Zepatier Approved for Chronic Hepatitis C

FRIDAY, Jan. 29, 2016 (HealthDay News) -- Zepatier (a combination of elbasavir and grazoprevir) has been approved by the U.S. Food and Drug Administration to treat chronic infection with the hepatitis C virus, genotypes 1 and 4.

Hepatitis C causes liver inflammation, which can lead to liver failure. Most infected people have no symptoms until the onset of liver damage, which could take several years, the FDA said in a news release. Possible symptoms include a yellowing of the eyes and skin known as jaundice, bleeding or liver cancer.

Genotype 1 is among the most common forms of hepatitis C, while genotype 4 is among the rarest, the agency said. Some 3 million Americans are believed infected with a form of the virus.

Zepatier, sometimes paired with another antiviral drug, ribavirin, was evaluated in 12-to-16-week clinical studies involving nearly 1,400 people. At the end of the studies, between 94 percent and 100 percent of infected patients had no detected virus in the blood, the FDA said.

The most common side effects of Zepatier included fatigue, headache and nausea. The drug's label includes a boxed warning that it could cause a spike in liver enzymes. As a result, the FDA said blood work should be obtained before starting therapy, and at certain intervals during treatment.

Zepatier should not be given to people with moderate-to-severe liver impairment, the agency added.

The drug is marketed by Merck & Co., based in Whitehouse Station, N.J.

-- Scott Roberts

MedicalNews
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