Stephan Christoph, Spinner Christoph D, Rieke Ansgar, Christensen Stefan, Mauss Stefan, Schreiber Sandra, Albuquerque Boris, Heinzkill Marion, Ramroth Heribert, Stellbrink Hans-Jürgen
Department of Internal Medicine 2, Infectious Diseases Unit, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.
TUM School of Medicine and Health, Department of Clinical Medicine - Clinical Department for Internal Medicine II, University Medical Center, Technical University of Munich, Munich, Germany.
HIV Med. 2025 Feb;26(2):239-251. doi: 10.1111/hiv.13728. Epub 2024 Oct 30.
Tenofovir alafenamide (TAF) was introduced in the European Union in 2015 as a novel prodrug of tenofovir showing similar efficacy in clinical trials and a more favorable safety profile than tenofovir disoproxil fumarate (TDF). The German TAFNES cohort study (2016-2019) was conducted to generate real-world evidence.
Treatment-naïve (TN) and treatment-experienced (TE) people with HIV (PWH) receiving elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF), rilpivirine/F/TAF (R/F/TAF) or F/TAF + 3rd agent were included. Month (M) 24 outcomes included virologic effectiveness (HIV RNA <50 copies/mL), treatment persistence, adverse drug reactions (ADRs) and patient-reported outcomes, using the HIV Symptom Index (HIV-SI), 36-Item Short Form Health Survey (SF-36) and HIV Treatment Satisfaction (HIVTSQ) questionnaires.
The study included 767 PWH (92% men, median age 46 years; 301 TN, 466 TE; E/C/F/TAF [n = 318], R/F/TAF [n = 192], F/TAF + 3rd agent [n = 257]). Among TN, 35% had late HIV diagnosis (CD4 < 350/μL and/or AIDS). Of TE, 95% were on suppressive antiretroviral therapy (ART) before switching. D:A:D (Data Collection on Adverse Effects of Anti-HIV Drugs) 5-year risks for chronic kidney disease were high for about 1 in 10 TN and 4 in 10 TE. Overall treatment persistence at M24 was 81% (E/C/F/TAF: 88%; R/F/TAF: 86%; F/TAF + 3rd agent: 70%, with ART simplification of multiple-tablet regimens in 13%). M24 viral suppression (missing = excluded) was 96% (479/501). Discontinuations due to virologic failure or ADRs were rare, 2% (12/767) and 4% (30/767), respectively. HIV-SI and SF-36 summary scores improved in TN; HIVTSQ change scores showed an improvement in treatment satisfaction in TE.
Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.
替诺福韦艾拉酚胺（TAF）于2015年在欧盟推出，是一种新型替诺福韦前体药物，在临床试验中显示出相似的疗效，且安全性优于富马酸替诺福韦二吡呋酯（TDF）。德国TAFNES队列研究（2016 - 2019年）旨在获取真实世界证据。
纳入初治（TN）和经治（TE）的HIV感染者（PWH），他们接受了埃替拉韦/考比司他/恩曲他滨/TAF（E/C/F/TAF）、利匹韦林/F/TAF（R/F/TAF）或F/TAF加第三种药物治疗。第24个月的结局包括病毒学疗效（HIV RNA <50拷贝/毫升）、治疗依从性、药物不良反应（ADR）以及患者报告的结局，使用HIV症状指数（HIV - SI）、36项简明健康调查（SF - 36）和HIV治疗满意度（HIVTSQ）问卷。
该研究纳入了767名PWH（92%为男性，中位年龄46岁；301名TN，466名TE；E/C/F/TAF [n = 318]，R/F/TAF [n = 192]，F/TAF加第三种药物 [n = 257]）。在TN中，35%的患者为HIV晚期诊断（CD4 < 350/μL和/或艾滋病）。在TE中，95%的患者在换药前接受了抑制性抗逆转录病毒治疗（ART）。抗HIV药物不良反应数据收集（D:A:D）中，约十分之一的TN和十分之四的TE患慢性肾病的5年风险较高。第24个月时总体治疗依从性为81%（E/C/F/TAF：88%；R/F/TAF：86%；F/TAF加第三种药物：70%，其中13%的多片方案进行了ART简化）。第24个月时病毒抑制率（缺失值 = 排除）为96%（479/501）。因病毒学失败或ADR停药的情况很少，分别为2%（12/767）和4%（30/767）。TN的HIV - SI和SF - 36总结评分有所改善；HIVTSQ变化评分显示TE的治疗满意度有所提高。
真实世界数据证实，基于F/TAF的ART具有良好的安全性、高病毒学疗效和高治疗满意度。
