Efficacy and safety of daclatasvir-based antiviral therapy in hepatitis C virus recurrence after liver transplantation. Role of cirrhosis and genotype 3
Salcedo M (1), Prieto M (2), Castells L (3), Pascasio JM (4), Montero Alvarez JL (5), Fernández I (6), Sánchez-Antolín G (7), González-Diéguez L (8), García-Gonzalez M (9), Otero A (10), Lorente S (11), Espinosa MD (12), Testillano M (13), González A (14), Castellote J (15), Casafont F (16), Londoño MC (17), Pons JA (18), Molina Pérez (19), Cuervas-Mons V (20), Pascual S (21), Herrero JI (22), Narváez I (23), Vinaixa C (24), Llaneras J (25), Sousa JM (26), Bañares R (27).
(1) Liver Transplant Unit and Digestive Disease Department, IISGM, CIBERehd, Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain.
(2) Liver Unit, Gastroenterology Department, CIBERehd, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
(3) Liver Unit, Internal Medicine Department, CIBERehd, Hospital General Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.
(4) UGC Digestive Diseases, CIBERehd, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
(5) Hepatology Unit, Hospital Universitario Reina Sofía, Córdoba, Spain.
(6) Digestive Disease Service, Hospital Universitario 12 de Octubre, Madrid, Spain.
(7) Liver Unit, Liver Transplantation Unit, Hospital Universitario Rio Hortega, Valladolid, Spain.
(8) Liver Unit, Hospital Universitario Central de Asturias, Oviedo, Spain.
(9) Digestive Diseases Department, Hospital Ramón y Cajal, Madrid, Spain.
(10) Liver Unit, Hospital Universitario de A Coruña, A Coruña, Spain.
(11) Digestive Diseases Department, Hospital Clínico Lozano Blesa de Zaragoza, IIS Aragón, Zaragoza, Spain.
(12) Liver Unit, UGC Digestive Diseases, Complejo Hospitalario Universitario de Granada, Granada, Spain.
(13) Liver Unit and Liver transplantation, Hospital Universitario de Cruces, Bilbao, Spain.
(14) Liver Unit, Hospital Universitario Ntra. Sra. de Candelaria, Tenerife, Spain.
(15) Digestive Disease Department, IDIBELL, Hospital Universitari de Bellvitge, Universidad de Barcelona, Barcelona, Spain.
(16) Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
(17) Liver Unit, CIBERehd, Hospital Clìnic Barcelona, Barcelona, Spain.
(18) Liver Unit, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.
(19) Abdominal Transplants Unit, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
(20) Liver Transplant Unit, Department of Medicine, Hospital Universitario Puerta de Hierro-Majadahonda, Universidad Autónoma de Madrid, Madrid, Spain.
(21) Liver Unit, Gastroenterology Department, CIBERehd, Hospital General Universitario de Alicante, Alicante, Spain.
(22) Liver Unit, Instituto de Investigación Sanitaria de Navarra (IdiSNA), CIBERehd, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.
(23) Liver Transplantation Unit, Gastroenterology Department, Complejo Hospitalario Universitario de Badajoz, "Infanta Cristina", Badajoz, Spain.
(24) Gastroenterology Department, CIBERehd, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
(25) Liver Unit, Internal Medicine Department, Hospital General Vall Hebrón, Barcelona, Spain.
(26) UGC Unit, Digestive Diseases Hospital Universitario Virgen del Rocío, Sevilla, Spain.
(27) Liver Transplant Unit and Digestive Disease Department, Facultad de Medicina Universidad Complutense, IISGM, CIBERehd, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Magazine: Transplant International
Date: Jun 13, 2017Hepatology
Direct-acting antiviral agents (DAA) combining daclatasvir (DCV) have reported good outcomes in the recurrence of hepatitis C virus (HCV) infection after liver transplant (LT).
However, its effect on the severe recurrence and the risk of death remains controversial. We evaluated the efficacy, predictors of survival, and safety of DAC-based regimens in a large real-world cohort. A total of 331 patients received DCV-based therapy.
Duration of therapy and ribavirin use were at the investigator's discretion. The primary end point was sustained virological response (SVR) at week 12. A multivariate analysis of predictive factors of mortality was performed.
Intention-to-treat (ITT) and per-protocol SVR were 93.05% and 96.9%. ITT-SVR was lower in cirrhosis (n = 163) (96.4% vs. 89.6% P = 0.017); the SVR in genotype 3 (n = 91) was similar, even in advanced fibrosis (96.7% vs. 88%, P = 0.2). Ten patients (3%) experienced virological failure. Therapy was stopped in 18 patients (5.44%), and ten died during treatment.
A total of 22 patients (6.6%) died. Albumin (HR = 0.376; 95% CI 0.155-0.910) and baseline MELD (HR = 1.137; 95% CI: 1.061-1.218) were predictors of death. DCV-based DAA treatment is efficacious and safe in patients with HCV infection after LT.
Baseline MELD score and serum albumin are predictors of survival irrespective of viral response.
CITATION Transpl Int. 2017 Jun 13. doi: 10.1111/tri.12999
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