Skip to main content
Top
Published in: Drugs 12/2014

01-08-2014 | Leading Article

New Therapies for Hepatitis C: Considerations in Patients with Renal Impairment

Authors: Sarah Zimner-Rapuch, Nicolas Janus, Gilbert Deray, Vincent Launay-Vacher

Published in: Drugs | Issue 12/2014

Login to get access

Abstract

Hepatitis C virus (HCV) is a major public health issue because infection may lead to liver failure, cirrhosis and hepatocellular carcinoma. In patients with renal dysfunction, hepatitis C can also worsen the underlying renal disease. Treating HCV infection is thus mandatory in this population. New therapies for hepatitis C have recently been developed, and some have been launched. Most of them are used in combination with the current standard of care, ribavirin and pegylated interferon alfa. Some of them can be used in regimens without ribavirin and/or pegylated interferon. However, few data are available on dosage adjustment for renal function in patients receiving these very new drugs. We reviewed the literature on this subject and gathered information, although scarce, to propose guidelines for using these drugs in patients with chronic kidney disease.
Literature
1.
go back to reference Kamar N, Alric L, Izopet J, Rostaing L. Hepatitis C virus and kidney disease. Clin Res Hepatol Gastroenterol. 2013;37:328–33.PubMedCrossRef Kamar N, Alric L, Izopet J, Rostaing L. Hepatitis C virus and kidney disease. Clin Res Hepatol Gastroenterol. 2013;37:328–33.PubMedCrossRef
2.
go back to reference Vallet-Pichard A, Pol S. Hepatitis C virus infection in hemodialysis patients. Clin Res Hepatol Gastroenterol. 2013;37:340–6.PubMedCrossRef Vallet-Pichard A, Pol S. Hepatitis C virus infection in hemodialysis patients. Clin Res Hepatol Gastroenterol. 2013;37:340–6.PubMedCrossRef
3.
go back to reference Goodkin DA, Bragg-Gresham JL, Koenig KG, et al. Association of comorbid conditions and mortality in hemodialysis patients in Europe, Japan, and the United States: the Dialysis Outcomes and Practice Patterns Study (DOPPS). J Am Soc Nephrol. 2003;14:3270–7.PubMedCrossRef Goodkin DA, Bragg-Gresham JL, Koenig KG, et al. Association of comorbid conditions and mortality in hemodialysis patients in Europe, Japan, and the United States: the Dialysis Outcomes and Practice Patterns Study (DOPPS). J Am Soc Nephrol. 2003;14:3270–7.PubMedCrossRef
4.
go back to reference Brennan BJ, Wang K, Blotner S, et al. Safety, tolerability, and pharmacokinetics of ribavirin in hepatitis C virus-infected patients with various degrees of renal impairment. Antimicrob Agents Chemother. 2013;57:6097–105.PubMedCentralPubMedCrossRef Brennan BJ, Wang K, Blotner S, et al. Safety, tolerability, and pharmacokinetics of ribavirin in hepatitis C virus-infected patients with various degrees of renal impairment. Antimicrob Agents Chemother. 2013;57:6097–105.PubMedCentralPubMedCrossRef
5.
go back to reference Tseng P-L, Chen T-C, Chien Y-S, et al. Efficacy and safety of pegylated interferon alfa-2b and ribavirin combination therapy versus pegylated interferon monotherapy in hemodialysis patients: a comparison of 2 sequentially treated cohorts. Am J Kidney Dis. 2013;62:789–95.PubMedCrossRef Tseng P-L, Chen T-C, Chien Y-S, et al. Efficacy and safety of pegylated interferon alfa-2b and ribavirin combination therapy versus pegylated interferon monotherapy in hemodialysis patients: a comparison of 2 sequentially treated cohorts. Am J Kidney Dis. 2013;62:789–95.PubMedCrossRef
6.
go back to reference Yee HS, Chang MF, Pocha C, et al. Update on the management and treatment of hepatitis C virus infection: recommendations from the Department of Veterans Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program Office. Am J Gastroenterol. 2012;107:669–89 (quiz 690).PubMedCrossRef Yee HS, Chang MF, Pocha C, et al. Update on the management and treatment of hepatitis C virus infection: recommendations from the Department of Veterans Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program Office. Am J Gastroenterol. 2012;107:669–89 (quiz 690).PubMedCrossRef
