Linezolid in South Africa: The regulatory authority’s role in supporting access to improved treatment regimens for drug-resistant tuberculosis

Julia Hill
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引用次数: 1

Abstract

Abstract The rising incidence of drug-resistant tuberculosis (DR-TB) in South Africa is cause for concern, with doctors having limited treatment options to offer patients who face excruciating side-effects from existing medications, and poor odds of treatment success. With several newer drugs showing efficacy against DR-TB, increased possibilities exist to stem the tide of the epidemic, shorten treatment duration, and improve outcomes. To take advantage of this potential TB treatment revolution, countries must rapidly facilitate access to existing and future drugs. This requires co-ordinated action from governments, and particularly regulatory authorities, in promoting early access to new treatments, tackling intellectual property and price barriers, expediting regulatory approval, adopting and implementing up-to-date TB management policies, and engaging with research and development processes for new regimens. Doctors Without Borders expended great effort to obtain a less expensive version of the drug, linezolid, for its DR-TB pilot program in Khayelitsha, South Africa. This piece describes that experience, and subsequently offers recommendations for policy reforms which could help South Africa more rapidly access other new TB drugs in the future. The South African experience may be of relevance to other countries seeking advice on how to facilitate access to new treatments and tackle their TB epidemics.
南非的利奈唑胺:监管机构在支持获得改进的耐药结核病治疗方案方面的作用
南非耐药结核病(DR-TB)发病率的上升引起了人们的关注,因为医生为患者提供的治疗选择有限,而这些患者面临着现有药物的严重副作用,而且治疗成功的几率很低。随着几种新药显示出对耐药结核病的疗效,遏制这一流行病的趋势、缩短治疗时间和改善结果的可能性增加。为了利用这一潜在的结核病治疗革命,各国必须迅速促进获得现有和未来的药物。这需要各国政府,特别是监管机构采取协调行动,促进早期获得新疗法,解决知识产权和价格障碍,加快监管审批,采用和实施最新的结核病管理政策,并参与新疗法的研发过程。无国界医生组织花费了巨大的努力,为其在南非Khayelitsha的耐药结核病试点项目获得了一种更便宜的药物利奈唑胺。这篇文章描述了这一经验,并随后提出了政策改革建议,这些建议可以帮助南非在未来更快地获得其他新的结核病药物。南非的经验可能对其他就如何促进获得新的治疗方法和应对结核病流行寻求建议的国家具有借鉴意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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