Current Edition

EU OKs paediatric use of Gilead’s Epclusa

The European Commission (EC) has expanded marketing authorisation for Gilead’s Epclusa (sofosbuvir/velpatasvir/sofosbuvir) to include the treatment of children with chronic hepatitis C infection (HCV).

HCV is a life-threatening virus impacting thousands of children in Europe, which, if left untreated, can lead to severe liver complications, including liver cancer.

The decision allows use of the therapy in the EU in children as young as six years of age and weighing at least 17kg, regardless of HCV genotype or liver disease severity.

It follows Phase II clinical data showing that, in children 12 to <18 years old, treatment with Epclusa resulted in a cure rate of 93% in those with genotype 1 HCV infection and 100% in those with genotypes 2, 3, 4 and 6.

In children 6 to <12 years old, the SVR rate was 93% in those with genotype 1 HCV infection, 91% in those with genotype 3 HCV infection, and 100% in those with genotypes 2 and 4.

The safety profile of Epclusa in children six years of age and older treated was generally consistent with that observed in clinical trials in adults, in which the most common adverse reactions (incidence greater than or equal to 10%) are headache and fatigue, the firm noted.

The approval of Epclusa simplifies the selection of appropriate treatment as this pan-genotypic, pan-fibrotic regimen removes the need for some pre-treatment assessments, minimising the time from diagnosis to treatment initiation and cure, said a company spokesperson.