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Review
. 2022 Sep 21;35(3):e0022721.
doi: 10.1128/cmr.00227-21. Epub 2022 Mar 21.

Tuberculosis Treatment Monitoring and Outcome Measures: New Interest and New Strategies

Jan Heyckendorf #  1   2   3   4 , Sophia B Georghiou #  5 , Nicole Frahm  6 , Norbert Heinrich  7 , Irina Kontsevaya  2   3   4 , Maja Reimann  2   3   4 , David Holtzman  5 , Marjorie Imperial  8 , Daniela M Cirillo  9 , Stephen H Gillespie  10 , Morten Ruhwald  5 ; UNITE4TB Consortium
Affiliations
Review

Tuberculosis Treatment Monitoring and Outcome Measures: New Interest and New Strategies

Jan Heyckendorf et al. Clin Microbiol Rev. .

Abstract

Despite the advent of new diagnostics, drugs and regimens, tuberculosis (TB) remains a global public health threat. A significant challenge for TB control efforts has been the monitoring of TB therapy and determination of TB treatment success. Current recommendations for TB treatment monitoring rely on sputum and culture conversion, which have low sensitivity and long turnaround times, present biohazard risk, and are prone to contamination, undermining their usefulness as clinical treatment monitoring tools and for drug development. We review the pipeline of molecular technologies and assays that serve as suitable substitutes for current culture-based readouts for treatment response and outcome with the potential to change TB therapy monitoring and accelerate drug development.

Keywords: biomarkers; outcome; treatment monitoring; tuberculosis.

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Conflict of interest statement

The authors declare a conflict of interest. S.B.G. and M.R. declare that they are employed by FIND, the global alliance for diagnostics. FIND is a not-for-profit foundation that supports the evaluation of publicly prioritized tuberculosis assays and the implementation of WHO-approved (guidance and prequalification) assays using donor grants. FIND has product evaluation agreements with several private sector companies that design diagnostics for tuberculosis and other diseases. These agreements strictly define FIND's independence and neutrality with regard to these private sector companies. N.H. reports receiving a product evaluation grant from a company developing TAM TB, and grants from EDCTP and German Center for Infection Research for product evaluations. S.H.G. reports receiving research grants to develop MBLA and also provides pro bono advice to LifeArc who are developing the assay commercially.

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