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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

ZEPATIER® (elbasvir/grazoprevir)

For all stages of CKD

Updated on 18/06/2019

HEPATITIS C

Power to cure* in patients with Chronic Kidney Disease (CKD)1

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ZEPATIER®▼ (elbasvir/grazoprevir) achieved 99% SVR overall for G1 patients with CKD, with or without cirrhosis1

ZEPATIER 99% SVR image
  • 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 study design

HCV infected patients with severe renal impairment – A difficult to treat population3

Therapeutic challenges

  • 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

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References

  1. 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.
  2. ZEPATIER Summary of Product Characteristics.
  3. 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.
  4. Lea-Henry TN et al. Clinical Pharmacokinetics in Kidney Disease: Fundamental Principles. Clin J Am Soc Nephrol 2018;13;1085-1095.
  5. 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.
  6. European Association for the Study of Liver. J Hepatol 2018;69;461-511.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-ZEP-00103 | Date of Preparation: June 2019