ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
The Frequency and Incidence of QT Prolongation With Extended Use of Bedaquiline or Delamanid in a Large, Multi-Country Multidrug-Resistant/Rifampicin-Resistant Tuberculosis Cohort.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of treatment regimens for drug-resistant tuberculosis in different regions: a systematic review and meta-analysis.BMC infectious diseases · 2026Pooled it
- Promethazine use and QT prolongation risk during treatment with a shortened all-oral regimen for MDR/RR-TB.JAC-antimicrobial resistance · 2026Article
- QT prolongation in participants receiving bedaquiline-containing regimens: analysis of data from Phase 3 STREAM Stage 2.IJTLD open · 2026Article
- Interim Effectiveness and Safety of Prolonged Bedaquiline Use in Comparison to Standard 24-Week Treatment for MDR-TB: A Multicenter Cohort Study in China.Infection and drug resistance · 2026Article
- Management of adverse events in TB care and active TB drug safety monitoring.Breathe (Sheffield, England) · 2026Article
- Factors influencing QT interval prolongation during rifampicin-resistant tuberculosis treatment: a multicenter real-world study from China.BMC infectious diseases · 2025Article
- New drugs for the management of tuberculosis.Current opinion in infectious diseases · 2025Review
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33 authors.
Funding
Abstract
backgroundThe 2022 World Health Organization (WHO) guidelines on multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) recommend 6 months of bedaquiline (Bdq) in the all-oral 9-month shorter regimen and 6 months or longer for Bdq and delamanid (Dlm) in the 18-20-month longer regimen. However, lack of evidence on extended treatment using Bdq or Dlm has limited their use to 6 months. We examine the frequency and incidence of QT prolongation based on duration of Bdq and/or Dlm use in longer regimens.
methodsWe analyzed a prospective cohort of MDR/RR-TB patients from 16 countries who initiated treatment with Bdq and/or Dlm containing regimens from 1 April 2015 to 30 September 2018. Data were systematically collected using a shared protocol. The outcome of interest was the first clinically relevant prolonged QT interval (grade 3 or above) or a serious adverse event (SAE) involving prolonged QT of any grade.
resultsAmong 2553 patients, 59% received >6 months of Bdq and/or Dlm. Of these, 579 (20.9%) patients experienced a prolonged QT event, the majority (95.5%) being grade 1 or 2. Sixty-four (2.5%) patients experienced the outcome of interest with only 12 (0.5%) having ≥1 QT prolonging drugs permanently suspended. The incidence rate of the first prolonged QT event was highest in the first six months of treatment and lower in subsequent 6-month periods.
conclusionsWe demonstrate that Bdq and/or Dlm use beyond 6 months is safe in longer MDR/RR-TB regimens with most clinically relevant QT prolongation events occurring in the first 6 months. Electrocardiogram (ECG) monitoring for early identification of QT prolongating events is possible in programmatic conditions.
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