[AASLD 2012]长期恩替卡韦治疗 v 其他核苷(酸)治疗

肝胆速递

CONTROL ID: 1424689
PRESENTATION TYPE: Oral or Poster
CURRENT CATEGORY: Hepatitis B
CURRENT DESCRIPTORS: I02. Treatment and Clinical Trials
TITLE: Randomized, observational study of long-term entecavir treatment versus other standard of care nucleos(t)ide analog therapy in nucleos(t)ide-naïve patients with chronic hepatitis B from a ‘real-world’ clinical practice setting in China
AUTHORS (FIRST NAME, LAST NAME): Jinlin Hou1, Jidong Jia2, Lai Wei3, Hong Ren4, Qing Xie5, Zhi-liang Gao6, Wei Zhao7, Yuming Wang8, Guozhong Gong9, Wukui Cao10, Miao Yu11, Cyril Llamoso11
Institutional Author(s):
INSTITUTIONS (ALL): 1. Hepatology Unit and Key Lab for Organ Failure Research, Nanfang Hospital, Southern Medical University, No 1838 North Guangzhou Avenue, Guangzhou 510515, China.
2. Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.
3. Peking University People's Hospital, Peking University Hepatology Institute, Beijing, China.
4. Chongqing Medical University 2nd Hospital, Chongqing, China.
5. Department of Infectious Diseases, Shanghai Ruijin Hospital, Jiao Tong University School of Medicine, Shanghai, China.
6. Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
7. Nanjing Second Hospital Affiliated to Medical College, Southeast University, Nanjing 210003, Jiangsu Province, China.
8. Institute of Infectious Diseases, Southwest Hospital, The Third Military Medical University, Chongqing, 400038, China.
9. Liver Diseases Center, Second Xiangya Hospital, Central South University, Changsha, China.
10. Tianjin Infectious Disease Hospital, Tianjin 300192, China.
11. Research and Development, Bristol-Myers Squibb Company, Wallingford, CT, United States.
ABSTRACT BODY: Background: Chronic hepatitis B (CHB) is a significant public health issue and an important cause of liver-related mortality in China. This study presents the virologic efficacy and limited safety data for up to 144 weeks of entecavir (ETV) therapy or other standard of care (oSOC) anti-HBV nucleos(t)ide analog (NUC) therapy (lamivudine, telbivudine or adefovir) in NUC-naïve CHB patients from a ‘real-world’ clinical practice setting in China.
Methods: This prospective, observational cohort comprised a sub-group of 3546 NUC-naïve CHB patients enrolled in the REALM study from 50 study sites in China. Patients were randomized to ETV or oSOC, and were assessed for virologic responses and limited safety parameters over 144 weeks.
Results: Overall, 3528 patients were treated (ETV: 1768; oSOC: 1760). Baseline patient characteristics were well balanced across treatment groups: approximately 80% male, 100% Asian, 64% HBeAg(+); mean HBV DNA ≈6.76 log10 IU/mL in both arms. More patients in the oSOC arm than in the ETV arm discontinued study therapy (134/1773 [8%] versus 78/1773 [4%]); the most common reasons were subject request (ETV 30 [2%], oSOC 54 [3%]), lost to follow-up (ETV 21 [1%], oSOC 39 [2%]), death (ETV 13 [<1%], oSOC 19 [1%]) and inadequate treatment response (ETV 1 [<1%], oSOC 10 [<1%]). At Week 144, 84% of ETV-treated patients had HBV DNA <50 IU/mL compared with 55% in the oSOC arm (non-completer=missing analysis). Serious treatment-related adverse events were infrequent (<1%) and comparable between both treatment arms. One patient (ETV arm) had increased alanine aminotransferase, 1 patient increased blood bilirubin (ETV arm), and 1 patient increased blood creatinine phosphokinase (oSOC arm). There were 13 deaths in the ETV arm and 21 in the oSOC arm (on treatment or during follow up).
Conclusions: In a real-world setting, nucleos(t)ide naïve Chinese CHB patients treated with ETV achieved higher rates of virologic response compared with patients receiving other standard of care over 3 years of therapy.

