Efficacy of Direct-Acting Antiviral Combination for Patients with Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease

Paul J. Pockros, K. Rajender Reddy, Parvez S. Mantry, Eric Cohen, Michael Bennett, Mark Sulkowski, David E. Bernstein, Daniel E. Cohen, Nancy S. Shulman, Deli Wang, Amit Khatri, Manal Abunimeh, Thomas Podsadecki, Eric Lawitz

Research output: Contribution to journalArticle

Abstract

Background & Aims Although hepatitis C virus (HCV) infection is common in patients with end-stage renal disease, highly efficacious, well-tolerated, direct-acting antiviral regimens have not been extensively studied in this population. We investigated the safety and efficacy of ombitasvir co-formulated with paritaprevir and ritonavir, administered with dasabuvir (with or without ribavirin) in a prospective study of patients with stage 4 or 5 chronic kidney disease (CKD). Methods We performed a single-arm, multicenter study of treatment-naïve adults with HCV genotype 1 infection, without cirrhosis and with CKD stage 4 (estimated glomerular filtration rate, 15-30 mL/min/1.73 m2) or stage 5 (estimated glomerular filtration rate, 2 or requiring hemodialysis). Twenty patients were given ombitasvir co-formulated with paritaprevir and ritonavir, administered with dasabuvir for 12 weeks. Patients with HCV genotype 1a infections also received ribavirin (n = 13), whereas those with genotype 1b infection did not (n = 7). The primary end point was sustained virologic response (serum HCV RNA

Original languageEnglish (US)
Pages (from-to)1590-1598
Number of pages9
JournalGastroenterology
Volume150
Issue number7
DOIs
StatePublished - Jun 1 2016

Keywords

  • NS3/4A Protease Inhibitor
  • NS5A Inhibitor
  • Renal Disease
  • RUBY-I

ASJC Scopus subject areas

  • Gastroenterology

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    Pockros, P. J., Reddy, K. R., Mantry, P. S., Cohen, E., Bennett, M., Sulkowski, M., Bernstein, D. E., Cohen, D. E., Shulman, N. S., Wang, D., Khatri, A., Abunimeh, M., Podsadecki, T., & Lawitz, E. (2016). Efficacy of Direct-Acting Antiviral Combination for Patients with Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease. Gastroenterology, 150(7), 1590-1598. https://doi.org/10.1053/j.gastro.2016.02.078