title: Sofosbuvir and simeprevir in hepatitis C genotype 1-patients with end-stage renal disease on haemodialysis or GFR <30 ml/min.
abstract: Treating chronic hepatitis C (CHC) in patients with end-stage renal disease (ESRD) has suboptimal tolerability and cure rates. Safety and efficacy of sofosbuvir plus simeprevir regimen in CHC-infected patients with ESRD on haemodialysis (HD) or glomerular filtration rate (GFR) <30 ml/min is unknown. We evaluated the safety and efficacy of sofosbuvir and simeprevir in this special patient population.
  
  
  
  All (n = 17) patients in the analysis had ESRD on HD or GFR <30 ml/min. All received sofosbuvir 400 mg daily and simeprevir 150 mg daily, without ribavirin for 12 weeks. Safety and efficacy data were collected; including SVR4 and SVR12 data for all patients after completing therapy.
  
  
  
  In this 17 patient cohort, eight (47%) were cirrhotic, four (24%) had stage three liver fibrosis and 13 (76%) were genotype 1A. All 17 have completed 12 weeks of therapy. Treatment was overall well tolerated with no treatment discontinuations reported. Four (24%) patients reported mild adverse events (AE). These AEs were insomnia (n = 2), headache (n = 1), nausea (n = 1) and worsening anaemia requiring blood transfusion (n = 1). All 17 patients reached post-treatment week-12 follow-up, and achieved SVR12 or virological cure (100% SVR12).
  
  
  
  Daily, full dose of sofosbuvir plus simeprevir for 12 weeks of therapy appears to be well tolerated in patients with ESRD on HD or GFR <30 ml/min. Most common AEs resembled those of healthier CHC patients without significant renal impairment. The cure rates obtained in this cohort treated with sofosbuvir and simeprevir are dramatically superior to any previous treatment regimen studied & published in this special patient population.
authors.affiliation: Division of Hepatology, The Liver Institute at Methodist Dallas Medical Center, Dallas, TX, USA.
authors.forename: Hector E
authors.initials: HE
authors.lastname: Nazario
authors.affiliation: Division of Hepatology, The Liver Institute at Methodist Dallas Medical Center, Dallas, TX, USA.
authors.forename: Milka
authors.initials: M
authors.lastname: Ndungu
authors.affiliation: Division of Hepatology, Liver Consultants of Texas, Baylor All Saints Medical Center, Fort Worth, TX, USA.
authors.forename: Apurva A
authors.initials: AA
authors.lastname: Modi
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008103:Liver Cirrhosis / Q000150:complications; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D000069616:Simeprevir / Q000008:administration & dosage* / Q000009:adverse effects; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects; D000072230:Sustained Virologic Response; D013781:Texas
chemical_list: D000998:Antiviral Agents; D000069616:Simeprevir; D000069474:Sofosbuvir
keywords: Chronic hepatitis C; Cirrhosis; end-stage renal disease; kidney transplant; liver transplantation; renal failure; severe renal impairment; simeprevir; sofosbuvir