FDA Approves Quad for Initial HIV Treatment

Coformulated tenofovir/FTC/elvitegravir/cobicistat is now the third fixed-dose, once-daily antiretroviral regimen approved for treatment-naive HIV-infected patients.

On August 27, 2012, the FDA approved a fixed-dose combination consisting of tenofovir, FTC, the integrase inhibitor elvitegravir, and the pharmacoenhancer cobicistat for treatment of HIV infection in antiretroviral-naive adults. The medication, known as Quad, will be marketed under the trade name Stribild. The recommended dose is one pill once daily with food.

Efficacy

The approval of Quad was based mainly on the results of two randomized, phase III clinical trials that showed Quad to be noninferior to two currently recommended first-line regimens (JW AIDS Clin Care Jul 9 2012). In one study, the comparator regimen was tenofovir/FTC/efavirenz (Atripla), and in the other, it was tenofovir/FTC + ritonavir-boosted atazanavir. Each of these place…

Author

Keith Henry, MD

Disclosures

Consultant/Advisory BoardViiV Advisory Board

Editorial BoardsJAIDS: Journal of Acquired Immune Deficiency Syndromes

Keith Henry, MD

Disclosures

Consultant/Advisory BoardViiV Advisory Board

Editorial BoardsJAIDS: Journal of Acquired Immune Deficiency Syndromes

FDA Approves Quad for Initial HIV Treatment

Topics

Efficacy

Author