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FDA Approves Sovaldi for Chronic Hepatitis C

Breakthrough drug doesn't need combined interferon

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.

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 reported by patients treated with Sovaldi and ribavirin were fatigue and headache. The most common side effects reported by patients taking Sovaldi, ribavirin, and peginterferon-alfa were fatigue, headache, nausea, insomnia, and anemia.

The drug is marketed by Gilead, based in Foster City, Calif.

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