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Chronic hepatitis C (HCV) is a life-threatening virus that affects thousands of Children in Europe and, if left untreated, can lead to serious liver complications, including liver cancer.
European Commission (EC) has expanded Gilead's Epclusa (sofosbuvir / velpatasvir / sofosbuvir) sales license to treat children with chronic hepatitis C (HCV).
Phase II clinical data show that among children aged 12 to 18, Epclusa has a 93% cure rate for people infected with genotype 1 HCV and 100% for patients with genotypes 2, 3, 4 and 6.
in children between the ages of 6 and 12, the SVR rate for people infected with genotype 1 HCV was 93%, the SVR rate for people infected with gene 3 HCV was 91%, and the SVR rate for people infected with type 2 and 4 HCV was 100%.
safety profiles in children 6 years of age and older are basically consistent with 2007 safety profiles observed in adult clinical trials.
in adults, the most common adverse reactions (the rate of occurrence is 10% or more) are headaches and fatigue.
Gilead said Epclusa's approval simplifies current treatment options for people with full genotype HCV infection, minimizing the time from diagnosis to cure.
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