New Oral Therapy Approved for HCV GT1, GT4 Infection

New Oral Therapy Approved for HCV GT1, GT4 Infection
New Oral Therapy Approved for HCV GT1, GT4 Infection

Merck announced that the Food and Drug Administration (FDA) has approved Zepatier (elbasvir/grazoprevir) tablets for the treatment of adults with chronic hepatitis C virus (HCV) genotype (GT) 1 or 4 infection, with or without ribavirin (RBV).

Zepatier is a once-daily, fixed-dose tablet that combines elbasvir, a NS5A inhibitor, and grazoprevir, a NS3/4A protease inhibitor. 

In clinical studies, Zepatier achieved high rates of sustained virologic response (defined as HCV RNA less than LLOQ at 12 weeks after cessation of treatment) ranging from 94–97% in GT1 infected patients, and 97–100% in GT4 infected patients. Its clinical program included 6 studies (n=1,373) that evaluated the rate of sustained virologic response 12 weeks after treatment completion (SVR12) with Zepatier. Study patients included a diverse range of HCV GT1 and GT4 infected patients, including treatment-naive patients and those who had failed prior therapy with peginterferon alfa (PegIFN) and ribavirin, as well as patients with compensated cirrhosis and HIV-1 co-infection. 

RELATED: Elbasvir/Grazoprevir Ups Health, Well-Being in Chronic HCV

Zepatier was granted priority review by the FDA. It was also given 2 breakthrough therapy designations for the treatment of chronic HCV GT1 infection in patients with end-stage renal disease on hemodialysis, and for the treatment of patients with chronic HCV GT4 infection. 

Zepatier will be available as 50mg/100mg strength tablets in two 14-count dose packs, for a total of 28 tablets. It is anticipated to start shipping within 7 business days. 

For more information call (877) 888-4231 or visit Zepatier.com.


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