FDA approves Gilead's drug for chronic hep C patients

Last Updated: 2017-07-18

By Reuters Staff

(Reuters) - Gilead Sciences Inc said on Tuesday that the U.S. Food and Drug Administration approved its hepatitis C drug for patients who had failed to respond to prior treatments.

Vosevi is a fixed-dose combination of sofosbuvir, velpatasvir and voxilaprevir. It is for patients with HCV genotypes 1-6 without cirrhosis or with mild cirrhosis.

Vosevi is the first drug to be approved for hepatitis C patients already treated with sofosbuvir or other drugs, which inhibit the NS5A protein, the FDA said in a release.

�€œDirect-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,�€ Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA�€™s Center for Drug Evaluation and Research, said in a news release.

The safety and efficacy of Vosevi was evaluated in two Phase 3 clinical trials that enrolled approximately 750 adults without cirrhosis or with mild cirrhosis.

Results of both trials demonstrated that 96-97 percent of patients who received Vosevi had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients�€™ infection had been cured.

However, the approval comes with a boxed warning about the risk of hepatitis B virus being reactivated in patients infected with both hepatitis C and hepatitis B.

Hepatitis C causes inflammation of the liver that can lead to diminished organ function or its failure. An estimated 2.7 million to 3.9 million people in the United States have chronic hepatitis C infection, according to the Centers for Disease Control and Prevention.