Conference Reports for NATAP

IAS 2015: 8th IAS Conference on HIV Pathogenesis Treatment and Prevention Vancouver, Canada 18-22 July 2015 Back

Efficacy and Safety of Switching to Simpler Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) in HIV-1/Hepatitis B Coinfected Adults in North America and Japan (NCT02071082): Week 48 Results       Reported by Jules Levin IAS 2015 Vancouver July 19-23   Joel Gallant,1 Jason Brunetta,2 Gordon Crofoot,3 Paul Benson,4 Anthony Mills,5 Cynthia Brinson,6 Andrew Cheng,7 Will Garner,7 Marshall Fordyce,7 Moupali Das,7 Scott McCallister7 1Southwest CARE Center, Santa Fe, New Mexico, USA; 2Family and Community Medicine, University of Toronto, Ontario, Canada; 3Gordon E. Crofoot MD, PA, Houston, Texas, USA; 4Be Well Medical Center, Berkley, Michigan, USA; 5Southern California MenŐs Medical Group, Los Angeles, California, USA; 6Central Texas Clinical Research, Austin, Texas, USA; 7Gilead Sciences, Inc., Foster City, California, USA   When will TAF be available......for HIV & HCV Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF).....http://www.natap.org/2015/HIV/070215_01.htm .......Under the Prescription Drug User Fee Act (PDUFA), the anticipated target action date for the R/F/TAF NDA is six months after the FDA's acceptance of the filing......R/F/TAF is Gilead's third TAF-based filing in less than a year......   .......In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review. In November 2014, Gilead filed an NDA for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF). Gilead filed another NDA in April 2015 for two doses of an investigational, fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for use in combination with other HIV antiretroviral agents. Under the PDUFA, the FDA has set a target action date of November 5, 2015, for E/C/F/TAF and April 7, 2016, for F/TAF.   .............Marketing Authorization Applications in the European Union were fully validated on December 23, 2014, and May 28, 2015, for E/C/F/TAF and F/TAF respectively. Gilead plans to submit a regulatory application for R/F/TAF in the European Union in the third quarter of 2015.   ------------------   IAS: Switching From a Tenofovir Disoproxil Fumarate (TDF)-Based Regimen to a Tenofovir Alafenamide (TAF)-Based Regimen: Data in Virologically Suppressed Adults Through 48 Weeks of Treatment - (07/22/15)   IAS: Subjects with Renal Impairment Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide Have Improved Renal and Bone Safety through 48 Weeks Study GS-US-292-0112 - (07/22/15)   ClinPharmWk/2015: Drug Interactions Between Anti-HCV Antivirals Ledipasvir/Sofosbuvir and Integrase Strand Transfer Inhibitor-Based Regimens......"LDV/SOF may be coadministered with E/C/F/TAF without monitoring" - (06/03/15)   IAS 2015: 8th IAS Conference on HIV Pathogenesis Treatment and Prevention Vancouver Canada18-22 July 2015 References: 1. Sax PE, et al. Lancet 2015;385:2606-15; 2. Agarwal K, et al. J Hepatol. 2015; 62:533-40; 3. Murakami E, et al. Antimicrob Agents Chemother 2015;59:3563-9; 4. Poynard T, et al. BMC Gastroenterol 2007;7:40: 5. Ahn SH, et al. J Hepatol 2005;42:188-94; 6. Liaw YF, et al. Hepatology 1991;13:627-31; 7. Plaza Z, et al. AIDS 2013;27:2219-24; 8. Simonetti J, et al. Hepatology 2010;51:1531-7; 9. van Bšmmel F, et al. Hepatology 2010;51:73-80.