Globally, between 130–150 million people globally have chronic hepatitis C infection. Approximately 700 000 people die each year from hepatitis C-related liver diseases. Antiviral medicines can cure approximately 90% of persons with hepatitis C infection, thereby reducing the risk of death from liver cancer and cirrhosis, but access to diagnosis and treatment is low. 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.
The U.S. Food and Drug Administration 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. Approval provides another oral treatment option for patients with genotypes 1 and 4 HCV infections without requiring use of interferon.
The overall SVR (sustained virologic response or SVR) rates ranged from 94-97 percent in genotype 1-infected subjects and from 97-100 percent in genotype 4-infected subjects across trials for the approved treatment regimens. In order to maximize SVR rates for patients, the product label provides recommendations regarding length of treatment with or without ribavirin specifically tailored to the characteristics of the patient and their virus. It is recommended that healthcare professionals screen genotype 1a-infected patients for certain viral genetic variations prior to starting treatment with Zepatier to determine dosage regimen and duration.
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 preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
Zepatier is marketed by Merck & Co. Inc. based in Whitehouse Station, New Jersey.