Comparison of Individual Regimen Containing Bedaquiline with Delamanid and Bedaquiline without Delamanid on Efficacy and Safety in MDR-TB Patients

Who

• Participants: 103 patients with multidrug-resistant tuberculosis (MDR-TB).

• Groups:

  • 26 patients received bedaquiline (Bdq) with delamanid

  • 77 patients received Bdq without delamanid

• Key characteristics: Diabetes mellitus was significantly more common in the Bdq–delamanid group (61.5% vs. 29.9%).

• Exclusions: Patients with baseline QTc >470 ms, hypoalbuminemia, electrolyte disturbances, hyperthyroidism, HIV, renal failure, or heart disease treated with furosemide/digoxin.

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What

• Focus: Comparison of efficacy (AFB sputum conversion and culture conversion) and safety (QTc interval prolongation) between Bdq-containing regimens with vs. without delamanid.

• Findings:

  • No statistically significant differences in AFB conversion, culture conversion, or QTc interval changes between groups.

  • Time to AFB and culture conversion was numerically faster in the Bdq–delamanid group, but not significant.

  • QTc prolongation incidence was lower in the Bdq–delamanid group, but also not significant.

• Conclusion: Regimens containing Bdq with delamanid demonstrated similar efficacy and safety compared with Bdq regimens without delamanid.

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When

• Study period: January 2021 to July 2023.

• Follow-up: Clinical, microbiological, and QTc data monitored up to the 6th month of treatment.

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Where

• Setting: Dr. Soetomo General Academic Hospital, Indonesia.

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Why

• To evaluate whether adding delamanid to Bdq-based individualized MDR-TB regimens improves treatment outcomes or increases cardiac risk, particularly when drugs from Groups A and B are limited or cannot be used.

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How

• Design: Observational analytic study with a retrospective approach.

• Sampling: Convenience sampling of complete medical records.

• Diagnostics: MDR-TB confirmed using GeneXpert MTB/RIF, line probe assays, and MGIT 960 culture-based drug susceptibility testing.

• Outcomes measured:

  • AFB sputum conversion

  • Mycobacterium tuberculosis culture conversion

  • QTc interval changes and QTc prolongation (≥470 ms)

• Analysis: Comparative statistical analysis between the two treatment groups across monthly evaluations.

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Overall interpretation:
An individualized MDR-TB regimen containing bedaquiline with delamanid provides comparable efficacy and safety to regimens without delamanid. Delamanid may be a preferred Group C option when drugs from Groups A and B are unavailable or unsuitable.

Sumber: Soedarsono, S., Mertaniasih, N.M., Kusmiati, T., Permatasari, A., Subay, S. and Adiono, S.H., 2024. Comparison of Individual Regimen Containing Bedaquiline with Delamanid and Bedaquiline without Delamanid on Efficacy and Safety in Multidrug-resistant Tuberculosis Patients: Implementation in Dr. Soetomo General Academic Hospital, Indonesia. The International Journal of Mycobacteriology, 13(2), pp.140-146.