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Gastroenterology
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FDA Approves Epclusa for Pediatric HCV

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The US Food and Drug Administration has approved Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis. Epclusa in combination with ribavirin is indicated for the treatment of pediatric patients 6 years and older or weighing at least 37 pounds with severe cirrhosis.

Epclusa was previously approved by the FDA to treat HCV in adults.

“This approval will provide additional treatment options for children and adolescents with HCV,” said Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research in a press release. “This approval will also be important in settings where there is limited ability for health care professionals to conduct HCV genotype testing.”

Read the full press release here.

 

Source: US Food and Drug Administration

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