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Short-course AmBisome effective against persistent leishmaniasis
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A 15-mg/kg dose of AmBisome given over 15 days in five biweekly infusions was safe and effective against post-kala-azar dermal leishmaniasis, or PKDL, a condition in which Leishmania parasites persist despite successful visceral leishmaniasis treatment, according to researchers.
Based on these findings, Margriet den Boer, MSc, PharmD, MPH, a public health specialist for Médecins Sans Frontiéres (MSF), and colleagues recommend replacing the standard 12-week miltefosine treatment for PKDL with AmBisome (amphotericin B liposome for injection, Gilead Sciences) in the Indian subcontinent, where the disease poses a “major challenge” to visceral leishmaniasis (VL) eradication.
“Compliance to 12 weeks of miltefosine has been shown to be poor, and recently, its efficacy in the treatment of both VL and PKDL was reported to decline in India and Nepal,” the researchers wrote in Clinical Infectious Diseases. “Moreover, miltefosine is difficult and expensive to obtain.”
Previously, MSF, also known as Doctors without Borders, investigated the safety and efficacy of 30 mg/kg of AmBisome administered in six doses over a 3-week period. den Boer and colleagues said the treatment appeared to be effective in more than 1,400 patients with PKDL, with 86.5% having complete or major recovery of nodular, popular and macular lesions 1 year after treatment. However, 25 patients developed rhabdomyolysis, which was likely caused by AmBisome-induced hypokalemia.
“As hypokalemia is known to be a dose-dependent side effect of AmBisome, it was assumed that halving the dose of AmBisome could result in a safe regimen for PKDL that would still be effective,” the researchers wrote. “As an extra measure of care, the total dose was divided in five doses of 3 mg/kg given over 15 days.”
In a recent observational study, den Boer and colleagues examined the outcomes of 273 patients with PDKL in Bangladesh who received the short-course AmBisome regimen. The patients, aged 12 years and older, were treated between April and November 2014 and followed for 12 months.
By the end of the follow-up period, 89.7% of patients had complete or major improvement in lesion incidence, and 78% were completely cured. Less than 5% of patients developed new lesions. Although most patients (76.4%) experienced at least one adverse event, most were mild, according to the researchers. No severe or serious adverse events were reported.
“We observed a good treatment response,” the researchers wrote. “Seeing that decreasing the total dose of AmBisome from 30 mg/kg to 15 mg/kg did not lead to decreased effectiveness in curing PKDL lesions, we propose that even shorter courses/lower doses of AmBisome may be effective in PKDL.”
Still, den Boer and colleagues concluded that the 15 mg/kg regimen is the best available option to date in the Indian subcontinent and represents “a safe, effective and feasible alternative to 12 weeks of miltefosine.” – by Stephanie Viguers
Disclosures: The authors report no relevant financial disclosures.
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