Renal Safety of Sofosbuvir-Based Regimens After Liver Transplantation

Sofosbuvir-based regimens administered for HCV recurrence after liver transplantation are safe for the kidneys.

Sofosbuvir-based regimens administered for hepatitis C virus (HCV) recurrence after liver transplantation are safe for the kidneys, according to a multicenter, longitudinal assessment published in Alimentary Pharmacology & Therapeutics.1

Sofosbuvir-based direct-acting antiviral regimens are highly efficacious in liver transplant recipients with HCV recurrence.2 However, sofosbuvir-based regimens are also associated with changes in renal function.2-8 Therefore, researchers retrospectively analyzed renal function by means of serum creatinine level in 139 patients in France and Belgium and calculated the estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration equation over an observation time of 16.5 to 22.5 months.1

Overall, they found that the posttreatment eGFR slope was significantly better than the pretreatment eGFR slope (P =.03), indicating that sofosbuvir-based regimens are not toxic to the kidneys, including during the on-treatment period. In addition, the pretreatment eGFR, ribavirin or mycophenolate mofetil use, and stage of fibrosis did not appear to affect the eGFR slope.

On-treatment eGFR slopes were used to separate patients into 3 tertiles: patients with the most negative on-treatment slope, patients with a neutral on-treatment slope, and patients with the most positive on-treatment slope. The researchers found that the pretreatment and posttreatment eGFR slopes were not significantly different among the groups (P =.34, .008, and .73, respectively).

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One of the limitations of this study was the use of serum creatinine to estimate GFR, which may fluctuate based on the assay method used, variations in the diet, and drug-dependent tubular elimination.1,9

The authors concluded that, “long-term longitudinal observations and several levels of serum creatinine should be considered to draw conclusions on the renal toxicity of sofosbuvir-based regimens, which were harmless for the kidney function in our cohort of liver transplant recipients with HCV recurrence.”1


  1. Anty R, Favre G, Coilly A, et al, the ANRS CUPILT Study Group. Safety of sofosbuvir‐based regimens after liver transplantation: longitudinal assessment of renal function in the prospective ANRS CO23 CUPILT study [published online April 17, 2018]. Aliment Pharmacol Ther. doi:10.1111/apt.14639
  2. Coilly A, Fougerou-Leurent C, de Ledinghen V, et al. Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence – the ANRS CUPILT study. J Hepatol. 2016;65:711-718.
  3. Brown RS Jr, O’Leary JG, Reddy KR, et al. Interferon-free therapy for genotype 1 hepatitis C in liver transplant recipients: real-world experience from the hepatitis C therapeutic registry and research network. Liver Transpl. 2016;22:24-33.
  4. Jackson WE, Hanouneh M, Apfel T, et al. Sofosbuvir and simeprevir without ribavirin effectively treat hepatitis C virus genotype 1 infection after liver transplantation in a two-center experience. Clin Transplant. 2016;30:709-713.
  5. Ciesek S, Proske V, Otto B, et al. Efficacy and safety of sofosbuvir/ledipasvir for the treatment of patients with hepatitis C virus re-infection after liver transplantation. Transpl Infect Dis. 2016;18:326-332.
  6. Charlton M, Gane E, Manns MP, et al. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015;148:108-117.
  7. Leroy V, Dumortier J, Coilly A, et al. Efficacy of sofosbuvir and daclatasvir in patients with fibrosing cholestatic hepatitis C after liver transplantation. Clin Gastroenterol Hepatol. 2015;13:1993-2001.e1-2.
  8. Manns M, Samuel D, Gane EJ, et al. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016;16:685-697.