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.

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)

• Pharmaceuticals Drug Trials
• Health
• cirrhosis
• Gilead Sciences Inc
• liver cancer
• liver transplant