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.
