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Author Topic: FDA Approves Epclusa to Treat Hep C in Children Ages 6 and Up  (Read 383 times)

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Offline Hep Editors

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    • Hep Mag
The Food and Drug Administration (FDA) has extended its approval of Gilead Sciences’ Epclusa (sofosbuvir/velpatasvir) to allow for treatment of all genotypes of hepatitis C virus (HCV) among children.

The federal agency first approved Epclusa for adults in 2016. The new approval applies to children ages six and older who weigh at least 37 pounds.

Gilead’s application for the pediatric indication was based on an open-label study of 173 children with hep C including those with and without mild cirrhosis of the liver. The children were treated with 12 weeks of Epclusa.

Read more...
https://www.hepmag.com/article/fda-approves-epclusa-treat-hep-c-children-ages-6

 


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