Gilead’s Vosevi receives FDA approval for re-treatment of chronic HCV
The US Food and Drug Administration (FDA) has approved biotechnology company Gilead Sciences’ Vosevi (sofosbuvir at 400mg / velpatasvir at 100mg / voxilaprevir at 100mg) tablets for the re-treatment of chronic hepatitis C virus (HCV) infection.
Vosevi is a single-tablet regimen that can be used to treat HCV infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.
Gilead Sciences president and chief executive officer Dr 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.”
The FDA approval is based on results derived from the Phase III POLARIS-1 and POLARIS-4 trials, which studied 12 weeks of Vosevi in direct-acting, antiviral-experienced, chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
Vosevi comes with a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV / HBV coinfected patients.
The most common adverse events among HCV patients who were treated with Vosevi were headache, fatigue, diarrhoea and nausea.
Image: Electron micrographs of hepatitis C virus purified from cell culture. Photo: courtesy of HCV_pictures / Wikimedia.