Gane E, et al. - A multicenter, open-label, phase 3 trial was performed to assess the efficacy and safety treatment of glecaprevir and pibrentasvir among patients with hepatitis C virus (HCV) and severe renal impairment. Among patients with stage 4 or 5 chronic kidney disease and HCV infection, treatment with glecaprevir and pibrentasvir for 12 weeks resulted in a high rate of sustained virologic response.

• The authors assessed 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.
• Neither had received any previous treatment for HCV infection or had received previous treatment with interferon or pegylated interferon, ribavirin, sofosbuvir, or a combination of these medications.
• A sustained virologic response 12 weeks after the end of treatment was the primary end point.

• 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 among the 104 patients enrolled in the trial.
• In this study, the sustained virologic response rate was 98% (102 of 104 patients; 95% confidence interval, 95 to 100).
• During treatment, no patients had virologic failure.
• No patients had a virologic relapse after the end of treatment.
• Pruritus, fatigue, and nausea were the adverse events that were reported in at least 10% of the patients.
• In 24% of the patients, serious adverse events were reported.
• Due to adverse events, 4 patients discontinued the trial treatment prematurely; 3 of these patients had a sustained virologic response.