DDW 2013:恩替卡韦长期治疗的慢性乙型肝炎患者安全，高效：

StephenW

Entecavir Is Safe and Highly Effective for Long-Term Treatment of Chronic Hepatitis B Patients : a Single Center Experience

Sa1011 |  Watcharasak Chotiyaputta, Phunchai Charatcharoenwitthaya, Siwaporn P. Chainuvati, Supot Nimanong, Tawesak Tanwandee


Gastroenterology, Internal Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand

Abstract:

Background and Aim: Entecavir (ETV) is a potent antiviral drug to treat chronic hepatitis B (CHB) patients with high genetic barrier. Aim of this study was to assess the effectiveness, safety, and rate of antiviral resistance of ETV monotherapy in nucleos(t)ide analogues (NUC) naïve CHB patients in clinical practice.
Methods: Charts of CHB patients were reviewed. CHB patients who were treated with ETV at least one year were included in this study. Clinical symptoms, liver function test and HBV DNA were monitored every 3-6 months. Virological breakthrough was defined as > 1 log IU/mL increase from nadir. Antiviral resistance testing was performed in patients who had confirmed virological breakthrough. Imaging studies using ultrasonography or CT of liver was monitored every 6 months for hepatocellular carcinoma (HCC) screening.
Results: 535 patients were included. At baseline, mean age was 51.8 years, 58.5% was male, 35.1% was HBeAg positive, mean HBV DNA was 6.8 log IU/mL, 87% had elevation of ALT, and 37.1% was cirrhosis. Mean of follow up was 40 months. The rates of undetectable HBV DNA progressively increased to more than 90% in both HBeAg positive and negative patients at year 5. HBeAg seroconversion and HBsAg loss was found in 10.5% and 1.7% at year 5, respectively. No virological breakthrough or antiviral resistance mutations was found in 5 years. Among 337 non-cirrhotic patients, 20 patients (5.9%) developed cirrhosis using imaging criteria during follow up; however, no patients in this group developed clinical decompensation. Of 198 cirrhotic patients, clinical decompensation was developed in 5 patients (2.5%). HCC occurred 12 patients (2.2%) in 5 years. No serious adverse event was demonstrated. Serum creatinine remained unchanged during ETV treatment.
Conclusion: ETV was safe and effectively suppressed hepatitis B virus without virological breakthrough throughout 5 years of treatment.

StephenW

摘要：

背景和目的：恩替卡韦（ETV）是一种强效的抗病毒药物治疗慢性乙型肝炎（CHB）患者的高基因屏障。本研究的目的是评估抗病毒药物耐药性ETV单药治疗的核苷（酸）类似物（NUC）天真的慢性乙肝患者，在临床实践中的有效性，安全性和速度。
方法：慢性乙型肝炎患者的图表进行了审查。至少一年谁是恩替卡韦治疗慢性乙型肝炎患者被纳入本研究。临床症状，肝功能检验和HBV DNA监测，每3-6个月。病毒学突破定义为> 1日志IU / mL的增加从最低点。病毒抗药性测试是在患者已证实病毒学突破。使用超声或CT肝的影像学监测，每6个月为肝细胞癌（HCC）筛查。
结果：535例患者都包括在内。在基线水平，平均年龄为51.8岁，58.5％为男性，35.1％，HBeAg阳性，意味着乙肝病毒DNA为6.8日志IU /毫升，87％ALT升高，37.1％为肝硬化。平均随访40个月。不到HBV DNA率逐步提升至90％以上，在HBeAg阳性和阴性患者5年。 HBeAg血清学转换，发现HBsAg消失5年，分别在10.5％和1.7％。无病毒学突破或抗病毒药物耐药突变被发现在5年内。其中337家非肝硬化患者，20例（5.9％），肝硬化随访期间使用成像标准;然而，没有在这组患者制定临床失代偿。 198例肝硬化患者，临床失代偿5例（2.5％）。肝癌发生在5年的12例（2.2％）。无严重不良反应事件被证实。血清肌酐ETV治疗期间保持不变。
结论：ETV是安全的，有效抑制乙肝病毒，整个治疗5年无病毒学突破。