Table 1.

Clinica l trials involving DAAs in patients with an eGFR of <30 ml/min per 1.73 m2 or those on dialysis and in recipients of kidney transplants

TrialRegimenNumber Enrolled, Study DesignPatient PopulationHCV Cure Rate (%)Overall SAE Rate
C-SURFER; Roth et al. (19)Elbasvir/grazoprevir235, randomized controlled trialCKD 4/5, ESKD9414% in immediate treatment group; 17% in deferred treatment group (no SAE considered treatment related in immediate treatment group; treatment-related SAE in deferred treatment group was increased lipase)
Expedition-4; Gane et al. (20)Glecaprevir/pibrentasvir104, single armCKD 4/5, ESKD9824% SAE, none treatment related
Expedition-5; Lawitz et al. (21)Glecaprevir/pibrentasvir101, single armCKD 3b/4/5, ESKD9712% SAEs, none treatment related
Borgia et al. (26)Sofosbuvir/velpatasvir59, single armESKD9519% SAEs, none treatment related
Chuang et al. (46)Sofosbuvir/ledipasvir95, single armESKD9413% SAEs, none treatment related
Colombo et al. (56)Sofosbuvir/ledipasvir114, randomized, open-label studyTransplant recipients, eGFR ≥40 ml/min per 1.73 m210011% SAEs (three treatment-related SAEs: syncope, pulmonary embolism, and serum creatinine increase)
Reau et al. (57)aGlecaprevir/pibrentasvir20 kidney transplants, single arm, open labelTransplant recipients, no eGFR cutoff1008% in overall cohort (n=20 kidney transplants, n=80 liver transplant; two treatment-related SAEs—sinusitis and abnormal hepatic function)
  • DAA, direct-acting antivir al; HCV, hepatitis C virus; SAE, serious adverse event; C-SURFER, Hepatitis C: Study to Understand Renal Failure's Effect on Responses; Expedition-4, A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection; Expedition-5, A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection.

  • a In this study, overall cohort was n=100, out of which 80 patients had liver transplant and 20 patients had a kidney transplant. The HCV cure rate was 20 out of 20 for patients with a kidney transplant, and the SAEs were 8% for the overall cohort.