Zepatier

grazoprevir/elbasvir (GZR/EBR)

FDA approved for use in HIV/HCV co-infection
Genotype
  • 1
  • 4

Standard Dose

One tablet once daily with or without food. Each tablet contains 100 mg of grazoprevir and 50 mg of elbasvir. Ribavirin may be added in patients with certain baseline NS5A polymorphisms (mutations that may make the Zepatier less effective).

Zepatier may be used in severe renal impairment, including patients on hemodialysis. NS3/4A protease inhibitors, such as grazoprevir, are contraindicated in patients with moderate or severe liver impairment (Child-Pugh B/C), which is also called decompensated cirrhosis. Using Zepatier in decompensated cirrhosis may cause significantly higher amounts of grazoprevir in the blood and may increase ALT (liver enzyme).

Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.

Black Box Warning

Before starting treatment with any direct-acting antiviral (DAA), including Zepatier, patients should take a blood test to check for hepatitis B (HBV) infection. HBV infection could get worse or reactivate during or after DAA treatment, potentially leading to serious liver problems, including liver failure or death. Patients with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment. See HBV Reactivation for more information and consult your medical provider.

Recommended treatment regimen and duration in persons with HCV genotype 1 or 4

Genotype 1a, treatment-naïve or PegIFN/RBV-experienced* without baseline mutations**

Zepatier for 12 weeks

Genotype 1a, treatment-naïve or PegIFN/RBV-experienced* with baseline mutations**

Zepatier + ribavirin for 16 weeks

Genotype 1b, treatment-naïve or PegIFN/RBV-experienced*

Zepatier for 12 weeks

Genotype 1a or 1b, PegIFN/RBV/PI-experienced***

Zepatier + ribavirin for 12 weeks

Genotype 4, treatment-naïve

Zepatier for 12 weeks

Genotype 4,

PegIFN/RBV-experienced*

Zepatier + ribavirin for 16 weeks

*     Pegylated interferon + ribavirin

**   NS5A polymorphisms at amino acid positions 28, 30, 31, 93

*** Pegylated interferon + ribavirin + NS3/4A protease inhibitor (boceprevir, telaprevir, simeprevir)

NOTES:

Testing for baseline NS5A polymorphisms is not required for

genotype 1b or in patients on hemodialysis.

For patients with CrCl greater than 50 mL per minute, the recommended dosage of ribavirin is weight-based (less than 66 kg = 800 mg per day, 66–80 kg = 1000 mg per day, 81–105 kg = 1200 mg per day, greater than 105 kg = 1400 mg per day) administered in two divided doses with food.

Manufacturer

Merck

AWP

$8,736 / month

Potential Side Effects and Toxicity

Potential Drug Interactions

More Information