HBeAg阴性慢性乙型肝炎中止口服抗病毒药后复发定义的意义

StephenW

Significance of definitions of relapse after discontinuation of oral antivirals in HBeAg‐negative chronic hepatitis B
George V. Papatheodoridis
Spilios Manolakopoulos
Tung‐Hung Su
Spyros Siakavellas
Chun‐Jen Liu
Anastasia Kourikou
Hung‐Chih Yang
Jia‐Horng Kao
First published: 31 August 2017
https://doi.org/10.1002/hep.29497
Cited by: 3

Potential conflict of interest: George V. Papatheodoridis advises, is on the speakers' bureau, and has received grants from Bristol‐Myers Squibb and Gilead and advises Roche. Spilios Manolakopoulos consults, advises, is on the speakers' bureau, and has received grants from Gilead and Bristol‐Myers Squibb and consults, advises, and is on the speakers' bureau for Novartis. Jia‐Horng consults, advises, and is on the speaker's bureau for Abbvie, Bristol‐Myers Squibb, Gilead Sciences, Merck Sharp & Dohme, and Novartis, and consults and advises for Roche.

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Abstract

Relapses are observed in most hepatitis B e antigen (HBeAg)‐negative chronic hepatitis B patients who discontinue treatment with nucleos(t)ide analogues (NAs); however, the rates of relapse vary widely among studies, and whether all patients with relapse need retreatment is unclear. The aim of this study was to assess the impact of different definitions on the rates of posttreatment relapse and therefore on the probability of retreatment in patients who have discontinued effective long‐term NA therapy. In total, 130 HBeAg‐negative chronic hepatitis B patients without cirrhosis and before NA treatment were included. All had on‐therapy virological remission for ≥24 months and close follow‐up for ≥12 months after stopping NA treatment or until retreatment, which started on stringent predefined criteria. Relapses rates based on several predetermined definitions of virological and perhaps biochemical criteria were assessed. The median duration of therapy was 60 months and the median duration of on‐therapy virological remission was 43 months. During a median off‐NAs follow‐up of 15 months, no patient experienced liver decompensation or died. Cumulative relapse rates were 2%‐49%, 4%‐73%, 11%‐82%, and 16%‐90% at 3, 6, 12, and 24 months, respectively, whereas cumulative retreatment rates were 15%, 22%, and 40% at 6, 12, and 24 months, respectively, after discontinuation of NA therapy. No patient characteristic was independently associated with the probability of relapse based on at least two definitions or of retreatment. Conclusion: In HBeAg‐negative chronic hepatitis B patients who discontinue NA therapy, the definition of relapse has a great impact on off‐NAs relapse rates and potentially on the probability of retreatment. Regardless of definition, off‐NAs relapses cannot be easily predicted by patient characteristics. A substantial proportion of such patients may not require retreatment if stringent criteria are adopted. (Hepatology 2017).

StephenW

HBeAg阴性慢性乙型肝炎中止口服抗病毒药后复发定义的意义
George V. Papatheodoridis
Spilios Manolakopoulos
苏东红
Spyros Siakavellas
刘春仁
Anastasia Kourikou
杨志志
Jia-Horng Kao
首次发布：2017年8月31日
https://doi.org/10.1002/hep.29497
引用次数：3

潜在的利益冲突：George V. Papatheodoridis建议，在发言人办公室，并获得了Bristol-Myers Squibb和Gilead的资助，并为罗氏提供建议。 Spilios Manolakopoulos为发言人提供咨询，建议，并获得了Gilead和Bristol-Myers Squibb的资助，并为Novartis的发言人提供咨询，建议和咨询。 Jia-Horng为Abbvie，Bristol-Myers Squibb，Gilead Sciences，Merck Sharp＆Dohme和Novartis的发言人提供咨询，建议和咨询，并为罗氏提供咨询和建议。

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在大多数乙型肝炎e抗原（HBeAg）阴性慢性乙型肝炎患者中观察到复发，这些患者停止用核苷（酸）类似物（NAs）治疗;然而，研究中复发率差异很大，所有复发患者是否需要再次治疗尚不清楚。本研究的目的是评估不同定义对治疗后复发率的影响，从而评估停止有效长期NA治疗的患者再次治疗的可能性。总共包括130名HBeAg阴性慢性乙型肝炎患者，无肝硬化和NA治疗前。所有患者均在治疗后病毒学缓解≥24个月，并在停止NA治疗或直至再治疗后接受随访≥12个月，该治疗始于严格的预定标准。评估基于病毒学和可能的生化标准的若干预定定义的重复率。治疗的中位持续时间为60个月，治疗中病毒学缓解的中位持续时间为43个月。在15个月的非中位随访期间，没有患者出现肝脏失代偿或死亡。累计复发率分别为3,6,12和24个月的2％-49％，4％-73％，11％-82％和16％-90％，而累积复发率为15％，22在停止NA治疗后，分别在6,12和24个月时分别为％和40％。基于至少两种定义或再治疗，没有患者特征与复发概率独立相关。结论：在停用NA治疗的HBeAg阴性慢性乙型肝炎患者中，复发的定义对非NAs复发率和可能的再治疗概率有很大影响。无论定义如何，都不能通过患者特征容易地预测非NA复发。如果采用严格的标准，相当大比例的此类患者可能不需要再治疗。 （Hepatology 2017）。