Global Alliance for TB Drug Development, New York, New York 10005, USA.
Int J Tuberc Lung Dis. 2011 Jun;15(6):746-53. doi: 10.5588/ijtld.10.0094.
The current tuberculosis (TB) treatment landscape has been studied extensively, but researchers rarely consider how it creates challenges or opportunities for future regimen change.
In 166 stakeholder interviews in the TB high-burden countries (HBCs), we investigated areas of first-line TB treatment and control that would affect, and be affected by, a future TB regimen change. Responses were compared with existing standardized data.
Public sector regimens are converging towards a single standard, which facilitates comparison with a single control arm from clinical trials. However, final product design is challenging if the goal is fixed-dose combinations and patient kits, whose current widespread use addresses continuing weaknesses in drug management. Any product must address broad groups, as relatively low levels of drug susceptibility testing (DST) do not allow for individualized therapy. Finally, the protection of new drugs from the development of resistance will be challenging, as the implementation of directly observed therapy and public-private mix programs is incomplete, and substantial private sectors have been identified as early adopters of these drugs.
Health systems for TB treatment and control must be improved not only to allow better implementation of current treatments but also to set the stage for implementation of new, improved TB regimens.
目前对结核病（TB）治疗领域进行了广泛的研究，但研究人员很少考虑它如何为未来的治疗方案改变带来挑战或机遇。
在结核病高负担国家（HBC）的 166 个利益攸关方访谈中，我们调查了影响和受一线结核病治疗和控制的领域，这些领域将影响未来的结核病治疗方案改变。将答复与现有标准化数据进行了比较。
公共部门的治疗方案正在趋同于单一标准，这有利于与临床试验中的单一对照臂进行比较。然而，如果目标是固定剂量组合和患者包，则最终产品设计具有挑战性，因为目前广泛使用这些产品解决了药物管理方面的持续弱点。任何产品都必须针对广泛的人群，因为药物敏感性测试（DST）水平相对较低，不允许进行个体化治疗。最后，由于直接观察治疗和公私混合方案的实施不完整，并且已确定大量私营部门是这些药物的早期采用者，因此保护新药免受耐药性的发展将具有挑战性。
结核病治疗和控制的卫生系统不仅必须加以改善，以便更好地实施现行治疗方法，而且还必须为实施新的、改进的结核病治疗方案奠定基础。
