Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Tablets

Abstract

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. Subscribers to The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. A drug class review is now published monthly with The Formulary Monograph Service.

Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The January 2013 monograph topics are onperampanel, omacetaxine mepesuccinate, ocriplasmin, sodium picosulfate/magnesium oxide/anhydrous citric acid, and lomitapide. The DUE/MUE is on perampanel.

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References

Stribild [package insert]. Foster City, CA: Gilead Sciences Inc; August 2012.

Gilead Sciences submits new drug application to FDA for HIV drug [news release]. Foster City, CA: Gilead Sciences Inc; August 26, 2012.

Antiretroviral agents. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; 2012. Accessed August 31, 2012.

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. Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. AIDS. 2011;25(6):F7–F12.

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. Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-tablet fixed-dose combination regimen for the treatment of HIV. J Acquir Immune Defic Syndr. 2010;55(3):323–329.

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; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomized, double-blind, phase 3, non-inferiority trial. Lancet. 2012;379(9835):2429–2438.

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; GS-US-236-0102 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomized, double blind, phase 3 trial, analysis of results after 48 weeks [published correction appears in Lancet. 2012;380(9843):730]. Lancet. 2012;379(9835):2439–2448.

Cox

. NDA approval letter: Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate NDA 203100). Food and Drug Administration Web site. http://www.accessdata.fda.gov/drugsatfda_docs/ appletter/2012/0203100Orig1s000ltr.pdf. Published August 27, 2012. Accessed September 5, 2012.