In:
Journal of Viral Hepatitis, Wiley, Vol. 26, No. 1 ( 2019-01), p. 55-64
Kurzfassung:
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.
Materialart:
Online-Ressource
ISSN:
1352-0504
,
1365-2893
DOI:
10.1111/jvh.2019.26.issue-1
Sprache:
Englisch
Verlag:
Wiley
Publikationsdatum:
2019
ZDB Id:
2007924-2
