HARVONI (sofosbuvir/ledipasvir), direct-acting antiviral

INFECTIOUS DISEASE - New indication

Opinions on drugs - Posted on Jul 18 2018

Extension of indication

High clinical benefit and moderate clinical added value for the treatment of chronic hepatitis C in adolescents aged from 12 to < 18 years.

HARVONI has now been granted a marketing authorisation for the treatment of chronic hepatitis C in adolescents aged from 12 to < 18 years.
The efficacy and safety in adolescents were assessed for the treatment of chronic hepatitis C virus (HCV) genotype 1-related infection with a similar profile to that described in adults. For genotypes 3, 4, 5 and 6, the marketing authorisation is extrapolated from the clinical data obtained on HCV genotype 1 and clinical feedback in adults.
It is a first-line option for the treatment of chronic hepatitis C infection associated with HCV genotypes 1, 3 (pretreated), 4, 5 and 6.