Antiviral Therapy Safely Stopped in HBeAg-Negative Patients with Hepatitis B Inf

StephenW

August 3, 2012 | Atif Zaman, MD, MPH
Reviewing: Hadziyannis SJ et al. Gastroenterology 2012 Jun 4;
Antiviral Therapy Safely Stopped in HBeAg-Negative Patients with Hepatitis B Infection

Discontinuing adefovir did not lead to any adverse events during5.5 years of follow-up.

Although oral antiviral agents are effective in suppressing hepatitis B virus (HBV) in hepatitis B e antigen (HBeAg)-negative patients, it is unclear if therapy can ever be stopped. Previous studies observed that viral relapse occurred universally after a short course of treatment (JGastroenterol Hepatol 2011; 26:456). Long-term suppressive therapy may afford an opportunity to eventually stop treatment.
In this observational study, a group of 33 well-characterized HBeAg-negative patients with HBV infection who had been receiving suppressive therapy with adefovir (10 mg daily) for 4 to 5 years discontinued treatment. Patients were then followed for 5.5 years, with measurement of serum alanine aminotransferase (ALT), hepatitis B surface antigen (HBsAg), and HBV DNA every 3 to 6 months to assess for relapse of HBV infection.
During a median follow-up of 69 months, 18 of 33 patients (55%) maintained persistently normal ALT and undetectable viral load (HBV DNA <29 IU/mL). Of these 18 responders, 13 (72%) cleared HBsAg, and 9 of the13 (69%) seroconverted to hepatitis B surface antibody (HBsAb). No adverse events occurred, and in the 45% of patients who relapsed, an oral antiviralagent was safely restarted.
Comment: This long-term, prospective cohort study of a small group of HBeAg-negative patients with hepatitis B infection suggests that patients whose viral loads are suppressed with an oral agent for 4 to 5 years can safely discontinue antiviral therapy. Moreover, about half will not experience viral relapse, and the majority of these patients will develop HBsAb. However, stopping therapy should be considered only in highly compliant patients without cirrhosis. In patients with cirrhosis, close monitoring is necessary, and viral relapse can lead to hepatic decompensation.
— AtifZaman, MD, MPH
Published in JournalWatch Gastroenterology August 3, 2012

Citation(s):

  

Hadziyannis SJ et al. Sustained responses and loss of HBsAg in   HBeAg-negative patients with chronic hepatitis B who stop long-term   treatment with adefovir.   Gastroenterology    2012 Jun 4;  [e-pub ahead of print]. (http://dx.doi.org/10.1053/j.gastro.2012.05.039)

在HBeAg阴性患者乙肝感染的抗病毒药物治疗的安全停止

停用阿德福韦没有导致任何不良事件在5.5年的跟进。

虽然口服抗病毒药物有效抑制B型肝炎病毒，B型肝炎e抗原（HBeAg）阴性患者（HBV）的，目前还不清楚，如果都不能停止治疗。以前的研究中观察到病毒复发的治疗后，短期课程（胃肠肝胆病杂志2011; 26:456）普遍发生。长期抑制疗法可能会提供一个机会，最终停止治疗。

在此观察研究，一组33的特点与HBV感染的HBeAg阴性患者已接受阿德福韦（每天10毫克），为4至5年内终止治疗抑制疗法。患者随访5.5年，测量血清谷丙转氨酶（ALT），乙肝表面抗原（HBsAg），乙型肝炎病毒DNA，每3至6个月评估乙肝病毒感染复发。

一个69个月位随访期间，33例（55％）18维持ALT持续正常不到病毒载量（HBV DNA <29 IU /毫升）。这18个反应，13（72％）清除乙肝表面抗原，血清阳转乙肝表面抗体（HBsAb）13（69％）9。无不良事件发生，谁复发的患者的45％，口服抗病毒药剂被安全地重新启动。

评论：这种长期的，小组的HBeAg阴性患者与乙肝病毒感染的前瞻性队列研究表明，患者的病毒载量为4至5年的口服剂抑制可以安全地停止抗病毒治疗。此外，约一半会不会遇到病毒复发，这些患者大部分将开发乙肝表面抗体。然而，应考虑停药，只有在高度兼容无肝硬化患者。肝硬化患者，密切监测是必要的，复发的病毒可导致肝功能失代偿。

- 阿特夫扎曼博士，公共卫生硕士

发表在杂志钟表消化八月3，2012年

引用（S）：

hadziyann​​is SJ等。持续的反应，在停止阿德福韦长期治疗慢性乙型肝炎HBeAg阴性患者乙肝表面抗原的损失。胃肠病学2012年06月04日[E-PUB提前打印]。 （http://dx.doi.org/10.1053/j.gastro.2012.05.039）

