Retrospective Cohort Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Sep 21, 2016; 22(35): 8050-8059
Published online Sep 21, 2016. doi: 10.3748/wjg.v22.i35.8050
Second-generation direct-acting-antiviral hepatitis C virus treatment: Efficacy, safety, and predictors of SVR12
Christoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Robert Beck, Nisar P Malek, Ulrich M Lauer, Christoph P Berg
Christoph R Werner, Julia M Schwarz, Daniel P Egetemeyr, Nisar P Malek, Ulrich M Lauer, Christoph P Berg, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, 72076 Tübingen, Germany
Robert Beck, Institute of Medical Virology, University Hospital Tübingen, 72076 Tübingen, Germany
Author contributions: Werner CR, Schwarz JM, Egetemeyr DP, Malek NP, Lauer UM and Berg CP designed the research, performed the research, and wrote the paper; Werner CR, Schwarz JM and Berg CP analyzed the data; Beck R contributed the virological analyses.
Institutional review board statement: The retrospective, anonymous analysis of individual patient data, which were obtained during diagnostics and treatment of own patients’ needs no approval by the institutional review board/ethical committee and no informed consent of the patients. No concerns exist against anonymous collection, analysis, and publication of those data.
Informed consent statement: The institutional review board of the Medical Faculty of the University of Tübingen approved this retrospective analysis and waived the need for written informed consent because of the anonymous evaluation of patient data from patient records.
Conflict-of-interest statement: Werner CR received travel grants from Gilead, Bristol-Myers-Squibb, Roche, and Janssen-Cilag, and lecture fees from Roche; Schwarz JM and Beck R declare no conflict; Egetemeyr DP received travel grants, and lecture fees from Roche; Malek NP declares no conflict; Lauer UM received travel grants from Roche; Berg CP received travel grants from Gilead, Bristol-Myers-Squibb, Roche, and Janssen-Cilag, and lecture fees from Gilead, Bristol-Myers-Squibb, Roche, and Janssen-Cilag. The authors received no financial support. No funding source exists.
Data sharing statement: Technical appendix, statistical code, and dataset are available from the corresponding author at christoph.berg@med.uni-tuebingen.de. Participants consent was not obtained but the presented data are anonymized and risk of identification is low.
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: Christoph P Berg, MD, Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, Otfried-Müller-Str. 10, 72076 Tübingen, Germany. christoph.berg@med.uni-tuebingen.de
Telephone: +49-7071-2982723 Fax: +49-7071-294423
Received: June 4, 2016
Peer-review started: June 5, 2016
First decision: June 20, 2016
Revised: July 21, 2016
Accepted: August 10, 2016
Article in press: August 10, 2016
Published online: September 21, 2016
Processing time: 102 Days and 18.7 Hours
Core Tip

Core tip: From 2014 on the second wave of direct acting antiviral agents was available for treatment of chronic hepatitis C infection. Due to the more heterogeneous character of patients in the “real world”, the therapeutic performance of these new drugs outside randomized clinical trials is of interest. Therefore, in this monocentric retrospective cohort study, we analyzed the efficacy, safety, and predictors of sustained virological response 12 for treatment with combinations of second generation direct acting antivirals in a “real-world” setting.