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| Gilead plays a central role in developing single tablet regimens – with one pill once a day, patients can take all of their medication in each dose. |
Always looking for NEW and BETTER ways to fight HIV
05/22/2017
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Gilead is working to develop next-generation HIV therapies for all
individuals who live with the disease, regardless of treatment status or
age. Our focus on advancing treatment options resulted in the
development of the investigational agent tenofovir alafenamide (TAF), a
novel form of the active ingredient in Viread® (tenofovir
disoproxil fumarate, or TDF). We believe that TAF-containing regimens
have the potential to help appropriate HIV patients who face life-long
antiretroviral therapy.
In November 2015 the Food and Drug Administration (FDA) approved 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 FDA approval.
Genvoya was studied in 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. The approval was supported by 48-week data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients in which the regimen met its primary objective 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. Tests of certain renal and bone laboratory parameters also favored Genvoya over Stribild.
In addition to E/C/F/TAF, two other TAF-based HIV treatments are currently under FDA review: an investigational combination of emtricitabine and TAF (F/TAF) - a potential new HIV treatment “backbone” to be used in combination with other antiretroviral medicines - and R/F/TAF, which is an investigational STR combining F/TAF plus Janssen’s rilpivirine. Janssen is also developing D/C/F/TAF, an investigational STR containing Janssen’s darunavir in combination with cobicistat and F/TAF, which if approved would be the first protease inhibitor-containing STR.
In November 2015 the Food and Drug Administration (FDA) approved 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 FDA approval.
Genvoya was studied in 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. The approval was supported by 48-week data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients in which the regimen met its primary objective 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. Tests of certain renal and bone laboratory parameters also favored Genvoya over Stribild.
In addition to E/C/F/TAF, two other TAF-based HIV treatments are currently under FDA review: an investigational combination of emtricitabine and TAF (F/TAF) - a potential new HIV treatment “backbone” to be used in combination with other antiretroviral medicines - and R/F/TAF, which is an investigational STR combining F/TAF plus Janssen’s rilpivirine. Janssen is also developing D/C/F/TAF, an investigational STR containing Janssen’s darunavir in combination with cobicistat and F/TAF, which if approved would be the first protease inhibitor-containing STR.
Check out this fun video by @GileadSciences about getting to Undetectable!
Read more about the research happening right now by Gilead Sciences, here.
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