Soto J et al.2004. Miltefosine for new world cutaneous leishmaniasis. Clin Infect Dis 238: 1266–1272.
Aronson N , Herwaldt BL , Libman M , Pearson R , Lopez-Velez R , Weina P , Carvalho EM , Ephros M , Jeronimo S , Magill A , 2016. Diagnosis and treatment of leishmaniasis: clinical practice guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Clin Infect Dis 63: e202–e264.
Franke ED , Wignall FS , Cruz ME , Rosales E , Tovar AA , Lucas CM , Llanos-Cuentas A , Berman JD , 1990. Efficacy and toxicity of sodium stibogluconate for mucosal leishmaniasis. Ann Intern Med 113: 934–940.
Pinart M , Rueda JR , Romero GA , Pinzón-Flórez CE , Osorio-Arango K , Silveira Maia-Elkhoury AN , Reveiz L , Elias VM , Tweed JA , 2020. Interventions for American cutaneous and mucocutaneous leishmaniasis. Cochrane Database Syst Rev 8: CD004834.
García AL, , Kindt A , Bermudez H , Llanos-Cuentas A , De Doncker S , Arevalo J , Wilber Quispe Tintaya K , Dujardin JC , 2004. Culture-independent species typing of neotropical Leishmania for clinical validation of a PCR based assay targeting heat shock protein 70 genes. J Clin Microbiol 42: 2294–2297.
Montalvo AM , Fraga J , Maes I , Dujardin JC , van der Auwera G , 2012. Three new sensitive and specific heat-shock protein 70 PCRs for global Leishmania species identification. Eur J Clin Microbiol Infect Dis 31: 1453–1461.
Bermúdez H, , Marco S , Mary R , Mauricio M , Omar L , María A , Paola T , 2005. Diagnóstico de leishmaniasis utilizando medio de cultivo TSTB en pacientes de trópico de Cochabamba. Gac Med (Guayaquil) 2005: 31–35.
Soto J , Paz D , Rivero D , Soto P , Quispe J , Toledo J , Berman J , 2016. Intralesional pentamidine: a novel therapy for single lesions of Bolivian cutaneous leishmaniasis. Am J Trop Med Hyg 94: 852–856.
Soto J , Soto P , Ajata A , Rivero D , Luque C , Tintaya C , Berman J , 2018. Miltefosine combined with intralesional pentamidine for leishmania braziliensis cutaneous leishmaniasis in Bolivia. Am J Trop Med Hyg 99: 1153–1155.
Soto J et al.2013. Intralesional antimony for single lesions of Bolivian cutaneous leishmaniasis. Clin Infect Dis 56: 1255–1260.
Soto J , Soto P , Ajata A , Luque C , Tintaya C , Paz D , Rivero D , Berman J , 2019. Topical 15% paromomycin-aquaphilic for Bolivian leishmania braziliensis cutaneous leishmaniasis: a randomized, placebo-controlled trial. Clin Infect Dis 68: 844–849.
García AL , Parrado R , Rojas E , Delgado R , Dujardin JC , Reithinger R , 2009. Leishmaniases in Bolivia: comprehensive review and current status. Am J Trop Med Hyg 80: 704–711.
Marsden PD , 1986. Mucosal leishmaniasis (“espundia” Escomel, 1911). Trans R Soc Trop Med Hyg 80: 859–876.
PAHO , 2020. Interactive Atlas of Leishmaniasis in the Americas. Clinical aspects and Differential diagnosis. Washington, DC: Pan-American Health Organization.
Cincurá C , de Lima CM , Machado PR , Oliveira-Filho J , Glesby MJ , Lessa MM , Carvalho EM , 2017. Mucosal leishmaniasis: a retrospective study of 327 cases from an endemic area of Leishmania (Viannia) braziliensis. Am J Trop Med Hyg 97: 761–766.
Cunha MA , Leão AC , de Cassia Soler R , Lindoso JA , 2015. Efficacy and safety of liposomal amphotericin B for the treatment of mucosal leishmaniasis from the new world: a retrospective study. Am J Trop Med Hyg 93: 1214–1218.
Soto J et al.2007. Treatment of Bolivian mucosal leishmaniasis with miltefosine. Clin Infect Dis 44: 350–356.
Soto J , Rea J , Valderrama M , Toledo J , Valda L , Ardiles J , Berman J , 2009. Efficacy of extended (six weeks) treatment with miltefosine for mucosal leishmaniasis in Bolivia. Am J Trop Med Hyg 81: 387–389.
