标题: 恩替卡韦或替诺福韦停药后HBsAg低于100 IU / mL的患者的发病率 [打印本页] 作者: StephenW 时间: 2020-5-5 15:01 标题: 恩替卡韦或替诺福韦停药后HBsAg低于100 IU / mL的患者的发病率
Clin Gastroenterol Hepatol. 2020 Apr 29. pii: S1542-3565(20)30534-6. doi: 10.1016/j.cgh.2020.04.037. [Epub ahead of print]
Incidence and Factors Associated With HBV Relapse After Cessation of Entecavir or Tenofovir in Patients With HBsAg Below 100 IU/mL.
Tseng TN1, Hu TH1, Wang JH1, Kuo YH1, Hung CH2, Lu SN2, Jeng WJ3, Chen CH4.
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Abstract
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) below 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 and 2015 or TDF from 2011 through 2016 in Taiwan. We identified 135 patients with levels of HBsAg below 100 IU/mL at the end of treatment (79 entecavir and 56 TDF) and collected data from them for a median 87 weeks (interquartile range, 48-161 weeks) for use as the development set. We collected data from 108 patients from separate medical centers in Taiwan, followed for a median 126 weeks (interquartile range, 61-214) weeks, and used these as the validation group. Post-treatment virologic relapse was defined as a serum level of HBV DNA above 2000 IU/mL and clinical relapse was defined as level of alanine aminotransferase (ALT) greater than 40 U/L and level of HBV DNA above 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. Baseline level of HBV DNA and end of treatment level of HBsAg were independently associated with relapse. In the development group, 17.3% of patients with end of treatment levels of HBsAg below 40 IU/mL had a virologic relapse within 5 y whereas 67.6% of patients with a level of HBsAg of 40 IU/mL or more had a virologic relapse within 5 y (P<.001); proportions of patients with clinical relapses were 10.2% (HBsAg below 40 IU/mL) and 57.6% (HBsAg ≥40 IU/mL; P<.001). In the validation groups, for patients with end of treatment HBsAg levels below 40 IU/mL or ≥40 IU/mL, the rates of virologic relapse 5 y were 31.1% and 80.5% (P<.001); rates of clinical relapse were 14.2% and 50.3% (P<.001), respectively. Rates of virologic and clinical relapse within 5 y were low (below 10%) in patients with a combination of end of treatment level of HBsAg below 40 IU/mL and baseline HBV DNA level below 5×104 IU/mL, or baseline hepatitis B core-related antigen level below 4 log U/mL in the development group.
CONCLUSIONS:
An end of treatment level of HBsAg of 40 IU/mL or lower is optimal for stopping nucleos(t)ide analog therapy. Waiting to stop therapy until patients have a combination of baseline levels of HBV DNA of 5×104 IU/mL or HBcrAg of 4 log U/mL and end of treatment level of HBsAg of 40 IU/mL might reduce the risk of HBV relapse.
我们调查了恩替卡韦或替诺福韦二富马酸富马酸酯（TDF）治疗停止后，HB表面抗原（HBsAg）水平低于100 IU / mL的患者中乙型肝炎病毒（HBV）感染复发的发生率和相关因素。
方法：
我们收集了台湾和台湾的2007年和2015年使用恩替卡韦治疗或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87周（四分位间距为48-161周）的数据中用作开发集。我们收集了来自台湾不同医疗中心的108位患者的数据，随后进行了中位126周（四分位间距为61-214周），并将其用作验证组。治疗后病毒学复发的定义是血清HBV DNA的水平高于2000 IU / mL，临床复发的定义是丙氨酸转氨酶（ALT）的水平高于40 U / L，HBV DNA的水平高于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％。 HBV DNA的基线水平和HBsAg治疗结束水平与复发独立相关。在发育组中，HBsAg治疗结束水平低于40 IU / mL的患者中有17.3％的病毒学复发在5 y内，而HBsAg≥40 IU / mL或更高的患者中67.6％的病毒学复发在5 y内。 5年（P <.001）;临床复发患者的比例分别为10.2％（HBsAg低于40 IU / mL）和57.6％（HBsAg≥40 IU / 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的患者，病毒学复发率5 y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）。 HBsAg治疗结束水平低于40 IU / mL且基线HBV DNA水平低于5×104 IU / mL或基线乙型肝炎的患者在5 y内病毒学和临床复发率很低（低于10％）发育组中核心相关抗原水平低于4 log U / mL。
结论：
HBsAg的治疗结束水平为40 IU / mL或更低，对于终止核苷类似物治疗是最佳的。等到患者基线水平为5×104 IU / mL的HBV DNA或4 log U / mL的HBcrAg和治疗结束水平为40 IU / mL的HBsAg组合后，才可以降低HBV复发的风险。