Gilead

Gilead sciences inc

Gilead is functioning to develop next-generation HIV therapies for all folks World Health Organization tolerate the sickness, in spite of treatment standing or age. Our specialize in advancing treatment decisions resulted inside the event of the investigational agent tenofovir alafenamide (TAF), a totally distinctive kind of the active ingredient in Viread® (tenofovir disoproxil fumarate, or TDF). we've an inclination to believe that TAF-containing regimens have the potential to help acceptable HIV patients World Health Organization face life-long antiretroviral treatment.

In solar calendar month 2015 the Food and Drug Administration (FDA) approved Genvoya® (elvitegravir 100 and fifty mg/cobicistat 100 and fifty mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is that the initial TAF-based program to receive authority approval.

Genvoya was studied in an exceedingly} very section 3 HIV clinical program in extra than 3,500 patients across twenty one countries, also as treatment-naïve, virologically suppressed, renally impaired and adolescent patients. The approval was supported by 48-week data from two section 3 double-blind studies (Studies one04 and one) among 1,733 treatment-naïve patients throughout that the program met its primary objective of non-inferiority compared to Stribild® (elvitegravir 100 and fifty mg, cobicistat 100 and fifty mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF). inside the combined analysis of the studies, 92.4 exploit Genvoya patients and ninety.4 exploit Stribild patients had HIV-1 polymer levels however fifty copies/mL at Week four8. Tests of sure urinary organ and bone laboratory parameters put together favored Genvoya over Stribild.

In addition to E/C/F/TAF, two different TAF-based HIV treatments square measure presently to a lower place associated Drug Administration|FDA|agency|federal agency|government agency|bureau|office|authority} review: associate investigational combination of emtricitabine and TAF (F/TAF) - a attainable new HIV treatment “backbone” to be used together with different antiretroviral medicines - and R/F/TAF, that's degree investigational STR combining F/TAF and Janssen’s rilpivirine. Janssen is in addition developing D/C/F/TAF, degree investigational STR containing Janssen’s darunavir along with cobicistat and F/TAF, that if approved would be the first proteolytic enzyme inhibitor-containing STR.