FOSTER CITY (dpa-AFX) - Gilead Sciences Inc. (GILD) announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive marketing authorization in the European Union.
Genvoya is indicated in the EU for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.
Today's marketing authorization is based on a Phase 3 HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients. It allows for the marketing of Genvoya in all 28 countries of the EU.
The marketing authorization is supported by 48-week data from two ongoing Phase 3 studies (Studies 104 and 111) among 1,733 treatment-naïve adult patients in which the regimen met its primary endpoint of non-inferiority compared to Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF).
In the combined analysis of the studies, 92.4 percent of Genvoya patients and 90.4 percent of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at Week 48. Certain renal and bone laboratory parameters favored Genvoya over Stribild.
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