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. The number of weeks on treatment depends on genotype, previous therapy, and presence of NS5A polymorphisms (mutations that may make the Zepatier less effective). Ribavirin may also be added in patients with certain baseline NS5A polymorphisms. See treatment duration tables at positivelyaware.com/drug-guides/zepatier.

Take missed dose as soon as possible unless it is less than 12 hours until 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, a blood test is recommended to check for hepatitis B (HBV) infection. HBV infection could worsen 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 on page 37 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 145 pounds (66 kg) = 800 mg per day; 146–176 pounds (66–80 kg) = 1,000 mg per day; 177–231 pounds (81–105 kg) = 1,200 mg per day; and greater than 231 pounds (105 kg) = 1,400 mg per day. All are administered in two divided doses with food.

Manufacturer

Merck

AWP

$8,736 / month

Potential Side Effects and Toxicity

Potential Drug Interactions

More Information