Randomized Clinical Trial
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 28, 2018; 24(12): 1361-1372
Published online Mar 28, 2018. doi: 10.3748/wjg.v24.i12.1361
Daclatasvir plus asunaprevir in treatment-naïve patients with hepatitis C virus genotype 1b infection
Lai Wei, Fu-Sheng Wang, Ming-Xiang Zhang, Ji-Dong Jia, Alexey A Yakovlev, Wen Xie, Eduard Burnevich, Jun-Qi Niu, Yong Jin Jung, Xiang-Jun Jiang, Min Xu, Xin-Yue Chen, Qing Xie, Jun Li, Jin-Lin Hou, Hong Tang, Xiao-Guang Dou, Yash Gandhi, Wen-Hua Hu, Fiona McPhee, Stephanie Noviello, Michelle Treitel, Ling Mo, Jun Deng
Lai Wei, Peking University People’s Hospital and Peking University Hepatology Institute, Beijing 100044, China
Fu-Sheng Wang, 302 Military Hospital of China, Beijing 100039, China
Ming-Xiang Zhang, the Sixth People’s Hospital of Shenyang, Shenyang 110006, Liaoning Province, China
Ji-Dong Jia, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
Alexey A Yakovlev, Saint-Petersburg State Healthcare Institution ‘Clinical Infectious Hospital n.a. S.P. Botkin’, Saint-Petersburg 191167, Russia
Wen Xie, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
Eduard Burnevich, I.M. Sechenov First Moscow State Medical University, Moscow 119991, Russia
Jun-Qi Niu, The First Hospital of Jilin University, Jilin 1300021, Jilin Province, China
Yong Jin Jung, SMG-SNU Boramae Medical Center, Seoul 07061, South Korea
Xiang-Jun Jiang, Qingdao Municipal Hospital, Qingdao 266011, Shandong Province, China
Min Xu, Guangzhou No. 8 People’s Hospital, Guangzhou 510060, Guangdong Province, China
Xin-Yue Chen, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
Qing Xie, Shanghai Ruijin Hospital, Jiaotong University School of Medicine, Shenyang 200025, Liaoning Province, China
Jun Li, TheFirst Affiliated Hospital with Nanjing Medical University, Nanjing 210029, Jiangsu Province, China
Jin-Lin Hou, Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China
Hong Tang, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
Xiao-Guang Dou, China Medical University, Shengjing Hospital, Shenyang 110004, Liaoning Province, China
Yash Gandhi, Wen-Hua Hu, Stephanie Noviello, Michelle Treitel, Bristol-Myers Squibb, Princeton, NJ 08540, United States
Fiona McPhee, Bristol-Myers Squibb, Wallingford, CT 06492, United States
Ling Mo, Jun Deng, Bristol-Myers Squibb, Shanghai 200040, China
Author contributions: Noviello S, Treitel M, Gandhi Y, Hu WH, Mo L, Deng J and McPhee F designed the research; Wang FS, Zhang MX, Jia JD, Yakovlev AA, Xie W, Burnevich EZ, Niu JQ, Jung YJ, Jiang XJ, Xu M, Chen XY, Xie Q, Li J, Hou JL, Tang H, Dou XG, Gandhi Y, Hu WH and McPhee F performed the research; Hu WH analyzed the data; Noviello S, Treitel M, Mo L and Deng J monitored the study conduct; All authors wrote the paper, had access to the study data and have reviewed and approved the final manuscript.
Supported by Bristol-Myers Squibb.
Institutional review board statement: The protocol was approved by the institutional review board/human research committee at each participating institution, and conformed to the ethical guidelines of the 2008 Declaration of Helsinki.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov, registration number NCT02496078 (https://clinicaltrials.gov/ct2/show/NCT02496078).
Informed consent statement: All patients provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors have no conflicts of interest for this manuscript.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author. Patients gave informed consent regarding the relevant use and sharing of key-coded data.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Jun Deng, MD, Virology Clinical Research, Bristol-Myers Squibb, 55F Wheelock Square, 1717 West Nanjing Road, Shanghai 200040, China. daniel.deng@bms.com
Telephone: +86-21-23218405 Fax: +86-21-32303705
Received: December 22, 2017
Peer-review started: December 22, 2017
First decision: January 4, 2018
Revised: February 9, 2018
Accepted: February 26, 2018
Article in press: February 26, 2018
Published online: March 28, 2018
Processing time: 93 Days and 22 Hours
Core Tip

Core tip: This phase 3, placebo-controlled study assessed the efficacy and safety of daclatasvir (NS5A inhibitor) plus asunaprevir (NS3/4A protease inhibitor) in treatment-naïve patients from mainland China, Russia and South Korea with hepatitis C virus (HCV) genotype 1b infection. The rate of sustained virologic response at posttreatment week 12 among patients in the immediate treatment arm was 92%, which was significantly higher than the historical comparator rate (70%). The combination was well tolerated during 24 wk of treatment. These results demonstrate that for countries such as China, where interferon-based combinations are still widely used for the treatment of HCV genotype 1b, daclatasvir/asunaprevir offers a more efficacious and tolerable alternative with a shorter treatment duration.