Case Study : FDA approves Zepatier

The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.
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.

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 is marketed by Merck & Co. Inc. based in Whitehouse Station, New Jersey.