Jérôme Dumortier1, François Bailly2, Georges-Philippe Pageaux3, Anaïs Vallet-Pichard4, Sylvie Radenne2, François Habersetzer5, Marie-Claude Gagnieu6, Jean-Didier Grangé7, Anne Minello8, Olivier Guillaud1, Nassim Kamar9, Laurent Alric10, Vincent Leroy11. 1. Department of Digestive Diseases, Edouard Herriot Hospital and University of Lyon 1, Hospices Civils de Lyon, Lyon, France. 2. Department of Hepatogastroenterology, Croix-Rousse Hospital, Hospices Civils de Lyon, Lyon, France. 3. Department of Hepatogastroenterology and Liver Transplantation, Saint Eloi University Hospital, University of Montpellier, Montpellier, France. 4. Department of Hepatology, Cochin Hospital, APHP, INSERM UMS-20 Institut Pasteur, Paris, France. 5. Hepatology Unit, Pôle Hépato-digestif, IHU Strasbourg, INSERM U1110, University of Strasbourg, Strasbourg, France. 6. Department of Pharmacology, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France. 7. Department of Hepatogastroenterology, Tenon Hospital, Paris, France. 8. Department of Hepatogastroenterology, Dijon University Hospital, Dijon, France. 9. Department of Nephrology and Organ Transplantation, Toulouse University Hospital, Université Paul Sabatier, INSERM U1043, IFR-BMT, Toulouse, France. 10. Internal Medicine-Digestive Department, CHU Purpan, UMR 152, IRD Toulouse 3 University, Toulouse, France. 11. Department of Hepatology and Gastroenterology and INSERM U823, CHU A Michallon, Université Grenoble Alpes, Grenoble, France.
Abstract
BACKGROUND: Chronic hepatitis C virus (HCV) infection is the most common chronic liver disease in patients with end-stage renal disease (ESRD). Over the last few years, second-generation direct-acting antivirals have been revolutionary in the treatment of hepatitis C, and sofosbuvir (SOF) is the backbone of most modern treatment strategies. Since SOF is eliminated through the kidney, the aim of this multicentre retrospective study was to assess its antiviral efficacy and safety in HCV-infected patients with severe renal failure [including haemodialysis (HD) patients]. METHODS: Fifty patients (36 males, mean age ± standard deviation 60.5 ± 7.5 years) with chronic HCV infection (G1: 28/56%, cirrhosis: 27/54%) and severe renal failure [i.e. MDRD estimated glomerular filtration rate (eGFR) <35 mL/min], including 35 on HD, were enrolled. Antiviral treatment consisted of SOF/ribavirin (RBV) (n = 7), SOF/RBV/pegylated interferon (n = 2), SOF/daclatasvir ± RBV (n = 30) or SOF/simeprevir ± RBV (n = 11) for 12 or 24 weeks. A reduced dose of SOF (400 mg three times a week or 400 mg every other day) was given to all HD patients. Initial dose of RBV (n = 12) ranged from 400 to 4200 mg/week. RESULTS: On an intent-to-treat-based analysis, sustained virological response rate was 86% at 12 weeks. During therapy, haemoglobin levels were not significantly modified, but recombinant erythropoietin (rEPO) dose significantly increased in patients treated with RBV. Two patients (4%) required blood transfusion. No patient had treatment discontinuation due to side effects. Dose of RBV was reduced in two patients (16.7%) during antiviral therapy. Dose of SOF was reduced in two non-HD patients because of side effects. In non-HD patients, median eGFR was not significantly modified during treatment. CONCLUSIONS: Our results strongly suggest that SOF-based antiviral therapy, with a reduced dose of SOF, is safe and effective for the treatment of HCV patients with ESRD, including HD patients.
BACKGROUND: Chronic hepatitis C virus (HCV) infection is the most common chronic liver disease in patients with end-stage renal disease (ESRD). Over the last few years, second-generation direct-acting antivirals have been revolutionary in the treatment of hepatitis C, and sofosbuvir (SOF) is the backbone of most modern treatment strategies. Since SOF is eliminated through the kidney, the aim of this multicentre retrospective study was to assess its antiviral efficacy and safety in HCV-infected patients with severe renal failure [including haemodialysis (HD) patients]. METHODS: Fifty patients (36 males, mean age ± standard deviation 60.5 ± 7.5 years) with chronic HCV infection (G1: 28/56%, cirrhosis: 27/54%) and severe renal failure [i.e. MDRD estimated glomerular filtration rate (eGFR) <35 mL/min], including 35 on HD, were enrolled. Antiviral treatment consisted of SOF/ribavirin (RBV) (n = 7), SOF/RBV/pegylated interferon (n = 2), SOF/daclatasvir ± RBV (n = 30) or SOF/simeprevir ± RBV (n = 11) for 12 or 24 weeks. A reduced dose of SOF (400 mg three times a week or 400 mg every other day) was given to all HD patients. Initial dose of RBV (n = 12) ranged from 400 to 4200 mg/week. RESULTS: On an intent-to-treat-based analysis, sustained virological response rate was 86% at 12 weeks. During therapy, haemoglobin levels were not significantly modified, but recombinant erythropoietin (rEPO) dose significantly increased in patients treated with RBV. Two patients (4%) required blood transfusion. No patient had treatment discontinuation due to side effects. Dose of RBV was reduced in two patients (16.7%) during antiviral therapy. Dose of SOF was reduced in two non-HD patients because of side effects. In non-HD patients, median eGFR was not significantly modified during treatment. CONCLUSIONS: Our results strongly suggest that SOF-based antiviral therapy, with a reduced dose of SOF, is safe and effective for the treatment of HCV patients with ESRD, including HD patients.
Authors: Charles R Swanepoel; Mohamed G Atta; Vivette D D'Agati; Michelle M Estrella; Agnes B Fogo; Saraladevi Naicker; Frank A Post; Nicola Wearne; Cheryl A Winkler; Michael Cheung; David C Wheeler; Wolfgang C Winkelmayer; Christina M Wyatt Journal: Kidney Int Date: 2018-02-03 Impact factor: 10.612
Authors: Meghan E Sise; Elke Backman; Guillermo A Ortiz; Gregory L Hundemer; Nneka N Ufere; Donald F Chute; Joseph Brancale; Dihua Xu; Jessica Wisocky; Ming V Lin; Arthur Y Kim; Ravi Thadhani; Raymond T Chung Journal: Clin J Am Soc Nephrol Date: 2017-09-07 Impact factor: 8.237
Authors: Paula Cox-North; Kelsey L Hawkins; Sean T Rossiter; Marie N Hawley; Renuka Bhattacharya; Charles S Landis Journal: Hepatol Commun Date: 2017-04-18