TRUVADA (emtricitabine, tenofovir disoproxil), antiretroviral combination

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



Clinical Added Value

no clinical added value


Therapeutic use


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