FDA Officially Approves 4-in-1 HIV Combo Drug for Market
BY Michelle Garcia
August 28 2012 12:00 AM ET
The Food and Drug Administration has officially approved Gilead's HIV medication tablet Stribild, previously known as Quad, which fuses four drugs into one pill.
Stribild combines elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg to a single daily dose for people with HIV. Paul Sax, M.D., of Brigham and Women’s Hospital who was a principal investigator of one of the Stribild studies, said the approval will be crucial for those beginning HIV therapy for the first time.
“Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” Edward Cox, M.D. of the FDA’s Center for Drug Evaluation and Research said in a statement. “New combination HIV drugs like Stribild help simplify treatment regimens.”
Stribild is the third single-tablet combination drug developed by Gilead, following Atripla in 2006 and Complera in 2011.