Evidence map›Paper›PMID 39375590›Full record

ArticleBMC infectious diseases2024

Bedaquiline versus injectable containing regimens for rifampicin-resistant and multidrug-resistant tuberculosis in a reference center in Brazil - a real-world evidence study using a retrospective design.

Ana Paula Santos, Cristóvão Jorge Benace, Janaina Aparecida de Medeiros Leung, Afrânio Lineu Kritski, Fernanda Carvalho de Queiroz Mello

Abstract readComparative Study
In one paragraph

Article in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Impact of new regimens and drugs on rifampin-resistant tuberculosis management in Mexico.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Ana Paula SantosThorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. anapsantos.ip@gmail.com.ORCID http://orcid.org/0000-0001-5226-4372
Cristóvão Jorge BenaceThorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID http://orcid.org/0009-0002-9977-063X
Janaina Aparecida de Medeiros LeungThorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID http://orcid.org/0000-0001-6015-9628
Afrânio Lineu KritskiThorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID http://orcid.org/0000-0002-5900-6007
Fernanda Carvalho de Queiroz MelloThorax Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.ORCID http://orcid.org/0000-0003-3250-6738

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDrug resistance (DR) is one of the several challenges to global tuberculosis (TB) control. The implementation of bedaquiline (BED) for DR-TB after more than 40 years was expected to improve treatment outcomes as well as microbiologic conversion and adverse events (AE) occurrence.

methodsRetrospective cohort study based on secondary data of patients with rifampicin-resistant (RR) or multidrug-resistant (MDR) TB reported to the Outpatient Clinic of Mycobacterial Diseases of the Thorax Diseases Institute - Federal University of Rio de Janeiro - Brazil, between 2016 and 2023. We aimed to evaluate microbiologic conversion, AE and TB treatment outcomes and compare them according to the treatment regimen used for RR/MDR-TB patients under routine conditions [Injectable Containing Regimens (ICR) versus BED Containing Regimens (BCR)]. Logistic regression and survival analysis using Cox regression and Kaplan Meier curve were used for statistical analysis.

resultsOf the 463 DR-TB patients notified during the study period, 297 (64.1%) were included for analysis (ICR = 197 and BCR = 100). Overall AEs were more frequent (83.7 vs. 16.3%, p < 0.001) and occurred earlier in the ICR group (15 days vs. 65 days, p = 0.003). There were no cases of cardiotoxicity requiring interruption of BED treatment. None of the regimens of treatment tested were associated with smear or culture conversion on Cox regression analysis (p = 0.60 and 0.88, respectively). BED-containing regimens were also associated with favorable outcomes in multivariable logistic regression [adjusted odds ratio (aOR) = 2.63, 95% confidence interval (CI)1.36-5.07, p = 0.004], as higher years of schooling, primary drug resistance, and no previous TB treatment. In the survival analysis, BCR was inversely associated with the occurrence of AE during treatment follow-up (aHR 0.24, 95% CI 0.14-0.41, p < 0.001). In addition, TB treatment regimens with BED were also associated with favorable outcomes (aHR 2.41, 95% CI 1.62-3.57, p < 0.001), along with no illicit drug use and primary drug resistance.

conclusionsThe implementation of a fully oral treatment for RR/MDR-TB in a reference center in Brazil was safe and associated with favorable outcomes under routine conditions, despite social, demographic, and behavioral factors that may influence TB treatment completion.

Indexed as

Antitubercular AgentsDiarylquinolinesRifampinTuberculosis, Multidrug-ResistantAdultBrazilFemaleHumansInjectionsMaleMiddle AgedMycobacterium tuberculosisRetrospective StudiesTreatment OutcomeYoung AdultAntitubercular AgentsbedaquilineDiarylquinolinesRifampinAdverse eventsBedaquilineMicrobiological conversionTreatment outcomeTuberculosis

Identifiers

PMID39375590
PMCPMC11457331

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.