                                                                                                                                                                    

StephenW

Sustained Responses and Loss of HBsAg in HBeAg-Negative Patients With Chronic Hepatitis B Who Stop Long-term Treatment With Adefovir

Stephanos J. Hadziyannis    ,    Vassilios Sevastianos    ,    Irene Rapti    ,   Dimitrios Vassilopoulos    ,    Emilia Hadziyannis
Department of Medicine and Hepatology, Henry Dunant Hospital, National and Kapodistrian University of Athens, Athens, Greece
Molecular Biology Laboratory of the Liver Unit at the Evgenidion Hospital, National and Kapodistrian University of Athens, Athens, Greece

Background & Aims

Little is known about the biochemical and virological effects of stopping long-term nucleos(t)ide analogue therapy for hepatitis B e antigen (HBeAg)-negative patients with chronic hepatitis B (CHB).
Methods

We performed a cohort observational study, following 33 HBeAg-negative patients with CHB, undetectable serum HBV DNA, and normal levels of aminotransferases after long-term (4 or 5 years) treatment with adefovir dipivoxil (ADV). All patients were followed for 5.5 years; follow-up visits included measurements of serum alanine aminotransferase (ALT), hepatitis B surface antigen (HBsAg), and HBV DNA monthly for the first 6 months and every 3–6 months thereafter. Various factors were measured at baseline, the end of treatment (EOT), and following treatment to identify those associated with clearance of HBsAg.
Results

During the first few months of the postdiscontinuation period, all patients experienced virological and 25 (76%) had biochemical relapse. During the follow-up period, 18 patients (55%) who had discontinued antiviral therapy achieved sustained response (HBV DNA level <2000 IU/L, persistently normal level of ALT). Among these, 13 (72%) cleared HBsAg. Fifteen patients (45%) with virological and/or biochemical relapse were re-treated with oral antiviral agents (11 during the first 18 months and 4 after the third year), without evidence of liver decompensation; only 1 lost HBsAg (6%). Higher pretreatment and EOT levels of ALT, no previous treatment with interferon, and lower level of HBsAg at the EOT were significantly associated with HBsAg clearance based on multivariate analysis.
Conclusions

In HBeAg-negative patients with CHB, it is safe and effective to discontinue ADV therapy after 4 or 5 years; 55% of patients have sustained responses, and 39% of patients lose HBsAg.

StephenW

持续的响应和停止长期阿德福韦治疗HBeAg阴性慢性乙型肝炎表面抗原的损失

研究Hadziyann​​is stephanos的Vassilios Sevastianos，拉布蒂艾琳，Vassilopoulos迪米特里奥斯，艾米利亚Hadziyann​​is
内科和肝病学系，亨利·杜南医院，国家和雅典大学Kapodistrian，雅典，希腊
肝组的分子生物学实验室的Evgenidion医院，国家和Kapodistrian雅典大学，雅典，希腊

背景与目的

停止长期的核苷（酸）类似物IDE治疗乙型肝炎e抗原（HBeAg）阴性慢性乙型肝炎（CHB）患者的生化和病毒学的影响知之甚少。
方法

我们进行了队列观察研究，后长期（4年或5年）与阿德福韦酯（ADV）治疗33例HBeAg阴性慢性乙型肝炎，血清HBV DNA检测不到，转氨酶正常水平以下。所有患者随访5.5年随访，包括测量血清谷丙转氨酶（ALT），乙肝表面抗原（HBsAg），乙型肝炎病毒DNA每月前6个月，以后每3-6个月。在基线，治疗结束（EOT），以下的治疗，以确定相关的HBsAg清除各种因素进行了测量。
结果

在头几个月的postdiscontinuation期间，所有患者都经历病毒学和生化复发25（76％）。在随访期间，18例（55％）已经停止抗病毒治疗取得持续应答（HBV DNA水平<2000 IU / L，ALT水平持续正常）。其中，13（72％）的HBsAg清除。病毒学和/或生化复发15例（45％）进行了重新处理口服抗病毒药物（11头18个月期间，第三年后4），无肝功能失代偿的证据，只有1赔乙肝表面抗原（6％） 。更高的预处理和EOT（ALT），没有以往的治疗，用干扰素和乙肝表面抗原的EOT的水平较低的水平显着相关的基础上多元分析HBsAg清除。
结论

HBeAg阴性慢性乙型肝炎患者中，它是安全有效的停止ADV治疗后4年或5年55％的患者有持续的反应，和39％的患者失去HBsAg的。