A 3-month clofazimine–rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial

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Discussion

Randomised trial assessed a new tuberculosis regimen versus standard care, suggesting potential efficacy concerns.

The 3-month clofazimine–rifapentine regimen had similar culture conversion rates to standard care, but lacked efficacy.
Adverse events were significantly higher in the clofazimine group, with 45% experiencing grade 3 or worse events.
The trial halted early due to unfavorable clinical outcomes and high adverse event rates among participants.
Primary outcomes included time to sputum culture-negative status and safety based on adverse event reports across 65 weeks.

Metcalfe et al. (2025) studied this question.

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