FDA Approvals Sovaldi Approved for Chronic Hepatitis C -- Scott Roberts

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MONDAY, Dec. 9, 2013 (HealthDay News) -- Sovaldi (sofosbuvir) has been approved by the U.S. Food and Drug Administration to treat chronic infection with Hepatitis C. It's considered a breakthrough medication since it's the first such drug that does not require same-time administration of interferon, the agency said in a news release.

Infection with the hepatitis C virus causes liver inflammation that can lead to liver failure. Most infected people have no symptoms for years until the onset of liver failure, the FDA said. Complications may include a yellowing of the eyes and skin called jaundice, liver cancer, bleeding or fluid accumulation in the abdomen. Some 3.2 million Americans are infected with hepatitis C, the agency said.

Sovaldi is designed to inhibit a protein that the virus needs to replicate. The drug's safety and effectiveness were evaluated in clinical studies involving 1,947 people who hadn't responded to other hepatitis C treatments, who hadn't been treated previously, or who couldn't tolerate the standard treatment of interferon, the FDA said.

The most common side effects of Sovaldi included fatigue and headache. The drug is marketed by Gilead, based in Foster City, Calif.

More information

The National Library of Medicine has more about hepatitis C.

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