The Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN)

西北大学艾滋病毒/艾滋病护理点技术创新中心 (C-THAN)

• 批准号: 10689433
• 负责人: SALLY Maureen MCFALL
• 金额: $ 118.49万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2023-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10689433
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Administrative Supplement; Africa; Age-Months; Area; Caring; Child; Clinical; Collaborations; Combined Modality Therapy; Country; Detection; Development; Devices; Diagnosis; Engineering; Epidemic; Expenditure; Generic Drugs; Goals; HIV; HIV Infections; Industrialization; Infection; Lamivudine; Measures; Medical Care Costs; Mission; Molecular; Monitor; Morbidity - disease rate; National Institute of Biomedical Imaging and Bioengineering; Patients; Persons; Pharmacologic Substance; Physicians; Plasma; Point of Care Technology; Price; RNA; Research; Research Personnel; Resources; Scientist; Structure; Technology; Testing; Treatment Efficacy; U-Series Cooperative Agreements; United Nations; United States; Universities; Viral; Viral Load result; Work; antiretroviral therapy; base; commercialization; cost estimate; diagnostic tool; experience; improved; innovation; pandemic disease; point of care; programs; prototype; success; treatment program

“The Point-of-Care Technologies for HIV Viral Load Program” (POC-HVL) is an administrative supplement to the Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN) Cooperative Agreement (U54 EB027049). POC-HVL will expand its current development pipeline of products for HIV/AIDS and its many morbidities and will develop a pipeline of needs-based, point-of-care technologies critical for improving the management of persons living with HIV/AIDS by specifically focusing on technologies that can measure plasma HIV RNA (viral load) at point-of-care. POC-HVL will harness the C- THAN expertise, research experience and clinical networks in the United States and Africa. The United Nations Program on HIV and AIDS (UNAIDS) has set the ambitious 95-95-95 goal to achieve detection of 95% of HIV cases, treatment for 95% of those cases, and viral suppression for 95% of those treated by 2025 and ending the HIV/AIDS pandemic by 2030. Significant progress has been made in controlling the HIV epidemic in the past 20 years, however, success in many areas has lagged and many countries have not reached the UNAIDS targets. In 2019, approximately 1.7 million people worldwide became infected with HIV, and 690,000 died from HIV-related illnesses. There has been substantial improvement in diagnosing infected patients and a significant improvement in overall generic drug pricing. The estimate cost of a one year course of TDF/3TC/DTG combination therapy is now $59. The total cost for that medical therapy in all 164 countries with treatment programs would be $2 billion annually; while global expenditure on HIV pharmaceuticals is $28 billion, this is now a feasible prospect. Lacking however, are broadly available tests that can measure treatment efficacy. The current standard is molecular-based, mostly performed in central labs, and relatively expensive. There is a need for accurate, rapid, and less expensive viral load testing at the point-of-care. Until this gap is filled, UNAIDS targets are unlikely to be achieved. C-THAN will serve as a platform for the support of products to develop POC technologies that address this unmet need to effectively monitor and document success of the current HIV treatment programs. Such a product can also serve as an effective diagnostic tool capable of diagnosing very early infection and infection in children <18 months of age. The C-THAN structure will incorporate clinical and user needs in project development while providing expertise and resources to address early barriers to commercialization and implementation. Its Core components will operate in an integrated manner to deliver a scope of work, entailing: 1) collaboration with relevant scientists, physicians, researchers, and engineers; 2) development of essential technical, clinical, industrial, and regulatory partnerships, and 3) testing of prototype POC devices in the field. The POC-HVL program will have a major impact on the management of persons treated with antiretroviral therapies and will assist in the UNAIDS goal of eliminating HIV infection worldwide.

“艾滋病病毒载量护理技术计划”(POC-HVL)是一项行政管理计划。 西北大学艾滋病毒/艾滋病护理点技术创新中心补充资料 合作协议(U54 EB027049)。POC-HVL将扩大其目前的开发管道 针对艾滋病毒/艾滋病及其许多疾病的产品，并将开发一条根据需要提供护理点的管道 对改善艾滋病毒/艾滋病患者管理至关重要的技术，具体侧重于 可以在护理地点测量血浆艾滋病毒RNA(病毒载量)的技术。POC-HVL将利用C- 比美国和非洲的专业知识、研究经验和临床网络更重要。 联合国艾滋病规划署(艾滋病规划署)将雄心勃勃的95-95-95目标定为 实现95%的艾滋病毒病例检测、95%的病例治疗和95%的病毒抑制 到2025年接受治疗，到2030年结束艾滋病毒/艾滋病大流行。在以下方面取得了重大进展 然而，在过去的20年里，在控制艾滋病毒流行方面，许多领域的成功是滞后的，许多 各国尚未达到联合国艾滋病规划署的目标。2019年，全球约有170万人成为 有690,000人死于与艾滋病毒有关的疾病。在以下方面有了实质性的改善 诊断受感染的患者，以及整体仿制药价格的显著改善。估算成本 TDF/3TC/DTG联合治疗一年的疗程现在是59美元。这种药物治疗的总成本 在所有164个国家实施治疗方案的国家每年将达到20亿美元；而全球用于艾滋病毒的支出 制药是280亿美元，这现在是一个可行的前景。然而，缺乏广泛可用的测试 这可以衡量治疗效果。目前的标准是基于分子的，主要在中央 实验室，而且相对昂贵。需要准确、快速且成本较低的病毒负载测试 护理点。在填补这一空白之前，联合国艾滋病规划署的目标不太可能实现。C-Than将作为一个 支持产品开发PoC技术的平台，以有效满足这一未得到满足的需求 监测和记录当前艾滋病毒治疗方案的成功情况。这样的产品还可以用作 有效的诊断工具，能够诊断早期感染和18个月大儿童的感染。 C-Than结构将在项目开发中纳入临床和用户需求，同时提供 解决商业化和实施的早期障碍的专门知识和资源。它的核心 组件将以集成的方式运行，以提供工作范围，包括：1)与 相关科学家、内科医生、研究人员和工程师；2)开发必要的技术、临床、 行业和监管伙伴关系，以及3)在现场测试PoC设备原型。POC-HVL 该计划将对接受抗逆转录病毒治疗的人的管理产生重大影响，并将 协助实现联合国艾滋病规划署在全球消除艾滋病毒感染的目标。