January 25, 2026Open Access

Evaluation of QT prolongation and arrhythmias in drug-resistant tuberculosis patients receiving bedaquiline-containing regimen: a prospective observational study in Eastern India

Key Result

In a study of 50 drug-resistant tuberculosis patients, 12% exhibited QT prolongation without arrhythmias, while 99% showed clinical improvement and sputum conversion.

Key Points

The aim is to evaluate QT prolongation and arrhythmias in drug-resistant tuberculosis patients receiving bedaquiline treatment.
Conducted a 1-year prospective observational study with 50 participants.
Monitored QT intervals using the corrected QT interval calculated by the Fridericia formula.
Evaluated adverse events related to clinical outcomes in accordance with PMDT 2019 guidelines.
12% of patients developed QT prolongation without any observed arrhythmias.
6 patients experienced grade 1 or 2 QT prolongation without clinical symptoms.
99% of patients showed clinical improvement and sputum conversion during the study.
8 patients died during the study, all with recent negative sputum cultures.

Structured PICO

Does a bedaquiline-containing regimen cause QT prolongation and arrhythmias in patients with drug-resistant tuberculosis?

Population

50 patients with drug-resistant tuberculosis (DR-TB) in Eastern India

Intervention

Bedaquiline-containing regimen

Outcome

QT prolongation, arrhythmias, and other adverse eventssafety

Bedaquiline-containing regimens for drug-resistant TB are associated with a 12% incidence of asymptomatic QT prolongation, highlighting the need for ECG monitoring without precluding its use.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Background: Preliminary studies on bedaquiline (BDQ) for drug-resistant tuberculosis (DR-TB) treatment have shown variable incidences of QT interval changes. Validating these findings across diverse ethnic and geographic groups is essential for ensuring the safety and efficacy of BDQ therapy. Methods: A 1-year prospective observational study was conducted on a group of 50 participants. QT prolongation, arrhythmias, and other adverse events were evaluated in relation to clinical outcomes, in accordance with programmatic management of drug resistant tuberculosis (PMDT) 2019 guidelines. QT intervals were monitored using the corrected QT interval calculated by the Fridericia formula (QTcF) throughout the study period. Results: Out of 50 patients, 6 (12%) developed QT prolongation between days 4 and 10 of treatment initiation, comprising two males and four females; however, no arrhythmias were observed in these cases. Four patients had grade 1 and two had grade 2 QT prolongation without clinical symptoms or electrolyte imbalances. Treatment was temporarily paused for 4 days in one patient with a QT interval >500 milliseconds. Clinical improvement and sputum conversion occurred in 99% of patients, while 8 (16%) patients died during the study period, all with recent negative sputum cultures. Conclusion: BDQ-containing regimens are effective in DR-TB patients, though they may lead to asymptomatic QT prolongation in a limited number of cases. Further studies are recommended to generalize these findings to broader populations.