7.
go back to reference Wendt A, Adhoute X, Castellani P, et al. Chronic hepatitis C: future treatment. Clin Pharmacol Adv Appl. 2014;6:1–17. Wendt A, Adhoute X, Castellani P, et al. Chronic hepatitis C: future treatment. Clin Pharmacol Adv Appl. 2014;6:1–17.
8.
go back to reference Charlton M. Telaprevir, boceprevir, cytochrome P450 and immunosuppressive agents—a potentially lethal cocktail. Hepatology. 2011;54:3–5.PubMedCrossRef Charlton M. Telaprevir, boceprevir, cytochrome P450 and immunosuppressive agents—a potentially lethal cocktail. Hepatology. 2011;54:3–5.PubMedCrossRef
10.
go back to reference Garg V, Kauffman RS, Beaumont M, van Heeswijk RPG. Telaprevir: pharmacokinetics and drug interactions. Antivir Ther. 2012;17:1211–21.PubMedCrossRef Garg V, Kauffman RS, Beaumont M, van Heeswijk RPG. Telaprevir: pharmacokinetics and drug interactions. Antivir Ther. 2012;17:1211–21.PubMedCrossRef
11.
go back to reference Dumortier J, Guillaud O, Gagnieu M-C, et al. Anti-viral triple therapy with telaprevir in haemodialysed HCV patients: is it feasible? J Clin Virol. 2013;56:146–9.PubMedCrossRef Dumortier J, Guillaud O, Gagnieu M-C, et al. Anti-viral triple therapy with telaprevir in haemodialysed HCV patients: is it feasible? J Clin Virol. 2013;56:146–9.PubMedCrossRef
12.
go back to reference Basu PP, Siriki R, Shah NJ, et al. Telaprevir with adjusted dose of ribavirin in naïve CHC-G1: efficacy and treatment in CHC in hemodialysis population. In: TARGET C (RCT) 48th annual meeting of the european association for the study of the liver, April 24–28, 2013. Amsterdam, Netherlands; 2013. Abstract 67. Basu PP, Siriki R, Shah NJ, et al. Telaprevir with adjusted dose of ribavirin in naïve CHC-G1: efficacy and treatment in CHC in hemodialysis population. In: TARGET C (RCT) 48th annual meeting of the european association for the study of the liver, April 24–28, 2013. Amsterdam, Netherlands; 2013. Abstract 67.
13.
go back to reference Garg V, van Heeswijk R, Lee JE, Alves K, Nadkarni P, Luo X. Effect of telaprevir on the pharmacokinetics of cyclosporine and tacrolimus. Hepatology. 2011;54:20–7.PubMedCrossRef Garg V, van Heeswijk R, Lee JE, Alves K, Nadkarni P, Luo X. Effect of telaprevir on the pharmacokinetics of cyclosporine and tacrolimus. Hepatology. 2011;54:20–7.PubMedCrossRef
14.
go back to reference Treitel M, Marbury T, Preston RA, et al. Single-dose pharmacokinetics of boceprevir in subjects with impaired hepatic or renal function. Clin Pharmacokinet. 2012;51:619–28.PubMedCrossRef Treitel M, Marbury T, Preston RA, et al. Single-dose pharmacokinetics of boceprevir in subjects with impaired hepatic or renal function. Clin Pharmacokinet. 2012;51:619–28.PubMedCrossRef
15.
go back to reference Mauss S, Hueppe D, Alshuth U. Renal impairment is frequent in chronic hepatitis C patients under triple therapy with telaprevir or boceprevir. Hepatology. 2014;59:46–8.PubMedCrossRef Mauss S, Hueppe D, Alshuth U. Renal impairment is frequent in chronic hepatitis C patients under triple therapy with telaprevir or boceprevir. Hepatology. 2014;59:46–8.PubMedCrossRef
16.
go back to reference Loustaud-Ratti V, Carrier P, Vong C, Essig M. Renal impairment is frequent in chronic hepatitis C patients under triple therapy with telaprevir or boceprevir. Hepatology 2014;59(6):2426. Loustaud-Ratti V, Carrier P, Vong C, Essig M. Renal impairment is frequent in chronic hepatitis C patients under triple therapy with telaprevir or boceprevir. Hepatology 2014;59(6):2426.
18.
go back to reference Clark VC, Peter JA, Nelson DR. New therapeutic strategies in HCV: second-generation protease inhibitors. Liver Int. 2013;33(Suppl 1):80–4.PubMedCrossRef Clark VC, Peter JA, Nelson DR. New therapeutic strategies in HCV: second-generation protease inhibitors. Liver Int. 2013;33(Suppl 1):80–4.PubMedCrossRef
