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

描述(申请人提供)：这项拟议的研究“艾滋病毒感染者和艾滋病毒/乙肝病毒混合感染者的肝病评估”旨在评估坦桑尼亚达累斯萨拉姆艾滋病毒/乙肝病毒混合感染者以及艾滋病毒和乙肝病毒单一感染者的肝纤维化。尽管撒哈拉以南非洲(SSA)艾滋病毒/乙肝病毒混合感染的负担很重，但在这些环境下，关于艾滋病毒/乙肝病毒混合感染者肝病的研究很少。乙肝病毒活性疗法的安全性和有效性也有待确定。与发达国家的共同感染者相比，携带艾滋病毒/乙肝病毒的非洲人患肝病的风险可能要大得多，因为他们感染乙肝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脏损伤风险。在这项研究中，将在启动乙肝病毒活性疗法之前和之后对艾滋病毒、乙肝病毒和艾滋病毒/乙肝病毒混合感染者进行肝病检查，以确定基线时的肝病数量以及乙肝病毒活性疗法对肝病进展的影响。肝脏疾病的评估将使用肝纤维化和肝硬变的两个非侵入性血清标志物，天冬氨酸氨基转移酶(AST)/血小板比率指数(APRI)和Fib-4。我们将比较艾滋病毒和乙肝病毒单一感染者和艾滋病毒/乙肝病毒混合感染者的结果，以确定混合感染者(已知肝病加速)患肝病的风险是否更高，以及他们的肝病对治疗的反应是否较差。还将评估具有乙肝病毒活性的抗逆转录病毒药物替诺福韦(TDF)对艾滋病毒/乙肝病毒混合感染者的肾脏毒性。这项提案是此类提案中最大的一项，旨在改善目前在SSA这些脆弱人群中对肝病的了解差距。

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.