2/6 COMpAAAS U01: Observation Study

2/6 COMPAAAS U01：观察研究

• 批准号: 9767633
• 负责人: Amy Caroline Justice
• 金额: $ 100.07万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-10 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9767633
• 关键词: Adverse effects; Adverse event; Adverse reactions; Age; Aging; Alcohol consumption; Alcohols; Bacterial Pneumonia; Biological Markers; Chronic; Cirrhosis; Clinical Data; Cohort Studies; Collaborations; Data; Data Analyses; Data Collection; Delirium; Drug Interactions; HIV; HIV Infections; HIV/HCV; Hepatitis C; Hepatitis C Therapy; Hepatitis C virus; Hospitalization; Individual; Infection; Intervention; Literature; Measurement; Measures; Medical; Methodology; Modeling; Observational Study; Outcome; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Physiological; Polypharmacy; Process; Provider; Reporting; Risk; Safety; Scoring Method; Systematic Bias; Techniques; Telephone; Text; Time; Veterans; alcohol exposure; alcohol use disorder; antiretroviral therapy; design; eHealth; experience; falls; frailty; human old age (65+); innovation; interactive therapy; mortality; personalized care; phosphatidylethanol; response; treatment response; virology

Summary Among those with HIV infection (HIV+) on antiretroviral therapy (ART), polypharmacy is three times more common than among those without infection and occurs 10 years earlier. Likely due to greater physiologic frailty, polypharmacy (5+ chronic medications) among those with HIV is also associated with greater mortality. Potentially inappropriate medications (PIMs) are those which likely cause more harm than benefit due to drug interactions and adverse reactions and these increase with polypharmacy. While criteria for PIMs among 65+ year olds (Aging PIMs) are established, they have not been validated among HIV+ individuals. Further, ART and alcohol use also increase PIMs. We do not know which non ART pharmacotherapies (co medications) are helpful and which are actually harmful among HIV+ who drink. Conversely, HIV and alcohol use may also be a barrier to receipt of helpful co medications. In the face of limited evidence, providers may be reluctant to treat Alcohol Use Disorder (AUD) with medications among HIV+ individuals due to safety concerns. Further, alcohol use is a relative contraindication for HCV treatment. As a result, drinkers may choose to under report alcohol use to gain access to direct acting agents (DAAs) but may experience more harm and less benefit. We draw on the rich, longitudinal clinical data in the Veterans Aging Cohort Study and enhance it with strategic additional data collection and innovative techniques to correct for systematic error in measurement and confounding by indication. We will quantify the impact of Aging, ART and Alcohol PIMs and of pharmacotherapies for AUD and HCV on patient salient outcomes (PSOs) including mortality, hospitalization, medically significant falls, bacterial pneumonia, and delirium to inform prioritization of medications and limit harm from polypharmacy among HIV+ individuals. Our study is timely and innovative. Polypharmacy is the norm, AUD is under treated, and DAAs for HCV have only recently become available. While others have quantified PIMs, we will measure their actual impact on PSOs. We will also measure the benefit from pharmacotherapy for AUD and HCV among HIV+ and uninfected individuals who drink. These studies will be instrumental in the design of eHealth interventions facilitating personalized care and simplification of co medications among HIV+ individuals (see U24s CHAMP & RIB).

概括 在接受抗逆转录病毒治疗 (ART) 的艾滋病毒感染者 (HIV+) 中，多重用药是其三倍 比未感染者更常见，且发生时间早 10 年。可能是由于更大的生理 HIV 感染者的虚弱、多重用药（5 种以上慢性药物）也与更高的死亡率相关。 潜在不当药物 (PIM) 是指因药物造成的弊大于利的药物 相互作用和不良反应，并且这些随着多药治疗而增加。而 65 岁以上 PIM 的标准 岁（老龄 PIM）已建立，但尚未在 HIV+ 个体中得到验证。此外，艺术 饮酒也会增加 PIM。我们不知道哪些非 ART 药物疗法（联合药物）是 对于艾滋病病毒感染者来说，哪些饮酒是有帮助的，但实际上是有害的。相反，艾滋病毒和饮酒也可能是一个 接受有用的联合药物的障碍。面对有限的证据，提供者可能不愿意治疗 出于安全考虑，艾滋病病毒感染者中的酒精使用障碍（AUD）与药物相关。此外，酒精 使用是 HCV 治疗的相对禁忌症。因此，饮酒者可能会选择少报酒精含量 用于获得直接作用剂 (DAA)，但可能会受到更多伤害而获益更少。我们画 退伍军人衰老队列研究中丰富的纵向临床数据，并通过战略性增强它 额外的数据收集和创新技术，以纠正测量和测量中的系统误差 通过指示混淆。我们将量化老龄化、ART 和酒精 PIM 的影响以及 AUD 和 HCV 药物治疗对患者显着结果 (PSO) 的影响，包括死亡率、住院治疗、 医学上严重的跌倒、细菌性肺炎和谵妄，以告知药物的优先顺序和限制 HIV+ 个体中多重用药的危害。我们的研究是及时且创新的。复方药物是 正常情况下，AUD 治疗不足，而针对 HCV 的 DAA 直到最近才出现。虽然其他人有 量化 PIM，我们将衡量它们对 PSO 的实际影响。我们还将衡量以下好处： HIV+和未感染饮酒者中针对 AUD 和 HCV 的药物治疗。这些研究将 有助于设计电子卫生干预措施，促进个性化护理和简化医疗服务 HIV+ 个体的药物治疗（参见 U24s CHAMP 和 RIB）。