Gilead’s HIV combo non-inferior in four Phase III trials

Gilead Sciences Inc. (NASDAQ:GILD) said a fixed-dose combination of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was non-inferior to combinations including Tivicay dolutegravir from ViiV Healthcare Ltd. (Brentford, U.K.), meeting the primary endpoints in three Phase III trials to treat HIV-1 infection. Gilead's combo also met the primary endpoint of an open-label study that compared it with multiple combinations.

Gilead plans to submit an NDA to FDA for the combination in 2Q17, and an MAA to EMA in 3Q17...