FDA approves first direct-acting antivirals for adolescents with hepatitis C

The US Food and Drug Administration (FDA), which is responsible for evaluating the safety and efficacy of medicines in the United States, has approved Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C in adolescents aged 12–17 years. The drugs are the first direct-acting antiviral treatments to be approved for treating this age group.

“These approvals will help change the landscape for hepatitis C treatment by addressing an unmet need in children and adolescents,” says Edward Cox, director of the Office of Antimicrobial Products, FDA Center for Drug Evaluation and Research.

The two treatments, which are already approved for use in adults, cover six major strains of hepatitis C. Harvoni is indicated for the treatment of infections with hepatitis C strains 1, 4, 5 or 6, while Sovaldi is recommended for treatment of strains 2 or 3.

The safety and efficacy of Harvoni use in adolescents was established in an open-label, multicentre clinical trial comprising 100 patients aged 12 years or over and weighing at least 35kg. The results were comparable to those seen in adults and 98% of the patients were found to be virus-free 12 weeks after finishing treatment.

Sovaldi was assessed in an open-label clinical trial comprising 50 patients aged 12 years or over and weighing at least 35kg. Again, the results were comparable with those of adults, and 12 weeks after finishing treatment 100% of patients with hepatitis C strain 2, and 97% with strain 3, were virus-free.

The most common side effects of both drugs were fatigue and headache.