Comparative study on liposomal amphotericin B and other therapies in the treatment of mucosal leishmaniasis: A 15-year retrospective cohort study

Santos, Carolina Rocio Oliveira; Tuon, Felipe Francisco; Cieslinski, Juliette; Souza, Regina Maia de; Imamura, Rui; Amato, Valdir Sabbaga

doi:10.1371/journal.pone.0218786

Cited by 13 publications

(11 citation statements)

References 26 publications

(35 reference statements)

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“…Treatment outcome variations are likely related to differences in susceptibility among local L. braziliensis strains. Although systemic amphotericin B is at least non-inferior to antimony to treat L. braziliensis MCL, costs and the severity of side effects make it the second-line treatment option [148][149][150][151]. Local amphotericin options currently do not seem to increase cure rates [152].…”

Section: Treatment Of American CLmentioning

confidence: 99%

Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments

Vries

Schallig

2022

Am J Clin Dermatol

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This review is an update of an earlier narrative review published in 2015 on developments in the clinical management of cutaneous leishmaniasis (CL) including diagnosis, treatment, prevention and control measurements. CL is a vector-borne infection caused by the protozoan parasite Leishmania . The vector is the female sandfly. Globally, CL affects 12 million cases and annually 2 million new cases occur. CL is endemic in almost 100 countries and the total risk population is approximately 350 million people. WHO lists CL an emerging and uncontrolled disease and a neglected tropical disease. Local experience-based evidence remains the mainstay for the management of CL. Whereas intralesional therapeutic options are the first treatment option for most CL patients, those with mucocutaneous and disseminated involvement require a systemic therapeutic approach. Moreover, different Leishmania species can vary in their treatment outcomes. Therefore, species determination is critical for optimal CL clinical management. New DNA techniques allow for relatively easy Leishmania species determination, yet they are not easily implemented in resource-limited settings. There is a desperate need for novel, less toxic, and less painful treatment options, especially for children with CL. Yet, the large and well conducted studies required to provide the necessary evidence are lacking. To further control and potentially eliminate CL, we urgently need to improve vector control, and diagnostics, and we require efficient and safe vaccines. Alas, since CL primarily affects poor people, biotechnical companies dedicate little investment into the research programs that could lead to diagnostic, pharmaceutical, and vaccine innovations.

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Section: Treatment Of American CLmentioning

confidence: 99%

Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments

Vries

Schallig

2022

Am J Clin Dermatol

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“…This marked differences in costs of different therapies reinforces the need to determine direct medical costs, costs due to adverse events, and their efficacies in making therapeutic choices, especially in the context of public health policies. Despite the high cost, liposomal amphotericin B presents a safety profile more favorable than that of meglumine antimoniate and deoxycholate amphotericin B, thus being a unique option for some patients with comorbidities 41 . Therefore, we need to consider successful therapeutic rates and avoided deaths in a comprehensive analysis.…”

Section: Discussionmentioning

confidence: 99%

Estimating direct costs of the treatment for mucosal leishmaniasis in Brazil

Carvalho

Assis

Simões

et al. 2021

Rev. Soc. Bras. Med. Trop.

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INTRODUCTION: The objective of this study was to estimate the direct medical costs of the treatment for mucosal leishmaniasis (ML) using three therapeutic approaches in the Brazilian context. METHODS: We performed this economic assessment from the perspective of the Brazilian public healthcare system. The following therapeutic approaches were evaluated: meglumine antimoniate, liposomal amphotericin B, and miltefosine. Direct medical costs were estimated considering four treatment components: a) drug, b) combined medical products, c) procedures, and d) complementary tests. RESULTS: Treatment with meglumine antimoniate had the lowest average cost per patient (US$ 167.66), followed by miltefosine (US$ 259.92) in the outpatient treatment regimen. The average cost of treatment with liposomal amphotericin B was US$ 715.35 both in inpatient regimen. In all estimates, the drugs accounted for more than 60% of the total cost for each treatment approach. CONCLUSIONS: These results demonstrate the marked differences in costs between the therapeutic alternatives for ML. In addition to efficacy rates and costs related to adverse events, our data have the potential to support a complete cost-effectiveness study in the future. Complete analyses comparing costs and benefits for interventions will assist health managers in choosing drugs for ML treatment in Brazil as well as in establishing effective public health policies.

