TDF长期治疗的无肝硬化HBeAg阴性慢乙肝患者可实现停药后的长

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Abstract
Background & Aims
There is currently no virological cure for chronic hepatitis B but successful nucleos(t)ide analogue (NA) therapy can suppress hepatitis B virus (HBV) DNA replication and, in some cases, result in HBsAg loss. Stopping NA therapy often leads to viral relapse and therefore life-long therapy is usually required. This study investigated the potential to discontinue tenofovir disoproxil fumarate (TDF) therapy in HBeAg-negative patients.

Methods
Non-cirrhotic HBeAg-negative patients who had received TDF for ≥4 years, with suppressed HBV DNA for ≥3.5 years, were randomly assigned to either stop (n=21) or continue (n=21) TDF monotherapy. Standard laboratory tests including HBV DNA viral load, HBsAg and alanine aminotransferase (ALT) measurements, and adverse event reporting were carried out during treatment and post-treatment follow-up for 144 weeks.

Results
Of the patients who stopped TDF therapy, 62% (n=13) remained off-therapy to Week 144. Median HBsAg change in this group was -0.59 log10 IU/mL (range -4.49–0.02 log10 IU/mL) versus 0.21 log10 IU/mL in patients who continued TDF therapy. Four patients (19%) achieved HBsAg loss. Patients stopping therapy had initial fluctuations in viral load and ALT; however, at Week 144, 43% (n=9) had either achieved HBsAg loss or had HBV DNA <2000 IU/mL. There were no unexpected safety issues identified with stopping TDF therapy.

Conclusions
This controlled study demonstrated the potential for HBsAg loss and/or sustained virological response in non-cirrhotic HBeAg-negative patients stopping long-term TDF therapy.
http://www.journal-of-hepatology.eu/article/S0168-8278(17)32155-4/fulltext

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摘要
背景与目标
目前没有病毒学治疗慢性乙型肝炎，但成功的核心（t）ide类似物（NA）治疗可以抑制乙型肝炎病毒（HBV）DNA复制，在某些情况下导致HBsAg损失。停止NA治疗通常会导致病毒复发，因此通常需要终身治疗。本研究调查了在HBeAg阴性患者中停用替诺福韦地索他芬富马酸（TDF）治疗的潜力。

方法
接受TDF≥4年的非肝硬化HBeAg阴性患者随机分为停药（n = 21）或继续（n = 21）次TDF单药治疗，HBV DNA≥3.5岁。在治疗和治疗后随访期间进行144周的标准实验室检查，包括HBV DNA病毒载量，HBsAg和丙氨酸氨基转移酶（ALT）测量以及不良事件报告。

结果
在停止TDF治疗的患者中，62％（n = 13）在第144周仍然处于非治疗状态。该组的中位HBsAg变化为-0.59log10IU / mL（范围为-4.49-0.02log10IU / mL）与0.21log10持续TDF治疗的患者IU / mL。 4例（19％）达HBsAg损失。停止治疗的患者病毒载量和ALT初始波动;然而，在第144周，43％（n = 9）已经达到HBsAg损失或HBV DNA <2000IU / mL。在停止TDF治疗方面没有发现意外的安全问题。

结论
这项对照研究证实了阻止长期TDF治疗的非肝硬化HBeAg阴性患者的HBsAg损失和/或持续的病毒学应答的潜力。

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TDF长期治疗的无肝硬化HBeAg阴性慢乙肝患者可实现停药后的长期应答

德国莱比锡大学临床中心Berg等近日完成的一项研究表明,无肝硬化的HBeAg阴性慢性乙型肝炎(CHB)患者经过替诺福韦酯(TDF)长期治疗,停药后有望达到HBsAg清除和(或)持续病毒学应答。

该项研究纳入接受TDF治疗≥4年,抑制HBV DNA ≥3.5年,无肝硬化的HBeAg阴性CHB患者,随机分组至停用TDF治疗(21例)或继续TDF单药治疗(21例),标准实验室检测包括HBV DNA、HBsAg和ALT水平,报告治疗期间和停用TDF治疗后随访144周期间的不良事件,对无肝硬化的HBeAg阴性CHB患者停用TDF治疗的可能性进行评估。

结果表明,在停用TDF治疗的患者中,144周时,13例(62%)患者未进行再次抗病毒治疗,停用TDF和继续TDF治疗患者的HBsAg中位水平分别为-0.59 log10 IU/mL和0.21 log10 IU/mL,4例(19%)患者获得HBsAg清除。停药组尽管最初易有HBV DNA和ALT水平的波动,但144周时,仍有9例(43%)患者获得了HBsAg清除或HBV DNA

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