Gilead rac­ing to FDA with a new HIV cock­tail boast­ing megablock­buster po­ten­tial

Gilead’s R&D team brought home a clean sweep for its four Phase III stud­ies adding the ex­per­i­men­tal drug bicte­gravir to its back­bone HIV ther­a­py.

Their cock­tail ther­a­py adding bicte­gravir to its main­stays emtric­itabine/teno­fovir alafe­namide (200/25mg) (FTC/TAF) proved non-in­fe­ri­or to do­lute­gravir and oth­er an­ti­retro­vi­ral ther­a­pies in the 4 late-stage stud­ies, set­ting up a new drug ap­pli­ca­tion in a mat­ter of weeks as Gilead races to a near-term mar­ket­ing OK.

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