Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment

Edward Gane, Eric Lawitz, David Pugatch, Georgios Papatheodoridis, Norbert Bräu, Ashley Brown, Stanislas Pol, Vincent Leroy, Marcello Persico, Christophe Moreno, Massimo Colombo, Eric M. Yoshida, David R. Nelson, Christine Collins, Yang Lei, Matthew Kosloski, Federico J. Mensa

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Abstract

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.

Original languageEnglish
Pages (from-to)1448-1455
Number of pages8
JournalNew England Journal of Medicine
Volume377
Issue number15
DOIs
Publication statusPublished - Oct 12 2017

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ASJC Scopus subject areas

  • Medicine(all)

Cite this

Gane, E., Lawitz, E., Pugatch, D., Papatheodoridis, G., Bräu, N., Brown, A., Pol, S., Leroy, V., Persico, M., Moreno, C., Colombo, M., Yoshida, E. M., Nelson, D. R., Collins, C., Lei, Y., Kosloski, M., & Mensa, F. J. (2017). Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. New England Journal of Medicine, 377(15), 1448-1455. https://doi.org/10.1056/NEJMoa1704053