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.
Dr Edward Gane and colleagues 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 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 sustained virologic response rate was 98%|
|New England Journal of Medicine|
The team's primary end point was a sustained virologic response 12 weeks after the end of treatment.
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 researchers found that the sustained virologic response rate was 98%.
No patients had virologic failure during treatment, and no patients had a virologic relapse after the end of treatment.
The team observed that adverse events 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.
The research team found that 3 of these patients had a sustained virologic response.
Dr Gane's team comments, "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."