Simulation Modeling to Improve HIV/HCV Screening, Treatment and Care

描述(申请人提供)：丙型肝炎病毒相关性肝病是美国HIV感染者死亡的主要原因。目前丙型肝炎病毒感染的治疗方法疗效有限，但第一批丙型肝炎病毒蛋白水解酶抑制剂最近被FDA批准，并显著改善了治疗结果。然而，许多丙型肝炎病毒感染者并不知道自己被感染了。此外，由于有限的治疗吸收和高失访率，很少有艾滋病毒/丙型肝炎病毒混合感染的患者开始丙型肝炎病毒治疗。认识到丙型肝炎病毒对公共卫生的挑战，医学研究所和美国肝病研究协会呼吁进行研究，以确定丙型肝炎病毒筛查和护理提供的最佳策略。我们建议建立艾滋病毒/丙型肝炎病毒混合感染的数学模型，以产生急需的证据，为筛查和治疗指南提供信息，并改善患者的预后。这三个具体目标是：1.建立和验证HIV/HCV混合感染的蒙特卡罗模拟模型，该模型包括丙型肝炎病毒和HIV的筛查、与护理的联系和保留以及治疗。2.使用该模型进行和传播一系列分析，这些分析将形成所需的证据，为在直接作用于抗丙型肝炎病毒的抗病毒疗法的时代识别和管理艾滋病毒/丙型肝炎病毒混合感染的临床指南提供信息。3.进行政策分析，以确定改善获得丙型肝炎病毒治疗的优先事项，并预测广泛可用的针对丙型肝炎病毒的直接作用疗法的预算影响。拟议的具体目标将回答有关识别和治疗丙型肝炎病毒和艾滋病毒/丙型肝炎病毒混合感染的最佳战略的关键问题。该项目将开发一个持久的平台，成为在有效的丙型肝炎病毒治疗的新时代，迅速对改善丙型肝炎病毒和艾滋病毒/丙型肝炎病毒治疗的战略的比较效益和成本效益进行严格分析的首要工具。

DESCRIPTION (provided by applicant): HCV-related liver disease is a leading cause of mortality among HIV-infected individuals in the U.S. Current therapy for HCV infection has limited efficacy, but the first HCV protease inhibitors were recently approved by the FDA and have substantially improved treatment outcomes. Many HCV-infected individuals, however, are not aware that they are infected. Further, as a result of limited treatment uptake and high rates of loss to follow- up, few HIV/HCV co-infected patients ever initiate HCV therapy. Recognizing the public health challenge represented by HCV, the Institute of Medicine and American Association for the Study of Liver Diseases have called for studies to identify the best strategies for HCV screening and care delivery. We propose to build a mathematical model of HIV/HCV co-infection to generate urgently-needed evidence that will inform screening and treatment guidelines and improve patient outcomes. The three specific aims are: 1. To develop and validate a Monte Carlo simulation model of HIV/HCV co-infection that includes HCV and HIV screening, linkage to and retention in care, and treatment. 2. To use the model to conduct and disseminate a series of analyses that will develop the evidence needed to inform clinical guidelines for identifying and managing HIV/HCV co-infection in the era of directly acting antiviral therapies against HCV. 3. To conduct policy analyses that will develop priorities for improving access to HCV treatment and project the budgetary impact of widely-available directly acting therapies against HCV. The proposed specific aims will answer critical questions about the best strategies for identifying and treating HCV and HIV/HCV co-infection. The project will develop a durable platform poised to be the premier tool for rapidly conducting rigorous analyses of the comparative-effectiveness and cost-effectiveness of strategies for improving HCV and HIV/HCV care in the new era of effective HCV therapy.