PMID- 27574549 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20160830 LR - 20200929 IS - 1948-5182 (Print) IS - 1948-5182 (Electronic) VI - 8 IP - 22 DP - 2016 Aug 8 TI - Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience. PG - 949-56 LID - 10.4254/wjh.v8.i22.949 [doi] AB - 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 naive (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. FAU - Cleo Study Group AU - Cleo Study Group AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Ascione, Antonio AU - Ascione A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Adinolfi, Luigi Elio AU - Adinolfi LE AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Amoroso, Pietro AU - Amoroso P AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Andriulli, Angelo AU - Andriulli A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Armignacco, Orlando AU - Armignacco O AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Ascione, Tiziana AU - Ascione T AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Babudieri, Sergio AU - Babudieri S AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Barbarini, Giorgio AU - Barbarini G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Brogna, Michele AU - Brogna M AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Cesario, Francesco AU - Cesario F AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Citro, Vincenzo AU - Citro V AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Claar, Ernesto AU - Claar E AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Cozzolongo, Raffaele AU - Cozzolongo R AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - D'Adamo, Giuseppe AU - D'Adamo G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - D'Amico, Emilio AU - D'Amico E AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Dattolo, Pellegrino AU - Dattolo P AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - De Luca, Massimo AU - De Luca M AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - De Maria, Vincenzo AU - De Maria V AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - De Siena, Massimo AU - De Siena M AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - De Vita, Giuseppe AU - De Vita G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Di Giacomo, Antonio AU - Di Giacomo A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - De Marco, Rosanna AU - De Marco R AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - De Stefano, Giorgio AU - De Stefano G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - De Stefano, Giulio AU - De Stefano G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Di Salvo, Sebastiano AU - Di Salvo S AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Di Sarno, Raffaele AU - Di Sarno R AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Farella, Nunzia AU - Farella N AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Felicioni, Laura AU - Felicioni L AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Fimiani, Basilio AU - Fimiani B AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Fontanella, Luca AU - Fontanella L AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Foti, Giuseppe AU - Foti G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Furlan, Caterina AU - Furlan C AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Giancotti, Francesca AU - Giancotti F AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Giolitto, Giancarlo AU - Giolitto G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Gravina, Tiziana AU - Gravina T AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Guerrera, Barbara AU - Guerrera B AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Gulminetti, Roberto AU - Gulminetti R AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Iacobellis, Angelo AU - Iacobellis A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Imparato, Michele AU - Imparato M AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Iodice, Angelo AU - Iodice A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Iovinella, Vincenzo AU - Iovinella V AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Izzi, Antonio AU - Izzi A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Liberti, Alfonso AU - Liberti A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Leo, Pietro AU - Leo P AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Lettieri, Gennaro AU - Lettieri G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Luppino, Ileana AU - Luppino I AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Marrone, Aldo AU - Marrone A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Mazzoni, Ettore AU - Mazzoni E AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Messina, Vincenzo AU - Messina V AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Monarca, Roberto AU - Monarca R AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Narciso, Vincenzo AU - Narciso V AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Nosotti, Lorenzo AU - Nosotti L AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Pellicelli, Adriano Maria AU - Pellicelli AM AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Perrella, Alessandro AU - Perrella A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Piai, Guido AU - Piai G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Picardi, Antonio AU - Picardi A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Pierri, Paola AU - Pierri P AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Pietromatera, Grazia AU - Pietromatera G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Resta, Francesco AU - Resta F AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Rinaldi, Luca AU - Rinaldi L AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Romano, Mario AU - Romano M AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Rossini, Angelo AU - Rossini A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Russello, Maurizio AU - Russello M AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Russo, Grazia AU - Russo G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Sacco, Rodolfo AU - Sacco R AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Sangiovanni, Vincenzo AU - Sangiovanni V AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Schiano, Antonio AU - Schiano A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Sciambra, Antonio AU - Sciambra A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Scifo, Gaetano AU - Scifo G AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Simeone, Filomena AU - Simeone F AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Sullo, Annarita AU - Sullo A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Tarquini, Pierluigi AU - Tarquini P AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Tundo, Paolo AU - Tundo P AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. FAU - Vallone, Alfredo AU - Vallone A AD - Luigi Elio Adinolfi, Barbara Guerrera, Internal Medicine Unit, Second University of Naples, 80125 Marcianise, Italy. LA - eng PT - Journal Article PL - United States TA - World J Hepatol JT - World journal of hepatology JID - 101532469 PMC - PMC4976214 OTO - NOTNLM OT - Antiviral therapy OT - Boceprevir OT - Chronic hepatitis OT - Peg-interferon OT - Ribavirin OT - Telaprevir EDAT- 2016/08/31 06:00 MHDA- 2016/08/31 06:01 PMCR- 2016/08/08 CRDT- 2016/08/31 06:00 PHST- 2016/02/23 00:00 [received] PHST- 2016/06/23 00:00 [revised] PHST- 2016/07/20 00:00 [accepted] PHST- 2016/08/31 06:00 [entrez] PHST- 2016/08/31 06:00 [pubmed] PHST- 2016/08/31 06:01 [medline] PHST- 2016/08/08 00:00 [pmc-release] AID - 10.4254/wjh.v8.i22.949 [doi] PST - ppublish SO - World J Hepatol. 2016 Aug 8;8(22):949-56. doi: 10.4254/wjh.v8.i22.949.