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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.
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SOVALDI has now been granted a marketing authorisation for the treatment of chronic hepatitis C in adolescents aged from 12 to < 18 years.
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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.
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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
|
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