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Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience

2016; Baishideng Publishing Group; Volume: 8; Issue: 22 Linguagem: Inglês

10.4254/wjh.v8.i22.949

1948-5182

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, E D'Amico, Pellegrino Dattolo, M. De Luca, Vincenzo De Maria, Massimo De Siena, Giuseppe De Vita, Antonio Di Giacomo, Rosanna De Marco, G. de Stefano, Giulio De Stefano, Sebastiano Di Salvo, Raffaele Di Sarno, Nunzia Farella, L Felicioni, Basilio Fimiani, Luca Fontanella, Giuseppe Foti, Caterina Furlan, Francesca R. Giancotti, Giancarlo Giolitto, Tiziana Gravina, Barbara Guerrera, Roberto Gulminetti, A. Iacobellis, Michele Imparato, Angelo Iodice, Vincenzo Iovinella, Antonio Izzi, A. Liberti, Pietro Leo, Gennaro Lettieri, Ileana Luppino, Aldo Marrone, Ettore Mazzoni, Vincenzo Messina, Roberto Monarca, Vincenzo Narciso, L. Nosotti, Adriano Pellicelli, Alessandro Perrella, G. Piai, Antonio Picardi, Paola Pierri, Grazia Pietromatera, Francesco Resta, Luca Rinaldi, Mario Romano, Angelo Rossini, Maurizio Russello, Grazia Russo, Rodolfo Sacco, Vincenzo Sangiovanni, A Schiano, Antonio Sciambra, Gaetano Scifo, Filomena Simeone, Annarita Sullo, Pierluigi Tarquini, Paolo Tundo, Alfredo Vallone,

HIV/AIDS drug development and treatment

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