TRUVADA (emtricitabine, tenofovir disoproxil), antiretroviral combination
INFECTIOUS DISEASE - New indication
Opinions on drugs -
Posted on
Jul 06 2018
Reason for request
Extension of indication
High clinical benefit for the adolescent population (12 - 18 years) but no proven clinical added value compared to the use of the free forms (VIREAD or EMTRIVA)
TRUVADA has now been granted a marketing authorisation for the treatment of HIV-1-infected adolescents, exhibiting resistance or toxicities to RTNIs preventing the use of first-line agents and aged from 12 to under 18 years.
It is an option in the absence of another therapeutic alternative, for the adolescent population aged from 12 to under 18 years, with established HIV susceptibility to tenofovir and in the absence of kidney failure.
Its prescription for the paediatric population requires a multidisciplinary approach and suitable monitoring during treatment.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |
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