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  • PA-583 Revolutionising tuberculosis treatment response monitoring and developing research capacity in Africa: progress and potential of the tuberculosis molecular bacterial load assay

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PA-583 Revolutionising tuberculosis treatment response monitoring and developing research capacity in Africa: progress and potential of the tuberculosis molecular bacterial load assay
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  1. Wilber Sabiiti1,
  2. Emmanuel Musisi1,
  3. Bariki Mtafya2,
  4. Peter Mbelele3,
  5. Khalide Azam4,5,
  6. Nyanda Elias Ntinginya2,
  7. Davis Kuchaka6,
  8. Mercy Kamdolozi7,
  9. Celso Khosa4,
  10. Willy Ssengooba8,
  11. Andrea Rachow9,
  12. Norbert Henreich9,
  13. Derek J Sloan1,
  14. Moses Joloba8,
  15. Gerry Davies7,10,
  16. Rob Aarnouste11,
  17. Martin Boeree11,
  18. Michael Hoelscher9,12,
  19. Gibson Sammy Kibiki6,13,
  20. Stephen H Gillespie1
  1. 1Division of Infection and Global Health, School of Medicine, University Of St Andrews, UK
  2. 2National Institute for Medical Research – Mbeya Medical Research Centre, Tanzania
  3. 3Kibong’oto Infectious Diseases Hospital, Kibong’oto, Tanzania
  4. 4National TB Reference Laboratory, Instituto Nacional de Saude Mocambique, Mozambique
  5. 5East, Central and Southern Africa Health Community, Tanzania
  6. 6Kilimanjaro Clinical Research Institute, Tanzania
  7. 7Kamuzu University of Health Sciences, Malawi
  8. 8School of Biomedical Sciences, College of Health Sciences, Makerere University, Uganda
  9. 9University Hospital, University of Munich (LMU), Division of Infectious Diseases and Tropical Medicine, Germany
  10. 10Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, UK
  11. 11Departments of lung diseases and Pharmacy, Radboud University Medical Centre, The Netherlands
  12. 12Fraunhofer ITMP, Immunology, Infection and Pandemic Research, Germany
  13. 13Africa Research Excellency Fund, UK

Abstract

Background Tuberculosis (TB) treatment is long and complex. Here we summarise data from EDCTP-funded studies of the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) as a TB treatment monitoring tool.

Methods Treatment naïve participants from four Sub-Saharan African countries were assessed for TB diagnosis and treatment response using TB-MBLA compared to liquid culture (MGIT) and other standard-of-care tests.

Results Diagnostic accuracy assessment using MGIT as gold standard showed TB-MBLA sensitivity, specificity, positive-and-negative-predictive values were 99%, 91%, 92% and 99% respectively among presumptive TB cases. TB-MBLA turn-around-time (clinic-laboratory-clinic) was <24h compared to 5–42 days of MGIT culture. 450 participants were assessed for treatment response across four studies. The pre-treatment bacillary load across cohorts was 5.33+1.33log10eCFU/mL which was cleared to zero in over 95% of the participants by month-6 of treatment. TB-MBLA revealed early bacillary load clearance in 7% (32/450) participants who achieved a stable negative TB-MBLA result by week-2 of treatment and was faster than MGIT to identify participants at a risk of disease relapse. High pre-treatment bacillary load =/>6log10eCFU/mL, was associated with failure to convert to negative by month-2 of treatment. Resolution of TB-MBLA-measured sputum bacillary load mirrored cough resolution, reduction of C-reactive protein levels in blood and correlated with MGIT culture time-to-positivity (Spearmans r= -0.5, p<0.0001) during treatment. Like MGIT, TB-MBLA demonstrated that regimens containing rifampicin-35mg/kg and rifampicin-20mg/kg-400mg-moxifloxacin cleared TB bacteria significantly faster than the standard-of-care regimen by month-2 of treatment, p=0.049 and p=0.008 respectively in DS-TB, and highlighted efficacy of bedaquiline-containing all oral regimen for DR-TB treatment. This work produced 5 African PhD graduates plus >500 clinical/laboratory scientists trained in principles of molecular diagnostic development and implementation globally.

Conclusion The data shows that TB-MBLA is a robust assay for TB treatment response monitoring and anti-TB drug development. It has contributed to research capacity building across Africa and beyond.

https://doi.org/10.1136/bmjgh-2023-EDC.241

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