长期现实世界恩替卡韦治疗在初治乙型肝炎患者：基线乙型

StephenW

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        Korean J Intern Med. 2016 Nov 4. doi: 10.3904/kjim.2016.096. [Epub ahead of print]
Long-term real-world entecavir therapy in treatment-naïve hepatitis B patients: base-line hepatitis B virus DNA and hepatitis B surface antigen levels predict virologic response.Cho JY1,2, Sohn W1,3, Sinn DH1, Gwak GY1, Paik YH1, Choi MS1, Koh KC1, Paik SW1, Yoo BC1, Lee JH1.
Author information

• 1Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
• 2Department of Medicine, Chosun University Hospital, Gwangju, Korea.
• 3Department of Hepatology, Daejin Medical Center, Bundang Jesaeng Hospital, Seongnam, Korea.
  

AbstractBackground/Aims: Entecavir is a potent nucleoside analogue with high efficacy and barrier for resistance. We aimed to investigate the long-term efficacy and viral resistance rate of entecavir and explore the factors associated with virologic response, including quantitative hepatitis B surface antigen (qHBsAg) levels.
Methods: One thousand and nine treatment-naïve chronic hepatitis B (CHB) patients were evaluated for cumulative rates of virologic response, biochemical response, and entecavir mutations. The role of baseline qHBsAg for virologic response was assessed in 271 patients with qHBsAg prior to entecavir treatment.
Results: The median duration of entecavir treatment was 26.5 months. The cumulative rate of virologic response at years 1, 3, and 5 were 79.0%, 95.6%, and 99.4%, respectively. The cumulative rate of entecavir resistance was 1.0% and 2.1% in years 3 and 5. Multivariate analysis identified baseline hepatitis B e antigen (HBeAg) negative status (p < 0.001) and lower hepatitis B virus (HBV) DNA (p < 0.001) as predictors of virologic response. Lower qHBsAg was an independent predictor of virologic response in patients with baseline qHBsAg. There were no serious adverse events during treatment.
Conclusions: Long-term entecavir treatment of nucleos(t)ide-naïve CHB patients was associated with an excellent virologic response and a low rate of entecavir-resistant mutations at 5 years. Baseline HBV DNA load, qHBsAg levels, and HBeAg status were predictors of virologic response during entecavir treatment.


KEYWORDS: Entecavir; Hepatitis B virus; Quantitative hepatitis B surface antigens; Virologic response

PMID:27809454DOI:10.3904/kjim.2016.096

StephenW

韩国J Intern Med。 2016 Nov 4. doi：10.3904 / kjim.2016.096。 [打印前的电子版]
长期现实世界恩替卡韦治疗在初治乙型肝炎患者：基线乙型肝炎病毒DNA和乙型肝炎表面抗原水平预测病毒学反应。
Cho JY1,2，Sohn W1,3，Sinn DH1，Gwak GY1，Paik YH1，Choi MS1，Koh KC1，Paik SW1，Yoo BC1，Lee JH1。
作者信息

    医学部，三星医疗中心，Sungkyunkwan大学医学院，韩国首尔。
    韩国光州朝鲜大学医院医学科2。
    韩国城南的Bundang Jesaeng医院大津医学中心肝脏病室。

抽象
背景/目的：

恩替卡韦是一种有效的核苷类似物，具有高效力和抗性屏障。我们的目的是调查恩替卡韦的长期功效和病毒耐药率，并探讨与病毒学反应相关的因素，包括定量乙型肝炎表面抗原（qHBsAg）水平。
方法：

一千和九个初治慢性乙型肝炎（CHB）患者的病毒学应答，生化反应和恩替卡韦突变的累积率评估。在恩替卡韦治疗前，在271名患有qHBsAg的患者中评估基线qHBsAg对病毒学应答的作用。
结果：

恩替卡韦治疗的中位持续时间为26.5个月。第1，第3和第5年的病毒学应答的累积率分别为79.0％，95.6％和99.4％。多变量分析确定了基线乙型肝炎e抗原（HBeAg）阴性状态（p <0.001）和低乙型肝炎病毒（HBV）DNA（p <0.001），而且在第3年和第5年，恩替卡韦的累积率为1.0％作为病毒学应答的预测因子。较低的qHBsAg是基线qHBsAg患者中病毒学应答的独立预测因子。治疗期间没有严重不良事件。
结论：

长期恩替卡韦治疗核（t）初始CHB患者与优秀的病毒学反应和5年内恩替卡韦耐药突变率低有关。基线HBV DNA负荷，qHBsAg水平和HBeAg状态是恩替卡韦治疗期间病毒学应答的预测因子。
关键词：

恩替卡韦乙型肝炎病毒;定量性乙型肝炎表面抗原;病毒学反应

PMID：
    27809454
DOI：
    10.3904 / kjim.2016.096