Gilead Will Extend Phase 3 Elvitegravir Trial to 96 Weeks

	SUMMARY: Gilead Sciences reported in a financial statement this month that it will follow a U.S. Food and Drug Administration (FDA) recommendation to double the duration of an ongoing Phase 3 clinical trial comparing its experimental integrase inhibitor elvitegravir versus raltegravir (Isentress), the sole approved drug in this class. The FDA asked that the study be extended to 96 weeks to obtain longer-term data on safety and effectiveness. The company said it does not expect the change to affect availability of its "Quad" pill, a single tablet regimen containing elvitegravir, the booster drug cobicistat, and tenofovir/emtricitabine (the drugs in Truvada).

Below in an excerpt from Gilead's recent Security and Exchange Commission (SEC) filing, Form 8-K -- Regulation FD Disclosure:

"Gilead Sciences, Inc. (Gilead) has decided, per the recommendation of the U.S. Food and Drug Administration (FDA), to amend the design of its ongoing Phase III clinical study of elvitegravir, the company's investigational integrase inhibitor in treatment experienced patients (GS-US-183-0145, "A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir Versus Raltegravir Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment Experienced Adults"), to extend the double-blinded study period to up to 96 weeks, rather than the initially planned 48-week duration."

"This change will be implemented to allow Gilead to obtain safety and efficacy data from a longer controlled and blinded study, the first clinical trial directly comparing two integrase inhibitors. Gilead has not been informed of any issues with the ongoing study that would cause Gilead to halt or otherwise amend the study design."

"Gilead does not expect this planned change to have any impact on timelines for availability of data from ongoing pivotal studies in support of the investigational "Quad" combination of Truvada (emtricitabine and tenofovir disoproxil fumarate), elvitegravir and cobicistat, or timelines, pending a positive outcome of these studies, for regulatory submissions of the Quad, cobicistat or elvitegravir."