Bedaquiline monotherapy may improve skin lesions in multibacillary leprosy patients, suggests study

A new study published in The New England Journal of Medicine showed that by 4 weeks of treatment, bedaquiline monotherapy eliminated Mycobacterium leprae in individuals with multibacillary leprosy, and by 7 weeks, the skin lesions looked better.

Mycobacterium leprae infection is the cause of leprosy, also known as Hansen's disease, which is a persistent bacterial infection. The gram-positive, obligatory intracellular bacillus M. leprae, belonging to the taxonomic order Actinomycetales and family Mycobacteriaceae, is acid-fast and has a preference for Schwann cells in peripheral nerves and phagocytes in the skin.

For a full year, multidrug treatment is used to treat multibacillary leprosy. However, medication resistance and serious side effects are just 2 of the numerous difficulties that treatment faces. For the treatment of leprosy, the WHO emphasizes the need for shorter and more efficient medication regimes. The mycobacterial ATP synthase is inhibited by the diarylquinoline bedaquiline.

The severe side effects of standard multidrug therapy for leprosy may exacerbate the stigma and prejudice experienced by those who have the illness. Furthermore, the threat presented by drug-resistant leprosy highlights the need for shorter, safer multidrug treatment regimens and alternate medication combinations. Therefore, Jaison Barreto and team conducted this study in order to check the efficacy of bedaquiline in multibacillary leprosy.

This study randomized individuals with untreated multibacillary leprosy to be given bedaquiline monotherapy for 8 weeks in Brazil. Following the 8-week bedaquiline treatment, the patients began normal multidrug therapy for leprosy, as defined by the WHO, and were monitored for 112 weeks. The change from baseline in the probabilities of Mycobacterium leprae growth in mice footpads following 8 weeks of bedaquiline medication was the main outcome measure. Changes in leprosy clinical signs and symptoms as well as M. leprae molecular viability (as determined by a quantitative reverse transcriptase–polymerase chain reaction test) were among the exploratory end goals.

The modified intention-to-treat analysis comprised 9 patients in total. After 4 weeks of bedaquiline monotherapy, the probabilities of positive M. leprae growth had dropped from 100% in all patients at baseline to 0.

All skin lesions of the patients looked better after 7 weeks of therapy than they had at the beginning. During therapy, 7 patients experienced at least one adverse event, all of which were grade 1 or 2. Overall, in individuals with multibacillary leprosy, bedaquiline therapy eliminated Mycobacterium leprae after four weeks of treatment.

Source:

Barreto, J., Sammarco Rosa, P., Adams, L., Aguilar, Z., Bakare, N., Chaplan, S. R., Akli, R. D., Ernault, E., Kulke, S., Lounis, N., Millington, D., Palmer, J. A., Remmerie, B., Wang, M., Young, S., Truman, R., & Rebello, P. F. B. (2024). Bedaquiline monotherapy for multibacillary leprosy. The New England Journal of Medicine, 391(23), 2212–2218. https://doi.org/10.1056/NEJMoa2312928