Impact of line probe assay-based molecular testing on individualized treatment in patients with rifampicin-resistant tuberculosis : data from the prospective INNOVA4TB cohort study in Ukraine
Dudnyk, Andrii (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Hempel, M.
Lytvyniuk, O.
Liudkevych, H.
Matsera, V.
Nikitchenko, T.
Blyzniuk, S.
Molina-Moya, Barbara (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Preyer, R.
Domínguez, José (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Universitat Autònoma de Barcelona

Fecha:	2024
Resumen:	Background: Ukraine remains a high World Health Organization priority country for drug-resistant tuberculosis (TB). Rifampicin-resistant TB (RR-TB) has a more protracted, more complicated, and more expensive treatment. In 2021, Ukraine reported 4025 RR-TB cases - 5. 4 times more (751) than all 30 European Union/ European Economic Area countries together. Objectives: The objective of the study was to determine the diagnostic accuracy of line probe assay (LPA), AID Autoimmun Diagnostika GmbH, for detecting resistance to anti-TB drugs and its clinical application for selecting treatment regimens. Design: A prospective observational cohort study. Methods: From May 2019 to June 2020, we consecutively enrolled patients with active TB hospitalized at the Regional Phthisiopulmonology Center (Vinnytsia, Ukraine), aged between 18 and 82 years. The LPA was performed in the Genetic Research Laboratory at National Pirogov Memorial Medical University, Vinnytsia, Ukraine. Results: A total of 84 clinical specimens and 97 culture isolates from 126 TB patients were tested during the study. Accuracy (95% confidence interval) of LPA for clinical samples in comparison with phenotypic drug susceptibility test (DST) was 80. 1 (68. 5-89. 0) for isoniazid (H), 74. 7 (62. 4-84. 6) for rifampicin (R), 74. 4 (62. 5-84. 1) for ethambutol, 71. 4 (41. 9-91. 6) for streptomycin, 84. 6 (62. 4-96. 5) for prothionamide/ethionamide, and 84. 6 (73. 6-92. 3) for levofloxacin (Lfx), respectively. We found a significantly higher sensitivity of LPA for H, R, and Lfx for the culture isolates compared to clinical specimens (p < 0. 05). LPA detected different mutations in 6 out of 17 (35. 5%) patients susceptible to R by Xpert. A shorter treatment regimen with an injectable agent demonstrated a low suitability rate of 5% (8/156) in a cohort of RR-TB patients from Ukraine. Conclusion: Initial LPA testing accurately identifies resistance to anti-TB drugs and facilitates the selection of an appropriate treatment regimen, minimizing exposure to empirical therapy.
Ayudas:	Instituto de Salud Carlos III PI19/01408 Instituto de Salud Carlos III PI22/01834
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	TB treatment ; Drug-resistant tuberculosis ; Line probe assay ; Molecular diagnostics
Publicado en:	Therapeutic Advances in Respiratory Disease, Vol. 18 (1-12 2024) , ISSN 1753-4666

DOI: 10.1177/17534666241249841
PMID: 38817020

18 p, 850.2 KB

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