Fields Sheldon D, Tung Elyse
The Pennsylvania State University, College of Nursing, University Park, PA, USA.
Kelley-Ross Pharmacy, Seattle, WA, USA.
Infect Dis Ther. 2021 Mar;10(1):165-186. doi: 10.1007/s40121-020-00384-5. Epub 2021 Feb 10.
Pre-exposure prophylaxis (PrEP) medication is a key component of the HIV prevention strategy in the US, which has been demonstrated to be highly effective in preventing HIV acquisition among individuals at risk. Two PrEP medications are currently approved: emtricitabine/tenofovir disoproxil fumarate (Truvada; F/TDF) was approved by the US Food and Drug Administration in 2012, followed by emtricitabine/tenofovir alafenamide (Descovy; F/TAF) in 2019. An ongoing randomized, double-blind, Phase 3 study (DISCOVER) demonstrated that F/TAF had non-inferior efficacy to F/TDF. While both medications have been found to be efficacious and well tolerated, several studies have identified that important differences exist with regards to pharmacokinetics, bone and renal safety profiles, and other factors. In this narrative review, we conducted a comprehensive evaluation of the populations at risk of HIV who may also be affected by, or at risk of, bone or renal conditions. We reviewed the safety profiles of F/TDF and F/TAF to develop an evidence-based algorithm for selecting the appropriate PrEP medication, based on biological, behavioral, and health characteristics of an individual at risk of HIV, and considered how the choice of PrEP medication may or may not compound safety concerns for these individuals. We identified that the introduction of F/TAF provides a valuable alternative to F/TDF, allowing the personalization of PrEP. F/TAF may be the preferred medication for cisgender men and transgender women at risk of HIV infection who are predisposed to, or already have, bone or renal conditions. While the approval of F/TAF is the first step in personalization of PrEP, additional options are still warranted to help accommodate the wide spectrum of individuals at risk of HIV with different lifestyles, medical histories, preferences, and requirements.
暴露前预防(PrEP)药物是美国艾滋病预防策略的关键组成部分,已被证明在预防高危人群感染艾滋病方面非常有效。目前有两种PrEP药物已获批准:恩曲他滨/替诺福韦酯(Truvada;F/TDF)于2012年获得美国食品药品监督管理局批准,随后恩曲他滨/替诺福韦艾拉酚胺(Descovy;F/TAF)于2019年获批。一项正在进行的随机、双盲3期研究(DISCOVER)表明,F/TAF的疗效不劣于F/TDF。虽然这两种药物都被发现有效且耐受性良好,但多项研究表明,在药代动力学、骨骼和肾脏安全性以及其他因素方面存在重要差异。在这篇叙述性综述中,我们对可能也受骨骼或肾脏疾病影响或有患这些疾病风险的艾滋病高危人群进行了全面评估。我们回顾了F/TDF和F/TAF的安全性,以便根据艾滋病高危个体的生物学、行为和健康特征,制定一种基于证据的算法来选择合适的PrEP药物,并考虑PrEP药物的选择如何可能或不可能加重这些个体的安全问题。我们发现,F/TAF的推出为F/TDF提供了一个有价值的替代方案,使PrEP能够个性化。对于有感染艾滋病风险且易患或已患有骨骼或肾脏疾病的顺性别男性和跨性别女性,F/TAF可能是首选药物。虽然F/TAF的获批是PrEP个性化的第一步,但仍需要更多选择来帮助适应具有不同生活方式、病史、偏好和需求的广泛艾滋病高危人群。