Hepatitis C

FDA Approves New Options for Pediatric Patients With Hepatitis C

The FDA has approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 to 17 years old.

The 2 drugs, previously approved for the treatment of HCV in adults, are the first direct-acting antiviral treatments approved for use in children with HCV.
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Between the 2 drugs, coverage is provided for 6 strains of HCV:

  • Harvoni is indicated for treatment of patients 12 years or older weighing at least 77 pounds with HCV genotype 1, 4, 5, or 6 without cirrhosis or with mild cirrhosis.
  • Sovaldi, in combination with ribavirin, is indicated for treatment of patients 12 years or older weighing at least 77 pounds with genotype 2 or 3 without cirrhosis or with mild cirrhosis.

The most common adverse reactions associated with Harvoni and with Sovaldi in combination with ribavirin are fatigue and headache.

—Michael Potts

Reference:

FDA approves two hepatitis C drugs for pediatric patients [press release]. FDA. April 7, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551407.htm.