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3/26/2018 8:48:04 AM | Browse: 1138 | Download: 2049
Publication Name World Journal of Gastroenterology
Manuscript ID 36551
Country China
Received
2017-12-22 10:55
Peer-Review Started
2017-12-22 14:00
To Make the First Decision
2018-01-04 06:02
Return for Revision
2018-01-04 09:15
Revised
2018-02-09 17:01
Second Decision
2018-02-25 09:40
Accepted by Journal Editor-in-Chief
Accepted by Company Editor-in-Chief
2018-02-25 23:05
Articles in Press
2018-02-25 23:05
Publication Fee Transferred
Edit the Manuscript by Language Editor
2018-03-16 22:05
Typeset the Manuscript
2018-03-23 08:59
Publish the Manuscript Online
2018-03-26 08:48
ISSN 1007-9327 (print) and 2219-2840 (online)
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/
Copyright © The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
Article Reprints For details, please visit: http://www.wjgnet.com/bpg/gerinfo/247
Permissions For details, please visit: http://www.wjgnet.com/bpg/gerinfo/207
Publisher Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
Website http://www.wjgnet.com
Category Virology
Manuscript Type Randomized Clinical Trial
Article Title Daclatasvir plus asunaprevir in treatment-naïve patients with hepatitis C virus genotype 1b infection
Manuscript Source Unsolicited Manuscript
All Author List Lai Wei, Fu-Sheng Wang, Ming-Xiang Zhang, Ji-Dong Jia, Alexey A Yakolev, 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 and Jun Deng
ORCID
Author(s) ORCID Number
Lai Wei http://orcid.org/0000-0003-2326-1257
Fu-Sheng Wang http://orcid.org/0000-0002-8043-6685
Ming-Xiang Zhang http://orcid.org/0000-0001-6519-3497
Ji-Dong Jia http://orcid.org/0000-0002-4673-8890
Alexey A Yakolev http://orcid.org/0000-0003-4163-5769
Wen Xie http://orcid.org/0000-0002-7314-8175
Eduard Burnevich http://orcid.org/0000-0002-7251-4284
Jun-Qi Niu http://orcid.org/0000-0002-9857-6520
Yong Jin Jung http://orcid.org/0000-0001-8785-2254
Xiang-Jun Jiang http://orcid.org/0000-0001-8786-9654
Min Xu http://orcid.org/0000-0003-0099-9101
Xin-Yue Chen http://orcid.org/0000-0003-3212-2398
Qing Xie http://orcid.org/0000-0002-2582-8803
Jun Li http://orcid.org/0000-0002-1961-7188
Jin-Lin Hou http://orcid.org/0000-0001-8230-8583
Hong Tang http://orcid.org/0000-0002-9790-6225
Xiao-Guang Dou http://orcid.org/0000-0002-5293-6009
Yash Gandhi http://orcid.org/0000-0001-7637-9617
Wen-Hua Hu http://orcid.org/0000-0002-8763-609X
Fiona McPhee http://orcid.org/0000-0002-9321-4483
Stephanie Noviello http://orcid.org/0000-0003-2705-1097
Michelle Treitel http://orcid.org/0000-0001-9488-7113
Ling Mo http://orcid.org/0000-0001-8272-4210
Jun Deng http://orcid.org/0000-0002-6390-7430
Funding Agency and Grant Number
Funding Agency Grant Number
Bristol-Myers Squibb
Corresponding Author Jun Deng, MD, Global Clinical Research, Bristol-Myers Squibb, 55F Wheelock Square, 1717 West Nanjing Road, Shanghai 200040, China. daniel.deng@bms.com
Key Words Asunaprevir; Daclatasvir; Direct-acting antiviral; Chronic hepatitis C; Liver disease; NS3; NS5A; Genotype 1b
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.
Publish Date 2018-03-26 08:48
Citation Wei L, Wang FS, Zhang MX, Jia JD, Yakovlev AA, Xie W, Burnevich E, Niu JQ, Jung YJ, Jiang XJ, Xu M, Chen XY, Xie Q, Li J, Hou JL, Tang H, Dou XG, Gandhi Y, Hu WH, Mcphee F, Noviello S, Treitel M, Mo L, Deng J. Daclatasvir plus asunaprevir in treatment-naïve patients with hepatitis C virus genotype 1b infection. World J Gastroenterol 2018; 24(12): 1361-1372
URL http://www.wjgnet.com/1007-9327/full/v24/i12/1361.htm
DOI http://dx.doi.org/10.3748/wjg.v24.i12.1361
Full Article (PDF) WJG-24-1361.pdf
Full Article (Word) WJG-24-1361.doc
CONSORT 2010 Statement 36551-CONSORT 2010 statement.pdf
Manuscript File 36551-Review.docx
Answering Reviewers 36551-Answering reviewers.pdf
Audio Core Tip 36551-Audio core tip.MP3
Biostatistics Review Certificate 36551-Biostatistics statement.pdf
Clinical Trial Registration Statement 36551-Clinical trial registration statement.pdf
Conflict-of-Interest Disclosure Form 36551-Conflict-of-interest statement.pdf
Copyright License Agreement 36551-Copyright assignment.pdf
Signed Informed Consent Form(s) or Document(s) 36551-Informed consent statement.pdf
Institutional Review Board Approval Form or Document 36551-Institutional review board statement.pdf
Non-Native Speakers of English Editing Certificate 36551-Language certificate.pdf
Supplementary Material 36551-Supplementary-Material-revision_3436.pptx
Peer-review Report 36551-Peer-review(s).pdf
Scientific Misconduct Check 36551-Scientific misconduct check.pdf
Scientific Editor Work List 36551-Scientific editor work list.pdf