Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy.
Just as one probably errant drug safety rumor was being debunked at Vertex, the FDA triggered a real alarm on a trio of prominent hep C drugs now linked with a lethal liver reaction.
The Food and Drug Administration (FDA) has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. All these medicines contain a hepatitis C virus (HCV) protease inhibitor and are not indicated for use in patients with moderate to severe liver impairment. In most patients, symptoms resolved or new onset worsening of liver function improved after stopping the medicine. These medicines have been widely used and are safe and effective in patients with no or mild liver impairment.
The Food and Drug Administration identified dozens of cases in which patients who weren't supposed to take a newer kind a hepatitis C medication did, and then got sicker, leading the agency to issue a safety warning Wednesday.