FDA Approves Two HCV Medications for Children

The US Food and Drug Administration (FDA) has approved Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir) for the treatment of the hepatitis C virus (HCV) in children ages 12 to 17. Both Harvoni and Sovaldi were already approved to treat hepatitis C in adults. These drugs are the first direct-acting antiviral (DAA) treatments approved for children with HCV.1

Harvoni is indicated for the treatment of children with HCV genotype 1, 4, 5, or 6 without cirrhosis or with mild cirrhosis. Sovaldi is indicated for children with HCV genotype 2 or 3 without cirrhosis or with mild cirrhosis.2 Both Harvoni and Sovaldi are marketed by Gilead Sciences, Inc.

Addressing an Unmet Need

“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” remarked Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research

The approvals of these treatments are supported by clinical trial data, which showed safety and efficacy of the treatments, comparable to what has been observed in adults. In two open-label clinical trials, more than 97% of participants were able to clear the virus after 12 weeks of treatment and remained clear in 12 weeks follow-up, which is a sustained virologic response (SVR) regarded as a cure.3 The most common adverse reactions reported were fatigue and headache.

Hepatitis C in Children and Adolescents

According to the CDC, there are an estimated 23,000 to 46,000 children in the US with chronic hepatitis C, most of whom were infected at birth. About 6% of infants born to mothers with hepatitis C will become infected with HCV. The risk of contracting HCV at birth is greater if the mother is infected with both HCV and HIV. Most infants who are infected with hepatitis C at birth have no symptoms of the virus.

Many babies are able to clear the virus on their own and will not develop chronic HCV infection. Babies are not usually tested for hepatitis C, and when they are, testing does not occur until they have reached 18 months of age. If the baby tests positive for HCV antibodies at 18 months, more tests are needed to confirm. If hepatitis C infection is suspected and testing is required before 18 months, HCV RNA testing can be performed at the baby’s first well visit, usually 1-2 months after birth.4

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