TY -的盟Bonacini Maurizio AU -金,Yoona盟——Pitney卡罗琳盟——McKoin李盟- Tran旋律AU -兰迪斯,查尔斯PY - 2020 DA - 2020/4/30 TI -无线观察治疗依从性和目标优化干预口服丙型肝炎治疗:观测试验研究乔- J地中海互联网Res SP - e15532六世- 22 - 4 KW -慢性丙型肝炎KW - HCV KW -合规KW -持续病毒学反应KW -抗病毒药物KW - sofosbuvir AB -背景:雷地帕韦/索非布韦(LDV/SOF)固定剂量联合治疗慢性丙型肝炎病毒(HCV)感染有效;然而,在现实世界的临床环境中,对处方方案的客观依从性尚未得到很好的研究。目的:本研究旨在评估使用LDV/SOF治疗的慢性HCV感染患者的依从性和病毒学结果,使用一种新的数字医学程序,直接测量药物摄入依从性。方法:这项前瞻性、观察性、开放标签、单臂试验研究在2个临床研究地点进行,随访了处方LDV/SOF并使用可消化传感器的HCV感染患者。患者分别治疗8周或12周。主要结果是摄食依从性、医疗干预、病毒学反应、安全性和患者满意度。结果:28例患者(平均59岁,SD 7)中,61%(17/28)为男性,61%(17/28)为非白种人,93%(26/28)接受治疗naïve。所有28例患者均为基因1型HCV,其中27例完成了8或12周的治疗。患者使用数字医疗程序的天数占预期天数的92%; the overall mean ingestion adherence rate was 97%. Providers used the digital medicine program data for same-day medication therapy management in 39% (11/28) of patients. End-of-treatment response was achieved in all the available 21 of 28 patients. Sustained virologic response at 12 weeks or more was achieved in 26 of 28 patients; of the 2 patients who relapsed, one had less than 90% adherence and the other had greater than or equal to 95% adherence, lending insights into reasons for treatment failure. A total of 4 subjects reported nonserious adverse events, which were resolved. Conclusions: The findings of this study suggest that digital medicines can be used for wirelessly observed therapy to support adherence to antiviral HCV therapy, reduce unnecessary medication wastage and retreatment costs, and potentially optimize sustained virologic response rates, especially in populations at high risk for nonadherence. SN - 1438-8871 UR - //www.mybigtv.com/2020/4/e15532 UR - https://doi.org/10.2196/15532 UR - http://www.ncbi.nlm.nih.gov/pubmed/32352385 DO - 10.2196/15532 ID - info:doi/10.2196/15532 ER -
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