Safety and efficacy of sofosbuvir-based treatment of acute hepatitis C in end-stage renal disease patients undergoing haemodialysis

Aliment Pharmacol Ther. 2018 Feb;47(4):526-532. doi: 10.1111/apt.14429. Epub 2017 Dec 18.

Abstract

Background: Hepatitis C virus (HCV) infection in patients undergoing haemodialysis is prevalent and aggressive. The treatment of chronic hepatitis C has been revolutionised by the advent of direct-acting antivirals (DAAs). However, the safety, efficacy, and tolerance of DAAs in the treatment of acute HCV infection in patients with end-stage renal disease who are on haemodialysis are unknown.

Aim: To evaluate the safety and efficacy of sofosbuvir plus daclatasvir in this specific, difficult-to-treat population.

Methods: We conducted a prospective and observational study of end-stage renal disease patients who were undergoing haemodialysis and were acutely infected with HCV. Patients received a half dose of sofosbuvir (200 mg) and a full dose of daclatasvir (60 mg) daily. The primary endpoint was the proportion of patients with sustained virological responses (SVRs); the other primary outcomes were safety and tolerability.

Results: Thirty-three patients were enrolled in the study. The median HCV RNA viral load at baseline was 6.8 log10 IU/mL. Twenty-four patients were infected with HCV genotype 2a, seven patients with 1b, and two patients with 2a+1b. All patients achieved a SVR at 12 weeks after the end of treatment. The treatment was well tolerated, and there were no drug-related serious adverse events.

Conclusion: A half dose of sofosbuvir (200 mg once daily) plus a full dose of daclatasvir (60 mg once daily) were suitable for the treatment of acute HCV-infected patients who were undergoing end-stage renal disease and were on haemodialysis.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Antiviral Agents* / administration & dosage
  • Antiviral Agents* / adverse effects
  • Carbamates
  • Drug Therapy, Combination / adverse effects
  • Female
  • Follow-Up Studies
  • Hepatitis C / complications*
  • Hepatitis C / drug therapy*
  • Humans
  • Imidazoles / administration & dosage
  • Imidazoles / adverse effects
  • Kidney Failure, Chronic / complications*
  • Kidney Failure, Chronic / therapy*
  • Male
  • Middle Aged
  • Prospective Studies
  • Pyrrolidines
  • Renal Dialysis*
  • Sofosbuvir* / administration & dosage
  • Sofosbuvir* / adverse effects
  • Sustained Virologic Response
  • Treatment Outcome
  • Valine / analogs & derivatives
  • Young Adult

Substances

  • Antiviral Agents
  • Carbamates
  • Imidazoles
  • Pyrrolidines
  • Valine
  • daclatasvir
  • Sofosbuvir