Observational Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Aug 8, 2016; 8(22): 949-956
Published online Aug 8, 2016. doi: 10.4254/wjh.v8.i22.949
Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience
CLEO Study Group, Antonio Ascione, Luigi Elio Adinolfi, Pietro Amoroso, Angelo Andriulli, Orlando Armignacco, Tiziana Ascione, Sergio Babudieri, Giorgio Barbarini, Michele Brogna, Francesco Cesario, Vincenzo Citro, Ernesto Claar, Raffaele Cozzolongo, Giuseppe D’Adamo, Emilio D’Amico, Pellegrino Dattolo, Massimo De Luca, Vincenzo De Maria, Massimo De Siena, Giuseppe De Vita, Antonio Di Giacomo, Rosanna De Marco, Giorgio De Stefano, Giulio De Stefano, Sebastiano Di Salvo, Raffaele Di Sarno, Nunzia Farella, Laura Felicioni, Basilio Fimiani, Luca Fontanella, Giuseppe Foti, Caterina Furlan, Francesca Giancotti, Giancarlo Giolitto, Tiziana Gravina, Barbara Guerrera, Roberto Gulminetti, Angelo Iacobellis, Michele Imparato, Angelo Iodice, Vincenzo Iovinella, Antonio Izzi, Alfonso Liberti, Pietro Leo, Gennaro Lettieri, Ileana Luppino, Aldo Marrone, Ettore Mazzoni, Vincenzo Messina, Roberto Monarca, Vincenzo Narciso, Lorenzo Nosotti, Adriano Maria Pellicelli, Alessandro Perrella, Guido Piai, Antonio Picardi, Paola Pierri, Grazia Pietromatera, Francesco Resta, Luca Rinaldi, Mario Romano, Angelo Rossini, Maurizio Russello, Grazia Russo, Rodolfo Sacco, Vincenzo Sangiovanni, Antonio Schiano, Antonio Sciambra, Gaetano Scifo, Filomena Simeone, Annarita Sullo, Pierluigi Tarquini, Paolo Tundo, Alfredo Vallone
Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy
Pietro Amoroso, Gennaro Lettieri, Paola Pierri, VI Division of Infectious Diseases, Cotugno Hospital, AORN “Ospedali dei Colli”, 80135 Naples, Italy
Angelo Andriulli, Angelo Iacobellis, Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, 71013 San Giovanni Rotondo, Italy
Orlando Armignacco, Division of Infectious Diseases, Belcolle Hospital, 01100 Viterbo, Italy
Tiziana Ascione, Giorgio De Stefano, Nunzia Farella, IX Division of Infectious Diseases, Cotugno Hospital, AORN “Ospedali dei Colli”, 80135 Naples, Italy
Sergio Babudieri, Clinical of Infectious Disease, University of Sassari, 07100 Sassari, Italy
Giorgio Barbarini, Roberto Gulminetti, Infectious Disease IRCCS San Matteo, 27100 Pavia, Italy
Michele Brogna, Alfredo Vallone, Division of Infectious Diseases and Liver Unit, “G. Iazzolino” Hospital, 89900 Vibo Valentia, Italy
Francesco Cesario, Division of Infectious Diseases, “Annunziata” Hospital, 87100 Cosenza, Italy
Vincenzo Citro, Giuseppe D’Adamo, Basilio Fimiani, Department of Internal Medicine, Umberto I Hospital, 84014 Nocera Inferiore, Italy
Ernesto Claar, Antonio Sciambra, Internal Medicine, Ospedale Evangelico Villa Betania, 80147 Naples, Italy
Raffaele Cozzolongo, Division of Gastroenterology, IRCCS “S. de Bellis” Hospital, 70013 Castellana Grotte, Italy
Emilio D’Amico, Laura Felicioni, Internal Medicine Unit, Pescara-Penne Hospital, 65121 Pescara, Italy
Pellegrino Dattolo, Gastroenterology Unit, Marcianise Hospital, 81025 Marcianise, Italy
Massimo De Luca, Liver Unit, AORN Cardarelli, 80131 Napoli, Italy
Vincenzo De Maria, Massimo De Siena, Sebastiano Di Salvo, Francesca Giancotti, Tiziana Gravina, Liver Unit, Policlinico “Mater Domini”, 80020 Catanzaro, Italy
Giuseppe De Vita, Service of Medical Day Hospital, “Rummo” Hospital, 82100 Benevento, Italy
Antonio Di Giacomo, Internal Medicine, Regina Margherita Hospital, 97013 Comiso, Ragusa, Italy
Rosanna De Marco, Pietro Leo, Ileana Luppino, Division of Gastroenterology, “Annunziata” Hospital, 87100 Cosenza, Italy
Giulio De Stefano, Grazia Pietromatera, Infectious Disease, Matera Hospital, 75100 Matera, Italy
Raffaele Di Sarno, Antonio Izzi, First Division of Infectious Diseases, Cotugno Hospital, AORN “Ospedali dei Colli”, 80135 Naples, Italy
