Hepatoxicity in an African HIV Treatment Cohort

描述（由申请人提供）：使用抗逆转录病毒（ARV）治疗来抑制艾滋病毒并允许免疫重建已将死亡率从机会性感染转移到慢性感染和抗逆转录病毒治疗的并发症。肝毒性是一种显著且可能致命的不良反应。最近在发展中国家迅速扩大抗逆转录病毒治疗有可能扭转目前在这些地区肆虐的艾滋病死亡率，但药物毒性可能成为规划成功的障碍。已知的肝毒性危险因素之一乙型肝炎（HBV）在非洲部分地区高度流行。除乙肝病毒外，还可能存在多种其他已知和潜在的肝毒性风险，包括酒精、传统药物和热带病。我们建议验证以下假设，即非洲与arv相关的肝毒性发生率高于北美，并且危险因素不同。本研究将测量非洲抗逆转录病毒治疗队列中肝毒性的发生率，并通过将病例与对照对照、检测血清库和进行结构化访谈来确定肝毒性的风险。它将在一个大型和正在进行的抗逆转录病毒药物队列中进行，该队列是南非工业集团和约翰霍普金斯大学之间的一个合作项目。

DESCRIPTION (provided by applicant): Use of antiretroviral (ARV) therapy to suppress HIV and allow immune reconstitution has shifted mortality from opportunistic infections to complications of chronic infections and ARV therapy. A significant and potentially fatal adverse effect is hepatotoxicity. Recent rapid expansion of ARV therapy in developing countries has the potential to reverse the AIDS mortality currently devastating these areas but drug toxicity may present a barrier to program success. One known risk factor for hepatotoxicity, hepatitis B (HBV), is hyper-endemic in parts of Africa. In addition to HBV, multiple other known and potential risks for hepatotoxicity may exist including alcohol, traditional medicines, and tropical diseases. We propose to test the hypothesis that the incidence of ARV-related hepatotoxicity is greater in Africa than in North America and that risk factors differ. This study will measure incidence of hepatotoxicity in an African ARV therapy cohort and identify risks for hepatotoxicity by matching cases with controls and testing banked serum and a administering a structured interview. It will be conducted within a large and on-going ARV cohort established as a collaborative project between a South African industrial conglomerate and Johns Hopkins University.