Sofosbuvir plus simeprevir treatment of recurrent genotype 1 hepatitis C after liver transplant

Clin Transplant. 2015 Dec;29(12):1105-11. doi: 10.1111/ctr.12634. Epub 2015 Oct 9.

Abstract

Background: Patients with recurrent hepatitis C (HCV) infection post-liver transplant can be difficult to treat safely and effectively. A prior (COSMOS) study in patients with non-transplant HCV, using sofosbuvir plus simeprevir, had high efficacy and tolerability in treating patients with HCV genotype 1, even prior non-responders to interferon therapy and those with cirrhosis. Our aim was to evaluate the efficacy of sofosbuvir and simeprevir in patients with genotype 1 HCV post-liver transplant.

Methods: In this prospective, observational study, patients received sofosbuvir 400 mg plus simeprevir 150 mg daily for 12 wk without ribavirin. The primary end point was a sustained virologic response 12 wk after the end of therapy.

Results: Forty-two patients completed the treatment. Twenty-six percent started the treatment ≤ 6 months post-liver transplant. Nineteen percent of the included patients had cirrhosis, 14% with decompensation. At week 4 on the treatment, 21% of patients had detectable virus but at the end of the treatment, 100% were undetectable. Twelve weeks after the end of the treatment, 95% of the patients had undetectable hepatitis C. The regimen was generally well tolerated.

Conclusion: The oral regimen of sofosbuvir plus simeprevir without ribavirin is efficacious and well tolerated in the treatment of patients with genotype 1 hepatitis C post-liver transplant.

Keywords: direct acting antiviral agents; hepatitis C; liver transplant; simeprevir; sofosbuvir.

Publication types

  • Clinical Trial
  • Observational Study

MeSH terms

  • Allografts
  • Antiviral Agents / therapeutic use*
  • DNA, Viral / genetics
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Genotype
  • Hepacivirus / genetics*
  • Hepacivirus / pathogenicity
  • Hepatitis C / prevention & control*
  • Hepatitis C / virology
  • Humans
  • Liver Transplantation / adverse effects*
  • Male
  • Middle Aged
  • Prognosis
  • Prospective Studies
  • Recurrence
  • Simeprevir / therapeutic use*
  • Sofosbuvir / therapeutic use*

Substances

  • Antiviral Agents
  • DNA, Viral
  • Simeprevir
  • Sofosbuvir