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Considerations for biomarker-targeted intervention strategies for tuberculosis disease prevention

Year: 2017
Type: article
Abstract: Current diagnostic tests for Mycobacterium tuberculosis (MTB) infection have low prognostic specificity for identifying individuals who will develop tuberculosis (TB) disease, making mass preventive therapy strategies targeting all MTB-infected individuals impractical in high-burden TB countries. Here we discuss general considerations for a risk-targeted test-and-treat strategy based on a highly specific transcriptomic biomarker that can identify individuals who are most likely to progress to active TB disease as well as individuals with TB disease who have not yet presented for medical care. Such risk-targeted strategies may offer a rapid, ethical and cost-effective path towards decreasing the burden of TB disease and interrupting transmission and would also be critical to achieving TB elimination in countries nearing elimination. We also discuss design considerations for a Correlate of Risk Targeted Intervention Study (CORTIS), which could provide proof-of-concept for the strategy. One such study in South Africa is currently enrolling 1500 high-risk and 1700 low-risk individuals, as defined by biomarker status, and is randomizing high-risk participants to TB preventive therapy or standard of care treatment. All participants are monitored for progression to active TB with primary objectives to assess efficacy of the treatment and performance of the biomarker.
Source: Tuberculosis
DOI: 10.1016/j.tube.2017.11.009
Authors: Andrew Fiore-Gartland, Lindsay N. Carpp, Kogieleum Naidoo, Ethan Thompson, Daniel E. Zak, Steve Self, Gavin Churchyard, Gerhard Walzl, Adam Penn-Nicholson, Thomas J. Scriba, Mark Hatherill
Institutions: Fred Hutch Cancer Center, Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Center for Infectious Disease Research, South African Medical Research Council, University of the Witwatersrand, Aurum Institute, Stellenbosch University, University of Cape Town, South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine
Language: English
Field: Medicine
Open Access status: hybrid
Estimated APC paid: $2,193
Funders: Bill and Melinda Gates Foundation, Aeras Global Tuberculosis Vaccine Foundation, South African Medical Research Council, National Institutes of Health, Medical Research Council, National Institute of Allergy and Infectious Diseases, Center for Global Health
Awards: G1002172096, G1236082472, G1301755124, University of Cape Town - to contribute to control of the global Tuberculosis (TB) epidemic by designing a clinical trial to test a Correlates of Risk-targeted screen-and-tr..., G2508599504, G3302793891, G3364447432, G3727868965, University of Cape Town - for conference support, University of Cape Town - to identify predictive gene expression signatures of risk of tuberculosis (TB) disease, following natural infection with Mycobacterium tuberculosis..., G6125649504, G9000168304
OpenAlex ID: W2769110263
FWCI: 2.136
Cites: 39
Cited by: 28
Related to: 10