Three-Month Clofazimine–Rifapentine Regimen for Drug‑Susceptible TB Failed to Improve Outcomes and Raised Safety Concerns: Lessons from Clo‑Fast (Phase 2c)
Highlights
– The Clo‑Fast randomized phase 2c trial compared a 3‑month rifapentine–clofazimine containing regimen (with a 2‑week clofazimine loading dose) to the standard 6‑month isoniazid‑rifampicin regimen for drug‑susceptible pulmonary tuberculosis.
– By week 12, sputum culture conversion rates were similar (≈89% in the experimental arm vs 90% control), but the trial was stopped early because the 3‑month regimen produced significantly more grade 3+ adverse events and a higher probability of unfavourable outcomes by week 65 (52% vs 27%).
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