阿姆斯特丹暴露前预防示范项目中，每日日记报告的暴露前预防用药摄入量与红细胞内替诺福韦二磷酸之间的一致性。

Concordance between daily diary reported pre-exposure prophylaxis intake and intraerythrocytic tenofovir diphosphate in the Amsterdam Pre-exposure Prophylaxis demonstration project.

作者信息

Wijstma Eline S, Jongen Vita W, Boyd Anders, van den Elshout Mark A M, de Vries Henry J C, Davidovich Udi, Anderson Peter L, Prins Maria, Hoornenborg Elske, Schim van der Loeff Maarten F

机构信息

Department of Infectious Diseases, Public Health Service of Amsterdam.

Stichting HIV Monitoring.

出版信息

AIDS. 2024 Jul 1;38(8):1248-1256. doi: 10.1097/QAD.0000000000003889. Epub 2024 Mar 20.

DOI:10.1097/QAD.0000000000003889

PMID:38518076

Abstract

OBJECTIVE

We assessed the association and concordance between self-reported oral pre-exposure prophylaxis (PrEP) intake in a diary app and intraerythrocytic drug metabolite concentrations.

DESIGN

AMPrEP was a prospective demonstration study providing daily and event-driven PrEP to MSM in Amsterdam, the Netherlands (2015-2020).

METHODS

Participants could record their PrEP intake in a diary app. Dried blood spots (DBS) were taken at 6, 12, 24, and 48 months and analysed for tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations. We included TFV-DP measurements preceded by diary completion on at least 90% of days in the 6 weeks prior. We examined the association between self-reported PrEP intake (i.e. number of pills) and TFV-DP concentrations using tobit regression with a random intercept per participant. We also calculated concordance between categorized PrEP intake (i.e. <2, 2-3, 4-6 or 7 pills per week) and categorized TFV-DP concentrations (i.e. <350, 350-699,700-1249 or ≥1250 fmol/punch) using weighted Cohen's kappa. Last, we calculated concordance between self-reported recent PrEP intake (yes/no, in past 2 days) and quantifiability of FTC-TP (yes/no) using Cohen's kappa.

RESULTS

Seven hundred and fifty-nine DBS measurements from 282 MSM were included. Self-reported PrEP intake was strongly and positively associated with TFV-DP concentration ( β = 0.77, 95% CI = 0.70-0.84, P < 0.0001). Concordance between categorized PrEP intake and TFV-DP concentration was moderate ( κ = 0.44, 95% CI = 0.39-0.50). Concordance between self-reported recent PrEP intake and FTC-TP quantifiability was perfect ( κ = 0.83, 95% CI 0.76-0.90).

CONCLUSION

Self-reported PrEP intake in a diary app is strongly correlated with actual use, and therefore reliable for comparing PrEP adherence between groups. Still, suboptimal criterion validity according to clinically relevant categories warrants caution when assessing 6-week reported adherence for individuals.

摘要

目的

我们评估了日记应用程序中自我报告的口服暴露前预防（PrEP）摄入量与红细胞内药物代谢物浓度之间的关联和一致性。

设计

AMPrEP是一项前瞻性示范研究，于2015年至2020年在荷兰阿姆斯特丹为男男性行为者提供每日和事件驱动的PrEP。

方法

参与者可以在日记应用程序中记录他们的PrEP摄入量。在第6、12、24和48个月采集干血斑（DBS），并分析二磷酸替诺福韦（TFV-DP）和三磷酸恩曲他滨（FTC-TP）的浓度。我们纳入了在之前6周中至少90%的日子完成日记记录后进行的TFV-DP测量。我们使用 Tobit 回归并为每个参与者设置随机截距，研究自我报告的PrEP摄入量（即药丸数量）与TFV-DP浓度之间的关联。我们还使用加权 Cohen's kappa计算分类的PrEP摄入量（即每周<2、2 - 3、4 - 6或7颗药丸）与分类的TFV-DP浓度（即<350、350 - 699、700 - 1249或≥1250 fmol/打孔）之间的一致性。最后，我们使用 Cohen's kappa计算自我报告的近期PrEP摄入量（是/否，过去2天内）与FTC-TP可量化性（是/否）之间的一致性。

结果

纳入了来自282名男男性行为者的759次DBS测量。自我报告的PrEP摄入量与TFV-DP浓度呈强正相关（β = 0.77，95% CI = = 0.70 - 0.84，P < 0.0001）。分类的PrEP摄入量与TFV-DP浓度之间的一致性为中等（κ = 0.44，95% CI = 0.39 - 0.50）。自我报告的近期PrEP摄入量与FTC-TP可量化性之间的一致性为完美（κ = 0.83，95% CI 为0.76 - 0.90）。