Drugs in Development – Children
The study included 100 adolescents aged 12 to 17 years old treated with ledipasiv/sofosbuvir that is being conducted in the U.S., U.K and Australia at 24 sites. There were 100 adolescents- male (37%); white (90%), genotype 1a (81%); all but one were non-cirrhotic; the transmission route was mostly mother-to-child (84%).
The overall cure rate was 97%. Three patients were lost to follow-up. More than 10% of the adolescents experienced the following side effects: headache, diarrhea, fatigue, nausea, cough, throat pain, and vomiting.
The study is on-going and includes children aged 3 to under 12 years of age.
This is an important study. The current standard of care for the treatment of children with chronic hepatitis C is the combination of pegylated interferon plus ribavirin. Most medical providers are reluctant to treat children with this combination unless a child has severe HCV disease progression. Hopefully, this trial will be completed soon and FDA will expedite the approval.