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Gilead Approved to Bring New Three-Drug HIV Treatment to China

publication date: Aug 9, 2019

Gilead Sciences was granted China approval for its once-daily novel three-in-one oral treatment for HIV. Biktarvy® is a combination of a novel, unboosted integrase strand transfer inhibitor (INSTI), bictegravir, with the two-drug treatment Descovy® (emtricitabine and tenofovir alafenamide). Biktarvy was approved in the US and EU in 2018. Gilead was not required to conduct specific China tests, but based its filing on four Phase III global studies that enrolled a diverse population of 2,414 HIV-1 infected patients. More details....

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