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

J. Stillo, M. Frick, J. Galarza, S. Kondratyuk, A. Makone, L. McKenna, W. Vandevelde, P. Winarni, P. Agbassi
Dec. 11, 2023, 9:47 p.m.
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A viewpoint, published in Public Health Action, advocates for transparent, accessible pre-approval access as a core element of person-centered care for drug-resistant TB.

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 addition 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.

A viewpoint, published in Public Health Action, advocates for transparent, accessible pre-approval access as a core element of person-centered care for DR-TB.

Access the full viewpoint here.