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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
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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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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. 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. _PLoS One_. 2019. Vol. 14, núm. 9, pàgs. e0221567. [consulta: 23 de gener de 2026]. ISSN: 1932-6203. [Disponible a: https://hdl.handle.net/2445/146637]