恩曲他滨/丙酚替诺福韦治疗方案治疗HIV-1感染的有效性、安全性及患者报告的结局：德国前瞻性TAFNES队列研究的最终24个月结果
Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study.
作者信息
Stephan Christoph, Spinner Christoph D, Rieke Ansgar, Christensen Stefan, Mauss Stefan, Schreiber Sandra, Albuquerque Boris, Heinzkill Marion, Ramroth Heribert, Stellbrink Hans-Jürgen
机构信息
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.
出版信息
HIV Med. 2025 Feb;26(2):239-251. doi: 10.1111/hiv.13728. Epub 2024 Oct 30.
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSION
Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.
背景
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。
方法
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。
结果
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。
结论
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。
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