Why ZEPATIER – For all stages of CKD
For all stages of CKD
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links
Power to cure* in patients with chronic kidney disease (CKD)
ZEPATIER®▼ (elbasvir/grazoprevir) achieved 99% SVR overall for G1 patients with CKD, with or without cirrhosis1
- No dosage adjustment of ZEPATIER is necessary in patients with mild, moderate or severe renal impairment or who are on dialysis2
- No considerations with phosphate binders2
C-Surfer: A Phase 3, randomised, double-blind, placebo-controlled trial in G1 infected treatment-naïve subjects or those who have failed prior therapy with IFN or PEG-IFN +/- RBV with or without compensated cirrhosis, with chronic kidney disease (stage 4 and 5 including haemodialysis patients). Randomised 1:1 to ZEPATIER for 12 weeks (immediate treatment group; n=122) or placebo (deferred treatment group; n=113). Primary efficacy endpoint was SVR12 after end of therapy. 1
HCV infected patients with severe renal impairment – a difficult to treat population3
- Altered clearances4
- Renal dysfunction may alter renal clearance, impacting elimination of some drugs
- Increased risk and limited data1
- Chronic hepatitis C virus (HCV) infection in patients with Stage 4 or 5 CKD increases the risk of death and renal graft failure
- Patients with chronic HCV and Stage 4 or 5 CKD have been historically underserved due to lack of clinical data supporting HCV treatment for these patients
*Cure defined as cure of HCV infection = sustained virologic response (SVR), the primary endpoint in all studies, was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) (≤15 IU/ml) at 12 weeks after the cessation of treatment6
** In the combined immediate treatment group and intensive pharmacokinetic population
- Roth D, Nelson DR, Bruchfeld A, et al. Grazoprevir plus elbasvir in treatment-naïve and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4–5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015;386:1537–1545.
- ZEPATIER Summary of Product Characteristics.
- Moorman AC et al. Prevalence of Renal Impairment and Associated Conditions Among HCV-Infected Persons in the Chronic Hepatitis Cohort Study (CHeCS). Dig Dis Sci. 2016;61;2087-2093.
- Lea-Henry TN et al. Clinical Pharmacokinetics in Kidney Disease: Fundamental Principles. Clin J Am Soc Nephrol. 2018;13;1085-1095.
- Goodkin DA et al. Mortality, Hospitalization, and Quality of Life among Patients with Hepatitis C Infection on Hemodialisys. Clin J Am Soc Nephrol. 2017;12:287-297.
- European Association for the Study of Liver. J Hepatol. 2018;69;461-511..
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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