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TIVICAY (dolutegravir), integrase inhibitor
INFECTIOUS DISEASES - New indication
Opinions on drugs -
Posted on
Jan 18 2018
Reason for request
Extension of indication
Minor improvement in the treatment of children aged 6 to 12 years infected with HIV-1 in the absence of integrase inhibitor resistance, just as in adults and adolescents.
Insufficient clinical benefit in children and adolescents infected with HIV-1 in the presence of integrase inhibitor resistance.
- TIVICAY has Marketing Authorisation in combination with other antiretroviral medicinal products for the treatment of HIV infected children aged 6 years or over.
- It is a first- or second-line therapeutic option, as an alternative to protease inhibitors (PI), in HIV infected children and adolescents without resistance to integrase inhibitors.
- Its use should be guided by genotypic resistance testing.
- Monitoring of psychiatric disorders in children is necessary.
Clinical Benefit
| Substantial |
- |
| Insufficient |
Clinical Added Value
| minor |
- |
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