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 journalArticle

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.

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

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Chronic Renal Insufficiency
Kidney
Safety
Glomerular Filtration Rate
Kidney Function Tests

Keywords

  • CKD
  • eGFR
  • Kidney
  • SVR

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Renal safety in 3264 HCV patients treated with DAA-based regimens : Results from a large Italian real-life study. / D'Ambrosio, Roberta; Pasulo, Luisa; Giorgini, Alessia; Spinetti, Angiola; Messina, Emanuela; Fanetti, Ilaria; Puoti, Massimo; Aghemo, Alessio; Viganò, Paolo; Vinci, Maria; Menzaghi, Barbara; Lombardi, Andrea; Pan, Angelo; Pigozzi, Marie Graciella; Grossi, Paolo; Lazzaroni, Sergio; Spinelli, Ombretta; Invernizzi, Pietro; Maggiolo, Franco; Terreni, Natalia; Monforte, Antonella D.Arminio; Poggio, Paolo Del; Taddei, Maria Teresa; Colombo, Silvia; Pozzoni, Pietro; Molteni, Chiara; Brocchieri, Alessandra; Bhoori, Sherrie; Buscarini, Elisabetta; Centenaro, Riccardo; Mendeni, Monia; Colombo, Alberto Eraldo; Di Marco, Mariella; Dionigi, Elena; Bella, Daniele; Borghi, Marta; Zuin, Massimo; Zaltron, Serena; Noventa, Franco; Annalisa, De Silvestri; Lampertico, Pietro; Fagiuoli, Stefano.

In: Digestive and Liver Disease, 01.01.2019.

Research output: Contribution to journalArticle

D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Viganò, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, MG, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, ADA, Poggio, PD, Taddei, MT, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, AE, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, DS, Lampertico, P & Fagiuoli, S 2019, 'Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study', Digestive and Liver Disease. https://doi.org/10.1016/j.dld.2019.11.006
D'Ambrosio, Roberta ; Pasulo, Luisa ; Giorgini, Alessia ; Spinetti, Angiola ; Messina, Emanuela ; Fanetti, Ilaria ; Puoti, Massimo ; Aghemo, Alessio ; Viganò, Paolo ; Vinci, Maria ; Menzaghi, Barbara ; Lombardi, Andrea ; Pan, Angelo ; Pigozzi, Marie Graciella ; Grossi, Paolo ; Lazzaroni, Sergio ; Spinelli, Ombretta ; Invernizzi, Pietro ; Maggiolo, Franco ; Terreni, Natalia ; Monforte, Antonella D.Arminio ; Poggio, Paolo Del ; Taddei, Maria Teresa ; Colombo, Silvia ; Pozzoni, Pietro ; Molteni, Chiara ; Brocchieri, Alessandra ; Bhoori, Sherrie ; Buscarini, Elisabetta ; Centenaro, Riccardo ; Mendeni, Monia ; Colombo, Alberto Eraldo ; Di Marco, Mariella ; Dionigi, Elena ; Bella, Daniele ; Borghi, Marta ; Zuin, Massimo ; Zaltron, Serena ; Noventa, Franco ; Annalisa, De Silvestri ; Lampertico, Pietro ; Fagiuoli, Stefano. / Renal safety in 3264 HCV patients treated with DAA-based regimens : Results from a large Italian real-life study. In: Digestive and Liver Disease. 2019.
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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.",
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author = "Roberta D'Ambrosio and Luisa Pasulo and Alessia Giorgini and Angiola Spinetti and Emanuela Messina and Ilaria Fanetti and Massimo Puoti and Alessio Aghemo and Paolo Vigan{\`o} and Maria Vinci and Barbara Menzaghi and Andrea Lombardi and Angelo Pan and Pigozzi, {Marie Graciella} and Paolo Grossi and Sergio Lazzaroni and Ombretta Spinelli and Pietro Invernizzi and Franco Maggiolo and Natalia Terreni and Monforte, {Antonella D.Arminio} and Poggio, {Paolo Del} and Taddei, {Maria Teresa} and Silvia Colombo and Pietro Pozzoni and Chiara Molteni and Alessandra Brocchieri and Sherrie Bhoori and Elisabetta Buscarini and Riccardo Centenaro and Monia Mendeni and Colombo, {Alberto Eraldo} and {Di Marco}, Mariella and Elena Dionigi and Daniele Bella and Marta Borghi and Massimo Zuin and Serena Zaltron and Franco Noventa and Annalisa, {De Silvestri} and Pietro Lampertico and Stefano Fagiuoli",
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TY - JOUR

T1 - Renal safety in 3264 HCV patients treated with DAA-based regimens

T2 - Results from a large Italian real-life study

AU - D'Ambrosio, Roberta

AU - Pasulo, Luisa

AU - Giorgini, Alessia

AU - Spinetti, Angiola

AU - Messina, Emanuela

AU - Fanetti, Ilaria

AU - Puoti, Massimo

AU - Aghemo, Alessio

AU - Viganò, Paolo

AU - Vinci, Maria

AU - Menzaghi, Barbara

AU - Lombardi, Andrea

AU - Pan, Angelo

AU - Pigozzi, Marie Graciella

AU - Grossi, Paolo

AU - Lazzaroni, Sergio

AU - Spinelli, Ombretta

AU - Invernizzi, Pietro

AU - Maggiolo, Franco

AU - Terreni, Natalia

AU - Monforte, Antonella D.Arminio

AU - Poggio, Paolo Del

AU - Taddei, Maria Teresa

AU - Colombo, Silvia

AU - Pozzoni, Pietro

AU - Molteni, Chiara

AU - Brocchieri, Alessandra

AU - Bhoori, Sherrie

AU - Buscarini, Elisabetta

AU - Centenaro, Riccardo

AU - Mendeni, Monia

AU - Colombo, Alberto Eraldo

AU - Di Marco, Mariella

AU - Dionigi, Elena

AU - Bella, Daniele

AU - Borghi, Marta

AU - Zuin, Massimo

AU - Zaltron, Serena

AU - Noventa, Franco

AU - Annalisa, De Silvestri

AU - Lampertico, Pietro

AU - Fagiuoli, Stefano

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - CKD

KW - eGFR

KW - Kidney

KW - SVR

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U2 - 10.1016/j.dld.2019.11.006

DO - 10.1016/j.dld.2019.11.006

M3 - Article

C2 - 31813755

AN - SCOPUS:85076566766

JO - Digestive and Liver Disease

JF - Digestive and Liver Disease

SN - 1590-8658

ER -