Zepatier (elbasvir and grazoprevir)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved January 2016

Specific Treatments:

chronic HCV genotypes 1 or 4

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General Information

Zepatier is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor.

Zepatier is specifically indicated with or without ribavirin for the treatment of chronic HCV genotypes 1 or 4 infection in adults.

Zepatier is supplied as a tablet for oral administration. Recommended dosage: One tablet taken orally once daily with or without food. Please see drug label for dosage regimens and durations for patients with Genotype 1 or 4 HCV with or without cirrhosis.

Clinical Results

FDA Approval

The FDA approval of Zepatier was based on six studies in 1,373 patients with chronic HCV GT1 or GT4 infection. These studies assessed the rate of sustained virologic response 12 weeks after the completion of treatment with Zepatier (SVR12). The clinical development program for Zepatier enrolled diverse groups of HCV GT1- and GT4-infected patients, including treatment-naïve patients and those who had failed prior therapy with peginterferon alfa (PegIFN) and RBV, as well as patients suffering with meaningful co-morbidities and health complications, such as compensated cirrhosis and HIV-1 co-infection. GT1-infected patients with severe renal impairment on hemodialysis and those who previously failed therapy with PegIFN and RBV in combination with an HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir) also were studied. Across the studies, subjects receiving Zepatier achieved high rates of sustained virologic response ranging from 94 to 97 percent in GT1-infected patients, and 97 to 100 percent in GT4-infected patients. Sustained virologic response is defined as HCV RNA levels measuring less than the lower limit of quantification at 12 weeks after the cessation of treatment (SVR12), indicating that a patient's HCV infection has been cured.

Side Effects

Adverse effects associated with the use of Zepatier may include, but are not limited to, the following:

  • fatigue
  • headache
  • nausea
  • anemia

Mechanism of Action

Zepatier is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor.

Literature References

For additional information regarding Zepatier or chronic HCV genotype 1 or 4, please visit https://www.zepatier.com/