To access the full text documents, please follow this link: http://hdl.handle.net/2445/146637
dc.contributor.author | Londoño Hurtado, María Carlota |
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dc.contributor.author | Riveiro Barciela, Mar |
dc.contributor.author | Ahumada, Adriana |
dc.contributor.author | Muñoz Gómez, Raquel |
dc.contributor.author | Roget, Mercé |
dc.contributor.author | Devesa Medina, María J. |
dc.contributor.author | Serra, Miguel Ángel |
dc.contributor.author | Navascués, Carmen A. |
dc.contributor.author | Baliellas Comellas, Mª Carme |
dc.contributor.author | Aldamiz Echevarría, Teresa |
dc.contributor.author | Gutiérrez, María L. |
dc.contributor.author | Polo Lorduy, Benjamín |
dc.contributor.author | Carmona, Isabel |
dc.contributor.author | Benlloch, Salvador |
dc.contributor.author | Bonet, Lucía |
dc.contributor.author | García Samaniego, Javier |
dc.contributor.author | Jiménez Pérez, Miguel |
dc.contributor.author | Morán Sánchez, Senador |
dc.contributor.author | Castro, Ángeles |
dc.contributor.author | Delgado, Manuel |
dc.contributor.author | Gea Rodríguez, Francisco |
dc.contributor.author | Martín Granizo, Ignacio |
dc.contributor.author | Montes, María Luisa |
dc.contributor.author | Morano, Luís |
dc.contributor.author | Castaño, Manuel A. |
dc.contributor.author | Santos, Ignacio de los |
dc.contributor.author | Laguno Centeno, Montserrat |
dc.contributor.author | Losa, Juan Emilio |
dc.contributor.author | Montero-Alonso, Marta |
dc.contributor.author | Rivero, Antonio |
dc.contributor.author | Álvaro, Cristina de |
dc.contributor.author | Manzanares, Amanda |
dc.contributor.author | Mallolas Masferrer, Josep |
dc.contributor.author | Barril, Guillermina |
dc.contributor.author | González Parra, Emilio |
dc.contributor.author | García Buey, Luisa |
dc.date | 2019-12-13T10:53:54Z |
dc.date | 2019-12-13T10:53:54Z |
dc.date | 2019-09-24 |
dc.date | 2019-12-10T08:21:10Z |
dc.identifier | 1932-6203 |
dc.identifier | 5865124 |
dc.identifier | 31550267 |
dc.identifier.uri | http://hdl.handle.net/2445/146637 |
dc.description | 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. |
dc.format | 14 p. |
dc.format | application/pdf |
dc.language | eng |
dc.publisher | Public Library of Science (PLoS) |
dc.relation | Reproducció del document publicat a: https://doi.org/10.1371/journal.pone.0221567 |
dc.relation | PLoS One, 2019, vol. 14, num. 9, p. e0221567 |
dc.relation | https://doi.org/10.1371/journal.pone.0221567 |
dc.rights | cc by (c) Londoño et al., 2019 |
dc.rights | http://creativecommons.org/licenses/by/3.0/es/ |
dc.rights | info:eu-repo/semantics/openAccess |
dc.subject | Malalties del ronyó |
dc.subject | Hepatitis C |
dc.subject | Kidney diseases |
dc.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 |
dc.type | info:eu-repo/semantics/article |
dc.type | info:eu-repo/semantics/publishedVersion |