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Autor/a:
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Londoño Hurtado, 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 Echevarría, 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
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Notas:
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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. |
