FDA approves sofosbuvir/ledipasvir and sofosbuvir for children aged 12 to 17
FDA HIV update
On 7 April 2017 the FDA approved supplemental applications for ledipasvir/sofosbuvir and sofosbuvir to treat hepatitis C virus (HCV) in children ages 12 to 17 or weighing at least 35 kilograms.
These approvals provide pediatric treatment options for six major genotypes of HCV using the standard adult dose.
Sofosbuvir/ledipasvir is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with HCV genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis.
Sofosbuvir in combination with ribavirin is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with genotype 2 or 3 HCV infection without cirrhosis or with compensated cirrhosis
For full details of paediatric use including label changes please see the updated labels at drugs@fda or DailyMed.
Both ledipasvir/sofosbuvir and sofosbuvir are manufactured and marketed by Gilead Sciences with the trade names Harvoni and Sovaldi respectively.
FDA HIV email update. FDA approves two Hepatitis C drugs for paediatric patients. (7 April 2017).