FDA approves first two antiviral hep C drugs for paediatric patients

The FDA has given the go-ahead for two hepatitis C treatments for use in young and adolescent patients: Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) – both products of Gilead – making them the first FDA-approved direct-acting antiviral treatments for the illness in children and adolescents.

Both treatments were previously approved for the same indication in adults. They work by inhibiting the virus’ ability to replicate, and in the majority of cases can eradicate it from the body.

Harvoni is approved for use in patients of at least 12 years of age with hepatitis C virus genotype 1, 4, 5 or 6 without cirrhosis or with mild cirrhosis. Sovaldi, in combination with ribavirin, is approved for same indication in genotypes 2 and 3. Edward Cox, Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said the approvals "will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents."

While safety evaluations carried out on the treatments found them to be mostly in-line with the results found in adult patients with corresponding genotypes, the FDA noted reports of hepatitis B virus reactivation in adults coinfected with both B and C strains of the virus. This lead to serious liver damage or even death, and as such the FDA’s approvals carried precautions against this in the new indications.

Currently, there are up to 46,000 children in the United States suffering from hepatitis C infection, while up to 3.9 million as a whole suffer from a chronic of the virus.