• María-Carlota Londoño, Mar Riveiro-Barciela, Adriana Ahumada, Raquel Muñoz-Gómez, Mercé Roget, María J Devesa-Medina, Miguel Ángel Serra, Carmen A Navascués, Carme Baliellas, Teresa Aldamiz-Echevarría, María L Gutiérrez, Benjamín Polo-Lorduy, Isabel Carmona, Salvador Benlloch, Lucía Bonet, Javier García-Samaniego, Miguel Jiménez-Pérez, Senador Morán-Sánchez, Ángeles Castro, Manuel Delgado, Francisco Gea-Rodríguez, Ignacio Martín-Granizo, Montes María Luisa ML HIV Unit, Hospital Universitario La Paz/IdiPaz, Madrid, Madrid, Spain., Luís Morano, Manuel A Castaño, Ignacio de Los Santos, Montserrat Laguno, Losa Juan Emilio JE 0000-0002-0750-0185 Infectious Diseases Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain., Marta Montero-Alonso, Antonio Rivero, Cristina de Álvaro, Amanda Manzanares, Josep Mallolas, Guillermina Barril, Emilio González-Parra, and Luisa García-Buey.
• Liver Unit, Hospital Clínic/IDIBAPS, Barcelona, Barcelona, Spain.
• Plos One. 2019 Jan 1; 14 (9): e0221567.

Background And AimsLimited 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.Material And MethodsNon-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.ResultsData 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.ConclusionsThese 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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