FDA approves two hepatitis C drugs for pediatric patients- Drug Information Update

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The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.

These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV.

Today’s approvals provide pediatric treatment options for six major genotypes, or strains, of HCV. Harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 77 pounds (35 kilograms) with HCV genotype 1, 4, 5 or 6 infection without cirrhosis (liver disease) or with mild cirrhosis. Sovaldi in combination with ribavirin is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 77 pounds (35 kilograms) with genotype 2 or 3 HCV infection without cirrhosis or with mild cirrhosis.

The most common adverse reactions observed with treatment with Harvoni were fatigue and headache.

The most common adverse events observed with Sovaldi in combination with ribavirin were fatigue and headache. All contraindications to ribavirin also apply to Sovaldi combination therapy.

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines resulted in serious liver problems or death. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi.

For more information please visit: HepatitisCPediatrics