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Gilead's HIV drug Genvoya cleared in EU

First TAF-based regimen to be approved in the US and EU

Gilead has received approval from the European Commission for its HIV drug Genvoya. 

The approval comes on the back of data from two ongoing phase III studies involving 1,733 treatment-naïve adult patients.

The drug met its primary endpoint of non-inferiority to Gilead's own HIV therapy Stribild (elitegravir, cobicstat, emtricitabine and TDF).

Norbert Bischofberger, executive vice president of research and development and chief scientific officer at Gilead, said: “For more than 25 years, Gilead has continually worked to develop new treatments to improve the management of HIV.

“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.”

Genvoya (elvitegravir/cobicstat/emitricitabine/tenofovir alafenamide) is the first TAF-based regimen to win approval in both the US and EU.

TAF is a novel targeted prodrug of tenofovir that has shown high antiviral activity similar to a dose less than one-tenth that of Gilead's Viread (tenofovir disoproxil fumarate, TDF).

However, because TAF enters cells more efficiently than TDF, it can be given at a lower dose and there is 91% less tenofovir in the bloodstream.

Additional Genvoya has also shown an improvement in renal and bone safety versus TDF therapy, which is crucial given that HIV patients are at increased risk from age and treatment related comorbidities such as low bone mineral density and renal impairment.

Article by
Nikhil Patel

25th November 2015

From: Regulatory



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