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Open Access Failure or relapse predictors for the STREAM Stage 1 short regimen for RR-TB

BACKGROUND: STREAM (Standardised Treatment Regimens of Anti-tuberculosis drugs for Multidrug-Resistant Tuberculosis) Stage 1 demonstrated non-inferior efficacy of a short regimen for rifampicin-resistant TB (RR-TB) compared to a long regimen as recommended by the WHO. The present paper analyses factors associated with a definite or probable failure or relapse (FoR) event in participants receiving the Short regimen.

METHODS: This analysis is restricted to 253 participants allocated to the Short regimen and is based on the protocol-defined modified intention to treat (mITT) population. Multivariable Cox regression models were built using backwards elimination with an exit probability of P = 0.157, equivalent to the Akaike Information Criterion, to identify factors independently associated with a definite or probable FoR event.

RESULTS: Four baseline factors were identified as being significantly associated with the risk of definite or probable FoR (male sex, a heavily positive baseline smear grade, HIV co-infection and the presence of costophrenic obliteration). There was evidence of association of culture positivity at Week 8 and FoR in a second model and Week 16 smear positivity, presence of diabetes and of smoking in a third model.

CONCLUSION: The factors associated with FoR outcomes identified in this analysis should be considered when determining the optimal shortened treatment regimen.

Keywords: factors predicting treatment outcome; failure or relapse; rifampicin-resistant tuberculosis; short regimen

Document Type: Research Article

Affiliations: 1: St Peter´s Tuberculosis Specialised Hospital/Global Health Committee, Addis Ababa, Ethiopia 2: MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK 3: Tuberculosis & HIV Investigative Network (THINK), Doris Goodwin Hospital, Pietermaritzburg, South Africa 4: Division of Pulmonary Medicine, Department of Internal Medicine, Wanfang Hospital, Taipei Medical University, Taipei, Taiwan, Division of Pulmonary Medicine, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan, International Union Against Tuberculosis and Lung Disease, Paris, France 5: Institute of Tropical Medicine, Antwerp, Belgium 6: Research Division, Vital Strategies, New York, USA

Publication date: August 1, 2022

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