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.

“艾滋病毒载量项目的护理点技术”（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的补充 （C-THAN）合作协议（U 54 EB 027049）。POC-HVL将扩大其目前的开发管道， 艾滋病毒/艾滋病及其多种疾病的产品，并将开发一个基于需求的护理点管道， 对改善艾滋病毒/艾滋病感染者管理至关重要的技术，具体侧重于 可以在护理点测量血浆HIV RNA（病毒载量）的技术。POC-HVL将利用C- THAN在美国和非洲的专业知识、研究经验和临床网络。 联合国艾滋病规划署（UNAIDS）制定了雄心勃勃的95-95-95目标， 实现95%的艾滋病毒病例的检测，95%的病例得到治疗，95%的病例得到病毒抑制， 到2025年治疗这些人，到2030年结束艾滋病毒/艾滋病流行病。取得重大进展 然而，在过去20年中，控制艾滋病毒流行的努力在许多领域取得了进展， 这些国家没有达到艾滋病规划署的目标。2019年，全球约有170万人成为 感染艾滋病毒，69万人死于艾滋病毒相关疾病。在以下方面有了实质性的改善： 对感染患者的诊断以及整体仿制药定价的显著改善。估计费用 TDF/3 TC/DTG联合治疗的一年疗程现在是59美元。药物治疗的总费用 在所有164个有治疗计划的国家，每年将有20亿美元;而全球在艾滋病毒上的支出 制药业是280亿美元，这是一个可行的前景。然而，缺乏广泛可用的测试， 可以衡量治疗效果的方法。目前的标准是以分子为基础的，主要是在中央 实验室，相对昂贵。需要准确、快速和更便宜的病毒载量检测， 即时护理在填补这一差距之前，艾滋病规划署的目标不可能实现。C-THAN将作为 支持产品开发POC技术的平台，以有效满足这一未满足的需求， 监测和记录目前艾滋病毒治疗方案的成功。这样的产品也可以作为 有效的诊断工具，能够诊断非常早期的感染和18个月以下儿童感染。 C-THAN结构将在项目开发中纳入临床和用户需求，同时提供 专业知识和资源，以解决商业化和实施的早期障碍。其核心 各组成部分将以综合方式运作，以提供一定范围的工作，包括：1）与 相关的科学家，医生，研究人员和工程师; 2）开发必要的技术，临床， 工业和监管伙伴关系，以及3）现场原型POC设备的测试。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， 协助实现艾滋病规划署在全世界消除艾滋病毒感染的目标。