Cost-Effectiveness Analysis of Thermotherapy Versus Pentavalent Antimonials for the Treatment of Cutaneous Leishmaniasis

Arias, Jaiberth Antonio Cardona; Carvajal, Liliana López; Tamayo, Mery Patricia; Vélez, Iván Darío

doi:10.2139/ssrn.3202879

Cited by 2 publications

(2 citation statements)

References 30 publications

(22 reference statements)

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“…guyanensis [ 1 , 4 ]. The standard treatment is still parenteral injections of meglumine antimoniate, 20 mg/kg/day/20 days, despite its cost (USD 60–550 per course) [ 7 ], variable efficacy of between approximately 36% and 95%, and toxicity [ 8 – 10 ]. Miltefosine, 2.5 mg/kg/day for 28 days is also available, but is only used in cases where subjects do not respond to meglumine antimoniate or its use is contraindicated [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

A phase II study to evaluate the safety and efficacy of topical 3% amphotericin B cream (Anfoleish) for the treatment of uncomplicated cutaneous leishmaniasis in Colombia

et al. 2018

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BackgroundPentavalent antimonials (Sb5) are the first-line drugs for treating cutaneous leishmaniasis in Colombia; however, given problems with toxicity, compliance, availability, and cost, it is imperative to look for better therapeutic options. Intravenous amphotericin B (AmB) has been used extensively to treat visceral leishmaniasis; however, evidence on its topical use for cutaneous leishmaniasis is limited. Anfoleish is a topical formulation based on 3% AmB, which was developed following GMP standards by HUMAX and PECET. Anfoleish was shown to be safe and efficacious in animal model and in an open label study in CL patients. Hereafter we show the results of the first controlled and randomized study assessing the safety and efficacy of Anfoleish administered topically, two or three times per day for 28 days, for the treatment of non-complicated cutaneous leishmaniasis in Colombia.MethodsAn open-label, randomized, non-comparative phase Ib/II clinical trial was performed. Adult volunteers with a parasitologically confirmed diagnosis of cutaneous leishmaniasis were randomly allocated to receive Anfoleish cream either 3 (TID group) or 2 (BID group) times per day for 4 weeks.Results80 out of 105 subjects screened were included in the study. In intention to treat analysis, final cure was observed in 13 (32.5%) out of 40 subjects (IC 95% = 20.1–48) and in 12 (30%) out of 40 subjects (IC 95% = 18.1–45.5) in the BID and TID group respectively. In the per protocol analysis, cure rates were 39.4% (n = 13) (IC 95% = 24.7–56.3) and 35.3% (n = 12) (IC 95% = 21.5–52.1) in the BID and TID groups respectively. Anfoleish proved to be safe, and the few adverse events reported were local, around the area of application of the cream, and of mild intensity.ConclusionAnfoleish showed to be a safe and well-tolerated intervention. Its efficacy results however do not support at this time continuing with its clinical development or recommending it for the treatment of CL. Additional, studies to improve its current formulation are needed before thinking in conducting additional studies in patients.Trial registrationRegistered in clinicaltrials.gov NCT01845727.

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Section: Introductionmentioning

confidence: 99%

A phase II study to evaluate the safety and efficacy of topical 3% amphotericin B cream (Anfoleish) for the treatment of uncomplicated cutaneous leishmaniasis in Colombia

et al. 2018

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“…The authors highlighted that according to the WHO-CHOICE criteria, treatment in Chaparral is not a cost-effective health intervention and may not even be justifiable from an economic point of view. Cardona-Arias et al 13 compared the cost effectiveness of thermotherapy and pentavalent antimonial for the treatment of CL. The thermotherapy showed average cost-effectiveness ratios ranging between $187 and $390, and Glucantime between $721 and $1,275.…”

Section: Economic Analysis Of Treatmentmentioning

confidence: 99%

Economic evaluations addressing diagnosis and treatment strategies for neglected tropical diseases: an overview

Assis

Rabello²,

Cota³

2021

Rev. Inst. Med. trop. S. Paulo

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Cost-Effectiveness Analysis of Thermotherapy Versus Pentavalent Antimonials for the Treatment of Cutaneous Leishmaniasis

Cited by 2 publications

References 30 publications

A phase II study to evaluate the safety and efficacy of topical 3% amphotericin B cream (Anfoleish) for the treatment of uncomplicated cutaneous leishmaniasis in Colombia

A phase II study to evaluate the safety and efficacy of topical 3% amphotericin B cream (Anfoleish) for the treatment of uncomplicated cutaneous leishmaniasis in Colombia

Economic evaluations addressing diagnosis and treatment strategies for neglected tropical diseases: an overview

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