title: Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Cleo Study Group
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Antonio
authors: A
authors: Ascione
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Luigi Elio
authors: LE
authors: Adinolfi
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Pietro
authors: P
authors: Amoroso
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Angelo
authors: A
authors: Andriulli
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Orlando
authors: O
authors: Armignacco
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Tiziana
authors: T
authors: Ascione
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Sergio
authors: S
authors: Babudieri
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Giorgio
authors: G
authors: Barbarini
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Michele
authors: M
authors: Brogna
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Francesco
authors: F
authors: Cesario
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Vincenzo
authors: V
authors: Citro
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Ernesto
authors: E
authors: Claar
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Raffaele
authors: R
authors: Cozzolongo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Giuseppe
authors: G
authors: D'Adamo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Emilio
authors: E
authors: D'Amico
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Pellegrino
authors: P
authors: Dattolo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Massimo
authors: M
authors: De Luca
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Vincenzo
authors: V
authors: De Maria
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Massimo
authors: M
authors: De Siena
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Giuseppe
authors: G
authors: De Vita
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Antonio
authors: A
authors: Di Giacomo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Rosanna
authors: R
authors: De Marco
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Giorgio
authors: G
authors: De Stefano
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Giulio
authors: G
authors: De Stefano
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Sebastiano
authors: S
authors: Di Salvo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Raffaele
authors: R
authors: Di Sarno
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Nunzia
authors: N
authors: Farella
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Laura
authors: L
authors: Felicioni
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Basilio
authors: B
authors: Fimiani
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Luca
authors: L
authors: Fontanella
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Giuseppe
authors: G
authors: Foti
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Caterina
authors: C
authors: Furlan
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Francesca
authors: F
authors: Giancotti
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Giancarlo
authors: G
authors: Giolitto
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Tiziana
authors: T
authors: Gravina
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Barbara
authors: B
authors: Guerrera
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Roberto
authors: R
authors: Gulminetti
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Angelo
authors: A
authors: Iacobellis
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Michele
authors: M
authors: Imparato
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Angelo
authors: A
authors: Iodice
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Vincenzo
authors: V
authors: Iovinella
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Antonio
authors: A
authors: Izzi
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Alfonso
authors: A
authors: Liberti
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Pietro
authors: P
authors: Leo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Gennaro
authors: G
authors: Lettieri
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Ileana
authors: I
authors: Luppino
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Aldo
authors: A
authors: Marrone
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Ettore
authors: E
authors: Mazzoni
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Vincenzo
authors: V
authors: Messina
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Roberto
authors: R
authors: Monarca
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Vincenzo
authors: V
authors: Narciso
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Lorenzo
authors: L
authors: Nosotti
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Adriano Maria
authors: AM
authors: Pellicelli
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Alessandro
authors: A
authors: Perrella
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Guido
authors: G
authors: Piai
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Antonio
authors: A
authors: Picardi
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Paola
authors: P
authors: Pierri
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Grazia
authors: G
authors: Pietromatera
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Francesco
authors: F
authors: Resta
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Luca
authors: L
authors: Rinaldi
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Mario
authors: M
authors: Romano
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Angelo
authors: A
authors: Rossini
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Maurizio
authors: M
authors: Russello
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Grazia
authors: G
authors: Russo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Rodolfo
authors: R
authors: Sacco
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Vincenzo
authors: V
authors: Sangiovanni
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Antonio
authors: A
authors: Schiano
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Antonio
authors: A
authors: Sciambra
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Gaetano
authors: G
authors: Scifo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Filomena
authors: F
authors: Simeone
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Annarita
authors: A
authors: Sullo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Pierluigi
authors: P
authors: Tarquini
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Paolo
authors: P
authors: Tundo
authors: Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy.
authors: Alfredo
authors: A
authors: Vallone
keywords: Antiviral therapy; Boceprevir; Chronic hepatitis; Peg-interferon; Ribavirin; Telaprevir