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.
|Journal||International Journal of Tuberculosis and Lung Disease|
|Number of pages||7|
|Publication status||Published - 2022|
- Antitubercular Agents/therapeutic use
- Rifampin/therapeutic use
- Treatment Outcome
- Tuberculosis, Multidrug-Resistant/drug therapy
- Tuberculosis, Pulmonary/drug therapy