Projected Use of Pretomanid, Bedaquiline and Linezolid in All-Oral Regimens for Multi-Drug Resistant Tuberculosis from 2021-2025

Background: The World Health Organization is urging countries to facilitate access to fully oral treatment regimens for patients with drug-resistant tuberculosis (DR-TB), which remains a public health crisis. TB Alliance has developed a new 6-month, all-oral regimen for DR-TB called BPaL (comprised of bedaquiline, pretomanid and linezolid), which is recommended by WHO for use under operational research conditions for patients with XDR-TB and in patients who are either unable to tolerate or who have failed MDR-TB treatment. The objective of this study is to project the use of BPaL, along with its components bedaquiline and linezolid, in DR-TB globally until the year 2025.  Methods: We conducted semi-structured interviews with National TB Programs in key countries to gather intelligence on country targets and planned regimens for DR-TB treatment for 2021-2025, and developed a deterministic model based on this data to project the use of these drugs globally.  Results: The study projects a consistent global growth in the use of bedaquiline, linezolid and BPaL, reaching 190,752, 137,712 and 103,122 patients respectively by 2025. Further, evidence from late-stage trials such as ZeNix, SimpliciTB and TB-PRACTECAL will inform the use of pretomanid-containing regimens.  Conclusion: This study can support global health stakeholders including donors, policy makers and manufacturers with planning and budgeting for DR-TB interventions. An estimation of future usage could help us estimate cost of the individual components of DR-TB regimens at different volumes. Above all, national efforts to scale up drug susceptibility testing and implement new treatments will be essential to ensuring they are accessible to all eligible patients in the coming years. Funding Information: The authors Aastha Gupta and Christiaan Mulder received financial support from TB Alliance for the research and writing of this manuscript. The funder reviewed the analysis, methodology and the manuscript, but was not involved in data collection, data interpretation and preparation of the results. Declaration of Interests: C. Mulder and A. Gupta received support and consulting fees from TB Alliance. All other authors have no conflicts to declare. Ethics Approval Statement: Request for ethical approval or informed consent was not deemed necessary as the data collected were reflecting national projections. All respondents agreed with the publication of these data in an anonymized way.