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SOVALDI (sofosbuvir), direct-acting antiviral

INFECTIOUS DISEASE - New indication
Opinions on drugs - Posted on Jul 18 2018

Reason for request

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.

 

  • SOVALDI 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, in combination with ribavirin, for the treatment of chronic hepatitis C virus (HCV) genotypes 2 and 3-related infection, with a similar profile to that described in adults.

  • It is a first-line option, in combination with ribavirin, for the treatment of chronic hepatitis C associated with HCV genotypes 2 and 3.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

moderate

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Therapeutic use

-