Sampaio RN , Silva JS , Paula CD , Porto C , Motta JO , Pereira LI , Martins SS , Barroso DH , Freire GS , Gomes CM , 2019. A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis. Rev Soc Bras Med Trop 52: e20180292.
Oliveira LF , Schubach AO , Martins MM , Passos SL , Oliveira RV , Marzochi MC , Andrade CA , 2011. Systematic review of the adverse effects of cutaneous leishmaniasis treatment in the New World. Acta Trop 118: 87–96.
FDA , 2021. Impavido Product Insert. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204684s006lbl.pdf. Accessed August 4, 2021.
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Although infection with Leishmania braziliensis is perhaps the key reason to treat New World cutaneous leishmaniasis (CL) and mucosal leishmaniasis (ML), the total literature contains relatively few reported cases. With the aim of supplementing the meager clinical information available, we searched the records of Jorochito (Dermatology) Hospital, Bolivia, for the years 1999–2020 and identified treatment records for 1,696 naive CL patients and 355 naive ML patients. Because follow-up was poor for this real-world treatment experience in the developing world, only 255 CL patients (15%) and 114 ML patients (32%) attended follow-up at Hospital. We therefore engaged in an Active Search for “lost” patients, located a further 542 CL patients (32%) and 142 ML patients (44%), thus eventually accomplished follow up on 697 CL patients (41%) and 256 ML patients (72%). Granular adverse event data derived from hospital records is listed for the 902 CL and 86 ML patients administered Glucantime intramuscularly, the 401 CL and 202 ML patients administered Glucantime intravenously, and the 163 CL and 89 ML patients administered miltefosine orally. Efficacy was obtained from hospital records for patients seen at hospital and from patient recall communicated by telephone for the patients found in the Active Search. The overall CL cure rate was 508 of 697 CL patients (73%) with follow-up: intramuscular Glucantime—196/293 (67%); intravenous Glucantime—90/126 (71%); intralesional Glucantime—34/54 (63%); oral miltefosine—52/69 (75%). The overall ML cure rate was 161 of 256 ML patients (63%) with follow-up: intramuscular Glucantime—26/48 (54%); intravenous Glucantime—66/104 (63%); intravenous amphotericin B deoxycholate—19/35 (54%); oral miltefosine—50/71 (70%). We offer this extensive adverse event and efficacy experience as useful guides for clinicians presented with a L. braziliensis infection. The cure rates also illustrate the quandary of New World CL and ML chemotherapy: sufficiently high to be useful but nevertheless needing augmentation with new agents.
Financial support: Grant from the AB Foundation to Dr. Jaime Soto.
Disclosure: J. D. B. is an employee of Fast-Track Drugs and Biologics, which has a contractual relationship with Knight Therapeutics, the NDA sponsor of Impavido (miltefosine).
Authors’ addresses: Jaime Soto and Patricia Gutiérrez, FUNDERMA (Fundación Nacional de Dermatología) and Hospital Dermatológico de Jorochito, Santa Cruz, Bolivia, E-mails: jaime.soto@infoleis.com and pgutierrezduenas@gmail.com. Paula Soto and Mia Sánchez, FUNDERMA (Fundación Nacional Dermatología), Santa Cruz, Bolivia, E-mails: dra.paula.dermalaser@gmail.com and sanchezmia1404@gmail.com. David Paz, Hospital Dermatológico de Jorochito, Santa Cruz, Bolivia, E-mail: davidpazmendoza@hotmail.com. Eduardo Cayhuara and Carmen Molina, Programa Nacional de Leishmaniasis, Ministerio de Salud del Estado Plurinacional de, Bolivia, E-mails: eduardocayhuara@gmail.com and carmen_molina123@hotmail.com. Jonathan Berman, AB Foundation, North Bethesda, MD, and Fast-Track Drugs, Potomac, MD, E-mail: jberman@fasttrackresearch.com.
Soto J et al.2004. Miltefosine for new world cutaneous leishmaniasis. Clin Infect Dis 238: 1266–1272.
Aronson N , Herwaldt BL , Libman M , Pearson R , Lopez-Velez R , Weina P , Carvalho EM , Ephros M , Jeronimo S , Magill A , 2016. Diagnosis and treatment of leishmaniasis: clinical practice guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Clin Infect Dis 63: e202–e264.
Franke ED , Wignall FS , Cruz ME , Rosales E , Tovar AA , Lucas CM , Llanos-Cuentas A , Berman JD , 1990. Efficacy and toxicity of sodium stibogluconate for mucosal leishmaniasis. Ann Intern Med 113: 934–940.
