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. 2024 Nov 19;19(11):e0310773.
doi: 10.1371/journal.pone.0310773. eCollection 2024.

Introducing BPaL: Experiences from countries supported under the LIFT-TB project

D F Wares  1 , M Mbenga  1 , V Mirtskhulava  1 , M Quelapio  1 , A Slyzkyi  1 , I Koppelaar  2 , S N Cho  3 , U Go  3 , J S Lee  3 , J-K Jung  3 , D Everitt  4 , S Foraida  4 , M Diachenko  4 , S Juneja  4 , E Burhan  5 , A Totkogonova  6 , Z Myint  7 , I Flores  8 , N A Lytvynenko  9 , N Parpieva  10 , N V Nhung  11 , A Gebhard  1
Affiliations

Introducing BPaL: Experiences from countries supported under the LIFT-TB project

D F Wares et al. PLoS One. .

Abstract

Background: Previously, drug-resistant tuberculosis (DR-TB) patients were treated with long, toxic, and relatively ineffective regimens. However, in recent years, there have been major improvements made. The 2020 World Health Organization DR-TB Treatment guidelines recommended the use of a 6-months all-oral BPaL (bedaquiline, pretomanid and linezolid) regimen under operational research (OR) conditions for selected DR-TB patients.

Methods: The processes, challenges, and interim results of introducing BPaL under OR conditions in 7 countries supported under the Korea International Cooperation Agency/TB Alliance-funded "Leveraging Innovation for Faster Treatment of Tuberculosis (LIFT-TB)" project are described here. The OR objectives were to explore the feasibility of introducing the BPaL regimen, and to estimate its effectiveness and safety in a select group of DR-TB patients.

Results: Between November 2020 and the end of March 2023, a total of 574 patients had been enrolled. Interim treatment success stands at an encouraging 90.9% (280/308). Although adverse events of special interest (AESI) were common, they were manageable, and only 1 patient had to discontinue the complete BPaL treatment regimen. In addition, no unexpected adverse events (AE) were seen.

Conclusion: With careful advocacy, frequent communication with partners, and following steps to strengthen essential aspects of the delivery system, the project's experiences show that BPaL OR was feasible across different country settings. Project documents were constantly updated. The sharing of information, experiences, and interim results had a significant positive and motivating effect within and across countries. Interim OR results show excellent patient responses and are comparable to those seen under trial conditions. Although common, the observed AEs and AESIs were manageable, and no unexpected AEs were seen.

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Conflict of interest statement

I have read the journal’s policy and the following co-authors of this manuscript -S. Foraida, M. Diachenko, and S. Juneja have the following competing interests: Paid employment or consultancy with TB Alliance, the developer of pretomanid. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Patient diagnostic pathway for the BPaL OR.
Fig 2
Fig 2. Timeline of BPaL OR and programmatic introduction of BPaL-based regimens in Kyrgyzstan, 2020–2023.
See this image and copyright information in PMC

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