Zoe Mariño1, Juan M Pascasio-Acevedo2, Adolfo Gallego3, Moisés Diago4, Carme Baliellas5, Rosa Morillas6, Martín Prieto7, José M Moreno8, Gloria Sánchez-Antolín9, Mercedes Vergara10, Montserrat Forné11, Inmaculada Fernández12, María A Castro13, Sonia Pascual14, Alexandra Gómez15, Lluis Castells16, José L Montero17, Javier Crespo18, José L Calleja19, Javier García-Samaniego20, Jose A Carrión21, Ana C Arencibia22, Alejandro Blasco23, Carmen López-Núñez24, Juan J Sánchez-Ruano25, Francisco Gea-Rodríguez26, Álvaro Giráldez2, Joaquín Cabezas18, Vanessa Hontangas7, Xavier Torras3, Jose Castellote5, Manuel Romero-Gómez27, Juan Turnes28, Tomás de Artaza25, Isidoro Narváez29, Valentín Cuervas-Mons19, Xavier Forns1. 1. Liver Unit, Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain. 2. Clinical Management Unit of Digestive Diseases, Hospital Universitario Virgen del Rocío, CIBERehd, Sevilla, Spain. 3. Liver Unit, Hospital Santa Creu i Sant Pau, CIBERehd, Barcelona, Spain. 4. Digestive Diseases, Hospital Universitario General, Valencia, Spain. 5. Liver Unit, Hospital Universitari Bellvitge-Instituto de Investigación Biomédica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain. 6. Liver Unit, Hospital Germans Trias i Pujol, CIBERehd, Badalona, Spain. 7. Liver Unit, Hospital Universitario La Fe, Valencia, Spain. 8. Department of Gastroenterology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain. 9. Department of Gastroenterology, Hospital Universitario Río Hortega, Valladolid, Spain. 10. Liver Unit, Servei d'Aparell Digestiu, Parc Tauli Sabadell Hospital Universitari, Universitat Autónoma Barcelona, Sabadell, Spain. 11. Liver Unit, Hospital Universitario Mutua de Terrassa, Terrassa, Spain. 12. Liver Unit, Hospital Universitario 12 de Octubre, Madrid, Spain. 13. Internal Medicine, Grupo de Virología Clínica, Instituto Investigación Biomédica A Coruña (INIBIC)-Hospital Universitario A Coruña, A Coruña, Spain. 14. Liver Unit, Hospital General Universitario Alicante, CIBERehd, Alicante, Spain. 15. Liver Unit, Hospital Universitario Donostia, San Sebastian, Spain. 16. Liver Unit, Internal Medicine Department, Hospital Universitari Vall Hebron, CIBERehd, Barcelona, Spain. 17. Liver Unit, Hospital Universitario Reina Sofía, CIBERehd, Córdoba, Spain. 18. Gastroenterology and Hepatology Department, University Hospital Marqués de Valdecilla, IDIVAL, University of Cantabria, Santander, Spain. 19. Liver Unit, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, CIBERehd, Madrid, Spain. 20. Liver Unit, Hospital Universitario La Paz, CIBERehd, IdiPAZ, Madrid, Spain. 21. Liver Section, Gastroenterology Department, Hospital del Mar, Universitat Autònoma de Barcelona, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. 22. Liver Unit, Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain. 23. Digestive Diseases, Hospital de Sant Joan Despi Moises Broggi, Barcelona, Spain. 24. Digestive Diseases, Hospital Universitari Dr.Josep Trueta, Girona, Spain. 25. Digestive Diseases, Hospital Universitario de Toledo, Toledo, Spain. 26. Liver Unit, Hospital Ramón y Cajal, Madrid, Spain. 27. Liver Unit, Hospital Virgen de Valme, Sevilla, Spain. 28. Digestive Diseases, Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra, Spain. 29. Liver Unit, Hospital Infanta Cristina, Badajoz, Spain.
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≤100×109 /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.
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≤100×109 /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.
Authors: Giovanni Battista Gaeta; Alessio Aghemo; Barbara Menzaghi; Gianpiero D'Offizi; Alessia Giorgini; Hamid Hasson; Giuseppina Brancaccio; Maria Palma; Roberta Termini Journal: Medicine (Baltimore) Date: 2018-07 Impact factor: 1.889