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.
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.
Authors: Fred Poordad; Jonathan McCone; Bruce R Bacon; Savino Bruno; Michael P Manns; Mark S Sulkowski; Ira M Jacobson; K Rajender Reddy; Zachary D Goodman; Navdeep Boparai; Mark J DiNubile; Vilma Sniukiene; Clifford A Brass; Janice K Albrecht; Jean-Pierre Bronowicki Journal: N Engl J Med Date: 2011-03-31 Impact factor: 91.245
Authors: Bruce R Bacon; Stuart C Gordon; Eric Lawitz; Patrick Marcellin; John M Vierling; Stefan Zeuzem; Fred Poordad; Zachary D Goodman; Heather L Sings; Navdeep Boparai; Margaret Burroughs; Clifford A Brass; Janice K Albrecht; Rafael Esteban Journal: N Engl J Med Date: 2011-03-31 Impact factor: 91.245
Authors: Stefan Zeuzem; Pietro Andreone; Stanislas Pol; Eric Lawitz; Moises Diago; Stuart Roberts; Roberto Focaccia; Zobair Younossi; Graham R Foster; Andrzej Horban; Peter Ferenci; Frederik Nevens; Beat Müllhaupt; Paul Pockros; Ruben Terg; Daniel Shouval; Bart van Hoek; Ola Weiland; Rolf Van Heeswijk; Sandra De Meyer; Don Luo; Griet Boogaerts; Ramon Polo; Gaston Picchio; Maria Beumont Journal: N Engl J Med Date: 2011-06-23 Impact factor: 91.245
Authors: Stuart C Gordon; Andrew J Muir; Joseph K Lim; Brian Pearlman; Curtis K Argo; Ananthakrishnan Ramani; Benedict Maliakkal; Imtiaz Alam; Thomas G Stewart; Monika Vainorius; Joy Peter; David R Nelson; Michael W Fried; K Rajender Reddy Journal: J Hepatol Date: 2014-09-10 Impact factor: 25.083
Authors: Savino Bruno; John M Vierling; Rafael Esteban; Lisa M Nyberg; Hugo Tanno; Zachary Goodman; Fred Poordad; Bruce Bacon; Keith Gottesdiener; Lisa D Pedicone; Janice K Albrecht; Clifford A Brass; Seth Thompson; Margaret H Burroughs Journal: J Hepatol Date: 2012-11-23 Impact factor: 25.083