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3/23/2016 4:26:00 PM | Browse: 1270 | Download: 1871
Publication Name World Journal of Gastroenterology
Manuscript ID 22243
Country United States
Received
2015-08-22 17:29
Peer-Review Started
2015-08-25 13:40
To Make the First Decision
2015-09-09 16:59
Return for Revision
2015-09-13 13:05
Revised
2015-10-17 00:33
Second Decision
2015-11-11 16:55
Accepted by Journal Editor-in-Chief
Accepted by Company Editor-in-Chief
2015-12-01 09:18
Articles in Press
2015-12-01 09:18
Publication Fee Transferred
Edit the Manuscript by Language Editor
Typeset the Manuscript
2016-03-03 17:31
Publish the Manuscript Online
2016-03-23 16:22
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) 2016. 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 Clinical Trials Study
Article Title Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1
Manuscript Source Unsolicited Manuscript
All Author List Ira Jacobson, Stefan Zeuzem, Robert Flisiak, Brygida Knysz, Stefan Lueth, Dorota Zarebska-Michaluk, Ewa Janczewska, Peter Ferenci, Moises Diago, Anna Linda Zignego, Rifaat Safadi, Yaacov Baruch, Dzhamal Abdurakhmanov, Stephen Shafran, Dominique Thabut, Rafael Bruck, Adrian Gadano, Alexander James Thompson, Justin Kopit, Fiona McPhee, Tracy Michener, Eric A Hughes, Philip D Yin and Stephanie Noviello
Funding Agency and Grant Number
Funding Agency Grant Number
Bristol-Myers Squibb
Corresponding Author Dr. Ira Jacobson, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, United States. ijacobson@chpnet.org
Key Words Direct-acting antiviral; Chronic hepatitis C; Daclatasvir; Genotype 1b; NS5A inhibitor; Liver disease
Core Tip This phase 3 study describes the first prospective comparison of an NS5A inhibitor and an NS3/4A protease inhibitor in peginterferon-based regimens. Combinations of peginterferon alfa-2a/ribavirin (pegIFN/RBV) with boceprevir or telaprevir were the standard-of-care for genotype (GT) 1-infected patients at the time of study design. In treatment-naive GT1b-infected patients, daclatasvir (NS5A inhibitor) plus pegIFN/RBV achieved a sustained virologic response at posttreatment week 12 (SVR12) of 85% and demonstrated noninferiority to telaprevir plus pegIFN/RBV showing 81% SVR12. Daclatasvir plus pegIFN/RBV was well-tolerated, with a superior safety profile for anemia compared with telaprevir plus pegIFN/RBV. These results support the ongoing investigation of daclatasvir in all-oral combinations in multiple patient populations.
Publish Date 2016-03-23 16:22
Citation Jacobson I, Zeuzem S, Flisiak R, Knysz B, Lueth S, Zarebska-Michaluk D, Janczewska E, Ferenci P, Diago M, Zignego AL, Safadi R, Baruch Y, Abdurakhmanov D, Shafran S, Thabut D, Bruck R, Gadano A, Thompson AJ, Kopit J, McPhee F, Michener T, Hughes EA, Yin PD, Noviello S. Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1. World J Gastroenterol 2016; 22(12): 3418-3431
URL http://www.wjgnet.com/1007-9327/full/v22/i12/3418.htm
DOI http://dx.doi.org/10.3748/wjg.v22.i12.3418
Full Article (PDF) WJG-22-3418.pdf
Full Article (Word) WJG-22-3418.doc
Manuscript File 22243-Review.docx
Answering Reviewers 22243-Answering reviewers.pdf
Audio Core Tip 22243-Audio core tip.wav
Biostatistics Review Certificate 22243-Biostatistics statement.pdf
Clinical Trial Registration Statement 22243-Clinical trial registration statement.pdf
Conflict-of-Interest Disclosure Form 22243-Conflict-of-interest statement.pdf
Copyright License Agreement 22243-Copyright Agreement.pdf
Signed Informed Consent Form(s) or Document(s) 22243-Clinical trial registration statement.pdf
Institutional Review Board Approval Form or Document 22243-Institutional review board statement.pdf
Supplementary Material 22243-Supplementary material.docx
Peer-review Report 22243-Peer-review(s).pdf
Scientific Misconduct Check 22243-Scientific misconduct check.pdf
Scientific Editor Work List 22243-Scientific editor work list.pdf