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Interferon-γ ELISPOT as a biomarker of treatment efficacy in latent tuberculosis infection a clinical trial

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Adetifa, I. M., Ota, M. O. C., Jeffries, D. J., Lugos, M. D., Hammond, A. S., Battersby, N. J., Owiafe, P. K., Donkor, S. D., Antonio, Martin, Ibanga, H. B., Brookes, R. H., Aka, P., Walton, Robert T., Adegbola, R. A. and Hill, P. C. (2013) Interferon-γ ELISPOT as a biomarker of treatment efficacy in latent tuberculosis infection a clinical trial. American Journal of Respiratory and Critical Care Medicine, 187 (4). pp. 439-445. doi:10.1164/rccm.201208-1352OC

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Official URL: https://doi.org/10.1164/rccm.201208-1352OC

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Abstract

Rationale: Biomarkers that can be used to evaluate new interventions against latent tuberculosis infection (LTBI) and predict reactivation TB disease are urgently required. Objectives: To evaluate ESAT-6 and CFP-10 (EC) IFN-g ELISPOT as a biomarker for treatment efficacy in LTBI. Methods: This was a randomized, blinded, and placebo-controlled trial of INH in EC ELISPOT and Mantoux test positive participants. Measurements and Main Results: Participants received a 6-month course of 900 mg INH twice weekly or a matching placebo. INH acetylator genotypes were determined and urine tested for INH metabolites to confirm adherence. The proportion of positive responders for CFP-10 and ESAT-6 between treatment armswas comparedusing mixed effects logistic regression models. A Tweedie (compound Poisson) model was fitted to allow for zero inflation and overdispersionofquantitativeresponse. The proportionsofECELISPOT- positive subjects reduced over time (P,0.001) but did not differby study arm (P = 0.36). Median spot-forming units for ESAT-6 and CFP-10 also declined significantly with time (P,0.001) but did not differby study arm (P = 0.74 and 0.71, respectively). There was no evidence of an interactionbetween acetylator status and INHtreatmentwithrespect to ELISPOT results over time. Conclusions: In contacts with LTBI, INH therapy plays no role in observed decreases in Mycobacterium tuberculosis antigen-specific T-cell responses over time. IFN-g ELISPOT is probably not a useful biomarker of treatment efficacy in LTBI. Clinical trial registered with www.clinicaltrials.gov (NCT 00130325).

Item Type: Journal Article
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET)
Faculty of Medicine > Warwick Medical School
Journal or Publication Title: American Journal of Respiratory and Critical Care Medicine
Publisher: American Thoracic Society
ISSN: 1073-449X
Official Date: 15 February 2013
Dates:
DateEvent
15 February 2013Published
25 October 2012Accepted
Volume: 187
Number: 4
Page Range: pp. 439-445
DOI: 10.1164/rccm.201208-1352OC
Status: Peer Reviewed
Publication Status: Published
Publisher Statement: cited By 23
Access rights to Published version: Open Access

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