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.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop cirrhosis over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 3 million Americans are infected with HCV, of which genotype 1 is the most common and genotype 4 is one of the least common.
The most common side effects of Zepatier without ribavirin were fatigue, headache and nausea. The most common side effects of Zepatier with ribavirin were anemia and headache.
Zepatier carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants, generally at or after treatment week eight. Liver-related blood tests should be performed prior to starting therapy and at certain times during treatment. Zepatier should not be given to patients with moderate or severe liver impairment.
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.
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.