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

Roberta D'Ambrosio, Luisa Pasulo, Alessia Giorgini, Angiola Spinetti, Emanuela Messina, Ilaria Fanetti, Massimo Puoti, Alessio Aghemo, Paolo Viganò, Maria Vinci, Barbara Menzaghi, Andrea Lombardi, Angelo Pan, Marie Graciella Pigozzi, Paolo Grossi, Sergio Lazzaroni, Ombretta Spinelli, Pietro Invernizzi, Franco Maggiolo, Natalia TerreniAntonella D.Arminio Monforte, Paolo Del Poggio, Maria Teresa Taddei, Silvia Colombo, Pietro Pozzoni, Chiara Molteni, Alessandra Brocchieri, Sherrie Bhoori, Elisabetta Buscarini, Riccardo Centenaro, Monia Mendeni, Alberto Eraldo Colombo, Mariella Di Marco, Elena Dionigi, Daniele Bella, Marta Borghi, Massimo Zuin, Serena Zaltron, Franco Noventa, De Silvestri Annalisa, Pietro Lampertico, Stefano Fagiuoli

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
JournalDigestive and Liver Disease
Publication statusAccepted/In press - Jan 1 2019


  • CKD
  • eGFR
  • Kidney
  • SVR

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology


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