FDA approves Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) for HIV- Gilead Sciences
The FDA has approved Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), from Gilead Sciences, as a complete regimen for the treatment of HIV-1 infection in adults and paediatric patients 12 years of age and older.
Genvoya’s safety and efficacy in adults were evaluated in 3171 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA approved HIV treatment. Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens.
Comment: Genvoya was recommended by the EMA's CHMP in September 2015. Tenofovir alafenamide (TAF) is a prodrug of tenofovir, the active agent in Viread (tenofovir disoproxil fumarate or TDF). Studies have identified a dose of TAF that is ten times lower than Viread. Gilead hopes that this smaller dosage of TAF may enable the development of new fixed-dose combinations and single tablet regimens for HIV therapy that are not feasible with Viread.
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