Comparative effectiveness of ART for HIV in patients with comorbidities

描述（由申请人提供）：本申请涉及广泛的挑战领域（05）比较有效性研究和特定的挑战主题05-AI-102：抗逆转录病毒治疗（ART）的比较有效性。我们建议评估ART在两个具有广泛重要性的特定患者人群中的比较有效性：具有心血管危险因素或已确诊心血管疾病的老年HIV感染者，以及具有多重耐药病毒的HIV感染者。我们响应2009年美国复苏和再投资法案，提出了一个准备执行的项目，将在2年内完成，将直接导致创造2个新的工作岗位（程序员和研究助理）和保留2个额外的工作岗位（Bendavid，Sundaram）。该项目可以立即开始，因为我们将进行分析的数据目前可用。我们拥有独特的数据来源，使我们能够比以前更明确地解决这些问题。我们组建了一支由经验丰富的研究人员组成的多学科团队，他们在比较有效性、成本效益、艾滋病临床护理、统计学、卫生经济学和数学建模方面拥有丰富的专业知识。我们的分析将为临床医生、患者和政策制定者提供关于艾滋病毒感染者治疗效果的重要信息。本研究有两个目的。1.评价对有心血管危险因素或已确诊心血管疾病的老年HIV阳性个体进行治疗的相对有效性和成本效益。我们将使用退伍军人事务部（VA）HIV临床病例登记处（CCR）的55，000多名HIV患者来评估暴露于特定抗逆转录病毒药物或方案是否与心血管风险或疾病患者的不良结局相关。我们将开发一个决策模型，以评估不同方案的长期健康和经济结果。2.评价使用新型抗逆转录病毒药物（包括但不限于第二代蛋白酶抑制剂、整合酶抑制剂和进入抑制剂）治疗经治疗的多重耐药病毒HIV感染者的相对有效性和成本效益。该项目旨在改善艾滋病毒感染者的治疗选择，方法是改善患有共病或耐多药艾滋病毒患者的抗逆转录病毒治疗选择。该项目将有助于设立新职位和保留现有职位。 公共卫生相关性：本申请涉及广泛的挑战领域（05）比较有效性研究和特定的挑战主题05-AI-102：抗逆转录病毒治疗（ART）的比较有效性。该项目将比较抗逆转录病毒策略在艾滋病毒感染者的心血管风险因素或心血管疾病，并在多药耐药艾滋病毒患者。该项目将提高人们对接受抗逆转录病毒治疗与健康结果之间关系的认识，并改善有心血管风险因素和多重耐药感染的个人选择抗逆转录病毒治疗的决定。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05) Comparative Effectiveness Research, and specific Challenge Topic 05-AI-102: Comparative-effectiveness of Anti Retroviral Therapy (ART). We propose to assess the comparative effectiveness of ART in two specific patient populations of widespread importance: older HIV-infected individuals with cardiovascular risk factors or established cardiovascular disease, and HIV- infected patients with multi-drug resistant virus. We respond to the American Recovery and Reinvestment Act of 2009 by proposing a project which is ready for execution, will be completed within 2 years, will lead directly to the creation of 2 new jobs (programmer and research assistant) and the retention of 2 additional jobs (Bendavid, Sundaram). The project can begin immediately because the data on which we will perform our analyses is currently available. We have unique data sources that will enable us to address these questions more definitively than has been possible previously. We have assembled a multi-disciplinary team of highly experienced investigators with extensive expertise in comparative effectiveness, cost effectiveness, clinical care of HIV disease, statistics, health economics, and mathematical modeling. Our analyses will provide important information for clinicians, patients, and policymakers on the comparative effectiveness of treatments for individuals with HIV. This study has 2 aims. 1. To evaluate the comparative effectiveness and cost effectiveness of treatment for older HIV-positive individuals with cardiovascular risk factors or established cardiovascular disease. We will use the Department of Veterans Affairs (VA) HIV Clinical Case Registry (CCR) of more than 55,000 HIV patients to assess whether exposure to specific antiretroviral drugs or regimens is associated with poorer outcomes in patients with cardiovascular risk or disease. We will develop a decision model to evaluate long-term health and economic outcomes of different regimens. 2. To evaluate the comparative effectiveness and cost effectiveness of the use of new antiretrovirals - including but not limited to second generation protease inhibitors, integrase inhibitors, and entry inhibitors - in treatment-experienced HIV-infected individuals with multi-drug resistant virus. The project will aim to improve treatment choices for individuals with HIV by improving ART choice selection in patients with co-morbid disease or with multi-drug resistant HIV. The project will aid both in creation of new positions and retention of existing positions. PUBLIC HEALTH RELEVANCE: This application addresses broad Challenge Area (05) Comparative Effectiveness Research, and specific Challenge Topic 05-AI-102: Comparative-effectiveness of Anti Retroviral Therapy (ART). The project will compare antiretroviral strategies in HIV-infected individuals with cardiovascular risk factors or cardiovascular disease, and in patients with multi-drug resistant HIV. The project will enhance knowledge about the relationship between exposure to antiretroviral therapy and health outcomes, and improve decisions about choice of ART in individuals with cardiovascular risk factors and with multi-drug resistant infection.