2026-07-21T11:48:50Zhttps://repisalud.isciii.es/rest/oai/requestoai:repisalud.isciii.es:20.500.12105/179132025-03-20T07:21:11Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16927col_20.500.12105_16961col_20.500.12105_16962col_20.500.12105_16963col_20.500.12105_16978col_20.500.12105_16982
Repisalud
author
Londoño, María-Carlota
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Riveiro-Barciela, Mar
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Ahumada, Adriana
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Muñoz-Gómez, Raquel
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Roget, Mercé
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Devesa-Medina, María J
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Serra, Miguel Ángel
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Navascués, Carmen A
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Baliellas, Carme
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Aldámiz-Echevarria, Teresa
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Gutiérrez, María L
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Polo-Lorduy, Benjamín
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Carmona, Isabel
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Benlloch, Salvador
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Bonet, Lucía
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García-Samaniego, Javier
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Jiménez-Pérez, Miguel
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Morán-Sánchez, Senador
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Castro, Ángeles
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Delgado, Manuel
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Gea-Rodríguez, Francisco
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Martín-Granizo, Ignacio
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Montes, María Luisa
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Morano, Luís
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Castaño, Manuel A
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de Los Santos, Ignacio
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Laguno, Montserrat
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Losa, Juan Emilio
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Montero-Alonso, Marta
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Rivero, Antonio
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de Álvaro, Cristina
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Manzanares, Amanda
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Mallolas, Josep
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Barril, Guillermina
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González-Parra, Emilio
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García-Buey, Luisa
2024-02-10T20:02:10Z
2024-02-10T20:02:10Z
2019-09-24
10.1371/journal.pone.0221567
1932-6203
PloS one
http://hdl.handle.net/10668/14541
31550267
http://hdl.handle.net/20.500.12105/17913
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.
eng
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.
research article