Ombitasvir/Paritaprevir/Ritonavir in Patients With HCV and Advanced Kidney Disease

Treatment with ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) ± dasabuvir (DSV) ± ribavirin (RBV) is well tolerated and provides a high sustained virologic response at posttreatment week 12 (SVR12) in patients with hepatitis C virus (HCV) genotype (GT) 1 or 4 infection and stage 4 or 5 chronic kidney disease (CKD), according to two phase 3, open-label, multicenter studies published in Kidney International Reports.¹

HCV is a risk factor for progression to end-stage renal disease (ESRD), and patients with ESRD also have a much higher incidence of HCV infection than the general population.^2-4 While few direct-acting antiviral (DAA) regimens can be administered to patients with severe renal insufficiency,^5,6 the DAA combination of OBV/PTV/r ± DSV contains 4 components that are eliminated via biliary excretion or are metabolized with minimal renal excretion.⁷ Researchers conducted 2 studies in which 1 study enrolled treatment-naïve or –experienced patients with HCV GT1a or 1b infection, with or without cirrhosis, to receive 12 weeks (24 weeks for GT1a patients with cirrhosis) of OBV/PTV/r + DSV.¹ In addition, all GT1a patients received RBV.

In the second study, researchers enrolled treatment-naïve patients without cirrhosis to receive 12 weeks of RBV-free treatment; patients with GT1a infection received OBV/PTV/r + DSV while GT4-infected patients received OBV/PTV/r. Sixty-six patients were enrolled overall in both studies, including 50 (76%) on dialysis and 15 (23%) had compensated cirrhosis. They found the overall SVR12 rate to be 95% (63/66) with 1 patient having virologic failure; 3 patients discontinued the study due to adverse events; and 73% (27/37) of patients receiving RBV had adverse events that required RBV dose modification.   

The authors concluded that, “these findings confirm the suitability of OBV/PTV/r ± DSV ± RBV as an [interferon] IFN-free DAA therapy for HCV-infected patients with ESRD, including those with compensated cirrhosis.”¹

References

1. Lawitz E, Gane E, Cohen E, et al. Efficacy and safety of ombitasvir/paritaprevir/ritonavir in patients with hepatitis C virus genotype 1 or 4 infection and advanced kidney disease. Kidney Int Rep. 2019;4:257-266.
2. Okoh EJ, Bucci JR, Simon JF, Harrison SA. HCV in patients with end-stage renal disease. Am J Gastroenterol. 2008;103:2123-2134.
3. Lee JJ, Lin MY, Chang JS, et al. Hepatitis C virus infection increases risk of developing end-stage renal disease using competing risk analysis. PLoS One. 2014;9:e100790.
4. Liu CH, Kao JH. Treatment of hepatitis C virus infection in patients with end-stage renal disease. J Gastroenterol Hepatol. 2011;26:228-239.
5. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2018. J Hepatol. 2018;69:461-511.
6. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org/. Updated May 24, 2018. Accessed July 23, 2018.
7. Viekira pak (ombitasvir, paritaprevir, and ritonavir tablets, dasabuvir tablets), co-packaged for oral use. [prescribing information]. North Chicago, IL: AbbVie Inc.; revised 11/2017.