HIV/AIDS Division, San Francisco General Hospital, University of California, San Francisco, CA 94110, USA.
Am J Respir Crit Care Med. 2011 Nov 15;184(10):1107-13. doi: 10.1164/rccm.201106-0995PP. Epub 2011 Aug 25.
An unprecedented number of new tuberculosis (TB) medications are currently in development, and there will be great pressure to deploy these new drugs among all populations after their efficacy is demonstrated. People living with HIV experience a large burden of TB and have a particularly pressing need for TB treatments that are shorter and less toxic. In addition, all people living with HIV now require antiretroviral therapy during TB treatment. A roadmap of the research, programmatic, and regulatory considerations includes the following: (1) inclusion of people living with HIV early in clinical trials for treatment and prevention using new TB medications, (2) prioritization of key studies of HIV-TB drug interactions and interactions between new TB agents, and (3) optimization of clinical trial infrastructure, laboratory capacity, and drug susceptibility testing.
目前,正在研发数量空前的新型结核病(TB)药物,一旦这些新药的疗效得到证实,将对所有人群的药物部署带来巨大压力。HIV 感染者承受着巨大的结核病负担,特别需要更短、毒性更小的结核病治疗方法。此外,所有 HIV 感染者现在都需要在结核病治疗期间接受抗逆转录病毒治疗。该研究、规划和监管考虑因素的路线图包括以下内容:(1)将 HIV 感染者纳入使用新型结核病药物进行治疗和预防的临床试验中,(2)优先进行 HIV-TB 药物相互作用和新型 TB 药物之间相互作用的关键研究,以及(3)优化临床试验基础设施、实验室能力和药敏试验。