1. Multidrug Therapy for Leprosy Can Cure Patients with Lobomycosis in Acre State, Brazil: A Proof of Therapy Study.
- Author
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Gonçalves FG, Rosa PS, de Farias Fernandes Belone A, Carneiro LB, Queiroz de Barros VL, Bispo RF, Alves da Silva Sbardelott Y, Viana Macedo Neves SA, Vittor AY, Woods WJ, and Laporta GZ
- Subjects
- Adult, Aged, Aged, 80 and over, Biopsy, Brazil epidemiology, Drug Therapy, Combination statistics & numerical data, Female, Humans, Lacazia pathogenicity, Leprosy epidemiology, Lobomycosis epidemiology, Male, Middle Aged, Skin microbiology, Skin pathology, Time Factors, Treatment Outcome, Young Adult, Drug Therapy, Combination methods, Lacazia drug effects, Leprostatic Agents therapeutic use, Leprosy drug therapy, Lobomycosis drug therapy
- Abstract
Lobomycosis, also referred to as lacaziosis, is an endemic cutaneous and subcutaneous fungal disease that mainly affects Amazonian forest dwellers in Brazil. There is no disease control program in place in Brazil, and antifungal therapy failures are common, and the therapy is inaccessible to most patients. We performed a randomized, unblinded clinical trial testing the cure rate of multiple drug therapy (MDT) for leprosy with surgical excision, with or without itraconazole. A control arm consisted of patients who did not adhere to either therapeutic regimens but continued to be followed up. Multiple drug therapy consisted of monthly supervised doses of 600 mg rifampicin, 300 mg clofazimine, and 100 mg dapsone, in addition to daily doses of 50 mg clofazimine and 100 mg dapsone. The patients in the MDT plus itraconazole arm also received itraconazole 100 mg twice daily. We followed up 54 patients from the MDT group and 26 patients from the MDT plus itraconazole group for an average of 4 years and 9 months. The 23 controls were followed up for 6 months on average. The following endpoints were observed: 1) unchanged (no apparent improvement), 2) improved (reduction in lesion size and/or pruritus), and 3) cured (complete remission of the lesions, no viable fungi, and no relapse for 2 years after the end of the drug treatment). The results indicated a significantly greater likelihood of cure associated with the use of multidrug therapy for leprosy with or without itraconazole when compared with the control group. The addition of itraconazole to MDT was not associated with improved outcomes, suggesting that MDT alone is effective.
- Published
- 2020
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