Bedaquiline Monotherapy Clears Leprosy Bacteria Rapidly, claims research

The study findings reveal that in patients with multibacillary leprosy, bedaquiline monotherapy effectively cleared M. leprae within four weeks of treatment. Additionally, improvements in the appearance of skin lesions were observed by the seventh week of treatment, indicating a rapid and sustained therapeutic response. These results emphasize bedaquiline’s ability to target the bacterial burden associated with multibacillary leprosy efficiently.

Standard multidrug therapy for leprosy is often linked to severe side effects, which can exacerbate the stigma and discrimination faced by individuals with the disease. Furthermore, the growing threat of drug-resistant leprosy highlights the urgent need for alternative drug combinations and shorter, safer treatment regimens.

Bedaquiline, originally approved for drug-resistant tuberculosis, is an innovative agent that inhibits the bacterial energy production pathway by targeting the ATP synthase enzyme.

Jaison Barreto, From the Research Division, Instituto Lauro de Souza Lima, Bauru (J.B., P.S.R.), and Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta, Manaus (P.F.B.R.), Brazil, and colleagues conducted a proof-of-concept, open-label study in Brazil, assigning patients with previously untreated multibacillary leprosy to receive bedaquiline monotherapy for 8 weeks. Following this 8-week treatment, patients transitioned to standard multidrug therapy as defined by the World Health Organization and were monitored for 112 weeks.

The primary endpoint assessed was the change from baseline in the likelihood of positive Mycobacterium leprae growth in mouse footpads after 8 weeks of bedaquiline therapy. The study's secondary endpoint focused on safety, while exploratory endpoints examined changes in clinical leprosy symptoms and the molecular viability of M. leprae using quantitative reverse-transcriptase–polymerase-chain-reaction analysis.

The study revealed the following findings:

• The modified intention-to-treat analysis included nine patients.
• The odds of positive M. leprae growth decreased from 100% at baseline to no growth after 4 weeks of bedaquiline monotherapy.
• After 7 weeks of treatment, all patients showed improvement in the appearance of skin lesions compared to baseline.
• Seven patients experienced at least one adverse event during treatment, and all events were classified as grade 1 or 2.

"The findings showed that Bedaquiline monotherapy cleared M. leprae in patients with multibacillary leprosy by 4 weeks of treatment and resulted in noticeable improvement in skin lesions by 7 weeks," the researchers concluded.

Reference:

DOI: 10.1056/NEJMoa2312928