High efficacy of Sofosbuvir plus Simeprevir in a large cohort of Spanish cirrhotic patients infected with genotypes 1 and 4.
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Mariño Zoe, Pascasio-Acevedo Juan M, Gallego Adolfo, Diago Moisés, Baliellas Carme, Morillas Rosa, Prieto Martín, Moreno José M, Sánchez-Antolín Gloria, Vergara Mercedes, Forné Montserrat, Fernández Inmaculada, Castro María A, Pascual Sonia, Gómez Alexandra, Castells Lluis, Montero José L, Crespo Javier, Calleja José L, García-Samaniego Javier, Carrión Jose A, Arencibia Ana C, Blasco Alejandro, López-Núñez Carmen, Sánchez-Ruano Juan J, Gea-Rodríguez Francisco, Giráldez Álvaro, Cabezas Joaquín, Hontangas Vanessa, Torras Xavier, Castellote Jose, Romero-Gómez Manuel, Turnes Juan, de Artaza Tomás, Narváez Isidoro, Cuervas-Mons Valentín, Forns Xavier
Аннотация
METHODS: 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.
RESULTS: 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%.
CONCLUSIONS: 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.