ZEPATIER^®▼ (elbasvir/grazoprevir)

DDIs and dosing simplicity

ZEPATIER can be used with the following drugs without clinically significant interactions or dose adjustments^2,3

Other categories without clinically significant interactions or dose adjustments include: antiarrhythmics (digoxin), antidepressants*, beta blockers, gastric acid suppressants (H2-receptor antagonist (famotidine), Proton Pump Inhibitor (pantoprazole), antacids), HBV and HIV NRTIs, HIV NNRTIs (rilpivirine), HIV integrase inhibitors (raltegravir and dolutegravir), HCV antivirals (sofosbuvir and ribavirin), immunosuppressants (prednisone, mycophenolate mofetil, tacrolimus**), phosphate binders (calcium acetate, sevelamer carbonate) and statins^† (pitavastatin, pravastatin).

Please consult the ZEPATIER SmPC before prescribing.²

*Coadministration has not been studied with mianserin, which is metabolised by CYPs 2D6 and 1A2, and to a lesser extent by CYP3A4. Grazoprevir is a weak CYP3A4 inhibitor. The clinical significance of any potential interaction is unknown³

**Frequent monitoring of tacrolimus whole blood concentrations, changes in renal function, and tacrolimus-associated adverse events is recommended upon the initiation of coadministration with ZEPATIER²

^†Other statins (HMG-CoA reductase inhibitors) - use low dose when concomitantly given with ZEPATIER²

Glucose levels of diabetic patients initiating DAA therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary

Dosing simplicity²

• One tablet once daily²
• With or without food²
• Blister pack with named days²
• 12 weeks without ribavirin for the majority of G1 + G4 patients²

*Not actual size*

Recommended ZEPATIER therapy for treatment of chronic Hepatitis C Infection in patients with or without compensated cirrhosis (Child-Pugh A only)²

Adapted from ZEPATIER Summary of Product Characteristics²

In the clinical studies, the dose of ribavirin was weight-based (<66 kg = 800 mg/day, 66 to 80 kg = 1,000 mg/day, 81 to 105 kg = 1,200 mg/day, >105 kg = 1,400 mg/day) administered in two divided doses with food.²

• Consider 16-week ZEPATIER treatment with ribavirin for G1a patients with baseline HCV RNA level >800,000 IU/ml and/or the presence of specific NS5A polymorphisms causing at least a 5-fold reduction in activity of elbasvir to minimise the risk of treatment failure²
• ZEPATIER for 16 weeks plus RBV should be considered in G4 patients with baseline HCV RNA level >800,000 IU/ml to minimise the risk of treatment failure²

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 treatment.⁴

Related content

References

1. Höner zu Siederdissen C, Maasoumy B, Marra F, et al. Drug-drug interactions with novel all oral interferon-free antiviral agents in a large real-world cohort. Clin Infect Dis. 2016;62:561–567.
2. ZEPATIER Summary of Product Characteristics.
3. Liverpool Drug Interactions Group, University of Liverpool. HCV directly acting antivirals & RBV. https://liverpool-hiv-hep.s3.amazonaws.com/prescribing_resources/pdfs/000/000/016/original/HCVChart_2019_2%28Apr%29.pdf?1556015400. Charts revised April 2019.
4. 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-00104 | Date of Preparation: June 2019