残余低HDV病毒血症与基于聚乙二醇干扰素α的丁型肝炎抗病毒治疗后HDV RNA复发相关：HIDIT-II研究结果

Residual low HDV viraemia is associated HDV RNA relapse after PEG-IFNa-based antiviral treatment of hepatitis delta: Results from the HIDIT-II study.

作者信息

Bremer Birgit, Anastasiou Olympia E, Hardtke Svenja, Caruntu Florin Alexandru, Curescu Manuela G, Yalcin Kendal, Akarca Ulus S, Gürel Selim, Zeuzem Stefan, Erhardt Andreas, Lüth Stefan, Papatheodoridis George V, Radu Monica, Idilman Ramazan, Manns Michael P, Cornberg Markus, Yurdaydin Cihan, Wedemeyer Heiner

机构信息

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

Institute for Virology, Essen University Hospital and Medical Faculty of the University of Duisburg-Essen, Essen, Germany.

出版信息

Liver Int. 2021 Feb;41(2):295-299. doi: 10.1111/liv.14740. Epub 2020 Dec 5.

DOI:10.1111/liv.14740

PMID:33217778

Abstract

The role of low levels of HDV-RNA during and after interferon therapy of hepatitis D is unknown. We re-analysed HDV RNA in 372 samples collected in the HIDIT-2 trial (Wedemeyer et al, Lancet Infectious Diseases 2019) with the Robogene assay (RA; Jena Analytics). Data were compared with the previously reported in-house assay (IA). We detected HDV-RNA in one-third of samples previously classified as undetectable using the highly sensitive RA. Low HDV viraemia detectable at week 48 or week 96 was associated with a high risk for post-treatment relapse, defined as HDV RNA positivity in both assays at week 120. HDV RNA relapses occurred in 10/15 (67%) patients with detectable low HDV RNA at week 48 and in 10/13 (77%) patients with low viraemia samples at week 96. In contrast, the post-treatment relapse rate was lower in patients with undetectable HDV RNA in both assays during treatment.

摘要

丁型肝炎干扰素治疗期间及之后低水平丁型肝炎病毒核糖核酸（HDV-RNA）的作用尚不清楚。我们使用Robogene检测法（RA；耶拿分析公司）对在HIDIT-2试验（韦德迈尔等人，《柳叶刀·传染病学》2019年）中收集的372份样本中的HDV RNA进行了重新分析。将数据与先前报告的内部检测法（IA）进行了比较。我们在先前使用高度灵敏的RA检测法分类为检测不到的三分之一样本中检测到了HDV-RNA。在第48周或第96周可检测到的低HDV病毒血症与治疗后复发的高风险相关，治疗后复发定义为在第120周两种检测法中HDV RNA均呈阳性。在第48周HDV RNA可检测到的低水平患者中，10/15（67%）出现了HDV RNA复发，在第96周病毒血症水平低的样本患者中，10/13（77%）出现了复发。相比之下，在治疗期间两种检测法中HDV RNA均检测不到的患者，其治疗后复发率较低。