Key result
Higher BMI linked to ~8% lower risk of bedaquiline-induced QTc prolongation per unit increase.
Why the study?
Bedaquiline improves culture conversion in DR-TB treatment but its main safety concern is QTc prolongation, especially when combined with other anti-TB drugs.
Cohort (n=532)
Yes
Bedaquiline-based regimens for DR-TB are associated with a notable incidence of QTc prolongation, particularly in patients with low BMI, warranting routine ECG monitoring despite not negatively impacting overall treatment success.
Answers are grounded in this paper and cite their sources.
QTc prolongation at 12/1,000 person-months linked to low BMI but not treatment failure; supports targeted monitoring yet leaves optimal strategies open in programmatic settings.
Background Bedaquiline improves culture conversion in drug-resistant tuberculosis (DR-TB) treatment, but its main safety concern is QTc prolongation, particularly when combined with other anti-TB drugs. This study assessed the incidence and predictors of QTc prolongation among DR-TB patients receiving Bedaquiline under programmatic conditions in Uganda. Methods We conducted a retrospective cohort study using medical records from 14 DR-TB treatment sites across Uganda (January 2017–December 2022). Data on demographics, clinical characteristics, Bedaquiline-based regimens, treatment duration, and QTc intervals were collected. Incidence rates with 95% confidence interval (CI) were calculated for QTc prolongation, while modified Poisson regression was used to identify predictors of QTc prolongation. Results Data were abstracted from 532 patients, 70.9% of whom were male. The mean (SD) age was 41.4 (±15.9) years, and 34.6% were co-infected with HIV. The baseline mean (SD) QTc was 426.8 (±28.4) ms, with a median follow-up of 10.3 months (IQR: 7.2–13.5). The overall incidence of QTc prolongation was 12.0 cases per 1,000 person-months (95% CI: 10.8–16.8). Lower BMI (IRR: 0.924 95% CI: 0.860, 0.993, p-value:0.031) increases risk of QTc prolongation. Treatment success was similar among patients with and without QTc prolongation: 73.9% (51/69) vs. 68.3% (316/463), p = 0.873. Conclusions An average of 12 new cases of QTc prolongation were observed for every 1,000-person months of accumulated observation time. The recommended monthly ECG monitoring should be emphasized among patients with low baseline BMI. QTc prolongation was not linked to poor treatment outcomes.
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Nasasira et al. (2026) conducted a cohort in Drug-resistant tuberculosis (DR-TB) (n=532). Bedaquiline-based TB regimens was evaluated on Incidence and predictors of QTc prolongation (predictor: Body Mass Index) (IRR 0.924, 95% CI 0.860-0.993, p=0.031). Among patients with drug-resistant tuberculosis receiving Bedaquiline, the incidence of QTc prolongation was 12.0 cases per 1,000 person-months, with lower BMI significantly increasing this risk (IRR 0.924; P=0.031).
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