| Autor: |
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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Předmět: |
|
| Zdroj: |
Kidney International Reports, Vol 4, Iss 2, Pp 257-266 (2019) |
| Druh dokumentu: |
article |
| ISSN: |
2468-0249 |
| DOI: |
10.1016/j.ekir.2018.10.003 |
| Popis: |
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. Keywords: chronic kidney disease, NS5A inhibitor, NS3/4A protease inhibitor, renal disease, RUBY |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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