Two medications for treating the hepatitis C virus (HCV) have been granted US Food & Drug Administration (FDA) approval for use on children. Sovaldi (sofosbuvir) and Harvoni (ledipasivir and sofosbuvir) are already prescribed to adults but are the first HCV medications given approval for pediatric patient treatment.
HVC is a viral condition causing inflammation of the liver. It may reduce liver function and eventually leads to liver failure if left untreated. Around 3.2 million people in the United States have a chronic hepatitis C infection, according to figures from Centers for Disease Control and Prevention (CDC). However, many are unaware of the condition, with about three-quarters not exhibiting any symptoms. HCV is transmitted through direct contact with infected blood, and babies born to mothers with HCV are particularly at risk. The CDC estimates up to 46,000 children in the United States have HCV.
"These approvals will help change the landscape for HCV treatment," stated Edward Cox M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. Approval for the two Gilead Sciences drugs addressed an "unmet need" in HCV treatment for children and adolescents, he added. This comes just weeks after a report by the National Academies of Sciences, Engineering, and Medicine suggested treating all chronic hepatitis C patients in the US would lead to a 90 percent reduction in infections by 2030. It also forecast that this measure would decrease fatalities by 65 percent over this period.
Sovaldi and Harvoni are direct-acting antiviral treatments and work by preventing the virus from multiplying. In the majority of cases, they offer a successful cure to the condition. The latest FDA approval means the drugs may now be prescribed to treat patients between the ages of 12 and 17. The results of a clinical trial of pediatric patients revealed 98 percent of patients were cured following a 12-week course of treatment. The most common side effects of both Sovaldi with ribavirin were fatigue and headaches.
Other drugs commonly used to treat hepatitis C include nucleoside analogue antivirals such as Rebetol (ribasphere, ribavirin) and protease inhibitors such as Zepatier (elbasvir, grazoprevir). A vaccination against HCV is also available.
