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Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA ‐C real‐world cohort

2018; Wiley; Volume: 26; Issue: 1 Linguagem: Inglês

10.1111/jvh.13008

1365-2893

Marta Hernández‐Conde, Inmaculada Fernández, Christie Perelló, Adolfo Gallego, Martín Bonacci, J.M. Pascasio, Manuel Romero‐Gómez, Susana Llerena, Conrado Fernández‐Rodríguez, José Luis Castro Urda, Luisa García Buey, Isabel Carmona, Rosa M. Morillas, Nuria Domínguez García, Francisco Gea, J.A. Carrión, José Castellote, J.M. Moreno Planas, Belén Piqueras Alcol, Esther Molina, M. Diago, Silvia Montoliu, Juan de la Vega, Fernando Menéndez, Juan José Sánchez‐Ruano, Javier García‐Samaniego, José Miguel Rosales Zábal, María Dolores Antón, Ester Badía, Raquel Souto‐Rodríguez, Francisco Salmerón, Miguel Fernández‐Bermejo, Blanca Figueruela, José Javier Moreno‐Palomares, José Luís Calleja,

Chronic Lymphocytic Leukemia Research

Summary In randomized controlled trials of patients with chronic HCV infection, elbasvir/grazoprevir ( EBR / GZR ) demonstrated high cure rates and a good safety profile. This study assessed the effectiveness and safety of EBR / GZR , with and without ribavirin, in a real‐world HCV patient cohort. HEPA ‐C is a collaborative, monitored national registry of HCV patients directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases. Patients entered into HEPA ‐C between December 2016 and May 2017, and treated with EBR / GZR with at least end‐of‐treatment response data, were included. Demographic, clinical and virologic data were analysed, and adverse events ( AE s) recorded. A total of 804 patients were included in the study. The majority were male (57.9%), with a mean age of 60 (range, 19‐92) years. Genotype ( GT ) distribution was GT 1, 86.8% (1a, 14.3%; 1b, 72.5%); GT 4, 13.2% and 176 patients (21.9%) were cirrhotic. Overall, among 588 patients with available data, 570 (96.9%) achieved sustained virologic response at 12 weeks post‐treatment ( SVR 12). SVR 12 rates by genotype were GT 1a, 97.7%; GT 1b, 98.6%; and GT 4, 98.1%. No significant differences in SVR 12 according to fibrosis stage were observed. Eighty patients experienced an AE , resulting in treatment discontinuation in three. In this large cohort of patients with chronic HCV managed in a real‐world setting in Spain, EBR / GZR achieved high rates of SVR 12, comparable to those observed in randomized controlled trials, with a similarly good safety profile.