19.
go back to reference Eley T, He B, Chang I, et al. The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor. Antivir Ther. 2014. doi:10.3851/IMP2773. Eley T, He B, Chang I, et al. The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor. Antivir Ther. 2014. doi:10.​3851/​IMP2773.
20.
go back to reference Garimella T, He B, Luo W-L, et al. Asunaprevir pharmacokinetics and safety in subjects with impaired renal function. In: 64th annual meeting of the american association for the study of liver diseases Nov 1–5, 2013. Washington, DC; 2013. Abstract. Garimella T, He B, Luo W-L, et al. Asunaprevir pharmacokinetics and safety in subjects with impaired renal function. In: 64th annual meeting of the american association for the study of liver diseases Nov 1–5, 2013. Washington, DC; 2013. Abstract.
21.
go back to reference Cornpropst M, Denning J, Clemons D, et al. The effect of renal impairment and end stage renal disease on the single-dose pharmacokinetics of PSI-7977. In: 47th annual meeting of the european association for the study of the liver (EASL), April 18–22, 2012. Barcelona, Spain; 2012. Abstract 1101. Cornpropst M, Denning J, Clemons D, et al. The effect of renal impairment and end stage renal disease on the single-dose pharmacokinetics of PSI-7977. In: 47th annual meeting of the european association for the study of the liver (EASL), April 18–22, 2012. Barcelona, Spain; 2012. Abstract 1101.
22.
go back to reference Herbst DA Jr, Reddy KR. Sofosbuvir, a nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus infection. Expert Opin Invest Drugs. 2013;22:527–36.CrossRef Herbst DA Jr, Reddy KR. Sofosbuvir, a nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus infection. Expert Opin Invest Drugs. 2013;22:527–36.CrossRef
25.
go back to reference Garimella T, Wang R, Luo W-L, et al. The effect of renal impairment on single-dose pharmacokinetics of daclatasvir, an HCV NS5A inhibitor. Presented at 15th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy, Washington DC, 19–21 May 2014. Available at http://www.natap.org/2014/Pharm/Pharm_18.htm. Accessed 10 July 2014. Garimella T, Wang R, Luo W-L, et al. The effect of renal impairment on single-dose pharmacokinetics of daclatasvir, an HCV NS5A inhibitor. Presented at 15th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy, Washington DC, 19–21 May 2014. Available at http://​www.​natap.​org/​2014/​Pharm/​Pharm_​18.​htm. Accessed 10 July 2014.
26.
go back to reference Gentile I, Buonomo AR, Borgia F, Castaldo G, Borgia G. Ledipasvir: a novel synthetic antiviral for the treatment of HCV infection. Expert Opin Invest Drugs. 2014;23:561–71.CrossRef Gentile I, Buonomo AR, Borgia F, Castaldo G, Borgia G. Ledipasvir: a novel synthetic antiviral for the treatment of HCV infection. Expert Opin Invest Drugs. 2014;23:561–71.CrossRef
27.
go back to reference Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483–93.PubMedCrossRef Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483–93.PubMedCrossRef
28.
go back to reference Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889–98.PubMedCrossRef Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889–98.PubMedCrossRef
29.
go back to reference Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879–88.PubMedCrossRef Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879–88.PubMedCrossRef
Metadata
Title
New Therapies for Hepatitis C: Considerations in Patients with Renal Impairment
Authors
Sarah Zimner-Rapuch
Nicolas Janus
Gilbert Deray
Vincent Launay-Vacher
Publication date
01-08-2014
Publisher
Springer International Publishing
Published in
Drugs / Issue 12/2014
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-014-0268-7

Other articles of this Issue 12/2014

Drugs 12/2014 Go to the issue