An Assessment of Liver Disease in HIV-infected and HIV/HBV Co-infected Tanzanians

描述（由申请人提供）：拟议的研究“坦桑尼亚HIV感染者和HIV/HBV合并感染者的肝脏疾病评估”旨在评估坦桑尼亚达累斯萨拉姆HIV/HBV合并感染者以及HIV和HBV单一感染者的肝纤维化。尽管撒哈拉以南非洲（SSA）的HIV/HBV合并感染负担很高，但在这些环境中，对HIV/HBV合并感染个体的肝脏疾病的研究很少。乙肝病毒活性疗法的安全性和有效性也有待确定。感染艾滋病毒/乙型肝炎病毒的非洲人患肝病的风险可能比发达国家的合并感染者大得多，因为他们感染乙型肝炎病毒的时间比感染艾滋病毒的时间长得多，而且经常面临其他相互竞争的肝损伤风险。在本研究中，将在开始HBV活性治疗前后对HIV、HBV和HIV/HBV共感染者进行肝脏疾病检查，以确定基线时肝脏疾病的数量以及HBV活性治疗对肝脏疾病进展的影响。肝脏疾病的评估将使用两种无创血清肝纤维化和肝硬化标志物，即天冬氨酸转氨酶（AST）与血小板比值指数（APRI）和Fib-4。我们将比较HIV和HBV单一感染个体与HIV/HBV合并感染个体的结果，以确定合并感染个体（已知肝脏疾病加速）发生肝脏疾病的风险是否更高，以及他们的肝脏疾病对治疗的反应是否较差。还将评估HBV活性抗逆转录病毒替诺福韦（TDF）对HIV/HBV合并感染个体的肾毒性。该提案是同类提案中规模最大的之一，旨在改善目前对SSA这些弱势人群肝病了解的差距。

DESCRIPTION (provided by applicant): The proposed study "An Assessment of Liver Disease in HIV-infected and HIV/HBV co-infected Tanzanians" aims to assess liver fibrosis in HIV/HBV co-infected as well as HIV and HBV mono- infected individuals in Dar es Salaam, Tanzania. Despite the high burden of HIV/HBV co- infection in sub-Saharan Africa (SSA), there has been very little study of liver disease in HIV/HBV co-infected individuals in these settings. The safety and efficacy of HBV-active therapies has also yet to be determined. Africans with HIV/HBV may be at significantly greater risk of liver disease than co-infected individuals in developed countries because they are infected with HBV much longer than HIV and are frequently exposed to other competing risks of liver injury. In this study, liver disease will be examined in HIV, HBV and HIV/HBV co-infected individuals before and after initiation of HBV-active therapies to determine the amount of liver disease at baseline and the effect of HBV-active therapies on liver disease progression. Liver disease will be assessed using two non-invasive serum markers of liver fibrosis and cirrhosis, aspartate aminotransferase (AST)-to-platelet ratio index (APRI) and Fib-4. We will compare results of individuals with HIV and HBV mono-infection to those with HIV/HBV co-infection to determine whether the risk of liver disease is higher among co-infected individuals (in whom liver disease is known to be accelerated) and whether their liver disease is less responsive to therapy. Renal toxicity of the HBV-active antiretroviral tenofovir (TDF) in HIV/HBV co-infected individuals will also be assessed. This proposal, one of the largest of its kind, is aimed to improve the current gap in understanding of liver disease in these vulnerable populations in SSA.