Hepatoxicity in an African HIV Treatment Cohort

描述（由申请人提供）：使用抗逆转录病毒（ARV）治疗抑制HIV并允许免疫重建，已将死亡率从机会性感染转变为慢性感染和ARV治疗的并发症。一个显著的和潜在的致命的不良反应是肝毒性。最近发展中国家抗逆转录病毒治疗的迅速扩展有可能扭转目前破坏这些地区的艾滋病死亡率，但药物毒性可能是项目成功的障碍。肝毒性的一个已知危险因素是B型肝炎（HBV），在非洲部分地区高度流行。除HBV外，可能存在多种其他已知和潜在的肝毒性风险，包括酒精、传统药物和热带疾病。我们建议检验这一假设，即非洲抗逆转录病毒相关肝毒性的发病率高于北美，而且风险因素不同。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组相匹配、检测库存血清和进行结构化访谈来识别肝毒性的风险。它将在一个大型和正在进行的抗逆转录病毒队列中进行，该队列是南非一家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.