Regulatory Affairs

FDA approves Gilead’s Vosevi to re-treat HCV infection in adults

PBR Staff Writer Published 19 July 2017

Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for its Vosevi to re-treat adults with chronic hepatitis C virus (HCV) infection.

The approval was granted for Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, which is a single-tablet regimen to re-treat chronic HCV infection in adults.

The approval was based on data from the 3 POLARIS-1 and POLARIS-4 studies, which assessed Vosevi for 12 weeks in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

POLARIS-1 study has assessed Vosevi for 12 weeks in adults with HCV genotype 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen.

POLARIS-4 study has evaluated Vosevi for 12 weeks in adults with HCV genotypes 1a and 3 with or without compensated cirrhosis who had failed prior treatment with a sofosbuvir-containing regimen that did not include an NS5A inhibitor.

According to the company, around 96% patients in two studies treated with Vosevi achieved the primary endpoint of SVR12, which is defined as maintaining undetectable viral load 12 weeks after completing therapy.

Gilead president and CEO John Milligan said: “The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible.

“The approval of Vosevi completes our portfolio by fulfilling the unmet need for an effective regimen for patients who could not be cured, despite prior treatment with certain DAA regimens.”

Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.