PLoS ONE (Jan 2019)

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,
  • Luisa García-Buey

DOI
https://doi.org/10.1371/journal.pone.0221567
Journal volume & issue
Vol. 14, no. 9
p. e0221567

Abstract

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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.