Journal
TUBERCULOSIS
Volume 109, Issue -, Pages 61-68Publisher
CHURCHILL LIVINGSTONE
DOI: 10.1016/j.tube.2017.11.009
Keywords
Correlate of risk; Biomarker; mRNA; Study design; Tuberculosis
Categories
Funding
- Bill and Melinda Gates Foundation (BMGF) Global Health grants [OPP1021972, OPP1023483, OPP1116632, OPP1137034]
- National Institutes of Health [RO1-AI087915]
- TB Collaborating Centre grant from the South African Medical Research Council [SAMRC-RFA-CC: TB/HIV/AIDS-01-2014]
- Strategic Health Innovation Partnerships (SHIP) Unit of the South African Medical Research Council
- South African Department of Science and Technology
- Aeras
- BMGF [GC 6-74, 37772, GC 12, 37885]
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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.
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