Pinart M , Rueda JR , Romero GA , Pinzón-Flórez CE , Osorio-Arango K , Silveira Maia-Elkhoury AN , Reveiz L , Elias VM , Tweed JA , 2020. Interventions for American cutaneous and mucocutaneous leishmaniasis. Cochrane Database Syst Rev 8: CD004834.
García AL, , Kindt A , Bermudez H , Llanos-Cuentas A , De Doncker S , Arevalo J , Wilber Quispe Tintaya K , Dujardin JC , 2004. Culture-independent species typing of neotropical Leishmania for clinical validation of a PCR based assay targeting heat shock protein 70 genes. J Clin Microbiol 42: 2294–2297.
Montalvo AM , Fraga J , Maes I , Dujardin JC , van der Auwera G , 2012. Three new sensitive and specific heat-shock protein 70 PCRs for global Leishmania species identification. Eur J Clin Microbiol Infect Dis 31: 1453–1461.
Bermúdez H, , Marco S , Mary R , Mauricio M , Omar L , María A , Paola T , 2005. Diagnóstico de leishmaniasis utilizando medio de cultivo TSTB en pacientes de trópico de Cochabamba. Gac Med (Guayaquil) 2005: 31–35.
Soto J , Paz D , Rivero D , Soto P , Quispe J , Toledo J , Berman J , 2016. Intralesional pentamidine: a novel therapy for single lesions of Bolivian cutaneous leishmaniasis. Am J Trop Med Hyg 94: 852–856.
Soto J , Soto P , Ajata A , Rivero D , Luque C , Tintaya C , Berman J , 2018. Miltefosine combined with intralesional pentamidine for leishmania braziliensis cutaneous leishmaniasis in Bolivia. Am J Trop Med Hyg 99: 1153–1155.
Soto J et al.2013. Intralesional antimony for single lesions of Bolivian cutaneous leishmaniasis. Clin Infect Dis 56: 1255–1260.
Soto J , Soto P , Ajata A , Luque C , Tintaya C , Paz D , Rivero D , Berman J , 2019. Topical 15% paromomycin-aquaphilic for Bolivian leishmania braziliensis cutaneous leishmaniasis: a randomized, placebo-controlled trial. Clin Infect Dis 68: 844–849.
García AL , Parrado R , Rojas E , Delgado R , Dujardin JC , Reithinger R , 2009. Leishmaniases in Bolivia: comprehensive review and current status. Am J Trop Med Hyg 80: 704–711.
Marsden PD , 1986. Mucosal leishmaniasis (“espundia” Escomel, 1911). Trans R Soc Trop Med Hyg 80: 859–876.
PAHO , 2020. Interactive Atlas of Leishmaniasis in the Americas. Clinical aspects and Differential diagnosis. Washington, DC: Pan-American Health Organization.
Cincurá C , de Lima CM , Machado PR , Oliveira-Filho J , Glesby MJ , Lessa MM , Carvalho EM , 2017. Mucosal leishmaniasis: a retrospective study of 327 cases from an endemic area of Leishmania (Viannia) braziliensis. Am J Trop Med Hyg 97: 761–766.
Cunha MA , Leão AC , de Cassia Soler R , Lindoso JA , 2015. Efficacy and safety of liposomal amphotericin B for the treatment of mucosal leishmaniasis from the new world: a retrospective study. Am J Trop Med Hyg 93: 1214–1218.
Soto J et al.2007. Treatment of Bolivian mucosal leishmaniasis with miltefosine. Clin Infect Dis 44: 350–356.
Soto J , Rea J , Valderrama M , Toledo J , Valda L , Ardiles J , Berman J , 2009. Efficacy of extended (six weeks) treatment with miltefosine for mucosal leishmaniasis in Bolivia. Am J Trop Med Hyg 81: 387–389.
Sampaio RN , Silva JS , Paula CD , Porto C , Motta JO , Pereira LI , Martins SS , Barroso DH , Freire GS , Gomes CM , 2019. A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis. Rev Soc Bras Med Trop 52: e20180292.
Oliveira LF , Schubach AO , Martins MM , Passos SL , Oliveira RV , Marzochi MC , Andrade CA , 2011. Systematic review of the adverse effects of cutaneous leishmaniasis treatment in the New World. Acta Trop 118: 87–96.
FDA , 2021. Impavido Product Insert. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204684s006lbl.pdf. Accessed August 4, 2021.
Past two years | Past Year | Past 30 Days | |
---|---|---|---|
Abstract Views | 855 | 293 | 36 |
Full Text Views | 145 | 64 | 0 |
PDF Downloads | 180 | 62 | 0 |