U.S. FDA approves Gilead’s hepatitis C drug for expanded use

(Reuters) – Drugmaker Gilead Sciences Inc said on Thursday the U.S. Food and Drug Administration had approved the expanded use of its blockbuster hepatitis C drug, Harvoni.

The drug can now be used to treat patients with subtypes of chronic hepatitis C virus (HCV) and patients who are co-infected with Human Immunodeficiency Virus (HIV), Gilead said in a statement.

The once-daily pill, used in combination with antiviral ribavirin, was also approved to be used for 12 weeks as an alternate therapy to Harvoni alone, which is used for 24 weeks to treat patients with cirrhosis.

Results from the study showed that about 93 percent of the patients with subtypes of the virus and 96 percent of patients co-infected with HIV showed a sustained response to the virus within 12 weeks of treatment.

Sustained viral response is the term for a successful hepatitis C treatment outcome. It means that hepatitis-C virus is undetectable for 12 or more weeks after the end of treatment.

Gilead’s blockbuster Harvoni was first approved by the FDA in October 2014. The drug had sales of about $3.3 billion in the latest quarter ended Sept 30.

Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure.

Patients with HCV and HIV co-infection represent about 30 percent of the total HIV-infected population in the United States, Gilead says.

Gilead’s shares were little changed in the after-market trading.

(Reporting by Rosmi Shaji in Bengaluru; Editing by Anil D’Silva and Ken Wills)

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