Giuseppe Foti, Division of Infectious Diseases, AO Melacrino-Bianchi-Morelli, 89121 Reggio Calabria, Italy
Caterina Furlan, Infectious and Tropical Disease, Policlinico Umberto I, 00185 Rome, Italy
Giancarlo Giolitto, Grazia Russo, Division of Infectious Disease, Maria SS Addolorata Hospital, 84025 Eboli, Salerno, Italy
Angelo Iodice, Vincenzo Messina, Filomena Simeone, Division of Infectious Diseases, S. Anna and S. Sebastiano Hospital, 81100 Caserta, Italy
Vincenzo Iovinella, Outpatients Service for Liver Diseases, “Loreto Crispi” Hospital, 80121 Naples, Italy
Alfonso Liberti, V Division of Infectious Diseases, Cotugno Hospital, AORN “Ospedali dei Colli”, 80135 Naples, Italy
Aldo Marrone, Luca Rinaldi, Department of Medical Surgical, Neurological, Geriatric, and Metabolic Sciences, Second University of Naples, 80131 Naples, Italy
Ettore Mazzoni, Liver Unit, Policlinico Casilino, 80132 Roma, Italy
Roberto Monarca, Medicine and Health Unit for Prisoners, Belcolle Hospital, 01100 Viterbo, Italy
Vincenzo Narciso, Internal Medicine Unit, “Ascalesi” Hospital, 80100 Naples, Italy
Lorenzo Nosotti, Gastrointestinal and Liver Department, National Institute for Health, Migration and Poverty, 80199 Rome, Italy
Adriano Maria Pellicelli, Liver Unit, Azienda Ospedaliera San Camillo Forlanini, 00151 Rome, Italy
Alessandro Perrella, VII Division of Infectious Diseases, Cotugno Hospital, AORN “Ospedali dei Colli”, 80135 Naples, Italy
Guido Piai, Division of Gastroenterology, S. Anna and S. Sebastiano Hospital, 8100 Caserta, Italy
Antonio Picardi, Liver Unit, University “Campus Biomedico”, 80199 Rome, Italy
Francesco Resta, Division of Infectious Disease, Taranto Hospital, 74121 Taranto, Italy
Mario Romano, Liver Unit, ¡°Sandro Pertini¡± Hospital, 80132 Rome, Italy
Angelo Rossini, Liver Unit, Service ¡°Spedali Civili¡± Hospital, 24121 Brescia, Italy
Maurizio Russello, Liver Unit, Garibaldi-Nesima Hospital, 95121 Catania, Italy
Rodolfo Sacco, Gastroenterology and Metabolism Diseases Unit, AO Pisana, 56121 Pisa, Italy
Vincenzo Sangiovanni, III Division of Infectious Diseases, Cotugno Hospital, AORN ¡°Ospedali dei Colli¡±, 80135 Naples, Italy
Antonio Schiano, Hepatology Unit, S. Giovanni di Dio Hospital, 80027 Frattamaggiore, Italy
Gaetano Scifo, Infectious Diseases Unit, P.O. Umberto I, 96100 Siracusa, Italy
Annarita Sullo, Infectious Diseases Unit, ¡°Umberto 1¡ã¡± Hospital, 84014 Nocera Inferiore, Italy
Pierluigi Tarquini, Infectious Diseases Unit, Giuseppe Mazzini Hospital, 64100 Teramo, Italy
Paolo Tundo, Division of Infectious Diseases, S. Caterina Novella Hospital, 73013 Galatina, Italy
Author contributions: All authors of CLEO study group equally contributed to conception and design of the study, acquisition of data, review the draft, and approved the final version.
Institutional review board statement: The study was reviewed and approved by the CLEO Governing Board.
Informed consent statement: All study participants, or their legal representative, provided verbal informed consent prior to study enrolment as decided by the CLEO Governing Board and according to the local rules.
Conflict-of-interest statement: The authors declare that they have no conflicts of interest regarding this study.
Data sharing statement: 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: Antonio Ascione, MD, Consultant Hepatologist, Department of Medicine, Center for Liver Diseases, “Buon Consiglio” - Fatebenefratelli Hospital, Via A. Manzoni 220, 80126 Naples, Italy. antonio.ascione@paginemediche.it
Telephone: +39-081-5981877
Received: February 23, 2016
Peer-review started: February 24, 2016
First decision: April 15, 2016
Revised: June 23, 2016
Accepted: July 20, 2016
Article in press: July 22, 2016
Published online: August 8, 2016
Abstract

