Efficacy and safety of emtricitabine/tenofovir alafenamide (FTC/TAF) vs. emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as a backbone for treatment of HIV-1 infection in virologically suppressed adults: subgroup analysis by third agent of a randomized, double-blind, active-controlled phase 3 trial^*

References

• Hall AM, Hendry BM, Nitsch D, et al. Tenofovir-associated kidney toxicity in HIV-infected patients: a review of the evidence. Am J Kidney Dis. 2011;57:773–780.10.1053/j.ajkd.2011.01.022
   PubMed Web of Science ®Google Scholar
• Gupta SK. Tenofovir-associated fanconi syndrome: review of the FDA adverse event reporting system. AIDS Patient Care STDs. 2008;22:99–103.10.1089/apc.2007.0052
   PubMed Web of Science ®Google Scholar
• Post FA, Moyle GJ, Stellbrink HJ, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010;55:49–57.10.1097/QAI.0b013e3181dd911e
   PubMed Web of Science ®Google Scholar
• Stellbrink HJ, Orkin C, Arribas JR, et al. Comparison of changes in bone density and turnover with abacavir‐lamivudine versus tenofovir‐emtricitabine in HIV‐infected adults: 48‐week results from the ASSERT study. Clin Infect Dis. 2010;51:963–972.10.1086/652982
   PubMed Web of Science ®Google Scholar
• Schafer JJ, Manlangit K, Squires KE. Bone health and human immunodeficiency virus infection. Pharmacotherapy. 2013;33:665–682.10.1002/phar.2013.33.issue-6
   PubMed Web of Science ®Google Scholar
• McComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: AIDS Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis. 2011;203:1791–1801.10.1093/infdis/jir188
   PubMed Web of Science ®Google Scholar
• Van Rompay KK, Durand-Gasselin L, Brignolo LL, et al. chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects. Antimicrob Agents Chemother. 2008;52:3144–3160.10.1128/AAC.00350-08
   PubMed Web of Science ®Google Scholar
• Ruane PJ, DeJesus E, Berger D, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-Day Monotherapy in HIV-1-positive adults. J Acquir Immune Defic Syndr. 2013;63:449–455.10.1097/QAI.0b013e3182965d45
   PubMed Web of Science ®Google Scholar
• Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015;385:2606–2615.10.1016/S0140-6736(15)60616-X
   PubMed Web of Science ®Google Scholar
• Wohl D, Oka S, Clumeck N, et al. Brief report: a randomized, double-blind comparison of tenofovir alafenamide versus tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine for initial HIV-1 treatment: week 96 results. J Acquir Immune Defic Syndr. 2016;72:58–64.10.1097/QAI.0000000000000940
   PubMed Web of Science ®Google Scholar
• Mills A, Arribas JR, Andrade-Villanueva J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016;16:43–52.10.1016/S1473-3099(15)00348-5
   PubMed Web of Science ®Google Scholar
• Pozniak A, Arribas JR, Gathe J, et al. Switching to tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment: 48 week results from a single-arm, multi-center, open-label, phase 3 study. J Acquir Immune Defic Syndr. 2016;71:530–537.10.1097/QAI.0000000000000908
   PubMed Web of Science ®Google Scholar
• Gallant JE, Daar ES, Raffi F, et al. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016;3:e158–e165.10.1016/S2352-3018(16)00024-2
   PubMed Web of Science ®Google Scholar
• Smith F, Hammerstorm T, Soon G, et al. A meta-analysis to assess the FDA DAVP’s TLOVR algorithm in HIV submissions. Drug Inf J. 2011;45:291–300.
   Google Scholar
• U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Guidance for Industry Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment. Draft Guidance. 2013;1–43. Available at chrome-extension://oemmndcbldboiebfnladdacbdfmadadm/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf. Accessed April 15, 2016.
   Google Scholar
• Gilead Sciences International Ltd. DESCOVY (emtricitabine/tenofovir alafenamide 200/10 mg). Summary of Product Characteristics. Accessed January 16, 2016.
   Google Scholar
• Lucas GM, Ross MJ, Stock PG, Shlipak MG, Wyatt CM, Gupta SK, et al. Clinical practice guideline for the management of chronic kidney disease in patients infected with HIV: 2014 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;59:e96–e138.10.1093/cid/ciu617
   PubMed Web of Science ®Google Scholar