Patient-Focused Selection of PrEP Medication for Individuals at Risk of HIV: A Narrative Review.
Patient-Focused Selection of PrEP Medication for Individuals at Risk of HIV: A Narrative Review.
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DOI：
10.1007/s40121-020-00384-5
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发表时间：
2021-03
影响因子：
5.4
通讯作者：
Tung E
中科院分区：
文献类型：
--
作者：
Fields SD;Tung E
暴露前预防（PrEP）药物是美国艾滋病毒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毒方面非常有效。目前批准了两种PrEP药物：恩曲他滨/富马酸替诺福韦二异丙酯（Truvada®; F/TDF）于2012年获得美国食品和药物管理局批准，随后是恩曲他滨/替诺福韦艾拉酚胺（Descovy®; F/TAF）于2019年获得批准。一项正在进行的随机、双盲、III期研究（DISCOVER）证明，F/TAF的疗效不劣于F/TDF。虽然这两种药物均有效且耐受性良好，但几项研究发现，在药代动力学、骨和肾脏安全性特征以及其他因素方面存在重要差异。在这篇叙述性综述中，我们对可能受骨或肾脏疾病影响或存在骨或肾脏疾病风险的HIV风险人群进行了全面评价。我们审查了F/TDF和F/TAF的安全性，以制定基于证据的算法，根据HIV风险个体的生物学，行为和健康特征选择适当的PrEP药物，并考虑PrEP药物的选择可能会或可能不会对这些个体产生安全性问题。我们发现，F/TAF的引入为F/TDF提供了一种有价值的替代方案，允许PrEP的个性化。F/TAF可能是易患或已经患有骨骼或肾脏疾病的有HIV感染风险的顺性别男性和跨性别女性的首选药物。虽然F/TAF的批准是PrEP个性化的第一步，但仍然需要额外的选择来帮助适应具有不同生活方式，病史，偏好和要求的艾滋病毒风险的广泛人群。暴露前预防（或PrEP）可防止有艾滋病毒感染风险的个体获得艾滋病毒。目前在美国有两种批准的PrEP选择;两者都是口服药物。2012年批准的第一种选择是两种药物的组合，称为恩曲他滨/替诺福韦酯，也称为Truvada®或F/TDF。2019年批准的第二种选择是恩曲他滨和一种不同的前药替诺福韦艾拉酚胺的组合，这种组合被称为Descovy®或F/TAF。如果每天服用，这两种选择在预防艾滋病毒方面的有效性为99%。虽然服用任何一种PrEP药物的严重副作用的风险很低，但F/TAF对骨骼和肾脏健康的影响较小，可能是患有骨骼或肾脏疾病的人的首选，或者是那些有骨质疏松症风险或有肾脏疾病风险因素的人，如糖尿病或高血压患者。由于艾滋病毒的风险有时会根据种族/民族，贫困，酒精/物质使用，吸烟和服用其他药物而与骨骼和肾脏健康的风险重叠，F/TAF作为替代PrEP药物允许PrEP选择取决于个人的更广泛的健康状况。“个性化医疗”意味着可以选择适合个人生物学，行为，生活方式和整体健康的药物。F/TAF的批准是PrEP药物个性化的第一步，而其他选择需要研究，以满足所有有艾滋病毒风险的个人的要求。
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. Pre-exposure prophylaxis (or PrEP) prevents HIV acquisition in individuals at risk of HIV infection. There are currently two approved options for PrEP in the US; both are oral medications. The first option, approved in 2012, is a combination of two drugs called emtricitabine/tenofovir disoproxil fumarate—also known as Truvada® or F/TDF. The second option, approved in 2019, is a combination of emtricitabine and a different prodrug, tenofovir alafenamide—this combination is called Descovy® or F/TAF. Both options are 99% effective in preventing HIV if taken daily. While the risk of serious side effects from taking either of the PrEP medications is low, F/TAF has demonstrated less effect on bone and kidney health, and may be the preferred option in people with bone or kidney conditions, or in those at risk of developing osteoporosis or having risk factors for kidney disease, such as people living with diabetes or high blood pressure. As the risk of HIV sometimes overlaps with risks to bone and renal health according to race/ethnicity, poverty, alcohol/substance use, smoking tobacco, and taking other medications, F/TAF as an alternative PrEP medication allows the PrEP choice to depend on the broader health conditions of the individual. ‘Personalized medicine’ means that medicines can be chosen to suit an individual’s biology, behavior, lifestyle, and overall health. The approval of F/TAF is the first step in personalization of PrEP medication, while additional options need to be researched to meet the requirements of all individuals at risk of HIV.
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影响因子：
13.3
作者：
Buckley, Lenore;Guyatt, Gordon;McAlindon, Timothy
通讯作者：
McAlindon, Timothy
影响因子：
16.1
作者：
Antoni, Guillemette;Tremblay, Cecile;Rabian, C.
通讯作者：
Rabian, C.
影响因子：
2.3
作者：
Dorman, Robin M.;Sutton, Sarah H.;Yee, Lynn M.
通讯作者：
Yee, Lynn M.
DOI：
10.15585/mmwr.mm6745a5
发表时间：
2018-11-16
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
--
作者：
Cullen KA;Ambrose BK;Gentzke AS;Apelberg BJ;Jamal A;King BA
通讯作者：
King BA
影响因子：
168.9
作者：
Choopanya, Kachit;Martin, Michael;Vanichseni, Suphak
通讯作者：
Vanichseni, Suphak