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Title: 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
Author: Londoño, María Carlota
Riveiro Barciela, Mar
Ahumada, Adriana
Muñoz Gómez, Raquel
Roget, Mercé
Devesa Medina, María J.
Serra, Miguel Ángel
Navascués, Carmen A.
Baliellas Comellas, Mª Carme
Aldamiz, Teresa
Gutiérrez, María L.
Polo Lorduy, Benjamín
Carmona, Isabel
Benlloch, Salvador
Bonet, Lucía
García Samaniego, Javier
Jiménez Pérez, Miguel
Morán Sánchez, Senador
Castro, Ángeles
Delgado, Manuel
Gea Rodríguez, Francisco
Martín Granizo, Ignacio
Montes, María Luisa
Morano, Luís
Castaño, Manuel A.
Santos, Ignacio de los
Laguno Centeno, Montserrat
Losa, Juan Emilio
Montero-Alonso, Marta
Rivero, Antonio
Álvaro, Cristina de
Manzanares, Amanda
Mallolas Masferrer, Josep
Barril, Guillermina
González Parra, Emilio
García Buey, Luisa
Keywords: Malalties del ronyó
Hepatitis C
Kidney diseases
Issue Date: 24-Sep-2019
Publisher: Public Library of Science (PLoS)
Abstract: 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.
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It is part of: PLoS One, 2019, vol. 14, num. 9, p. e0221567
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ISSN: 1932-6203
Appears in Collections:Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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