Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-AMC, Aurora, Colorado, USA.
Department of Biostatistics and Bioinformatics, Colorado School of Public Health, Aurora, Colorado, USA.
Pharmacotherapy. 2021 Mar;41(3):291-298. doi: 10.1002/phar.2490. Epub 2021 Jan 9.
To assess the association between tenofovir diphosphate (TFV-DP) in dried blood spots (DBS), a measure of cumulative tenofovir-based antiretroviral (ART) adherence, with medication regimen complexity in persons with human immunodeficiency virus (PWH).
Prospective clinical cohort (up to three visits over 48 weeks).
Academic-based HIV clinic.
PWH receiving tenofovir disoproxil fumarate (TDF)-based ART.
DBS for TFV-DP were collected at every study visit. Baseline patient-level medication regimen complexity index (pMRCI) scores were calculated and categorized into three sub-scores (disease-specific [ART], non-ART, and over-the-counter [OTC]). The pMRCI scores were evaluated to assess the association with TFV-DP in DBS <350 fmol/punch after adjusting for clinical covariates. pMRCI scores were also categorized to estimate the adjusted relative risk (aRR) of having a TFV-DP <350 fmol/punch between pMRCI quartiles.
Data from 525 participants (1,146 person-visits) were analyzed. Baseline median (interquartile range [IQR]) pMRCI scores for participants with TFV-DP in DBS <350 vs. ≥350 fmol/punch were 4 (3, 8) vs. 4 (2, 6) for ART, 27 (12, 31) vs. 12 (5, 22) for non-ART, and 0 (0, 1) vs. 0 (0, 2) for OTC, respectively. For the non-ART scores, the aRR for having a TFV-DP in DBS <350 fmol/punch was 6.4 (95% CI: 2.0, 20.6; P=0.002) when comparing participants in the highest pMRCI quartile with those in the lowest quartile.
Higher pMRCI for non-ART medications is associated with lower adherence as measured by TFV-DP in DBS. Future research should investigate whether reducing non-ART medication complexity improves ART adherence and exposure in PWH.
评估干血斑（DBS）中的替诺福韦二磷酸（TFV-DP），这是衡量基于替诺福韦的抗逆转录病毒（ART）药物依从性的累积量，与人类免疫缺陷病毒（HIV）感染者的药物治疗方案复杂性之间的关联。
前瞻性临床队列（48 周内最多进行三次访视）。
基于学术的 HIV 诊所。
接受富马酸替诺福韦二吡呋酯（TDF）的 HIV 感染者。
在每次研究访视时收集 DBS 以用于 TFV-DP。计算基线患者水平药物治疗方案复杂性指数（pMRCI）评分，并分为三个亚评分（特定于疾病的[ART]、非 ART 和非处方[OTC]）。评估 pMRCI 评分，以调整临床协变量后评估 DBS 中 TFV-DP <350 fmol/刺的相关性。pMRCI 评分也进行分类，以估计 pMRCI 四分位数之间 TFV-DP <350 fmol/刺的调整相对风险（aRR）。
分析了 525 名参与者（1146 人次）的数据。DBS 中 TFV-DP <350 与 ≥350 fmol/刺的参与者的基线中位数（四分位距 [IQR]）pMRCI 评分分别为 4（3，8）与 4（2，6），用于 ART，27（12，31）与 12（5，22），用于非 ART，0（0，1）与 0（0，2），用于 OTC。对于非 ART 评分，当比较最高 pMRCI 四分位数与最低四分位数的参与者时，DBS 中 TFV-DP <350 时的 aRR 为 6.4（95%CI：2.0，20.6；P=0.002）。
非 ART 药物的 pMRCI 较高与 DBS 中的 TFV-DP 测量的较低依从性相关。未来的研究应该调查减少非 ART 药物复杂性是否会改善 HIV 感染者的 ART 依从性和暴露。
