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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
QT prolongation in the STREAM Stage 1 Trial
International Journal of Tuberculosis and Lung Disease, Volume 26, No. 4, Year 2022
Notification
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Description
BACKGROUND: STREAM (Standardized Treatment Regimen of Anti-TB Drugs for Patients with MDRTB) Stage 1 demonstrated non-inferior efficacy of a shortened regimen (the Short regimen) for rifampicinresistant TB (RR-TB) compared to the contemporaneous WHO-recommended regimen. This regimen included moxifloxacin and clofazimine, known to cause QT prolongation, and severe prolongation was more common on the Short regimen. Here we investigate risk factors for QT prolongation with the Short regimen. METHODS : Data from patients prescribed the Short regimen (n=282) were analysed to identify risk factors for severe QT prolongation (QT/QTcF ≥500 ms or ≥60 ms increase in QTcF from baseline). RESULT S : Of the 282 patients on the Short regimen, 94 (33.3%) developed severe QT prolongation: 31 QT/ QTcF ≥500 ms; 92 experienced ≥60 ms QTcF increase from baseline. The median time to QT/QTcF ≥500 ms was 20 weeks (IQR 8-28), and the time to ≥60 ms increase from baseline was 18 weeks (IQR 8-28). Prolongation ≥500 ms was most frequent in patients from Mongolia (10/22, 45.5%) compared with 3.5- 11.9% at other sites, P < 0.001. Higher baseline QTcF increased risk of prolongation to ≥500 ms (QTcF ≥400 ms: OR 5.99, 95% CI 2.04-17.62). CONCLUS ION: One third of patients on the Short regimen developed severe QT prolongation. QT/QTcF ≥500 ms was more common in patients from Mongolia and in those with a higher baseline QTcF, which may have implications for implementation of treatment. © 2022 The Union.
Authors & Co-Authors
Hughes, Gareth
United Kingdom, London
Medical Research Council
Bern, Henry
United Kingdom, London
Medical Research Council
Chiang, Chenyuan
Taiwan, Taipei
Taipei Medical University
France, Paris
International Union Against Tuberculosis and Lung Disease
Goodall, Ruth L.
United Kingdom, London
Medical Research Council
Nunn, Andrew J.
United Kingdom, London
Medical Research Council
Rusen, I. D.
United States, New York
Vital Strategies
Meredith, Sarah K.
United Kingdom, London
Medical Research Council
Statistics
Citations: 9
Authors: 7
Affiliations: 4
Identifiers
Doi:
10.5588/ijtld.21.0403
ISSN:
10273719
Research Areas
Infectious Diseases