Roberta D'Ambrosio1, Luisa Pasulo2, Alessia Giorgini3, Angiola Spinetti4, Emanuela Messina5, Ilaria Fanetti6, Massimo Puoti7, Alessio Aghemo8, Paolo Viganò9, Maria Vinci10, Barbara Menzaghi11, Andrea Lombardi12, Angelo Pan13, Marie Graciella Pigozzi4, Paolo Grossi14, Sergio Lazzaroni2, Ombretta Spinelli15, Pietro Invernizzi16, Franco Maggiolo2, Natalia Terreni17, Antonella D'Arminio Monforte3, Paolo Del Poggio2, Maria Teresa Taddei3, Silvia Colombo2, Pietro Pozzoni18, Chiara Molteni19, Alessandra Brocchieri20, Sherrie Bhoori21, Elisabetta Buscarini22, Riccardo Centenaro23, Monia Mendeni4, Alberto Eraldo Colombo15, Mariella Di Marco2, Elena Dionigi23, Daniele Bella4, Marta Borghi24, Massimo Zuin3, Serena Zaltron4, Franco Noventa25, De Silvestri Annalisa26, Pietro Lampertico24, Stefano Fagiuoli2. 1. Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, CRC A.M. e A. Migliavacca Center for Liver Diseases, Gastroenterology and Hepatology, Milan, Italy. Electronic address: roberta.dambrosio@policlinico.mi.it. 2. ASST Papa Giovanni XXIII, Bergamo HCV Network, Bergamo, Italy. 3. ASST Santi Paolo e Carlo, Gastroenterology and Hepatology, Milan, Italy. 4. ASST Brescia, Brescia HCV Network, Brescia, Italy. 5. San Raffaele Hospital, Infectious Diseases, Milan, Italy. 6. San Giuseppe Hospital, Università degli Studi di Milano, Hepatology, Milan, Italy. 7. ASST Grande Ospedale Metropolitano Niguarda, Infectious Diseases, Milan, Italy. 8. Humanitas Research Hospital, Humanitas University, Internal Medicine and Hepatology, Milan, Italy. 9. ASST Ovest Milanese, Infectious Diseases, Milan, Italy. 10. ASST Grande Ospedale Metropolitano Niguarda, Gastroenterology and Hepatology, Milan, Italy. 11. Busto Arsizio Hospital, ASST Valle Olona, Infectious Diseases, Busto Arsizio, Italy. 12. Fondazione IRCCS Policlinico San Matteo, University of Pavia, Infectious Diseases, Pavia, Italy. 13. ASST Cremona, Infectious Diseases, Cremona, Italy. 14. Ospedale di Circolo e Fondazione Macchi, Infectious Diseases, Varese, Italy. 15. ASST Lariana, Como, Italy. 16. San Gerardo Hospital, Gastroenterology and Hepatology, Monza, Italy. 17. Valduce Hospital, Gastroenterology, Como, Italy. 18. ASST Lecco, Internal Medicine, Lecco, Italy. 19. ASST Lecco, Infectious Diseases, Lecco, Italy. 20. ASST Lodi, Internal Medicine, Lodi, Italy. 21. Fondazione IRCCS Istituto Nazionale Tumori di Milano, General Surgery and Liver Transplantation Unit, Milan, Italy. 22. Maggiore Hospital, ASST Crema, Gastroenterology, Crema, Italy. 23. ASST Melegnano Martesana, Internal Medicine, Milan, Italy. 24. Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, CRC A.M. e A. Migliavacca Center for Liver Diseases, Gastroenterology and Hepatology, Milan, Italy. 25. QUOVADIS No Profit Association, Univerisity of Padua, Padua, Italy. 26. Fondazione IRCCS Policlinico San Matteo, Clinical Epidemiology and Biometric Unit, Pavia, Italy.
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.
BACKGROUND:Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCVpatients 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 HCVpatients with any chronic kidney disease (CKD). METHODS: All HCVpatients 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.
Authors: Mark Sulkowski; Laura E Telep; Massimo Colombo; Francois Durand; K Rajender Reddy; Eric Lawitz; Marc Bourlière; Nelson Cheinquer; Stacey Scherbakovsky; Liyun Ni; Lindsey Force; Heribert Ramroth; Anuj Gaggar; Anand P Chokkalingam; Meghan E Sise Journal: Aliment Pharmacol Ther Date: 2022-03-02 Impact factor: 9.524