-- Scott Roberts
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
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
The most common side effects of Sovaldi included fatigue and
headache. The drug is marketed by Gilead, based in Foster City,
The National Library of Medicine has more about
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