Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for Genvoya to treat HIV-1 infection in patients aged 12 years and older.
Genvoya (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg or E/C/F/TAF) is the first TAF-based regimen to receive FDA approval.
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The fixed-dose combination (FDC) drug, approved as a complete regimen, is designed to treat earlier untreated patients weighing about 35kg.
The drug is approved for those who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya.
The company said that Genvoya includes a new form of tenofovir that has not been approved earlier.
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The new form of tenofovir offers lower levels of drug in the bloodstream and higher levels within the cells where HIV-1 replicates.
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By GlobalDataThe drug was evaluated in a Phase III HIV clinical programme in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients.
The FDA approval is based on a 48-week data from two Phase III double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients where the regimen met its primary objective of non-inferiority compared to Stribild.
Stribild is comprises elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir disoproxil fumarate 300mg (E/C/F/TDF).
In addition, the approval is supported by a Phase II trial (Study 109) evaluating Genvoya among virologically suppressed patients who switched from TDF-based regimens.
Gilead Sciences chairman and CEO John Martin said: "While exceptional progress has been made in the field of HIV, there is still a need for new treatment options that may help improve the health of people as they grow older with the disease.
"For more than 25 years, Gilead has been committed to changing the trajectory of HIV management and we are now pleased to introduce Genvoya, the first in a portfolio of TAF-based products that have the potential to advance the long-term treatment of HIV."
Currently, two other TAF-based regimens are under evaluation by the FDA.
The first is an investigational, FDC of emtricitabine 200mg and tenofovir alafenamide 25 or 10mg (F/TAF) for use in combination with other antiretroviral agents, while the second is an investigational, once-daily single tablet regimen that combines emtricitabine 200mg, tenofovir alafenamide 25mg and rilpivirine 25mg (R/F/TAF).
Image: Scanning electron micrograph of HIV-1 (in green) budding from cultured lymphocyte. Photo: courtesy of Optigan13.
