1. High efficacy of Sofosbuvir plus Simeprevir in a large cohort of Spanish cirrhotic patients infected with genotypes 1 and 4.
- Author
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Mariño Z, Pascasio-Acevedo JM, Gallego A, Diago M, Baliellas C, Morillas R, Prieto M, Moreno JM, Sánchez-Antolín G, Vergara M, Forné M, Fernández I, Castro MA, Pascual S, Gómez A, Castells L, Montero JL, Crespo J, Calleja JL, García-Samaniego J, Carrión JA, Arencibia AC, Blasco A, López-Núñez C, Sánchez-Ruano JJ, Gea-Rodríguez F, Giráldez Á, Cabezas J, Hontangas V, Torras X, Castellote J, Romero-Gómez M, Turnes J, de Artaza T, Narváez I, Cuervas-Mons V, and Forns X
- Subjects
- Adult, Aged, Aged, 80 and over, Drug Therapy, Combination, Female, Hepacivirus genetics, Hepatitis C genetics, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Young Adult, Antiviral Agents therapeutic use, Hepatitis C drug therapy, Registries, Simeprevir therapeutic use, Sofosbuvir therapeutic use
- Abstract
Background and Aims: 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., 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≤100×10
9 /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., (© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)- Published
- 2017
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