The FDA has approved the use of Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) and Sovaldi to treat hepatitis C virus (HCV) in 12- to 17-year-olds, MedPage Today reports. This is the first approval of direct-acting antivirals (DAAs) to treat hep C among the pediatric population.
Harvoni and Sovaldi are both already approved for adult use.
According to the Centers for Disease Control and Prevention, an estimated 23,000 to 46,000 children are living with hep C in the United States, most of whom contracted the virus from their mothers at birth.
The Harvoni approval was for those age 12 and older who weigh at least 77 pounds, have hep C genotypes 1, 4, 5 or 6 and have no greater liver damage than mild cirrhosis. Sovaldi plus ribavirin was approved for those with genotypes 2 and 3 who otherwise fit this profile.
The approval for Harvoni among those with genotype 1 is based on an open-label multicenter trial of 100 pediatric participants age 12 and older. Ninety-eight percent achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), a result comparable to those seen in adult trials of the therapy. The study also found that the children processed the drug similarly to adults.
Another study of Harvoni among children in this age group who had genotypes 4, 5 or 6 also saw similar success rates and similar drug levels in the body compared with those seen in adult trials.
An open-label clinical trial gave Sovaldi plus ribavirin to 50 participants in the same age group and also saw comparable success rates to those seen in adult trials. All of those with genotype 2 and 97 percent of those with genotype 3 were cured.
The most common side effects linked with Harvoni were fatigue, headache and weakness or lack of energy (known as asthenia). The most common side effects associated with Sovaldi plus ribavirin were fatigue, headache and nausea.
In its announcement about the approval, the FDA stressed that adults who are coinfected with HCV and hepatitis B virus have experienced reactivation of HBV during or after treatment with DAA treatment for hep C. This effect can lead to serious liver damage or death.
To read the MedPage Today article, click here.
To read an FDA press release on the approval, click here.