Posted by Michael Wonder on 26 Sep 2019
FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks
26 September 2019 - The U.S. FDA today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment naïve).
Mavyret is now the first eight-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.
The efficacy and safety of Mavyret was established in clinical trials, which cumulatively evaluated more than 2,500 people with HCV genotype 1, 2, 3, 4, 5 or 6 infection who received Mavyret for eight, 12 or 16 weeks duration. The trials included patients with HIV-co-infection, kidney or liver transplant recipients and patients with advanced kidney disease, including those requiring haemodialysis.
