Key result
Moxifloxacin-clofazimine linked to ~45% higher QTc prolongation risk vs levofloxacin-clofazimine in rifampicin-resistant TB.
Why the study?
Effective rifampicin-resistant tuberculosis regimens often include multiple QT-prolonging drugs, necessitating evaluation across different combinations for cardiotoxicity.
Does a moxifloxacin and clofazimine regimen increase the risk of QTc prolongation compared to a levofloxacin and clofazimine regimen in patients with rifampicin-resistant tuberculosis?
Cohort (n=410)
Does a moxifloxacin and clofazimine regimen increase the risk of QTc prolongation compared to a levofloxacin and clofazimine regimen in patients with rifampicin-resistant tuberculosis?
Hazard Ratio: 1.45 (95% CI 1.01–2.07)
Absolute Event Rate: 48.4% vs 31.1%
p-value: p=0.044
In patients with rifampicin-resistant tuberculosis, a regimen containing moxifloxacin and clofazimine significantly increases the risk of QTc prolongation compared to a levofloxacin-based regimen, necessitating close ECG monitoring.
Prompts closer QTc monitoring with moxifloxacin-clofazimine in rifampicin-resistant tuberculosis; extends insufficient safety data but leaves regimen choice open.
OBJECTIVES: Effective rifampicin-resistant tuberculosis (RR-TB) regimens often include multiple QT-prolonging drugs, necessitating evaluation across different combinations. METHODS: Using pooled electrocardiogram data from two trials, three QT-prolonging shorter regimens for RR-TB were studied: the injectable-containing regimen comprising moxifloxacin and clofazimine (Mfx/Cfz), a levofloxacin-based regimen with clofazimine (Lfx/Cfz), and a bedaquiline-containing regimen with clofazimine (Bdq/Cfz). The prevalence and severity of corrected QT interval (QTc) prolongation between regimens were compared, and risk factors were evaluated. RESULTS: Among 410 RR-TB participants, significant QTc prolongation was reported in 48.4% (78/161) of participants receiving the Mfx/Cfz regimen, 31.1% (51/164) receiving the Lfx/Cfz regimen, and 34.1% (29/85) receiving the Bdq/Cfz regimen. Nearly half of the significant QTc prolongation events occurred within 4 months of treatment. Seven episodes of symptomatic arrhythmia were documented. Compared with the Lfx/Cfz regimen, the Mfx/Cfz regimen was associated with an increased risk of significant QTc prolongation (adjusted hazard ratio 1.45, 95% confidence interval 1.01-2.07, P = 0.044). Additionally, pre-existing thyroid disease, cavitation, and older age were identified as independent risk factors of significant QTc prolongation. CONCLUSION: The Mfx/Cfz combination was associated with an elevated risk of QTc prolongation. Close electrocardiogram monitoring throughout the entire treatment course is advised in patients receiving such combination.
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Zhang et al. (2026) conducted a cohort in Rifampicin-resistant tuberculosis (RR-TB) (n=410). Moxifloxacin and clofazimine (Mfx/Cfz) regimen vs. Levofloxacin-based regimen with clofazimine (Lfx/Cfz) was evaluated on Significant QTc prolongation (HR 1.45, 95% CI 1.01-2.07, p=0.044). The moxifloxacin/clofazimine regimen was associated with an increased risk of significant QTc prolongation compared with the levofloxacin/clofazimine regimen (HR 1.45; 95% CI 1.01-2.07; P=0.044).
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