Open forum infectious diseases · 2026
Incidence and Predictors of QTC Prolongation Among Drug-Resistant Tuberculosis Patients Receiving Bedaquiline-Based TB Regimens in Uganda: A Countrywide Retrospective Cohort Study.
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Nasasira Marble, Ojiambo Kevin Ouma, Iraguha Daniel, Baluku Joseph Baruch
Аннотация
BACKGROUND: Bedaquiline improves culture conversion in drug-resistant tuberculosis (DR-TB) treatment; 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% CIs 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 coinfected with HIV. The baseline mean (SD) QTc was 426.8 (28.4) ms, with a median follow-up (interquartile range) of 10.3 (7.2-13.5) months. The overall incidence of QTc prolongation was 12.0 cases per 1000 person-months (95% CI, 10.8-16.8). Lower body mass index (BMI; incidence rate ratio [IRR], 0.924; 95% CI, 0.860; IRR, 0.993; P = .031) increased 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 = .873.
CONCLUSIONS: An average of 12 new cases of QTc prolongation was observed for every 1000 person-months of accumulated observation time. The recommended monthly electrocardiogram monitoring should be emphasized among patients with low baseline BMI. QTc prolongation was not linked to poor treatment outcomes.
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% CIs 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 coinfected with HIV. The baseline mean (SD) QTc was 426.8 (28.4) ms, with a median follow-up (interquartile range) of 10.3 (7.2-13.5) months. The overall incidence of QTc prolongation was 12.0 cases per 1000 person-months (95% CI, 10.8-16.8). Lower body mass index (BMI; incidence rate ratio [IRR], 0.924; 95% CI, 0.860; IRR, 0.993; P = .031) increased 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 = .873.
CONCLUSIONS: An average of 12 new cases of QTc prolongation was observed for every 1000 person-months of accumulated observation time. The recommended monthly electrocardiogram monitoring should be emphasized among patients with low baseline BMI. QTc prolongation was not linked to poor treatment outcomes.