GENVOYA (emtricitabine, cobicistat, elvitegravir and tenofovir alafenamide), antiviral combination

High clinical benefit but no clinical benefit demonstrated in the treatment strategy for HIV-1 in children aged 6 – 12.

• GENVOYA now has MA in the treatment of HIV-1 infection in children aged 6 to 12, weighing at least 25kg, in whom other treatments cannot be used due to toxicity.

• No study has evaluated its efficacy in this population.

• The pharmacokinetic data available show significant overexposure in children when the adult form is used. This exposes this growing population to a high risk of renal and bone toxicity.

• It is a last resort therapeutic option in the treatment of HIV-1 infection with no known integrase inhibitor (elvitegravir, dolutegravir or raltegravir), emtricitabine or tenofovir resistance mutation.