As impressive as GILD has been on the commercial front, they are equally impressive on the clinical front. Case in point: GILD persuaded the FDA to allow only one phase-3 study of Elvitegravir vs Isentress in support of an Elvitegravir NDA in treatment-experienced HIV by substituting two planned phase-3 studies of Quadro* in treatment-naïve HIV for what would’ve been the second phase-3 study of Elvitegravir vs Isentress. Insofar as the substituted Quadro studies are not even in the same clinical setting, this is quite a coup for GILD!
The phase-3 trial of Elvitegravir vs Isentress (#msg-30900183), which started in July, has already enrolled 40% of the 700 patients.
The planned phase-3 Quadro studies will have 600 patients each and will seek to show non-inferiority of Quadro vs Atripla. GILD will run one or more phase-2 trials before embarking on phase-3.
If Quadro can be shown to be non-inferior to Atripla on efficacy, it could eventually become the standard of care treatment in first-line HIV due to a Elvitegravir’s having a lower incidence of CNS side effects and a superior safety profile for pregnant patients relative to Sustiva.
>These data suggest that GS 9350 has significant and selective pharmacoenhancing ability, no antiviral activity against HIV and differentiated biological properties in vitro compared to ritonavir, currently the only drug used to boost certain HIV treatments, including protease inhibitors. Study results also show that GS 9350 effectively boosts elvitegravir, when both drugs are dosed as part of a single tablet complete fixed-dose regimen with Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg).<
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