BACKGROUND: Chronic hepatitis C virus (HCV) infection is more prevalent among 
patients who have chronic kidney disease than among those who do not have the 
disease. Patients with chronic kidney disease who also have HCV infection are at 
higher risk for progression to end-stage renal disease than those who have 
chronic kidney disease without HCV infection. Patients with both HCV infection 
and advanced chronic kidney disease have limited treatment options.
METHODS: We conducted a multicenter, open-label, phase 3 trial to evaluate the 
efficacy and safety of treatment with the combination of the NS3/4A protease 
inhibitor glecaprevir and the NS5A inhibitor pibrentasvir for 12 weeks in adults 
who had HCV genotype 1, 2, 3, 4, 5, or 6 infection and also had compensated 
liver disease (with or without cirrhosis) with severe renal impairment, 
dependence on dialysis, or both. Patients had stage 4 or 5 chronic kidney 
disease and either had received no previous treatment for HCV infection or had 
received previous treatment with interferon or pegylated interferon, ribavirin, 
sofosbuvir, or a combination of these medications. The primary end point was a 
sustained virologic response 12 weeks after the end of treatment.
RESULTS: Among the 104 patients enrolled in the trial, 52% had genotype 1 
infection, 16% had genotype 2 infection, 11% had genotype 3 infection, 19% had 
genotype 4 infection, and 2% had genotype 5 or 6 infection. The sustained 
virologic response rate was 98% (102 of 104 patients; 95% confidence interval, 
95 to 100). No patients had virologic failure during treatment, and no patients 
had a virologic relapse after the end of treatment. Adverse events that were 
reported in at least 10% of the patients were pruritus, fatigue, and nausea. 
Serious adverse events were reported in 24% of the patients. Four patients 
discontinued the trial treatment prematurely because of adverse events; three of 
these patients had a sustained virologic response.
CONCLUSIONS: Treatment with glecaprevir and pibrentasvir for 12 weeks resulted 
in a high rate of sustained virologic response in patients with stage 4 or 5 
chronic kidney disease and HCV infection. (Funded by AbbVie; ClinicalTrials.gov 
number, NCT02651194 .).