On January 28, 2016, Food and Drug Administration (FDA) has approved Merck and Co. manufactured Zepatier, a new oral treatment for adult patients with Chronic Hepatitis C (HCV) virus genotype 1 and 4 infections.
Zepatier is a once a day fixed-dose oral combination product containing elbasvir (HCV NS5A inhibitor) and grazoprevir (HCV NS3/4A protease inhibitor) and indicated for use with or without ribavirin, not requiring use of interferon.
Zepatier was granted breakthrough therapy designation for the treatment of chronic HCV genotype 1 infection in patients with end stage renal disease on hemodialysis and for the treatment of chronic HCV genotype 4 infection. Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and have preliminary clinical evidence to indicate that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
The cost of the 12 week therapy is $54,000 which is approximately 40-50% lower than currently existing therapies. EmpiRx Health has added Zepatier to the formularies with Prior Authorization requirements.