肝胆速递

肝胆速递

当前类别：B型肝炎
描述符：I02。治疗与临床试验
标题：随机，观察性研究的长期恩替卡韦治疗与护理核苷（酸）IDE模拟治疗的核苷（酸）从“真实世界”在中国的临床实践中设定IDE慢性乙肝初治患者与其他标准的
香港（姓氏，名字），赖WEI3，香港Ren4次佳2 Hou1吉林，冀东，清Xie5，志良Gao6，魏Zhao7玉明Wang8，Gong9国忠，Wukui Cao10，苗Yu11，西里尔Llamoso11
机构（S）：
机构（ALL）：1。肝病单位和器官衰竭的研究重点实验室，南方医科大学南方医院，南方医科大学，1838北广州大道，广州510515，中国。
2。肝病研究中心，首都医科大学附属北京友谊医院，北京100050，中国。
3。北京大学人民医院，北京大学肝病研究所，北京，中国。
4。重庆医科大学附属第二医院，重庆，中国。
5。传染病系，上海瑞金医院，上海交通大学医学院，中国。
6。附属第三医院，广州，中国孙中山大学。
7。南京医学院附属第二医院，东南大学，南京210003，中国江苏省。
8。传染病研究所，第三军医大学西南医院，重庆，400038，中国。
9。肝病中心，中南大学湘雅二医院，中南大学，长沙，中国。
10。天津市传染病医院，天津300192，中国。
11。研究与发展，百时美施贵宝施贵宝公司，沃灵福德，CT，美国。
抽象的身体：背景：慢性乙型肝炎（CHB）是一个重要的公共卫生问题和肝脏相关死亡率在中国的一个重要原因。这项研究提出了恩替卡韦（ETV）治疗或其他标准的护理（OSOC）的抗HBV核苷（酸）IDE模拟（NUC）治疗（拉米夫定，替比夫定和阿德福韦）在长达144周的的病毒学疗效和安全数据有限，从“真实世界”在中国的临床实践中设定的NUC初治的慢性乙型肝炎患者。
方法：本前瞻性，观察性队列包括3546 NUC初治的慢性乙型肝炎患者进入领域中的研究，在中国的50个研究点的一个子群。的患者随机ETV或OSOC的，为超过144周的病毒学反应和有限的安全参数，并进行了评估。
结果：总体而言，3528例患者接受治疗（ETV：1768 OSOC：1760）。患者基线特征以及平衡各治疗组，约80％的男性，100％亚洲，64％的HBeAg（+），平均HBV DNA≈6.76 log10的国际单位/毫升的双组。更多的患者比ETV组终止研究治疗在OSOC组（1773分之134[8％]与一千七百七十三分之七十八[4％]）;最常见的原因是病人请求（ETV 30 [％]，OSOC 54 [ 3％），失去了后续（ETV 21 [％]，OSOC 39 [％]），死亡（ETV 13 <1％，OSOC 19 [％]）和不充分的治疗反应（ETV 1 [<1％]，OSOC 10 [<1％）]。在144周，84％的ETV治疗的患者HBV DNA <50 IU / mL的相比55％中的OSOC组（非完成=缺少分析）。治疗相关的严重不良事件是罕见（<1％），两治疗组之间的比较。一个病人增加了谷丙转氨酶（ETV组），1例患者增加血液中胆红素（ETV组），1例增加血中肌酸磷酸激酶（OSOC组）。在ETV组有13人死亡和21在OSOC组（治疗或随访期间）。
结论：在现实世界中的设置，核苷（酸）IDE天真的中国慢性乙型肝炎患者恩替卡韦治疗取得了与其他标准的护理患者接受治疗超过3年的病毒学应答率较高。