Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said Sovaldi is the first drug with demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. It is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection -- in November, the FDA approved Olysio, or simeprevir.
"Today's approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C," Cox said in a statement.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years.
Some people with chronic HCV infection develop scarring and poor liver function, or cirrhosis, over many years, which can lead to complications such as bleeding, jaundice, fluid accumulation in the abdomen, infections or liver cancer.
Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate and is to be used as a component of a combination anti-viral treatment regimen for chronic HCV infection, Cox said.