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FDA expands use of Gilead's liver drug to rare subset of patients
February 16, 2016 / 3:01 PM / 2 years ago

FDA expands use of Gilead's liver drug to rare subset of patients

(Reuters) - The U.S. Food and Drug Administration has expanded the use of Gilead Sciences Inc’s blockbuster drug Harvoni to some hepatitis C patients in the advanced stage of cirrhosis, including those who have undergone liver transplant.

A view shows the U.S. Food and Drug Administration (FDA) logo at the lobby of its headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

Chronic hepatitis C patients often develop scarring and poor liver function also known as cirrhosis, which can lead to complications such as bleeding, jaundice, fluid accumulation in the abdomen and liver cancer.

The once-daily pill, used in combination with antiviral ribavirin, was also approved to treat gentotype 1 and 4 liver transplant recipients with compensated cirrhosis, a slightly less severe form of the condition.

AbbVie Inc had identified cases of hepatic decompensation and liver failure in patients with liver cirrhosis who were taking its medicines Viekira Pak and Technivie, the FDA said in October.

Harvoni had $13.86 billion worldwide sales in 2015.

Reporting by Amrutha Penumudi in Bengaluru; Editing by Don Sebastian

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