APASL2013 HBeAg阴性患者终止长期ETV治疗研究901

StephenW

Abstract

Safety and Antiviral Suppression among HBeAg-negative CHB Patients who Discontinued Long-term ETV Therapy in Study 901 T T. Chang1, Filipe Calinas2, William Sievert3, Tawesak Tanwandee4, Suchat Wongcharatrawee5, Cyril Llamoso6 1College of Medicine, National Cheng Kung University, Tainan, Taiwan R.O.C., 2Centro Hospitalar Lisboa Central, Hospital Santo António Capuchos, Lisboa, Portugal, 3Gastroenterology and Hepatology Unit, Monash Medical Centre and Centre for Inflammatory Diseases, Monash University, Melbourne, VIC, Australia, 4Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand, 5Bristol-Myers Squibb, Shanghai, China, 6Research and Development, Bristol-Myers Squibb Company, Wallingford, CT, USA Background: In HBeAg(-) chronic hepatitis B (CHB) patients receiving antiviral therapy, HBV relapse is frequent after treatment discontinuation. We assessed the durability of antiviral responses in patients who stopped ETV therapy after maintaining viral suppression in study ETV-901. Methods: HBeAg(-) patients from study ETV-027 who subsequently received ETV for ≥192 weeks in ETV-901, had HBV DNA < 300 copies/mL for ≥48 weeks, ALT ≤1 x ULN, and consented to off-treatment follow-up for up to 96 weeks were studied. The primary endpoint was the proportion of patients with sustained HBV DNA < 10,000 copies/mL at off-treatment Week 48. Failure endpoints included hepatitis flare† and confirmed virologic relapse (HBV DNA ≥10,000 copies/mL and ALT ≥2 x ULN or HBV DNA ≥100,000 copies/mL at 2 consecutive time points ≥4 weeks apart). Results: Patients (N=29) were predominantly male and Asian (72% each); mean duration of ETV therapy was 254.1 weeks. Overall, 24/29 patients completed 96 weeks off-treatment follow-up. At off-treatment Week 48, 6/29 (21%) had HBV DNA < 10,000 copies/mL. Seven patients experienced confirmed virologic relapse. No ETV resistance was detected among patients who met criteria for resistance testing. Ten patients re-started ETV, and all had HBV DNA < 300 copies/mL within 3 months after re-starting treatment. Conclusions: In this cohort of HBeAg(-), predominantly Asian patients, discontinuation of long-term ETV treatment resulted in increased viral replication (HBV DNA ≥10,000 copies/mL) in most patients, thus demonstrating the need for continued antiviral treatment in HBeAg(-) patients. Re-treatment with ETV resulted in rapid suppression of viral replication.

StephenW

背景：对于HBeAg（ - ）慢性乙型肝炎（CHB）患者接受抗病毒治疗，乙肝治疗停药后复发频繁。我们评估了耐久性的抗病毒反应维持病毒抑制在研究ETV-901后停止ETV治疗的患者。
方法：大三阳（ - ）患者研究ETV-027随后接受ETV ETV-901≥192周，HBV DNA <300拷贝/ ml≥48周，ALT≤1×ULN，并同意关闭处理随访96周进行了研究。主要终点是患者持续HBV DNA <10000拷贝/ ml的比例在治疗48周。故障端点包括肝炎耀斑†病毒学证实复发（HBV DNA≥10000拷贝/ ml和ALT≥2×ULN或HBV DNA≥100,000拷贝/毫升，连续2个时间点间隔≥4周）。
结果：患者（N = 29）以男性为主和亚洲（72％）; ETV治疗的平均持续时间为254.1周。总体而言，24/29例患者完成96周，场外治疗随访。在治疗48周，6/29（21％），HBV DNA <10000拷贝/ ml。七名病人经历证实病毒学复发。无ETV耐药检测的患者谁见了电阻测试标准。 10患者重新开始ETV，一切都得重新开始治疗后3个月内HBV DNA <300拷贝/ ml。
结论：在这个群体对HBeAg（ - ），以亚洲为主的患者，停药长期ETV治疗导致病毒复制增加，大多数患者（HBV DNA≥10000拷贝/ ml），从而证明需要继续抗病毒治疗的HBeAg阳性（ - ）的患者。恩替卡韦治疗，导致在快速抑制病毒复制。

替比佩乐能

什么东西都看不明白

替比佩乐能

我就是小但肝炎，现在恩替中

StephenW

回复 替比佩乐能 的帖子

一个非常令人失望的研究.
27个小三, ≥192周的ETV治疗, HBV DNA<300拷贝/ ml ≥48周, ALT≤1×ULN - 停止ETV与随访96周:
大多数患者停药后,病毒复制增加（HBV DNA≥10000拷贝/ ml）.因此停药未成功.

替比佩乐能

回复 StephenW 的帖子

也就是说小三肝炎就得长治久安

StephenW

回复 替比佩乐能 的帖子

我不认为如此。台湾研究员刚出版的论文显示，停止恩替卡韦, 1年后的复发率
是46%.

我会稍后发贴论文摘要.