Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking. Aim: To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD). Methods: All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included. Results: Among 3264 patients [65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min], CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively). Conclusions: During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.

Renal safety in 3264 HCV patients treated with DAA-based regimens : results from a large Italian real-life study / R. D'Ambrosio, L. Pasulo, A. Giorgini, A. Spinetti, E. Messina, I. Fanetti, M. Puoti, A. Aghemo, P. Vigano, M. Vinci, B. Menzaghi, A. Lombardi, A. Pan, M.G. Pigozzi, P. Grossi, S. Lazzaroni, O. Spinelli, P. Invernizzi, F. Maggiolo, N. Terreni, A. D'Arminio Monforte, P.D. Poggio, M.T. Taddei, S. Colombo, P. Pozzoni, C. Molteni, A. Brocchieri, S. Bhoori, E. Buscarini, R. Centenaro, M. Mendeni, A.E. Colombo, M. Di Marco, E. Dionigi, D. Bella, M. Borghi, M. Zuin, S. Zaltron, F. Noventa, D.S. Annalisa, P. Lampertico, S. Fagiuoli. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1590-8658. - 52:2(2020 Feb), pp. 190-198.

Renal safety in 3264 HCV patients treated with DAA-based regimens : results from a large Italian real-life study

L. Pasulo;A. Giorgini;I. Fanetti;A. Aghemo;B. Menzaghi;A. Lombardi;O. Spinelli;A. D'Arminio Monforte;M. Zuin;P. Lampertico;
2020-02

Abstract

Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking. Aim: To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD). Methods: All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included. Results: Among 3264 patients [65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min], CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively). Conclusions: During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.
CKD; eGFR; Kidney; SVR
Settore MED/12 - Gastroenterologia
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/777064
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