The frequency of acute kidney injury in patients with chronic hepatitis C virus infection treated with sofosbuvir-based regimens

Aliment Pharmacol Ther. 2017 Jul;46(1):46-55. doi: 10.1111/apt.14117. Epub 2017 May 3.


Background: Guidelines recommend withholding sofosbuvir (SOF) in patients with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min.

Aim: To assess the risk of acute kidney injury (AKI) in patients with no renal contraindications for SOF-based treatment.

Methods: This multicenter retrospective observational study included all consecutive patients that were treated with SOF-based or telaprevir/boceprevir (TVR/BOC)-based regimens at two tertiary university centers in North America. AKI was defined as an increase of ≥0.3 mg/dL (≥26.5 μmol/L) in serum creatinine level. Multivariable logistic regression analysis was used to identify risk factors for the occurrence of AKI.

Results: In total, 426 patients were included and treated with a SOF-based regimen (n=233, 54.7%) or TVR/BOC-based regimen (n=193, 45.3%). Among patients treated with a TVR/BOC-based regimen 34 (18%) of 193 patients experienced AKI compared to 26 (11%) of 233 patients treated with SOF-based regimens (P=.056). Multivariable logistic regression analysis showed that the presence of ascites (OR: 4.44, 95%CI: 1.46-13.54, P=.009) and the use of NSAIDs (OR: 4.47, 95%CI: 1.32-15.19, P=.016) were associated with a risk of AKI during SOF-based antiviral therapy. Creatinine levels returned to normal at end of follow-up in 23 (88%) of the 26 patients who experienced AKI with a SOF-based regimen and had a creatinine level available during follow-up.

Conclusions: Although the risk for AKI was lower than for patients treated with TVR/BOC-based regimens, AKI was seen during 11% of SOF-based regimens and was mostly reversible. Patients with ascites and patients using NSAIDs have an increased risk for AKI during SOF-based antiviral therapy.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Acute Kidney Injury / chemically induced*
  • Adult
  • Aged
  • Antiviral Agents / adverse effects*
  • Antiviral Agents / therapeutic use
  • Drug Therapy, Combination
  • Female
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Oligopeptides / adverse effects
  • Oligopeptides / therapeutic use
  • Proline / adverse effects
  • Proline / analogs & derivatives
  • Proline / therapeutic use
  • Risk Factors
  • Sofosbuvir / adverse effects*
  • Sofosbuvir / therapeutic use


  • Antiviral Agents
  • Oligopeptides
  • telaprevir
  • N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
  • Proline
  • Sofosbuvir