The US Food and Drug Administration (FDA) has approved the first treatment for all genotypes of hepatitis C in paediatric patients.
The drug, AbbVie’s Mavyret (a glecaprevir and pibrentasvir combination), treats all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17 and was previously approved to treat HCV in adults in 2017.
Mayvret is a direct-acting antiviral drug, which “reduces the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” said Jeffrey Murray, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
The approval "represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV," he added.
The decision is based on clinical trials that evaluated 47 patients with genotype 1, 2, 3, or 4 HCV without cirrhosis or with mild cirrhosis. All 100% of children who received the therapy for either 8 or 16 weeks had no detected virus in their blood samples post-12 weeks, indicating cured infection.
In paediatric patients with cirrhosis, history of a kidney and/or liver transplant, or genotype 5 or 6 HCV infection, the safety and efficacy of Mavyret are supported by previous studies observed in glecaprevir and pibrentasvir in adults.
HCV is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure, affecting an estimated 2.7 to 3.9 million people in the US. It is estimated that there are 23,000 to 46,000 children in the country with HCV infection.