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news.The European Commission has granted marketing authorization for Gilead Sciences' single tablet regimen Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) to treat HIV-1 infection.
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Genvoya is indicated in the European Union to treat adults and adolescents, aged 12 and older with body weight about 35 kg, infected with HIV-1 without any known mutations related with resistance to the integrase inhibitor class, emtricitabine or tenofovir.
In a Phase 3 HIV clinical program, Genvoya demonstrated high efficacy with improved renal and bone parameters compared to TDF-based regimens.
The company carried out the program in over 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients.
Gilead Sciences executive vice president of research and development and chief scientific officer Norbert Bischofberger said: "Genvoya, along with other investigational products in our TAF-based portfolio, have the potential to deliver long-term health benefits to people living with HIV across Europe and around the world."
TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at one tenth the dose of Gilead’s Viread (tenofovir disoproxil fumarate) and exerted less stress on the bones and kidneys.
Apart from Genvoya, the European Medicines Agency is currently evaluating two other TAF-based regimens.
Image: Genvoya box and bottle with tablets. Photo: courtesy of Gilead.