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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
Author(s) -
HernándezConde Marta,
Fernández Inmaculada,
Perelló Christie,
Gallego Adolfo,
Bonacci Martin,
Pascasio Juan M.,
RomeroGómez Manuel,
Llerena Susana,
FernándezRodríguez Conrado,
Castro Urda José L.,
García Buey Luisa,
Carmona Isabel,
Morillas Rosa M.,
García Nuria Domínguez,
Gea Francisco,
Carrión José A.,
Castellote Jose,
MorenoPlanas Jose M.,
Piqueras Alcol Belén,
Molina Esther,
Diago Moises,
Montoliu Silvia,
Vega Juan,
Menéndez Fernando,
Sánchez Ruano Juan J.,
GarcíaSamaniego Javier,
RosalesZabal Jose M.,
Anton María D.,
Badia Ester,
SoutoRodríguez Raquel,
Salmeron Francisco J.,
FernándezBermejo Miguel,
Figueruela Blanca,
MorenoPalomares Jose J.,
Calleja Jose L.
Publication year - 2019
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.13008
Subject(s) - hepa , medicine , pharmacology , virology , filter (signal processing) , computer science , computer vision
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.