Digestive Diseases and Sciences

, Volume 63, Issue 5, pp 1334–1340 | Cite as

Low-Dose Sofosbuvir Is Safe and Effective in Treating Chronic Hepatitis C in Patients with Severe Renal Impairment or End-Stage Renal Disease

  • Sunil Taneja
  • Ajay Duseja
  • Arka De
  • Manu Mehta
  • Raja Ramachandran
  • Vivek Kumar
  • Harbir Singh Kohli
  • Krishan Lal Gupta
  • Radha Krishan Dhiman
  • Yogesh Chawla
Original Article


Background and Aims

There is sparse data on the use of Sofosbuvir based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2. We evaluated the safety and efficacy of low-dose Sofosbuvir plus full-dose Daclatasvir in CHC patients with CKD.


Sixty-five CHC patients with CKD with eGFR less than 30 mL/min/1.73 m2 [54 (83%) patients with ESRD on hemodialysis] were included. All patients irrespective of genotype were treated with half-dose Sofosbuvir [200 mg (half tablet of 400 mg)] plus full-dose Daclatasvir (60 mg) given daily for either 12 or 24 weeks given in patients with genotype 3 cirrhosis. The efficacy was assessed by the sustained virological response (SVR12) with negative HCV RNA 12 weeks after the end of treatment (ETR).


The median HCV RNA level in 65 patients (Males 40, mean age 42.9 ± 13 years) was 1.65 × 106 (1.2 × 103–1.73 × 108) IU/mL with 42 (64.6%) patients having HCV genotype 1, followed by genotype 3 and 2 in 22 (34%) and 1 (1.4%) patients, respectively. Twenty-one (32%) patients had evidence of cirrhosis, and ten (15.4%) patients were treatment experienced. Sixty-four (98.5%) patients achieved ETR, and 65 (100%) patients attained SVR12. All patients tolerated the DAAs well with none of the patients reporting any serious adverse events. Minor side effects noted were nausea seen in five (7.7%) patients, insomnia and headache in four (6.2%) patients each, and pruritus in one (1.5%) patient.


Low-dose Sofosbuvir and full-dose Daclatasvir are safe and effective in treating CHC in patients with CKD with eGFR less than 30 mL/min/1.73 m2.


Chronic hepatitis C Sofosbuvir Daclatasvir Chronic kidney disease 


Compliance with ethical standards

Conflict of interest

The authors who have taken part in this study declared that they do not have anything to disclose regarding funding or conflict of interest with respect to this manuscript.


