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oai:recercat.cat:2445/1466372025-12-04T19:15:31Zcom_2072_1057col_2072_478858col_2072_478916col_2072_478917col_2072_478921

00925njm 22002777a 4500 dc Londoño, María Carlota author Riveiro-Barciela, Mar author Ahumada, Adriana author Muñoz Gómez, Raquel author Roget, Mercé author Devesa Medina, María J. author Serra, Miguel Ángel author Navascués, Carmen A. author Baliellas Comellas, Mª Carme author Aldamiz, Teresa author Gutiérrez, María L. author Polo Lorduy, Benjamín author Carmona, Isabel author Benlloch, Salvador author Bonet, Lucía author García Samaniego, Javier author Jiménez Pérez, Miguel author Morán Sánchez, Senador author Castro, Ángeles author Delgado, Manuel author Gea Rodríguez, Francisco author Martín Granizo, Ignacio author Montes, María Luisa author Morano, Luís author Castaño, Manuel A. author Santos, Ignacio de los author Laguno Centeno, Montserrat author Losa, Juan Emilio author Montero-Alonso, Marta author Rivero, Antonio author Álvaro, Cristina de author Manzanares, Amanda author Mallolas Masferrer, Josep author Barril, Guillermina author González Parra, Emilio author García Buey, Luisa author 2019-12-13T10:53:54Z 2019-12-13T10:53:54Z 2019-09-24 2019-12-10T08:21:10Z Limited data are available on the effectiveness and tolerability of direct-acting antivirals (DAAs) therapies in the real world for HCV-infected patients with comorbidities. This study aimed to describe the effectiveness of OBV/PTV/r ± DSV (3D/2D regimen) with or without ribavirin (RBV) in HCV or HCV/HIV co-infected patients with GT1/GT4 and CKD (IIIb-V stages), including those under hemodialysis and peritoneal dialysis in routine clinical practice in Spain in 2015.Non-interventional, retrospective, multicenter data collection study in 31 Spanish sites. Socio-demographic, clinical variables, study treatment characteristics, effectiveness and tolerability data were collected from medical records.Data from 135 patients with a mean age (SD) of 58.3 (11.4) years were analyzed: 92.6% GT1 (81.6% GT1b and 17.6% GT1a) and 7.4% GT4, 14 (10.4%) HIV/HCV co-infected, 19.0% with fibrosis F3 and 28.1% F4 by FibroScan®, 52.6% were previously treated with pegIFN and RBV. 11.1%, 14.8% and 74.1% of patients had CKD stage IIIb, IV and V respectively. 68.9% of patients were on hemodialysis; 8.9% on peritoneal dialysis and 38.5% had history of renal transplant. A total of 125 (96.2%) of 135 patients were treated with 3D, 10 (7.4%) with 2D and 30.4% received RBV. The overall intention-to-treat (ITT) sustained virologic response at week 12 (SVR12) was 92.6% (125/135) and the overall modified-ITT (mITT) SVR12 was 99.2% (125/126). The SVR12 rates (ITT) per sub-groups were: HCV mono-infected (91.7%), HCV/HIV co-infected (100%), GT1 (92.0%), GT4 (100%), CKD stage IIIb (86.7%), stage IV (95%) and stage V (93%). Among the 10 non-SVR there was only 1 virologic failure (0.7%); 4 patients had missing data due lost to follow up (3.0%) and 5 patients discontinued 3D/2D regimen (3.7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision.These results have shown that 3D/2D regimens are effective and tolerable in patients with advanced CKD including those in dialysis with GT 1 or 4 chronic HCV mono-infection and HIV/HCV coinfection in a real-life cohort. The overall SVR12 rates were 92.6% (ITT) and 99.2% (mITT) without clinically relevant changes in eGFR until 12 weeks post-treatment. These results are consistent with those reported in clinical trials. Malalties del ronyó Hepatitis C Kidney diseases Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice - Vie-KinD study