FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease

Reports to FDA warn that use of these medicines to treat chronic hepatitis C in patients with moderate/severe liver impairment (LI) has resulted in rare cases of worsening liver function/liver failure. FDA states these medicines are safe and effective in patients with no/mild LI.

In most patients, symptoms resolved or new onset worsening of liver function improved after stopping the medicine All these medicines contain a hepatitis C virus protease inhibitor and are not licensed for use in patients with moderate to severe liver impairment.

 

Vosevi contains sofosbuvir, velpatasvir and voxilaprevir. Zepatier contains elbasvir and grazoprevir. Mavyret (Maviret in UK) contains glecaprevir and pibrentasvir.