- The approval follows the clinical study results assessing Mavyret (glecaprevir & pibrentasvir) in 47 children aged 12-17 yrs. with genotype 1, 2, 3 or 4 HCV infection without/mild Cirrhosis resulted in no virus detection @12wks. after receiving Mavyret for 8/16wks.
- The study assessing Mavyret in pediatric patients with cirrhosis/history of a kidney or liver transplant/genotype 5 or 6 HCV infection, safety & efficacy follows the clinical study conducted in adults in 2017
- Mavyret is an oral combination therapy of glecaprevir (ABT-493, broad-genotypic NS3/4A protease inhibitor) and pibrentasvir (ABT-530, NS5A inhibitor) and has received FDA’s PR & BT designation for HCV in adults
Click here to read full press release/ article | Ref: The US FDA | Image: Cystic Fibrosis News Today