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

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, María Luisa Montes, Luís Morano, Manuel A Castaño, Ignacio de los Santos, Montserrat Laguno, Juan Emilio Losa, Marta Montero-Alonso, Antonio Rivero, Cristina de Álvaro, Amanda Manzanares, Josep Mallolas, Guillermina Barril, Emilio González-Parra and Luisa García-Buey

PLOS ONE, 2019, vol. 14, issue 9, 1-14

Abstract: Background and aims: 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. Material and methods: 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. Results: 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. Conclusions: 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.

Date: 2019
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0221567

DOI: 10.1371/journal.pone.0221567

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