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FDA approves AbbVie's Mavyret for children with Hepatitis C (HCV)

Published on 01/05/19 at 10:52am

The FDA has approved AbbVie’s Mavyret tables (glecaprevir/pibrentasvir) as a treatment for hepatitis C (HCV) in children aged 12 to 17 years old.

AbbVie’s two drug combo tablets have been approved as a treatment for all six genotypes of HCV in children. The combination of glecaprevir and pibrentasvir was approved for adults in 2017.

“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” said Dr Jeffrey Murray, deputy director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research.

“Today's approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”

Children born to HCV-positive mothers are at risk of HCV infection. It is estimated that between 23,000 and 46,000 children are infected with HCV in the United States.

A trial of 47 patients found 100% of patients who received Mavyret had no virus detected in their blood 12 weeks after finishing treatment. The most common adverse reactions were headache and fatigue.

Louis Goss

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