1. Aschenbrenner, Diane S. MS, RN


* Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) are now approved to treat hepatitis C virus genotypes 1 through 6 in pediatric patients ages 12 to 17.



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Two direct-acting antivirals used in the treatment of hepatitis C virus (HCV), Sovaldi (sofosbuvir) and Harvoni (a combination of ledipasvir and sofosbuvir), are now approved by the Food and Drug Administration (FDA) for use in pediatric patients ages 12 to 17. The drugs were previously approved to treat HCV in adults.


Infants born to HCV-positive mothers are at risk for contracting HCV. Adolescents are also at risk for HCV if they abuse injection drugs and use contaminated needles. Direct-acting antivirals prevent HCV from multiplying and, in most cases, cure the virus.


Sovaldi and Harvoni provide treatment for six of the major HCV genotypes. Sovaldi is used in combination with ribavirin (Rebetol and others) for genotype 2 and 3 infections. Harvoni is used to treat genotype 1, 4, 5, and 6 infections. Both drugs are indicated for adolescents ages 12 and older or weighing at least 77 pounds (35 kilograms). Neither drug should be used if the patient has cirrhosis. Open-label trials in adolescents found that these drugs cleared HCV infection, similar results to those of clinical trials in adults.


Because HCV direct-acting antivirals have been associated with reactivation of hepatitis B virus (HBV) in adults, adolescents should be screened for current or prior HBV infection prior to starting treatment with either Sovaldi or Harvoni. The FDA news release regarding the approval of both drugs can be found at