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The approval of sofosbuvir and velpatasvir comes after a multicenter clinical trial confirmed the safety and efficacy of the treatment.
The US Food and Drug Administration (FDA) has approved a supplemental application for sofosbuvir and velpatasvir (Epclusa) to treat hepatitis C virus (HCV) in children.
The approval will give additional treatment options for children >6 years old or for those who weigh >37 pounds with any of the 6 HCV strains, Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement.
The agency approved the treatment following an open-label, multicenter clinical trial to test the safety, efficacy, and pharmacokinetics of the combination therapy to treat HCV genotypes 1-4 or 6.
Investigators enrolled 173 treatment-naïve and treatment-experienced pediatric patients who were >6 years old without cirrhosis or with mild cirrhosis. The team saw no meaningful differences in pediatric patients compared with adults.
Safety and efficacy were comparable to those observed in adults. Among 102 patients 12-17 years old, 93% of patients with genotype 1 and 100% of those with genotypes 2-4 and 6 had no detectable virus in their blood 12 weeks after finishing the twelve-week treatment. Of the 71 children ages 6-11 years old with HCV genotypes 104, 93% with genotype 1, 91% with genotype 3, and 100% with genotypes 2 and 4 had no virus detected 12 weeks after finishing treatment.
The results suggested that the patients’ infection was cured.
Adverse effects of the combination therapy included fatigue and headache, on par with reactions observed in clinical trials of the treatment in adults.
The FDA approval could be important in settings where there is limited ability for providers to conduct HCV genotype testing, Birnkrant said.
The agency has already approved sofosbuvir and velpatasvir to treat adults with HCV.