恩替卡韦或替诺福韦停药后HBsAg低于100 IU / mL的患者中HBV复发

StephenW

Incidence and Factors Associated With HBV Relapse After Cessation of Entecavir or Tenofovir in Patients With HBsAg Below 100 IU/mL
Tzu-Ning Tseng∗
, Tsung-Hui Hu∗
, Jing-Houng Wang∗
, Yuan-Hung Kuo∗
, Chao-Hung Hung‡
, Sheng-Nan Lu‡
, Wen-Juei Jeng§
, Chien-Hung Chen∗,∗,'Correspondence information about the author Chien-Hung ChenEmail the author Chien-Hung Chen
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Background & Aims

We investigated the incidence and factors associated with relapse of hepatitis B virus (HBV) infection in patients with levels of HB surface antigen (HBsAg) less than 100 IU/mL after cessation of entecavir or tenofovir disoproxil fumarate (TDF) treatment.
Methods

We collected data from patients with chronic HBV infection without cirrhosis treated with entecavir from 2007 through 2015 or TDF from 2011 through 2016 in Taiwan. We identified 135 patients with levels of HBsAg less than 100 IU/mL at the end of treatment (79 entecavir and 56 TDF) and collected data from them for a median of 87 weeks (interquartile range, 48–161 wk) for use as the development set. We collected data from 108 patients from separate medical centers in Taiwan, followed up for a median of 126 weeks (interquartile range, 61–214 wk), and used these as the validation group. Post-treatment virologic relapse was defined as a serum HBV DNA level greater than 2000 IU/mL, and clinical relapse was defined as an alanine aminotransferase level greater than 40 U/L and a HBV DNA level greater than 2000 IU/mL.
Results

In the development group, the 5-year incidences of virologic relapse, clinical relapse, and HBsAg loss were 40.9%, 32.5%, and 47%, respectively. The baseline HBV DNA and end-of-treatment levels of HBsAg were associated independently with relapse. In the development group, 17.3% of patients with end-of-treatment HBsAg levels less than 40 IU/mL had a virologic relapse within 5 years, whereas 67.6% of patients with a HBsAg level of 40 IU/mL or more had a virologic relapse within 5 years (P < .001); proportions of patients with clinical relapses were 10.2% (HBsAg <40 IU/mL) and 57.6% (HBsAg ≥40 IU/mL; P < .001). In the validation groups, for patients with end-of-treatment HBsAg levels less than 40 IU/mL or 40 IU/mL or more, the rates of virologic relapse at 5 years were 31.1% and 80.5% (P < .001), and rates of clinical relapse were 14.2% and 50.3% (P < .001), respectively. Rates of virologic and clinical relapse within 5 years were low (<10%) in patients with a combination of end-of-treatment HBsAg level less than 40 IU/mL and baseline HBV DNA level less than 5 × 104 IU/mL, or baseline hepatitis B core–related antigen level less than 4 log U/mL in the development group.
Conclusions

An end-of-treatment HBsAg level of 40 IU/mL or less is optimal for stopping nucleos(t)ide analog therapy. Waiting to stop therapy until patients have a combination of baseline HBV DNA level of 5 × 104 IU/mL or hepatitis B core–related antigen of 4 log U/mL and end-of-treatment HBsAg level of 40 IU/mL might reduce the risk of HBV relapse.

StephenW

恩替卡韦或替诺福韦停药后HBsAg低于100 IU / mL的患者中HBV复发的发生率和相关因素
曾子宁*
，胡宗辉*
王景雄
，郭元鸿*
洪朝洪‡
卢胜男‡
，文文瑞§
，Chenen-Hung Chen ∗，∗，'关于作者Chien-Hung Chen的通讯信息给作者发送电子邮件Chien-Hung Chen
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背景与目标

我们调查了恩替卡韦或替诺福韦富马酸替诺福韦酯（TDF）治疗停止后HB表面抗原（HBsAg）水平低于100 IU / mL的患者中与乙型肝炎病毒（HBV）感染复发的发生率和相关因素。
方法

我们收集了台湾地区2007年至2015年使用恩替卡韦或2011年至2016年使用TDF治疗的无肝硬化的慢性HBV感染患者的数据。我们确定了135名在治疗结束时HBsAg水平低于100 IU / mL的患者（79恩替卡韦和56 TDF），并从他们收集的中位值为87周（四分位间距为48-161 wk）的数据中开发集。我们收集了来自台湾不同医疗中心的108名患者的数据，随访中位数为126周（四分位间距为61–214 wk），并将其用作验证组。治疗后病毒学复发的定义是血清HBV DNA水平大于2000 IU / mL，临床复发的定义是丙氨酸转氨酶水平大于40 U / L和HBV DNA水平大于2000 IU / mL。
结果

在发育组中，病毒学复发，临床复发和HBsAg丢失的5年发生率分别为40.9％，32.5％和47％。基线HBV DNA和HBsAg治疗结束水平与复发独立相关。在发育组中，治疗结束时HBsAg水平低于40 IU / mL的患者中有17.3％的患者在5年内出现病毒学复发，而HBsAg水平为40 IU / mL或更高的患者中有67.6％接受了病毒学治疗5年内复发（P <.001）；临床复发患者的比例为10.2％（HBsAg <40 IU / mL）和57.6％（HBsAg≥40IU / mL; P <.001）。在验证组中，对于治疗结束时HBsAg水平低于40 IU / mL或40 IU / mL或更高的患者，5年病毒学复发率分别为31.1％和80.5％（P <.001），临床复发率分别为14.2％和50.3％（P <.001）。治疗结束时HBsAg水平低于40 IU / mL且基线HBV DNA水平低于5×104 IU / mL的患者中5年内病毒学和临床复发率较低（<10％），或者在开发组中，基线乙肝核心相关抗原水平低于4 log U / mL。
结论

治疗结束时HBsAg水平为40 IU / mL或更低是停止核苷酸（t）类似物治疗的最佳选择。等待停止治疗，直到患者的基线HBV DNA水平为5×104 IU / mL或与乙肝核心相关抗原的浓度为4 log U / mL且治疗结束时HBsAg水平为40 IU / mL的组合可能会降低HBV复发的风险。