Use of sofosbuvir-based direct-acting antiviral therapy for hepatitis C viral infection in patients with severe renal insufficiency

Infect Dis (Lond). 2015;47(12):924-9. doi: 10.3109/23744235.2015.1078908. Epub 2015 Aug 18.


Sofosbuvir-based direct-acting antiviral therapy revolutionized the treatment of hepatitis C virus (HCV) infection. However, sofosbuvir use is not approved for patients with severe renal insufficiency (estimated glomerular filtration (eGFR) rate below 30 ml/min) or end-stage renal disease (ESRD) based on concerns raised during premarket animal testing over hepatobiliary and cardiovascular toxicity in this population. We report the first published data on use of sofosbuvir-based regimens in patients with severe renal insufficiency and ESRD, focusing on clinical efficacy and safety. Six patients were treated with full dose sofosbuvir; three received sofosbuvir and simeprevir, two received sofosbuvir and ribavirin, and one received sofosbuvir, ribavirin, and interferon. Three of the patients had cirrhosis. On-treatment viral suppression was 100% and sustained virological response (SVR) rate at 12 weeks was 67%. One patient had to discontinue antiviral therapy early due to side effects. No hepatobiliary or cardiovascular toxicity was reported.

Keywords: Hepatitis C; chronic kidney disease; end-stage renal disease; sofosbuvir.

Publication types

  • Case Reports
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antiviral Agents / economics
  • Antiviral Agents / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Genotype
  • Hepacivirus / drug effects
  • Hepacivirus / pathogenicity
  • Hepatitis C / complications
  • Hepatitis C / drug therapy*
  • Hepatitis C, Chronic / complications
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Interferon-alpha / therapeutic use
  • Kidney Failure, Chronic / complications*
  • Kidney Failure, Chronic / virology
  • Liver Cirrhosis / virology
  • Male
  • Middle Aged
  • Polyethylene Glycols / therapeutic use
  • RNA, Viral / blood
  • Retrospective Studies
  • Ribavirin / therapeutic use
  • Sofosbuvir / administration & dosage
  • Sofosbuvir / adverse effects
  • Sofosbuvir / therapeutic use*
  • Treatment Outcome
  • Viral Load


  • Antiviral Agents
  • Interferon-alpha
  • RNA, Viral
  • Polyethylene Glycols
  • Ribavirin
  • Sofosbuvir