title: Treatment of Disseminated Leishmaniasis With Liposomal Amphotericin B.
abstract: BACKGROUND
  Disseminated leishmaniasis (DL) is a severe and emerging form of American tegumentary leishmaniasis, associated primarily with infection by Leishmania brasiliensis. DL is defined by the presence of ≥10 mixed-type lesions such as inflammatory papules and ulcers, located in ≥2 body parts. Most patients have hundreds of lesions all over the body, and mucosal involvement is detected in up to 44% of cases. DL is a difficult to cure disease and pentavalent antimony (Sb(v)) is used as standard treatment, its highest dosage being 20 mg/kg/day, for 30 days. However, less than 25% of DL cases will be cured after standard therapy, and the majority of cases will require more than one course of Sb(v) for a cure. In this context, new therapies are needed that offer a higher cure rate and a better safety profile, with convenience in drug administration.
  
  
  METHODS
  We have evaluated liposomal amphotericin B in 20 patients with DL in an open clinical trial. The total dose ranged from 17 to 37 mg/kg, used in 7 to 14 days of treatment.
  
  
  RESULTS
  Cure rate at 3 months after therapy was 70%. One relapse was documented 4 months after treatment, producing a final cure rate of 65%. Although liposomal amphotericin B was considered well tolerated, mild adverse events were documented in 75% of the patients.
  
  
  CONCLUSIONS
  Liposomal amphotericin B is an effective therapy for DL, with a higher final cure rate of 75% observed when used in a total dose above 30 mg/kg.
  
  
  BACKGROUND
  NCT02025491.
authors.affiliation: Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT/CNPq), Salvador, Bahia, Brazil.
authors.forename: Paulo R L
authors.initials: PR
authors.lastname: Machado
authors.affiliation: Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia.
authors.forename: Maria Elisa A
authors.initials: ME
authors.lastname: Rosa
authors.affiliation: Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT/CNPq), Salvador, Bahia, Brazil.
authors.forename: Luís H
authors.initials: LH
authors.lastname: Guimarães
authors.affiliation: Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia.
authors.forename: Fernanda V O
authors.initials: FV
authors.lastname: Prates
authors.affiliation: Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT/CNPq), Salvador, Bahia, Brazil.
authors.forename: Adriano
authors.initials: A
authors.lastname: Queiroz
authors.affiliation: Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT/CNPq), Salvador, Bahia, Brazil.
authors.forename: Albert
authors.initials: A
authors.lastname: Schriefer
authors.affiliation: Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT/CNPq), Salvador, Bahia, Brazil.
authors.forename: Edgar M
authors.initials: EM
authors.lastname: Carvalho
mesh_terms: D000328:Adult; D000666:Amphotericin B / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D058492:Drug Repositioning; D005260:Female; D006801:Humans; D007892:Leishmania braziliensis / Q000187:drug effects*; D007896:Leishmaniasis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B
keywords: American tegumentary leishmaniasis; disseminated leishmaniasis; liposomal amphotericin B