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.
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.