Direct-Acting Antivirals Approved for Children 12+ With HCV
Sofosbuvir, ledipasvir previously approved only for adults with hepatitis C virus infection
MONDAY, April 10, 2017 (HealthDay News) -- The U.S. Food and Drug Administration has approved two drugs to treat hepatitis C virus (HCV) infection in children aged 12 and older.
Sovaldi (sofosbuvir) and Harvoni (ledipasvir, sofosbuvir) are the first direct-acting antiviral treatments approved for children and adolescents with HCV, the agency said in a news release Friday.
The two approvals provide pediatric treatment options for six major genotypes of HCV: Harvoni is indicated for the treatment of pediatric patients ≥12 years or weighing ≥35 kg with HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with mild cirrhosis. Sovaldi in combination with ribavirin is indicated for the treatment of pediatric patients ≥12 years or weighing ≥35 kg with HCV genotype 2 or 3 infection without cirrhosis or with mild cirrhosis.
In clinical studies, the most common side effects of both drugs were fatigue and headache. Health care professionals should screen all patients for evidence of current or prior hepatitis B virus infection before starting treatment with Harvoni or Sovaldi, the agency advised.
"These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents," Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement.
Harvoni and Sovaldi are marketed by Gilead Sciences, in Foster City, Calif.