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XF: received support in part by Instituto de Salud Carlos III (PI15/00151), Spanish Health Ministry, integrated in Plan Nacional I+D+I, and co-funded by Fondo Europeo de Desarrollo Regional (FEDER-Una manera de Hacer Europa). XF also received a grant from Secretaria d'Universitats i Recerca del Departament d'Economia i Coneixement (grant 2014_SGR_605). ZM and XF also received support by the Spanish Health Ministry (Plan Estrategico Nacional contra la Hepatitis C). CIBERehd is funded by the Instituto de Salud Carlos III

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High efficacy of Sofosbuvir plus Simeprevir in a large cohort of Spanish cirrhotic patients infected with genotypes 1 and 4.

Publicat a:Liver International. 37 (12): 1823-1832 - 2017-12-01 37(12), DOI: 10.1111/liv.13470

Autors: Marino, Zoe; Pascasio-Acevedo, Juan M; Gallego, Adolfo; Diago, Moises; Baliellas, Carme; Morillas, Rosa; Prieto, Martin; Moreno, Jose M; Sanchez-Antolin, Gloria; Vergara, Mercedes; Forne, Montserrat; Fernandez, Inmaculada; Castro, Maria A; Pascual, Sonia; Gomez, Alexandra; Castells, Lluis; Montero, Jose L; Crespo, Javier; Calleja, Jose L; Garcia-Samaniego, Javier; Carrion, Jose A; Arencibia, Ana C; Blasco, Alejandro; Lopez-Nunez, Carmen; Sanchez-Ruano, Juan J; Gea-Rodriguez, Francisco; Giraldez, Alvaro; Cabezas, Joaquin; Hontangas, Vanessa; Torras, Xavier; Castellote, Jose; Romero-Gomez, Manuel; Turnes, Juan; de Artaza, Tomas; Narvaez, Isidoro; Cuervas-Mons, Valentin; Forns, Xavier

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Hepatitis C (HCV) therapy with Sofosbuvir (SOF)/Simeprevir (SMV) in clinical trials and real-world clinical practice, showed high rates of sustained virological response (SVR) in non-cirrhotic genotype (GT)-1 and GT-4 patients. These results were slightly lower in cirrhotic patients. We investigated real-life effectiveness and safety of SOF/SMV with or without ribavirin (RBV) in a large cohort of cirrhotic patients.This collaborative multicentre study included data from 968 patients with cirrhosis infected with HCV-GT1 or 4, treated with SOF/SMV±RBV in 30 centres across Spain between January-2014 and December-2015. Demographic, clinical, virological and safety data were analysed.Overall SVR was 92.3%; the majority of patients were treated with RBV (62%) for 12 weeks (92.4%). No significant differences in SVR were observed between genotypes (GT1a:94.3%; GT1b:91.7%; GT4:91.1%). Those patients with more advanced liver disease (Child B/C, MELD?10) or portal hypertension (platelet count?100×109 /L, transient elastography?21 Kpa) showed significantly lower SVR rates (84.4%-91.9%) than patients with less advanced liver disease (93.8%-95.9%, P<.01 in all cases). In the multivariate analysis, the use of RBV, female gender, baseline albumin?35 g/L, MELD<10 and lack of exposure to a triple therapy regimen were independent predictors of SVR (P<.05). Serious adverse events (SAEs) and SAE-associated discontinuation events occurred in 5.9% and 2.6%.In this large cohort of cirrhotic patients managed in the real-world setting in Spain, SOF/SMV±RBV yielded to excellent SVR rates, especially in patients with compensated liver cirrhosis. In addition, this combination showed to be safe, with low rates of SAEs and early discontinuations.© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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