AIM: To check the safety and efficacy of boceprevir/telaprevir with peginterferon/ribavirin for hepatitis C virus (HCV) genotype 1 in the real-world settings.

METHODS: This study was a non-randomized, observational, prospective, multicenter. This study involved 47 centers in Italy. A database was prepared for the homogenous collection of the data, was used by all of the centers for data collection, and was updated continuously. All of the patients enrolled in this study were older than 18 years of age and were diagnosed with chronic infection due to HCV genotype 1. The HCV RNA testing was performed using COBAS-TaqMan2.0 (Roche, LLQ 25 IU/mL).

RESULTS: All consecutively treated patients were included. Forty-seven centers enrolled 834 patients as follows: Male 64%; median age 57 (range 18-78), of whom 18.3% were over 65; mean body mass index 25.6 (range 16-39); genotype 1b (79.4%); diagnosis of cirrhosis (38.2%); and fibrosis F3/4 (71.2%). The following drugs were used: Telaprevir (66.2%) and PEG-IFN-alpha2a (67.6%). Patients were naïve (24.4%), relapsers (30.5%), partial responders (14.8%) and null responders (30.3%). Overall, adverse events (AEs) occurred in 617 patients (73.9%) during the treatment. Anemia was the most frequent AE (52.9% of cases), especially in cirrhotic. The therapy was stopped for 14.6% of the patients because of adverse events or virological failure (15%). Sustained virological response was achieved in 62.7% of the cases, but was 43.8% in cirrhotic patients over 65 years of age.

CONCLUSION: In everyday practice, triple therapy is safe but has moderate efficacy, especially for patients over 65 years of age, with advanced fibrosis, non-responders to peginterferon + ribavirin.

Keywords: Boceprevir, Telaprevir, Chronic hepatitis, Antiviral therapy, Peg-interferon, Ribavirin

Core tip: This study describes the role of antiviral therapy for chronic hepatitis C virus infections in everyday practice. Boceprevir or telaprevir, in combination with pegylated interferon and ribavirin, were used in this multicenter study organized by the Italian Association of Hospital Hepatologists (CLEO). A total of 834 patients were enrolled with this first available combination of direct-acting antiviral drugs. The data on the efficacies were quite similar to those produced by the registration studies; however, in the real world experience, patients were older and had more advanced liver disease. In this category of patients, the sustained virological response was less than 50%.