Bedaquiline Monotherapy for Multibacillary Leprosy

This proof-of-concept phase 2 trial evaluated 8 weeks of bedaquiline monotherapy in nine Brazilian patients with untreated multibacillary leprosy. The primary endpoint reduction in Mycobacterium leprae growth in mouse footpads showed clearance by week 4. All patients displayed marked clinical improvement in skin lesions by week 7. Molecular testing via qRT-PCR confirmed absence of hsp18 expression from week 4 onward. No treatment-related serious adverse events occurred. Findings support bedaquiline’s rapid bactericidal activity and highlight potential for streamlined regimens in WHO leprosy strategy targets.

This proof-of-concept phase 2 trial evaluated 8 weeks of bedaquiline monotherapy in nine Brazilian patients with untreated multibacillary leprosy. The primary endpoint reduction in Mycobacterium leprae growth in mouse footpads showed clearance by week 4. All patients displayed marked clinical improvement in skin lesions by week 7. Molecular testing via qRT-PCR confirmed absence of hsp18 expression from week 4 onward. No treatment-related serious adverse events occurred. Findings support bedaquiline’s rapid bactericidal activity and highlight potential for streamlined regimens in WHO leprosy strategy targets.