  1. 1.
    Fissell RB, Bragg-Gresham JL, Woods JD, et al. Patterns of hepatitis C prevalence and seroconversion in hemodialysis units from three continents: The DOPPS. Kidney Int. 2004 [cited 2018 Feb 2];65:2335–2342. Available from:
  2. 2.
    Finelli L, Miller JT, Tokars JI, Alter MJ, Arduino MJ. Special article: National surveillance of dialysis-associated diseases in the United States, 2002. Semin Dial. 2005 [cited 2018 Feb 2];18:52–61. Available from:
  3. 3.
    Jasuja S, Gupta AK, Choudhry R, et al. Prevalence and associations of hepatitis C viremia in hemodialysis patients at a tertiary care hospital. Indian J Nephrol. 2009 [cited 2018 Feb 2];19:62–67. Available from:
  4. 4.
    Selcuk H, Kanbay M, Korkmaz M, et al. Distribution of HCV genotypes in patients with end-stage renal disease according to type of dialysis treatment. Dig Dis Sci. 2006;51:1420–1425. Scholar
  5. 5.
    Fabrizi F, Dixit V, Dixit V. Impact of hepatitis C on survival in dialysis patients: A link with cardiovascular mortality? J Viral Hepat. 2012;19:601–607.CrossRefPubMedGoogle Scholar
  6. 6.
    Singh N, Neidlinger N, Djamali A, et al. The impact of hepatitis C virus donor and recipient status on long-term kidney transplant outcomes: University of Wisconsin experience. Clin Transplant. 2012 [cited 2018 Feb 2];26:684–693. Available from:
  7. 7.
    AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. [cited 2018 Feb 2]. Available from: Accessed 26 Jan 2018.
  8. 8.
    Roth D, Nelson D, Bruchfeld A, et al. Grazoprevir plus elbasvir in treatment-naive and treatment experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): A combination phase 3 study. Lancet. 2015;386:1537–1545.CrossRefPubMedGoogle Scholar
  9. 9.
    Pockros PJ, Reddy KR, Mantry PS, et al. Efficacy of direct-acting antiviral combination for patients with hepatitis C Virus genotype 1 infection and severe renal impairment or end-stage renal disease. Gastroenterology. 2016 [cited 2018 Feb 2];150:1590–1598. Available from:
  10. 10.
    Gane E, Lawitz E, Pugatch D, et al. Glecaprevir and Pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med. 2017 [cited 2018 Feb 2];377:1448–1455. Available from:
  11. 11.
    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 [cited 2018 Feb 2];33:189–192. Available from:
  12. 12.
    Gordon CE, Uhlig K, Lau J, Schmid CH, Levey AS, Wong JB. Interferon treatment in hemodialysis patients with Chronic Hepatitis C virus infection: A systematic review of the literature and meta-analysis of treatment efficacy and harms. Am J Kidney Dis. 2008 [cited 2018 Feb 2];51:263–277. Available from:
  13. 13.
    Alavian SM, Tabatabaei SV. Meta-analysis of factors associated with sustained viral response in patients on hemodialysis treated with standard or pegylated interferon for hepatitis C infection. Iran J Kidney Dis. 2010 [cited 2018 Feb 2];4:181–194. Available from:
  14. 14.
    Okoh EJ, Bucci JR, Simon JF, Harrison SA. HCV in patients with end-stage renal disease. Am J Gastroenterol. 2008 [cited 2018 Feb 2];103:2123–2134. Available from:
  15. 15.
    Carrion AF, Fabrizi F, Martin P. Should ribavirin be used to treat hepatitis C in dialysis patients? Semin Dial. 2011 [cited 2018 Feb 2];24:272–274. Available from:
  16. 16.
    Liu C-H, Huang C-F, Liu C-J, et al. Pegylated interferon-α2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 1 receiving hemodialysis. Ann Intern Med. 2013 [cited 2018 Feb 2];159:729. Available from:
  17. 17.
    Sofosbuvir For Treatment of Chronic Hepatitis C Infection. 2013 [cited 2018 Feb 2]. Available from:
  18. 18.
    Gane EJ, Robson RA, Bonacine M, et al. Safety, antiviral efficacy, and pharmacokinetics of sofosbuvir in patients with severe renal impairment. In: 65th annual meeting of the American association for the study of liver diseases, 7 Nov 2014. Boston, MA; 2014.Google Scholar
  19. 19.
    Ram BK, Frank C, Adam P, et al. Safety, efficacy and tolerability of half-dose Sofosbuvir plus simeprevir in treatment of Hepatitis C in patients with end stage renal disease. J Hepatol. 2015;63:763–765. Scholar
  20. 20.
    Choudhary NS, Kumar A, Bodh V, et al. Efficacy and safety of Sofosbuvir-based regimens in Chronic Hepatitis C patients on dialysis. Indian J Gastroenterol. 2017;36:113–116.CrossRefPubMedGoogle Scholar
  21. 21.
    KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. 2013 [cited 2018 Feb 2];3. Available from:
