The US Food and Drug Administration has approved a hepatitis C drug for patients who have not responded to other forms of treatment.
Manufactured by Gilead Sciences Inc., the drug, called Vosevi, is the first to be approved for hepatitis C patients who have already undergone previous treatments like Sovaldi, Reuters reports. The drugs inhibit the protein NS5A.
Vosevi is a combination tablet that contains two other approved drugs, sofosbuvir and velpatasvir, and a new drug called voxilaprevir.
Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said, “Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past.”
The FDA’s green light came from two late-stage studies, which examined the use of the drug in previously treated patients for a span of 12 weeks. Approximately 750 adults took part in the study, some of whom had liver cirrhosis.
However, the FDA approval comes with a warning regarding the risk of hepatitis B being reactivated if patients have both hepatitis B and C.
Gilead has been growing because of its multiple hepatitis C drugs, and had said earlier this year that sales of its high-priced drugs were dropping because fewer patients continue to be seen as eligible for treatment. There has also been more competition as other drug companies have launched their own drugs.
Hepatitis C causes an inflammation of the liver that can lead to damaged organs and failure to function. Between 2.7 to 3.9 million Americans have chronic hepatitis C infections, according to the Centers for Disease Control and Prevention. Patients who suffer from chronic hepatitis C over many years appear jaundiced, and develop medical complications like bleeding, infections, fluid accommodation in the stomach, liver cancer, and even death.
