Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir With or Without Ribavirin in Patients With Kidney Disease

David E. Bernstein, Albert Tran, Paul Martin, Kris V. Kowdley, Marc Bourliere, Mark S. Sulkowski, Paul J. Pockros, Boris Renjifo, Deli Wang, Diana L. Shuster, Daniel E. Cohen, Ira M. Jacobson

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

Introduction: Patients with hepatitis C virus (HCV) infection and chronic kidney disease (CKD) are a high-priority population for treatment. Methods: We performed a post hoc pooled efficacy and safety analysis that included HCV genotype 1–infected patients with compensated liver disease and CKD stages 1 to 3 who received the all-oral 3–direct-acting antiviral regimen of ombitasvir, paritaprevir, ritonavir, and dasabuvir ± ribavirin (OBV/PTV/r + DSV ± RBV) in 11 phase 3 clinical trials. Sustained virologic response rates at posttreatment week 12 (SVR12) and treatment-related adverse events (AEs), serious AEs, and renal-associated AEs are reported. Mean changes from baseline in serum creatinine and estimated glomerular filtration rate (eGFR) were calculated to assess changes in renal function. Factors associated with improved eGFR were assessed by stepwise logistic regression analysis of data from 7 trials in which baseline urinalysis was collected. Results: SVR12 rates in patients with stage 1, 2, and 3 CKD were 97% (439/453), 98% (536/547), and 97% (32/33), respectively, with OBV/PTV/r + DSV; and, 96% (1172/1221), 96% (1208/1254), and 93% (55/59), respectively, with OBV/PTV/r + DSV + RBV. Overall rates of serious AEs and renal AEs were 3% (95/3567) and 2% (56/3567), respectively. Factors associated with an eGFR increase of ≥10 ml/min per 1.73 m 2 were baseline proteinuria, body mass index, nonblack race, and history of diabetes. Conclusion: OBV/PTV/r + DSV ± RBV achieved high SVR rates and was generally well tolerated irrespective of CKD stage.

Original languageEnglish (US)
Pages (from-to)245-256
Number of pages12
JournalKidney International Reports
Volume4
Issue number2
DOIs
StatePublished - Feb 2019

Keywords

  • chronic hepatitis C
  • chronic kidney disease
  • direct-acting antiviral
  • hepatitis C virus

ASJC Scopus subject areas

  • Ophthalmology
  • Nephrology

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