Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis St., Boston, MA, 02115, USA.
The Fenway Institute, Fenway Health, Boston, MA, USA.
Curr HIV/AIDS Rep. 2022 Oct;19(5):433-445. doi: 10.1007/s11904-022-00625-x. Epub 2022 Sep 1.
This review summarizes the recent advancements and future directions of digital pill systems (DPS) - which utilize ingestible sensors to directly measure medication ingestion events in real-time - in the context of HIV prevention and treatment.
Two DPS are cleared by the US Food and Drug Administration. The bioequivalence and stability of digitized pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) have been established, and pilot studies have demonstrated the feasibility and acceptability of using DPS for PrEP and ART adherence measurement. Important bioethical and implementation considerations have been identified for future clinical trials. Continued technological advancement may reduce barriers to use, and integration of DPS into behavioral interventions may facilitate adherence improvement efforts. DPS represent an innovative tool for PrEP and ART adherence measurement. Future work will optimize the technology to reduce operational barriers. DPS have significant potential for expansion across a diverse array of diseases, though key bioethical considerations must be examined prior to large-scale implementation.
本综述总结了数字药丸系统（DPS）——利用可摄入传感器实时直接测量药物摄入事件——在 HIV 预防和治疗方面的最新进展和未来方向。
两种 DPS 获得美国食品和药物管理局批准。数字化暴露前预防（PrEP）和抗逆转录病毒疗法（ART）的生物等效性和稳定性已经确立，并且试点研究已经证明了 DPS 用于 PrEP 和 ART 依从性测量的可行性和可接受性。已经确定了未来临床试验的重要生物伦理和实施考虑因素。持续的技术进步可能会降低使用障碍，并且将 DPS 整合到行为干预中可能会促进依从性改善。DPS 是 PrEP 和 ART 依从性测量的创新工具。未来的工作将优化技术以减少操作障碍。DPS 在各种疾病中的应用具有巨大潜力，尽管在大规模实施之前必须检查关键的生物伦理问题。
