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Multidrug Therapy for Leprosy Can Cure Patients with Lobomycosis in Acre State, Brazil: A Proof of Therapy Study

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  • 1 Setor de Pós-graduação, Pesquisa e Inovação, Centro Universitário Saúde ABC, Fundação ABC, Santo André, Brazil;
  • 2 Laboratório Pesquisa do Centro Universitário Uninorte (UNINORTE), Rio Branco, Brazil;
  • 3 Serviço Estadual de Dermatologia do Acre, Programa Estadual de Dermatologia do Acre, Programa Estadual de Controle da Hanseníase (SESACRE), Rio Branco, Brazil;
  • 4 Divisão de Pesquisa e Ensino, Instituto Lauro de Souza Lima, Bauru, Brazil;
  • 5 Universidade Federal do Acre, Rio Branco, Brazil;
  • 6 Division of Infectious Diseases and Global Medicine, Department of Medicine, College of Medicine, University of Florida, Gainesville, Florida

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.

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Author Notes

Address correspondence to Patrícia Sammarco Rosa, Divisão de Pesquisa e Ensino, Instituto Lauro de Souza Lima, Rod. João Ribeiro de Barros, 17034-971 Bauru, Brazil, E-mail: prosa@ilsl.br or Gabriel Zorello Laporta, Setor de Pós-graduação, Pesquisa e Inovação, Centro Universitário Saúde ABC, Fundação ABC, Av. Lauro Gomes, 09060-870 Santo André, Brazil, E-mail: gabriel.laporta@fmabc.br.

Authors’ addresses: Franciely Gomes Gonçalves and Gabriel Zorello Laporta, Faculdade de Medicina do ABC, Setor de Pós-graduação, Pesquisa e Inovação, Santo Andre, Brazil, E-mails: francielygg@hotmail.com and gabriel.laporta@fmabc.br. Patrícia Sammarco Rosa and Andrea de Farias Fernandes Belone, Divisão de Pesquisa e Ensino, Institute Lauro de Souza Lima, Bauru, Brazil, E-mails: prosa@ilsl.br and abelone@ilsl.br. Léia Borges Carneiro, Vânia Lúcia Queiroz de Barros, Rosineide Ferreira Bispo, Yally Alves da Silva Sbardelott, and William John Woods, Serviço Estadual de Dermatologia do Acre, Programa Estadual de Controle da Hanseníase (SESACRE), Rio Branco, Brazil, E-mails: leia.borges@bol.com.br, vannyla_ice@hotmail.com, rosebispo_8@hotmail.com, yallysbardelott@hotmail.com, and william.ac@brturbo.com.br. Sebastião Afonso Viana Macedo Neves, Centro de Ciências da Saúde e do Desporto, Universidade Federal do Acre, Rio Branco, Brazil, E-mail: tiaoviana.sebastiao@gmail.com. Amy Y. Vittor, Emerging Pathogens Institute, University of Florida, Gainesville, FL, E-mail: amy.vittor@medicine.ufl.edu.

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