Gilead has announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for patients as young as six for the treatment of chronic hepatitis C.
The indication is for those weighing at least 17 kg, regardless of HCV genotype or liver disease severity, with the recommended dosage of Epclusa in children ages 6 years and older based on weight and liver function.
The decision, based on data from a Phase II, open-label clinical trial means that Epclusa is the first pan-genotypic, protease inhibitor-free regimen approved in the United States for adults and children.
In children 12 to <18 years old, treatment with Epclusa resulted in a cure rate of 93% (71/76) in those with genotype 1 HCV infection and 100% in those with genotype 2 (6/6), genotype 3 (12/12), genotype 4 (2/2) and genotype 6 (6/6) HCV infection.
“While the treatment of HCV has been transformed in recent years, physicians caring for some children have still needed to take several factors into consideration, including genotype and liver disease severity, when selecting the appropriate treatment plan,” said Kathleen B Schwarz, professor of paediatrics, Johns Hopkins University School of Medicine. “The expanded approval of Epclusa can help eligible children living with HCV combat this life-threatening and debilitating disease.”
Gilead reminds that in the United States, there are approximately 23,000-46,000 children living with HCV. Children born to mothers with HCV are a growing concern, increasing in prevalence by 60% from 2011 to 2014.