Adherence and HIV Protection Thresholds for Emtricitabine and Tenofovir Disoproxil Fumarate Preexposure Prophylaxis among Cisgender Women: A Systematic Review.

IF 3.7 2区 医学 Q2 INFECTIOUS DISEASES Current HIV/AIDS Reports Pub Date : 2024-10-01 Epub Date: 2024-08-09 DOI:10.1007/s11904-024-00705-0
Linxuan Wu, Xin Niu, Marisa Kaitlin Brunelli, Kenneth K Mugwanya
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Abstract

Purpose of review: Adherence-concentration-efficacy benchmarks have not been fully characterized for cisgender women using emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) oral daily pre-exposure prophylaxis (PrEP) for HIV prevention.

Recent findings: We conducted a systematic review to investigate current evidence on the adherence-concentration-efficacy relationship of tenofovir-diphosphate (TFV-DP) derived from FTC/TDF PrEP in dried blood spots (DBS) and peripheral mononuclear cells (PBMC) in cisgender women without HIV, including during pregnancy. We searched for completed and ongoing studies published before May 2024 in PubMed, Embase, Cochrane Library, CINAHL, and clinicaltrial.gov.  Overall, 11 studies assessing adherence benchmarks focusing on (n = 5) or involving (n = 6) cisgender women were included. Women-specific median steady-state TFV-DP concentration for daily dosing ranged from 17 to 51 fmol/106 in PBMC and 1389 to 1685 fmol/punch in DBS in non-pregnant women; 50 to 71 fmol/106 in PBMC and 583 to 965 fmol/punch in DBS in pregnant women; and 618 to 1406 fmol/punch in DBS in postpartum women. DBS TFV-DP levels were 14-43% lower in pregnancy versus postpartum or non-pregnant periods, but PBMC TFV-DP levels appear to be comparable. Clinical and modeling studies demonstrate effective HIV protection for women taking at least four doses/week of oral TDF-based PrEP, and emerging evidence suggests that systemic drug levels are more likely to be predictive of efficacy than local tissue levels at the site of exposure. The preponderance of emerging evidence points to comparable efficacy and similar adherence requirement for women as men among those with detectable drug levels, although there was an indication that the highest achievable efficacy may be reached at a lower adherence level in men than women. In this review, we found evidence that women-specific TFV-DP adherence benchmarks in DBS and PBMC are within range of US-based historical thresholds derived from healthy men and women. Emerging evidence suggests that imperfect but adequate adherence to oral FTC/TDF PrEP with at least four doses/week provides sufficient HIV protection in cisgender women as it does in MSM, but more data are still needed to refine intrinsic achievable efficacy estimates for cisgender women.

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顺性别女性对恩曲他滨和富马酸替诺福韦二吡呋酯预防性暴露疗法的依从性和艾滋病毒保护阈值:系统回顾。
审查目的:对于使用恩曲他滨/富马酸替诺福韦二吡呋酯(FTC/TDF)每日口服暴露前预防疗法(PrEP)预防艾滋病的顺性别女性,其依从性-浓度-药效基准尚未完全定性:我们进行了一项系统性综述,调查了目前关于FTC/TDF PrEP衍生的替诺福韦-二磷酸替诺福韦(TFV-DP)在未感染HIV的顺性别女性(包括孕期女性)干血斑(DBS)和外周单核细胞(PBMC)中的依从性-浓度-药效关系的证据。我们在 PubMed、Embase、Cochrane Library、CINAHL 和 clinicaltrial.gov 中检索了 2024 年 5 月之前发表的已完成和正在进行的研究。 总共纳入了 11 项评估依从性基准的研究,重点关注(5 项)或涉及(6 项)顺性别女性。女性每日用药的稳态 TFV-DP 浓度中位数为:非孕妇 PBMC 17 至 51 fmol/106,DBS 1389 至 1685 fmol/punch;孕妇 PBMC 50 至 71 fmol/106,DBS 583 至 965 fmol/punch;产后妇女 DBS 618 至 1406 fmol/punch。妊娠期与产后或非妊娠期相比,DBS 的 TFV-DP 水平低 14-43%,但 PBMC 的 TFV-DP 水平似乎相当。临床和模型研究表明,每周至少服用四次口服 TDF 型 PrEP 的女性可有效预防 HIV,而新出现的证据表明,全身药物水平比暴露部位的局部组织水平更有可能预测疗效。大量新出现的证据表明,在可检测到药物水平的人群中,女性与男性的疗效相当,对依从性的要求也相似,但有迹象表明,男性的依从性水平可能低于女性,但却能达到最高的疗效。在本综述中,我们发现有证据表明,在 DBS 和 PBMC 中,女性特异性 TFV-DP 依从性基准在基于美国健康男性和女性的历史阈值范围内。新出现的证据表明,在顺性别女性中,坚持口服 FTC/TDF PrEP(每周至少四次)可提供足够的 HIV 防护,就像在 MSM 中一样,但仍需要更多数据来完善顺性别女性的内在可实现疗效估计值。
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来源期刊
Current HIV/AIDS Reports
Current HIV/AIDS Reports INFECTIOUS DISEASES-
CiteScore
8.10
自引率
2.20%
发文量
45
期刊介绍: This journal intends to provide clear, insightful, balanced contributions by international experts that review the most important, recently published clinical findings related to the diagnosis, treatment, management, and prevention of HIV/AIDS. We accomplish this aim by appointing international authorities to serve as Section Editors in key subject areas, such as antiretroviral therapies, behavioral aspects of management, and metabolic complications and comorbidity. Section Editors, in turn, select topics for which leading experts contribute comprehensive review articles that emphasize new developments and recently published papers of major importance, highlighted by annotated reference lists. An international Editorial Board reviews the annual table of contents, suggests articles of special interest to their country/region, and ensures that topics are current and include emerging research. Commentaries from well-known figures in the field are also provided.
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