It is now available a new and the first direct-acting antiviral hepatitis C virus (HCV) treatment for children and adolescents aged 12 to 17. It is the supplemental application for sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni). According to Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, the new HCV treatment will meet the needs of children.

Treatment indications

Harvoni:

  • Pediatric patients 12 years and older or weighing at least 77 pounds
  • HCV genotype 1, 4, 5, or 6 infection without cirrhosis or mild cirrhosis

Sovaldi plus ribavirin:

  • Pediatric patients 12 years and older or weighing at least 77 pounds
  • HCV genotype 2 or 3 infection without cirrhosis or with mild cirrhosis

The clinical trials included 100 children 12 years and older and examined Harvoni’s safety and effectiveness for the treatment of HCV genotype 1.  The results were equivalent to those detected in adults. After the treatment, the virus was no longer detected in 98% of patients. Headache and fatigue are the common adverse events (AE) with Harvoni.

Call the expert pharmacists at Saf-T Drugs for advice on Hep C in children. They are your go-to pharmacists for specialty medications made-to-order for your specific needs.