Abstract
Introduction
Patients with end-stage renal disease (ESRD) have poor treatment tolerance and outcome to interferon-based regimens. Sofosbuvir-based regimens have improved treatment success in chronic hepatitis C. There is limited data in ESRD patients as sofosbuvir is excreted by the kidney. Several small studies have shown good results.
Methods
Sixteen consecutive patients of ESRD (on dialysis) and chronic hepatitis C were treated with sofosbuvir-based regimens as they were prospective kidney transplantation recipients, at a tertiary care center in north India. Sofosbuvir was given 400 mg on alternate days. Data is shown as number, mean (SD), and median (range).
Results
Sixteen patients (12 males) aged 45±12 years received sofosbuvir-based treatment. These patients were on hemodialysis from 10 (2–48) months. Eleven of these patients had genotype 1, four had genotype 3, and one had genotype 4 infection; baseline RNA was 7 (5–8) log. The following treatment regimens were used: sofosbuvir, ribavirin, and low dose peginterferon (n = 8; 6 genotype 1 and one each had genotype 3 and 4); sofosbuvir and daclatasvir (n = 7); sofosbuvir, ribavirin, and daclatasvir (n = 1). Ten patients achieved end of treatment response and 8 (80%) of these achieved sustained virological response at 12 weeks (SVR12); six are on treatment. Two patients with genotype one (including one with cirrhosis) had relapse. Seven patients needed blood transfusion; interferon was stopped in one due to thrombocytopenia. Fatigue was present in 4 patients.
Conclusion
Sofosbuvir-based regimens can be used in ESRD patients on dialysis with good efficacy.
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References
Morales JM, Fabrizi F. Hepatitis C and its impact on renal transplantation. Nat Rev Nephrol. 2015;11:172–82.
Duseja A, Choudhary NS, Gupta S, Dhiman RK, Chawla Y, Sakhuja V. Treatment of chronic hepatitis C in end stage renal disease: experience at a tertiary care centre. Trop Gastroenterol. 2012;33:189–92.
AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015;62:932–54.
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 [abstract 1101]. 47th Annual Meeting of the European Association for the Study of the Liver (EASL), April 18-22, 2012, Barcelona.
Smolders EJ, de Kanter CT, van Hoek B, Arends JE, Drenth JP, Burger DM. Pharmacokinetics, efficacy, and safety of hepatitis C virus drugs in patients with liver and/or renal impairment. Drug Saf. 2016;39:589–611.
Saxena V, Koraishy FM, Sise ME, et al. Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function. Liver Int. 2016;36:807–16.
Singh T, Guirguis J, Anthony S, Rivas J, Hanouneh IA, Alkhouri N. Sofosbuvir-based treatment is safe and effective in patients with chronic hepatitis C infection and end stage renal disease: a case series. Liver Int. 2016;36:802–6.
Nazario HE, Ndungu M, Modi AA. Sofosbuvir and simeprevir in hepatitis C genotype 1-patients with end-stage renal disease on haemodialysis or GFR <30 ml/min. Liver Int. 2016;36:798–801.
Beinhardt S, Al Zoairy R, Ferenci P, et al. DAA-based antiviral treatment of patients with chronic hepatitis C in the pre- and postkidney transplantation setting. Transpl Int. 2016;29:999–1007.
Desnoyer A, Pospai D, Lê MP, et al. Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. J Hepatol. 2016;65:40–7.
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NSC, AK, VB, SBB, RS, MJ, SS, and NS declare that they have no conflict of interest.
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The authors declare that the study was performed in a manner to conform to the Helsinki declaration of 1975, as revised in 2000 and 2008 concerning Human and Animal Rights, and the authors followed the policy concerning Informed Consent as shown on Springer.com.
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Choudhary, N.S., Kumar, A., Bodh, V. et al. Efficacy and safety of sofosbuvir-based regimens in chronic hepatitis C patients on dialysis. Indian J Gastroenterol 36, 113–116 (2017). https://doi.org/10.1007/s12664-017-0735-7
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DOI: https://doi.org/10.1007/s12664-017-0735-7