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“…Most studies were conducted in Brazil (17 studies), and the other countries were Bolivia (3), Peru (4), Argentina (1), Panama (1) and Ecuador (1). In total, 1,666 patients with ML were gathered, and the interventions evaluated were pentavalent antimonials [26][27][28][29], both meglumine antimonate (MA) [29][30][31][32][33][34][35][36][37][38][39][40] and sodium stibogluconate (SSG) [29,[41][42][43][44][45]; different lipid formulations of amphotericin, such as liposomal preparation (L-AMB), a lipid complex (ABLC) and a colloidal dispersion (c-AMB) [28,31,33,46,47] and deoxycholate amphotericin B (d-AMB) [28,33,48,49]; aminosidine sulfate (AS) [50,51]; pentamidine (PENT) [28,33]; miltefosine (MF) [30,32,48,52]; imidazoles (IMIDZ) [26,28,31,33,53]; and few combined therapies based on antimony derivatives and sulfa...…”

Section: Studies and Population Characteristicsmentioning

confidence: 99%

“…Several other criteria were used for classifying the disease severity, including the presence of PLOS NEGLECTED TROPICAL DISEASES extranasal involvement [38,45], presence of septum perforation [34,44,53] and number of lesions [51]. No severity classification was presented in 11 studies [26][27][28][29]36,37,41,43,46,47,49]. Nine studies presented Leishmania species identification in a variable percentage of patients [30,32,38,[42][43][44][45]48,53].…”

Section: Studies and Population Characteristicsmentioning

confidence: 99%

The cure rate after different treatments for mucosal leishmaniasis in the Americas: A systematic review

et al. 2022

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Background Mucosal or mucocutaneous leishmaniasis is the most severe form of tegumentary leishmaniasis due to its destructive character and potential damage to respiratory and digestive tracts. The current treatment recommendations are based on low or very low-quality evidence, and pentavalent antimonial derivatives remain strongly recommended. The aim of this review was to update the evidence and estimate the cure rate and safety profile of the therapeutic options available for mucosal leishmaniasis (ML) in the Americas. Methodology A systematic review was conducted in four different databases and by different reviewers, independently, to evaluate the therapeutic efficacy and toxicity associated with different treatments for ML. All original studies reporting cure rates in more than 10 patients from American regions were included, without restriction of design, language, or publication date. The risk of bias was assessed by two reviewers, using different tools according to the study design. The pooled cure rate based on the latest cure assessment reported in the original studies was calculated grouping all study arms addressing the same intervention. The protocol for this review was registered at the International Prospective Register of Systematic Reviews, PROSPERO: CRD42019130708. Principal findings Twenty-seven original studies from four databases fulfilled the selection criteria. A total of 1,666 patients with ML were treated predominantly with pentavalent antimonials in Brazil. Other interventions, such as pentamidine, miltefosine, imidazoles, aminosidine sulfate, deoxycholate and lipidic formulations of amphotericin B (liposomal, lipid complex, colloidal dispersion), in addition to combinations with pentoxifylline, allopurinol or sulfa were also considered. In general, at least one domain with a high risk of bias was identified in the included studies, suggesting low methodological quality. The pooled cure rate based on the latest cure assessment reported in the original studies was calculated grouping all study arms addressing the same intervention. It was confirmed that antimony is still the most used treatment for ML, with only moderate efficacy (possibly increased by combining with pentoxifylline). There is already evidence for the use of miltefosine for ML, with a cure rate similar to antimony, as observed in the only direct meta-analysis including 57 patients (OR: 1.2; 0.43–3.49, I2 = 0). It was possible to gather all descriptions available about adverse events reported during ML treatment, and the toxicity reflected the pattern informed in the manufacturers’ technical information. Conclusions This study provides an overview of the clinical experience in the Americas related to ML treatment and points out interventions and possible combinations that are eligible to be explored in future well-designed studies.

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Comparative study on liposomal amphotericin B and other therapies in the treatment of mucosal leishmaniasis: A 15-year retrospective cohort study

Cited by 13 publications

References 26 publications

Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments

Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments

Estimating direct costs of the treatment for mucosal leishmaniasis in Brazil

The cure rate after different treatments for mucosal leishmaniasis in the Americas: A systematic review

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