Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir in Patients With Hepatitis C Virus Genotype 1 or 4 Infection and Advanced Kidney Disease

Eric Lawitz, Edward Gane, Eric Cohen, John Vierling, Kosh Agarwal, Tarek Hassanein, Parvez S. Mantry, Paul J. Pockros, Michael Bennett, Nyingi Kemmer, Giuseppe Morelli, Jiuhong Zha, Deli Wang, Nancy S. Shulman, Daniel E. Cohen, K. Rajender Reddy

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

Introduction: Hepatitis C virus (HCV) infection is common in patients with end-stage renal disease. We investigated the safety and efficacy of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) ± dasabuvir (DSV) ± ribavirin (RBV) in 2 phase 3, open-label, multicenter studies in patients with stage 4 or 5 chronic kidney disease (CKD). Methods: RUBY-I, Cohort 2 enrolled treatment-naïve or -experienced patients with HCV genotype (GT) 1a or 1b infection, with or without cirrhosis. Patients received 12 weeks (24 weeks for GT1a patients with cirrhosis) of OBV/PTV/r + DSV; all GT1a patients received RBV. RUBY-II enrolled treatment-naïve patients with GT1a or GT4 infection without cirrhosis. All patients received 12 weeks of RBV-free treatment: OBV/PTV/r + DSV for GT1a-infected patients; OBV/PTV/r for GT4-infected patients. The primary endpoint was sustained virologic response at posttreatment week 12 (SVR12). Results: RUBY-I, Cohort 2 and RUBY-II enrolled 66 patients, including 50 (76%) on dialysis; 15 (23%) had compensated cirrhosis. Overall, the SVR12 rate was 95% (63/66); 1 patient had virologic failure. There were 3 discontinuations due to adverse events. Seventy-three percent (27/37) of patients receiving RBV had adverse events leading to RBV dose modification. The RBV-free RUBY-II study had no hemoglobin-associated adverse events. Conclusion: Treatment with OBV/PTV/r ± DSV ± RBV was well tolerated and patients with HCV GT1 or 4 infection and stage 4 or 5 CKD had high SVR12 rates, including patients with compensated cirrhosis and/or prior treatment experience.

Original languageEnglish (US)
Pages (from-to)257-266
Number of pages10
JournalKidney International Reports
Volume4
Issue number2
DOIs
StatePublished - Feb 2019

Keywords

  • chronic kidney disease
  • NS3/4A protease inhibitor
  • NS5A inhibitor
  • renal disease
  • RUBY

ASJC Scopus subject areas

  • Ophthalmology
  • Nephrology

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    Lawitz, E., Gane, E., Cohen, E., Vierling, J., Agarwal, K., Hassanein, T., Mantry, P. S., Pockros, P. J., Bennett, M., Kemmer, N., Morelli, G., Zha, J., Wang, D., Shulman, N. S., Cohen, D. E., & Reddy, K. R. (2019). Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir in Patients With Hepatitis C Virus Genotype 1 or 4 Infection and Advanced Kidney Disease. Kidney International Reports, 4(2), 257-266. https://doi.org/10.1016/j.ekir.2018.10.003