Pediatric Labeling Changes for Sovaldi and Harvoni

FDA says it recently approved changes to Gilead’s Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) labeling to include new dosage forms and use in pediatric patients three years of age to less than 12 years of age. An online post summarizes the changes for each product.

Sovaldi is now indicated for treating chronic hepatitis C virus genotype 2 or 3 infection in pediatric patients three years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

Harvoni is indicated for treating adult and pediatric patients three years of age and older with chronic hepatitis C virus genotype 1, 4, 5, 6 infection without cirrhosis or with compensated cirrhosis; genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin; and genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhoisis, for use in combination with ribavirin.