  22. 22.
    Taneja S, Tohra S, Duseja A, Dhiman RK, Chawla YK. Noninvasive assessment of liver fibrosis by transient elastography and FIB4/APRI for prediction of treatment response in Chronic Hepatitis C-an experience from a tertiary care hospital. J Clin Exp Hepatol. 2016 [cited 2018 Feb 2];6:282–290. Available from:
  23. 23.
    Taneja S, Borkakoty A, Rathi S, et al. Assessment of liver fibrosis by transient elastography should be done after hemodialysis in end stage renal disease patients with liver disease. Dig Dis Sci. 2017;62:3186–3192. Scholar
  24. 24.
    Castéra L, Vergniol J, Foucher J, et al. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in Chronic Hepatitis C. Gastroenterology. 2005 [cited 2018 Jan 6];128:343–350. Available from:
  25. 25.
    Pyne MT, Mallory M, Hillyard DR. HCV RNA measurement in samples with diverse genotypes using versions 1 and 2 of the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV test. J Clin Virol. 2015 [cited 2018 Feb 2];65:54–57. Available from:
  26. 26.
    Association for the Study of the Liver E. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. 2016 [cited 2018 Feb 2]; Available from:
  27. 27.
    Satsangi S, Mehta M, Duseja A, Taneja S, Dhiman RK, Chawla Y. Dual treatment with Sofosbuvir plus ribavirin is as effective as triple therapy with pegylated interferon plus Sofosbuvir plus ribavirin in predominant genotype 3 patients with Chronic Hepatitis C. J Gastroenterol Hepatol. 2017 [cited 2018 Feb 2];32:859–863. Available from:
  28. 28.
    Shah SR, Chowdhury A, Mehta R, et al. Sofosbuvir plus ribavirin in treatment-naïve patients with Chronic Hepatitis C virus genotype 1 or 3 infection in India. J Viral Hepat. 2017 [cited 2018 Feb 2];24:371–379. Available from:
  29. 29.
    Tohra SK, Taneja S, Ghosh S, et al. Prediction of sustained virological response to combination therapy with Pegylated interferon alfa and ribavirin in patients with genotype 3 Chronic Hepatitis C. Dig Dis Sci. 2011 [cited 2018 Feb 2];56:2449–2455. Available from:
  30. 30.
    Taneja S, Duseja A, De A, et al. Successful treatment of Chronic Hepatitis C infection with directly acting antivirals in renal transplant recipients. Nephrology. 2017 [cited 2018 Feb 2]; Available from:
  31. 31.
    Gevers TJG, Burger D, Schipper-Reintjes E, Kooistra MP, Richter C. Full-dose Sofosbuvir and Daclatasvir for Chronic Hepatitis C infection in haemodialysis patients. Neth J Med. 2016;74:225–227.PubMedGoogle Scholar
  32. 32.
    Hundemer GL, Sise ME, Wisocky J, et al. Use of Sofosbuvir-based direct-acting antiviral therapy for hepatitis C viral infection in patients with severe renal insufficiency. Infect Dis (Auckl). 2015;47:924–929.CrossRefGoogle Scholar
  33. 33.
    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;36:802–806.CrossRefPubMedGoogle Scholar
  34. 34.
    Nazario H, Ndungu M, Modi A, Modi A. Sofosbuvir and Simeprevir in hepatitis C genotype 1-patients with endstage renal disease on haemodialysis or GFR < 30 mL/min. Liver Int. 2016;36:798–801.CrossRefPubMedGoogle Scholar
  35. 35.
    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;36:807–816.CrossRefPubMedGoogle Scholar
  36. 36.
    Sperl J, Frankova S, Kreidlova M, Merta D, Tothova M, Spicak J. Combination of Sofosbuvir and Daclatasvir in the treatment of genotype 3 Chronic Hepatitis C virus infection in patients on maintenance hemodialysis. Ther Clin Risk Manag. 2017 [cited 2018 Feb 2];13:733–738. Available from:
  37. 37.
    Singhal R, Ahlawat R, Tiwari P, Duseja A. Efficacy and safety of Sofosbuvir with Simeprevir in hepatitis C infected patients with severe chronic kidney disease: A systematic review and meta-analysis. Biol Eng Med Sci Rep. 2016 [cited 2018 Feb 2];2:05–12. Available from:

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Sunil Taneja
    • 1
  • Ajay Duseja
    • 1
  • Arka De
    • 1
  • Manu Mehta
    • 1
  • Raja Ramachandran
    • 2
  • Vivek Kumar
    • 2
  • Harbir Singh Kohli
    • 2
  • Krishan Lal Gupta
    • 2
  • Radha Krishan Dhiman
    • 1
  • Yogesh Chawla
    • 1
  1. 1.Department of HepatologyPostgraduate Institute of Medical Education and ResearchChandigarhIndia
  2. 2.Department of NephrologyPostgraduate Institute of Medical Education and ResearchChandigarhIndia

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