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©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 14, 2015; 21(30): 9163-9174
Published online Aug 14, 2015. doi: 10.3748/wjg.v21.i30.9163
Published online Aug 14, 2015. doi: 10.3748/wjg.v21.i30.9163
Effectiveness and safety of first-generation protease inhibitors in clinical practice: Hepatitis C virus patients with advanced fibrosis
Javier Salmerón, Carmen Vinaixa, Juan Manuel Pascasio, Manuel Romero-Gómez, José Antonio Pons, Francisco Jorquera, Ana Gila, Paloma Muñoz de Rueda, Rosa Quiles, CIBERehd, Instituto de Salud Carlos III, 28029 Madrid, Spain
Javier Salmerón, Rubén Berenguer, Ana Gila, Dolores Espinosa, Unit for Clinical Management of Digestive Diseases, Complejo Hospitalario Universitario de Granada, 18014 Granada, Spain
Javier Salmerón, Ana Belén Martín, Paloma Muñoz de Rueda, Rosa Quiles, Instituto de Investigación Biosanitaria de Granada, 18012 Granada, Spain
Carmen Vinaixa, University Hospital Politécnico La Fe, 46009 Valencia, Spain
Juan Manuel Pascasio, Unit for Clinical Management of Digestive Diseases, University Hospital Virgen Del Rocío, 41013 Sevilla, Spain
Juan José Sánchez Ruano, Hospital Toledo, 45004 Toledo, Spain
Miguel Ángel Serra, University Clinic Hospital of Valencia, 46010 Valencia, Spain
Moisés Diago, University General Hospital of Valencia, 46014 Valencia, Spain
Manuel Romero-Gómez, Unit for Clinical Management of Digestive Diseases, University Hospital Nuestra Señora de Valme, 41014 Sevilla, Spain
José María Navarro, Department of Gastroenterology and Hepatology Agencia Sanitaria Costa del Sol, Marbella, 29600 Málaga, Spain
Milagros Testillano, University Hospital Cruces, 48180 Bilbao, Spain
Conrado Fernández, Gastroenterology Unit, University Hospital Fundación Alcorcón, 28922 Madrid, Spain
Isabel Carmona, University Hospital Virgen Macarena, 41009 Sevilla, Spain
José Antonio Pons, University Hospital Virgen de la Arrixaca, 30120 Murcia, Spain
Francisco Jorquera, Hospital of León, 24004 León, Spain
Francisco Javier Rodriguez, University General Hospital Reina Sofía, 30003 Murcia, Spain
Ramón Pérez, Department Gastroenterology and Hepatology, University Hospital Central de Asturias, 33011 Asturias, Spain
José Luis Montero, University Hospital Reina Sofía, 14004 Córdoba, Spain
Rafael Granados, University Hospital De Gran Canaria Dr. Negrín, 35010 Gran Canaria, Spain
Miguel Fernández, Hospital San Pedro de Alcántara, 10003 Cáceres, Spain
Author contributions: Quiles R and Muñoz de Rueda P equally contributed to the work; Salmerón J contributed to planning and conducting the study, collecting and interpreting the date; Berenguer R, Muñoz de Rueda P and Quiles R contributed collecting and interpreting the data, drafting the manuscript; Martín AB contributed collecting the data; Muñoz de Rueda P contributed to biostatistical analysis; Vinaixa C, Pascasio JM, Sánchez Ruano JJ, Serra MÁ, Gila A, Diago M, Romero-Gómez M, Navarro JM, Testillano M, Fernández C, Espinosa D, Carmona I, Pons JA, Jorquera F, Rodriguez FJ, Pérez R, Montero JL, Granados R, Fernández M and the Alhambra Spanish Study Group contributed to treatment of patients and planning the study.
Institutional review board statement: The study was reviewed and approved by Andalusian Coordinating Committee for Biomedical Research Ethics and Spanish Agency of Medicines and Health Product.
Clinical trial registration statement: This study is registered at https://clinicaltrials.gov/ct2/show/NCT02004379. The registration identification number is NCT02004379.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors have no potential conflicts of interest to disclose.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at rosa-quiles@hotmail.com. Informed consent for data sharing was obtained from the participants as the presented data are anonymized, and the risk of identification is very low. No additional data are available.
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: Dr. Rosa Quiles, CIBERehd Researcher, Instituto de Investigación Biosanitaria de Granada, University Hospital San Cecilio of Granada, Dr/Olóriz 16, 18012 Granada, Spain. rosa-quiles@hotmail.com
Telephone: +34-958023655 Fax: +34-958023434
Received: March 4, 2015
Peer-review started: March 5, 2015
First decision: April 13, 2015
Revised: April 29, 2015
Accepted: June 26, 2015
Article in press: June 26, 2015
Published online: August 14, 2015
Peer-review started: March 5, 2015
First decision: April 13, 2015
Revised: April 29, 2015
Accepted: June 26, 2015
Article in press: June 26, 2015
Published online: August 14, 2015
Core Tip
Core tip: To the best of our knowledge, this study objectively evaluates the effectiveness and safety of first-generation protease inhibitors in routine clinical practice against chronic C virus infection. A total of 1057 patients with chronic hepatitis C genotype 1, treatment with triple therapy (boceprevir or telaprevir in combination with peginterferon and ribavirin) were included: 30% (n = 319) were treatment-naïve and the remaining 738 (70%) were treatment-experienced: 28% were relapsers, 12% were partial responders, 25% were null-responders and for 5% the prior response was unknown. At present not all patients can be treated with new molecules as simeprevir or sofosbuvir.