Generic sofosbuvir-based direct-acting antivirals in hepatitis C virus-infected patients with chronic kidney disease

Liver Int. 2018 Dec;38(12):2137-2148. doi: 10.1111/liv.13863. Epub 2018 May 14.

Abstract

Background & aims: There is scant data on use of sofosbuvir containing directly acting antiviral (DAA) regimens in chronic kidney disease (CKD) patients. Recently generic versions of DAAs have become available in low-income countries including India. The aim of this study was to study the efficacy and safety of generic sofosbuvir in combination with generic ribavirin, ledipasvir or daclatasvir in HCV-infected patients with CKD including patients with advanced CKD (CKD stage 4 or 5 with an estimated glomerular filtration rate (GFR) <30 mL/min or those on dialysis).

Methods: Seventy-one CKD patients (76% male, 84.5% on maintenance haemodialysis, 23.9% cirrhosis) with HCV infection were included in the study. Full-dose sofosbuvir was used in combination with ribavirin (n = 26, for 24 weeks, 69.2% genotype 1, 30.8% genotype 3), ledipasvir (n = 26, for 12 weeks, all genotype 1) and daclatasvir (n = 19, for 12 weeks, all genotype 3).

Results: Sustained virological response (SVR) (HCV RNA <12 IU/mL) at 12 weeks after stopping treatment was seen in 100% of the patients in all the 3 groups. At 24-week follow-up after end of therapy, 1 patient in sofosbuvir plus ledipasvir group relapsed. At 48-week follow-up after end of therapy, 1 more patient in sofosbuvir plus ribavirin group relapsed.

Conclusion: Full-dose sofosbuvir-based DAA therapy using generics is highly effective for individuals with HCV infection and CKD including advanced CKD (CKD stage 4 or 5 with an e-GFR <30 mL/min or those on dialysis).

Keywords: chronic kidney diseases; dialysis; direct-acting antiviral; hepatitis c; sofosbuvir.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antiviral Agents / therapeutic use*
  • Benzimidazoles / therapeutic use
  • Drug Therapy, Combination
  • Drugs, Generic / therapeutic use
  • Female
  • Fluorenes / therapeutic use
  • Genotype
  • Glomerular Filtration Rate
  • Hepacivirus / drug effects*
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / complications
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Imidazoles / therapeutic use
  • India
  • Liver Cirrhosis / complications
  • Liver Cirrhosis / virology
  • Male
  • Middle Aged
  • Renal Dialysis
  • Renal Insufficiency, Chronic / complications
  • Renal Insufficiency, Chronic / therapy*
  • Ribavirin / therapeutic use
  • Sofosbuvir / therapeutic use*
  • Sustained Virologic Response
  • Treatment Outcome
  • Viral Load
  • Young Adult

Substances

  • Antiviral Agents
  • Benzimidazoles
  • Drugs, Generic
  • Fluorenes
  • Imidazoles
  • ledipasvir
  • Ribavirin
  • daclatasvir
  • Sofosbuvir