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Open Access Addressing the needs of people with extensively drug-resistant TB through pre-approval access to drugs and research

This article is Open Access under the terms of the Creative Commons CC BY licence.

Multiple therapeutic options exist for people with drug-resistant TB (DR-TB), but there is an urgent need to improve access to novel compounds and regimens for people with difficult to treat forms of TB. In additional to formal research studies and clinical trials, other mechanisms of accessing promising new TB compounds need to be introduced as soon as these drugs have shown efficacy and safety in phase II trials. Pre-approval access programs for newer TB drugs such as bedaquiline, delamanid, and pretomanid all suffered from shortcomings. These can be addressed for the next generation of new TB drugs through a series of concerted actions by stakeholders at multiple levels. In this viewpoint, we advocate for transparent, accessible pre-approval access as a core element of person-centered care for DR-TB.

Keywords: XDR-TB; compassionate use; novel TB drugs

Document Type: Research Article

Affiliations: 1: Department of Anthropology, Wayne State University, Detroit, MI, USA, Global Tuberculosis Community Advisory Board, New York, NY, USA 2: Global Tuberculosis Community Advisory Board, New York, NY, USA, Treatment Action Group, New York, NY, USA 3: Global Tuberculosis Community Advisory Board, New York, NY, USA, McGovern Medical School at the University of Texas Health Science Center, Houston, TX, USA 4: Global Tuberculosis Community Advisory Board, New York, NY, USA 5: Global Tuberculosis Community Advisory Board, New York, NY, USA, Department of Political Science, Stellenbosch University, Cape Town, South Africa 6: Global Tuberculosis Community Advisory Board, New York, NY, USA, GNP+, Cape Town, South Africa

Publication date: December 1, 2023

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