Gilead heads to FDA after wrapping a PhIII HIV combo drug program

Gilead says that a pair of late-stage studies of its single-tablet combo therapy for HIV hit their primary endpoints, paving the way to an FDA filing later in the year. The combination of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF) was non-inferior to Gilead's ($GILD) Stribild, which earned $270 million in the second quarter alone. Gilead has been working on a combo approach that could make it easier for patients to keep the lethal virus in check. "As individuals with HIV are living longer, there is a need for treatments that are not only highly effective, but also offer an improved safety profile," said Gilead R&D chief Norbert Bischofberger. "Based on these Phase III results, we believe that the E/C/F/TAF single tablet regimen has the potential to optimize HIV therapy for a wide range of treatment-naïve patients." Combo regimens are all the rage these days in HIV. GSK's ViiV recently won an approval for its three-way combination pill Triumeq, which adds ViiV's newest antiviral, Tivicay (dolutegravir), to two commonly used treatments, abacavir and lamivudine. Release

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