Raffi François, Orkin Chloe, Clarke Amanda, Slama Laurence, Gallant Joel, Daar Eric, Henry Keith, Santana-Bagur Jorge, Stein David K, Bellos Nicholaos, Scarsella Anthony, Yan Mingjin, Abram Michael E, Cheng Andrew, Rhee Martin S
*CHU de Nantes, Nantes, France; †Grahame Hayton Unit, Royal London Hospital, London, United Kingdom; ‡Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom; §Hotel Dieu University Hospital, Paris, France; ‖Southwest CARE Center, Santa Fe, NM; ¶Los Angeles Biomedical Research Institute at Harbor-UCLA, Torrance, CA; #Hennepin County Medical Center, Minneapolis, MN; **University of Puerto Rico School of Medicine, Rio Piedras, PR; ††Jacobi Medical Center, Bronx, NY; ‡‡Southwest Infectious Disease Clinical Research, Dallas, TX; §§Pacific Oaks Medical Group, Beverly Hills, CA; and ‖‖Gilead Sciences, Foster City, CA.
J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):226-231. doi: 10.1097/QAI.0000000000001344.
In a double-blind, phase 3 trial, 663 HIV-infected, virologically suppressed adults were randomized to switch to tenofovir alafenamide (TAF; n = 333) vs. remain on tenofovir disoproxil fumarate (TDF; n = 330), each coformulated with emtricitabine (FTC), while continuing their third agent (boosted protease inhibitor or unboosted third agent). At week 96, 88.6% on FTC/TAF and 89.1% on FTC/TDF had HIV-1 RNA <50 copies per milliliter [adjusted difference -0.5% (95% confidence interval: -5.3 to 4.4%)]. Proteinuria, albuminuria, proximal renal tubular function, and bone mineral density improved after switching to TAF- from TDF-containing regimens. These longer-term data support FTC/TAF as a safe, well-tolerated, and durable nucleotide reverse transcriptase inhibitor backbone.
在一项双盲3期试验中，663名病毒学得到抑制的HIV感染成人被随机分组，转而使用替诺福韦艾拉酚胺（TAF；n = 333）与继续使用富马酸替诺福韦二吡呋酯（TDF；n = 330），二者均与恩曲他滨（FTC）联合使用，同时继续使用第三种药物（增强型蛋白酶抑制剂或未增强的第三种药物）。在第96周时，接受FTC/TAF治疗的患者中有88.6%以及接受FTC/TDF治疗的患者中有89.1%的HIV-1 RNA低于每毫升50拷贝[校正差异-0.5%（95%置信区间：-5.3至4.4%）]。从含TDF的治疗方案转而使用TAF后，蛋白尿、白蛋白尿、近端肾小管功能和骨密度均有所改善。这些长期数据支持FTC/TAF作为一种安全、耐受性良好且持久的核苷酸逆转录酶抑制剂主干药物。
