Active Viral Hepatitis Diagnostics to Support Prevention/Treatment of HCC

主动病毒性肝炎诊断支持 HCC 的预防/治疗

• 批准号: 8929186
• 负责人: ROBERT Leo MURPHY
• 金额: $ 44.5万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8929186
• 关键词: Ablation; Address; Africa South of the Sahara; Alcohols; Antigens; Antiviral Agents; Bedside Testings; Biological Assay; Blood specimen; Chronic; Chronic Hepatitis B; Chronic viral hepatitis; Clinic; Clinical; Clinical Sensitivity; Collaborations; Country; Detection; Development; Diagnosis; Diagnostic; Diagnostic tests; Disease; Early Diagnosis; Early treatment; Foundations; Genotype; Goals; Gold; HBV Genotype; HIV Infections; HIV-1; Health; Hepatitis B; Hepatitis B Virus; Hepatitis C; Hepatitis C virus; Immunoassay; Income; Infant; Infection; Laboratories; Lateral; Life; Life Expectancy; Malignant Neoplasms; Manufacturer Name; Marketing; Molecular; Monitor; Morbidity - disease rate; Nigeria; Nucleic Acids; Outcome; Patients; Performance; Plasma; Polymerase Chain Reaction; Prevention; Primary carcinoma of the liver cells; Reagent; Refrigeration; Resources; Reverse Transcription; Risk; Risk Factors; Sampling; Sensitivity and Specificity; Shipping; Ships; Specimen; Staging; System; Teaching Hospitals; Testing; Universities; Validation; Viral; Viral Antigens; Viral Load result; Viral Markers; Viral hepatitis; Virus Diseases; active method; amplification detection; carcinogenesis; cost; design; global health; improved; meetings; mortality; outcome forecast; performance tests; point-of-care diagnostics; rapid diagnosis; reagent testing; response; screening; standard of care; tumor; validation studies

DESCRIPTION (provided by applicant): Active Viral Hepatitis Diagnostics to Support Prevention/Treatment of HCC Hepatocellular carcinoma (HCC) is very common in sub-Saharan Africa due to highly prevalent chronic hepatitis B (HBV) and hepatitis C (HCV) viral infection. Currently, patients in sub-Saharan Africa typically present in late stage disease, having a life expectancy of just three months. Earlier diagnosis could reduce HCC mortality in two ways: 1) patients with HBV or HCV would be staged earlier and tumors, if present, would be smaller and therefore easier to treat with alcohol ablation, the current standard of care in the region; and 2) patients identified earlier with chronic HBV or HCV could be treated with direct acting antiviral agents (DAAs) leading to reduced morbidity including less HCC. The goal of this application is to develop low cost point-of-care diagnostic tests to detect and monitor the treatment of active HBV and/or HCV infections. The first test to be developed will be an HCV core antigen qualitative test to identify patients with an active HCV infection. This assay will be ported on th LYNX immunoassay platform developed in collaboration with the Northwestern Global Health Foundation (NGHF). The test conditions developed for the LYNX p24 Antigen Rapid Lateral Flow Assay for Rapid Diagnosis of HIV Infection in Infants will be adapted to address a highly analogous problem: the detection of the HCV core antigen viral marker from plasma. The second test will be a multiplexed HBV/HCV viral load assay to determine when to initiate therapy and to monitor the viral response to DAA treatment. This assay will be ported onto the Savanna integrated nucleic acid extraction, amplification & detection system that is currently being developed in collaboration with the Quidel Corporation and NGHF. The test conditions developed for the Savanna RealTime HIV-1 Assay(R) will be used for the HBV/HCV viral load assay. Both the LYNX and the Savanna platforms have been designed for use in limited resource settings. They are inexpensive, easy to operate and robust. All reagents are provided with the test kits and no refrigeration is required. The analytical and clinical performance of these assays will be demonstrated in both laboratory and clinical validation studies at the Jos University Teaching Hospital in Jos, Nigeria. The tests will be transferred to their respective manufacturers, and regulatory approval for will be sought. The impact of earlier detection and improved monitoring of viral hepatitis will prompt earlier treatment resulting in prevention of carcinogenesis and/or earlier stage diagnosis with improved outcomes in patients in low and middle income countries.

描述（由申请人提供）：活动性病毒性肝炎诊断以支持HCC的预防/治疗肝细胞癌（HCC）在撒哈拉以南非洲非常普遍，因为慢性乙型肝炎（HBV）和丙型肝炎（HCV）病毒感染非常普遍。目前，撒哈拉以南非洲的患者通常处于疾病晚期，预期寿命仅为3个月。早期诊断可以从两个方面降低HCC的死亡率：1)HBV或HCV患者可以更早地分期，如果存在肿瘤，肿瘤会更小，因此更容易用酒精消融术治疗，这是该地区目前的护理标准；和2)