一项随机，双盲，双模拟，对照，多中心研究清中（替诺福

StephenW

Medicine (Baltimore). 2019 Aug;98(33):e16778. doi: 10.1097/MD.0000000000016778.
A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48.
Liang RY1, Xu JH1, Si CW1, Wang S1, Shang J2, Yu ZJ3, Mao Q4, Xie Q5, Zhao W6, Li J7, Gao ZL8, Wu SM9, Tang H10, Cheng J11, Chen XY12, Zhang WH13, Wang H14, Xu ZN15, Wang L15, Dai J15, Yu YY1.
Author information

1
    Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Peking.
2
    Department of Infectious Diseases, Henan Provincial People's Hospital.
3
    Department of Infectious Diseases, First Affiliated Hospital of Zhengzhou University, Henan.
4
    Department of Infectious Diseases, Southwest China Hospital, Chongqing.
5
    Department of Infectious Diseases, Ruijin Hospital, Jiaotong University School of Medicine, Shanghai.
6
    Department of Infectious Diseases, The Second Affiliated Hospital of Southeast University.
7
    Department of Infectious Diseases, The First Affiliated Hospital with Nanjing Medical University, Nanjing.
8
    Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangdong.
9
    Department of Infectious Diseases, Shanghai Public Health Clinical Center, Fudan University, Shanghai.
10
    Department of Infectious Diseases, West China Hospital of Sichuan University, Sichuan.
11
    Department of Infectious Diseases, Beijing Ditan Hospital.
12
    Department of International Medicine, Beijing Youan Hospital, Capital Medical University, Beijing.
13
    Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai.
14
    Department of Infectious Diseases, Peking University People's Hospital, Beijing.
15
    Jiangsu Chia-tai Tianqing Pharmaceutical Co, Ltd, Nanjing, China.

Abstract
BACKGROUND:

Tenofovir disoproxil fumarate (TDF) has been widely recommended as a first-line antiviral agent to treat chronic hepatitis B (CHB). Qingzhong and Viread, formulations of TDF commercialized by Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd and GlaxoSmithKline, respectively, have both been approved by the State Food and Drug Administration, China. This study analyzed the efficacy and safety of these 2 TDF agents in Chinese patients with CHB.
METHODS:

In this multicenter, randomized, double-blind, double-dummy, noninferiority phase 3 clinical trial (ClinicalTrials.gov identifier: NCT02287857), 330 Chinese patients with CHB [hepatitis B envelope antigen-positive (HBeAg) (+): 232] were randomly assigned to receive Qingzhong (group A: 161 patients) or Viread (group B: 169 patients) 300 mg once daily for 48 weeks. Subsequently, all patients were administered Qingzhong 300 mg once daily from week 49 to week 240. The primary end point was the degree of decline of plasma hepatitis B virus (HBV) DNA levels at week 48 and the secondary endpoints were viral suppression, normalization of alanine aminotransferase (ALT) levels, hepatitis B surface antigen (HBsAg)/HBeAg loss or seroconversion, and virological breakthrough.
RESULTS:

Among patients with CHB who were HBeAg (+), the mean HBV DNA titer decreased similarly between the groups at week 48. The percentages of patients who achieved undetectable HBV DNA were similar between the groups (85.11% and 82.35% in groups A and B, respectively) and similar losses of HBeAg and HBeAg seroconversion rates were achieved. Moreover, for patients with CHB who were HBeAg (-), reductions in HBV DNA were similar. Among all patients with CHB, the rates of normalization of ALT and the loss of HBsAg were similar. The overall incidence of adverse events was comparable between the groups.
CONCLUSION:

In conclusion, the 48-week administration of Qingzhong showed noninferior efficacy and safety profiles compared to Viread in Chinese patients with CHB.

PMID:
    31415381
DOI:
    10.1097/MD.0000000000016778

StephenW

医学（巴尔的摩）。 2019年8月; 98（33）：e16778。 doi：10.1097 / MD.0000000000016778。
一项随机，双盲，双模拟，对照，多中心研究清中（替诺福韦地索普西富马酸盐）与Viread治疗慢性乙型肝炎：第48周的第一阶段结果。
Liang RY1，Xu JH1，Si CW1，Wang S1，Shang J2，Yu ZJ3，Mao Q4，Xie Q5，Zhao W6，Li J7，Gao ZL8，Wu SM9，Tang H10，Cheng J11，Chen XY12，Zhang WH13，Wang H14 ，徐ZN15，王L15，戴J15，于YY1。
作者信息

1
北京大学第一医院肝病中心传染病科。
2
河南省人民医院感染科。
3
河南郑州大学第一附属医院感染科
4
重庆市西南医院感染科
五
上海交通大学医学院附属瑞金医院感染科
6
东南大学附属第二医院感染科。
7
南京医科大学第一附属医院感染科，南京。
8
广东中山大学附属第三医院感染科
9
复旦大学上海市公共卫生临床中心传染病科，上海。
10
四川大学华西医院感染科，四川。
11
北京地坛医院感染科。
12
首都医科大学附属北京佑安医院国际医学​​系，北京。
13
复旦大学附属华山医院感染科，上海。
14
北京大学人民医院感染科，北京。
15
江苏嘉泰天晴药业有限公司，中国南京。

抽象
背景：

替诺福韦地索普西富马酸盐（TDF）已被广泛推荐用作治疗慢性乙型肝炎（CHB）的一线抗病毒药物。由江苏嘉泰天晴药业有限公司和葛兰素史克分别商​​业化的TDF配方Qingzhong和Viread均已获得中国国家食品药品监督管理局批准。本研究分析了这2种TDF药物在中国CHB患者中的疗效和安全性。
方法：

在这项多中心，随机，双盲，双模拟，非劣效性3期临床试验（ClinicalTrials.gov标识：NCT02287857）中，330名中国CHB患者[乙型肝炎包膜抗原阳性（HBeAg）（+）：232]为随机分配接受清中（A组：161名患者）或Viread（B组：169名患者）300 mg，每日一次，共48周。开放，所有患者从第49周至第240周每天一次给予青中300毫克。主要终点是48周时血浆乙型肝炎病毒（HBV）DNA水平下降的程度，次要终点为病毒抑制，正常化丙氨酸氨基转移酶（ALT）水平，乙型肝炎表面抗原（HBsAg）/ HBeAg丢失或血清转换，以及病毒学突破。
结果：

在HBeAg（+）的CHB患者中，第48周时各组之间HBV DNA滴度平均下降相似。各组间HBV DNA检测不到的患者比例相似（A组和B组分别为85.11％和82.35％）同时，HBeAg和HBeAg血清学转换率也有类似的下降，而HBeAg（ - ）的CHB患者HBV DNA降低相似。在所有CHB患者中，ALT正常化率和损失率HBsAg相似，不良事件的总发生率在各组之间显着。
结论：

总之，与中国CHB患者中的Viread相比，清中48周给药显示出非劣效性和安全性。

结论：
31415381
DOI：
10.1097 / MD.0000000000016778

StephenW

https://insights.ovid.com/crossref?an=00005792-201908160-00035

齐欢畅