伊朗医科大学公共卫生学院流行病学系，伊朗德黑兰。
    2
    伊朗医学大学，伊朗德黑兰，结直肠研究中心。
    3
    伊朗医科大学儿科传染病研究中心，伊朗德黑兰。
    4
    拉夫桑詹医科大学医学院临床生物化学系，伊朗拉夫桑詹。
    5
    伊朗医学大学，伊朗德黑兰，医学院。
    6
    伊朗医科大学医学院病毒学系，伊朗德黑兰。
    7
    伊朗医学大学，伊朗德黑兰，结直肠研究中心。电子地址：[email protected]。

    PMID：32762882 DOI：10.1016 / j.jiac.2020.07.005

抽象

背景：最近的研究报道了关于在核苷酸（t）ide类似物中添加聚乙二醇化干扰素-α（Peg-IFNα）的不一致结论。这项研究旨在比较Peg-IFNα和替诺福韦富马酸替诺福韦（TDF）联合疗法与每种疗法的疗效。

方法：在这项开放标签的随机临床试验中，将未接受过治疗的乙型肝炎e抗原（HBeAg）阴性患者随机分为三个治疗组：A组：Peg-IFNα（180 mcg /周）加TDF（300 mg） /天）; B组：TDF（300毫克/天）； C组：Peg-IFNα（180微克/周）。干预时间跨度为48周，每12周进行一次随访。主要终点是HBV DNA负荷<20 IU / mL。

结果：A，B和C组分别由22、23和22位患者组成。与B组和C组相比，A组具有HBV DNA抑制作用的患者人数明显更高（P = 0.034）。三组之间的血清ALT水平正常化趋势未观察到显着差异（P = 0.082）。在第48周，与TDF单一疗法相比，联合疗法在将HBV DNA浓度抑制至检测水平以下方面更为有效（OR = 2.1，95％CI：1.18-4.15； P = 0.034）。此外，单药治疗组之间的比较显示，两种干预措施对总体预后都有相似的影响（OR = 1.24，95％CI：1.02-5.8； P = 0.062）。

结论：Peg-IFNα和TDF联合治疗可改善HBeAg阴性患者的病毒学应答，并且安全。与之相比，采用Peg-IFNα或TDF的单药治疗获益有限。

试验注册：该研究已在伊朗临床试验注册中心（IRCT20181113041635N1）中注册。

关键字：功效；乙型肝炎病毒;聚乙二醇干扰素–alpha;安全;替诺福韦;治疗。

版权所有©2020日本化学疗法学会和日本传染病协会。由Elsevier Ltd.出版。保留所有权利。