Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa
Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa
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DOI：
10.1186/s12879-018-3080-2
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发表时间：
2018-04-11
影响因子：
3.7
通讯作者：
O'Donnell, M. R.
中科院分区：
文献类型：
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作者：
Bionghi, N.;Daftary, A.;O'Donnell, M. R.
背景：贝达喹啉是 40 多年来第一种新型抗分枝杆菌药物，它的推出凸显了耐药结核病 (DR-TB) 治疗中坚持用药的重要性，以防止耐药性放大并获得持续获益。实时电子剂量监测 (EDM) 可准确测量依从性，并允许滴定抗逆转录病毒治疗 (ART) 的依从性支持。本研究的目的是评估下一代电子药盒 (Wisepill RT2000) 对于含贝达奎林的结核病治疗方案的准确性和可接受性。方法：符合条件的患者是在南非夸祖鲁-纳塔尔省住院接受含贝达奎林治疗方案的耐药结核病/艾滋病毒合并感染成人。采用单向交叉设计来评估 EDM 的依从性和患者接受程度。连续三周为每位患者提供了一个 Wisepill 装置，其中充满了 ART、左氧氟沙星或贝达喹啉。使用 Wisepill 计数、患者报告的 7 天回忆和每周药丸计数来衡量药物依从性。研究结束时的开放式定性调查问卷评估了参与者对 Wisepill 装置的可接受性。结果：我们招募了 21 名 21 名 DR-TB/HIV 合并感染住院患者，他们从 2016 年 8 月到 9 月开始接受贝达奎林治疗。总体而言，根据药丸计数，患者对贝达奎林 (100%) 的依从性与左氧氟沙星 (100%) 和 ART (98.9%) 的依从性相似。与 7 天回忆 (0%) 相比，Wisepill 在检测不依从事件方面更敏感 (100%) (p = 0.02)。患者报告了使用 Wisepill 的积极体验，并表示愿意在整个耐药结核病治疗过程中使用该设备。无需担心耻辱、保密或远程监控。结论：在这项试点研究中，通过所有依从性措施，患者对贝达奎林的依从性很高。然而，通过药丸计数和 Wisepill 得出的 ART 依从性较低，表明 ART 依从性可能面临挑战。使用 EDM 发现的漏服剂量明显多于 7 天召回。 Wisepill 受到南非耐药结核病/艾滋病毒患者的高度认可，是支持和监测复杂治疗方案中药物依从性的一种有前景的方式。
Background: The introduction of Bedaquiline, the first new antimycobacterial drug in over 40 years, has highlighted the critical importance of medication adherence in drug-resistant tuberculosis (DR-TB) treatment to prevent amplified drug-resistance and derive sustained benefit. Real-time electronic dose monitoring (EDM) accurately measures adherence and allows for titration of adherence support for anti-retroviral therapy (ART). The goal of this study was to evaluate the accuracy and acceptability of a next-generation electronic pillbox (Wisepill RT2000) for Bedaquiline-containing TB regimens.Methods: Eligible patients were DR-TB/HIV co-infected adults hospitalized for the initiation of Bedaquiline-containing treatment regimens in KwaZulu-Natal, South Africa. A one-way crossover design was used to evaluate levels of adherence and patient acceptance of EDM. Each patient was given a Wisepill device which was filled with ART, Levofloxacin or Bedaquiline over three consecutive weeks. Medication adherence was measured using Wisepill counts, patient-reported seven-day recall, and weekly pill count. An open-ended qualitative questionnaire at the end of the study evaluated participant acceptability of the Wisepill device.Results: We enrolled 21 DR-TB/HIV co-infected inpatients admitted for the initiation of Bedaquiline from August through September 2016. In aggregate patients were similarly adherent to Bedaquiline (100%) compared to Levofloxacin (100%) and ART (98.9%) by pill count. Wisepill was more sensitive (100%) compared to seven-day recall (0%) in detecting non-adherence events (p = 0.02). Patients reported positive experiences with Wisepill and expressed willingness to use the device during a full course of DR-TB treatment. There were no concerns about stigma, confidentiality, or remote monitoring.Conclusion: In this pilot study patients were highly adherent to Bedaquiline by all adherence measures. However, there was lower adherence to ART by pill count and Wisepill suggesting a possible challenge for adherence with ART. The use of EDM identified significantly more missed doses than seven-day recall. Wisepill was highly acceptable to DR-TB/HIV patients in South Africa, and is a promising modality to support and monitor medication adherence in complex treatment regimens.