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A Randomized, Double-Blind Comparison of
Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, for Initial HIV-1 Treatment: Week 96 Results
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Reported by Jules Levin
EACS 2015 Oct 21-24 Barcelona - 15th European AIDS Conference
From Jules: in the opening oral session
David Wohl,1 Shinichi Oka,2 Nathan Clumeck,3 Amanda Clarke,4 Cynthia Brinson,5 Jeffrey Stephens,6 Karen Tashima,7 Jose Arribas,8 Bruce Rashbaum,9 Antoine Chéret,10 Jason Brunetta,11 Cristina Mussini,12 Pablo Tebas,13 Paul Sax,14 Lijie Zhong,15 Moupali Das,15 Marshall Fordyce15
1University of North Carolina, Chapel Hill, North Carolina, USA; 2National Center for Global Health and Medicine, Tokyo, Japan; 3CHU Saint-Pierre University Hospital, Brussels, Belgium; 4Brighton and Sussex Medical School, Brighton and Sussex University Hospitals NHS Foundation Trust, Brighton, UK; 5Central Texas Clinical Research, Austin, Texas, USA; 6Mercer University School of Medicine, Macon, Georgia, USA; 7Alpert Medical School of Brown University, Providence, Rhode Island, USA; 8Hospital La Paz, Madrid, Spain; 9Capital Medical Associates, Washington, DC, USA; 10Tourcoing Hospital, Paris, France; 11University of Toronto, Ontario, Canada; 12University of Modena and Reggio Emilia, Modena, Italy; 13University of Pennsylvania, Philadelphia, Pennsylavania, USA; 14Harvard Medical School, Boston, Massachusetts, USA; 15Gilead Sciences, Inc., Foster City, California, USA
EACS: Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV - (10/23/15)
On September 24, 2015, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on the company's Marketing Authorization Application for Genvoya. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. Based on initial data from Studies 104 and 111, announced in September 2014, Gilead filed a New Drug Application for Genvoya with the U.S. Food and Drug Administration (FDA) on November 5, 2014. Under the Prescription Drug User Fee Act, the agency has set a target action date of November 5, 2015. Genvoya is an investigational product and has not been determined to be safe or efficacious.
References
1. Babusis D, et al. Mol Pharm 2013;10:459-66; 2. Birkus G, et al. Antimicrob Agents Chemother 2007;51:543-50; 3. Lee W, et al. Antimicrob Agents Chemother 2005;49:1898-906; 4. Ruane P, et al. J Acquir Immune Defic Syndr 2013;63:449-5; 5. Sax P, et al. J Acquir Immune
Defic Syndr 2014;67:52-8; 6. Sax PE, et al. Lancet 2015;385:2606-15; 7. Wohl D, et al. CROI 2015, oral 113LB; 8. Tungsiripat M, et al. AIDS. 2010; 24:1781-4; 9. Mulligan K, et al. 15th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV, 2013.
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