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Amphotericin B safe, effective for pediatric treatment of visceral leishmaniasis
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The use of short-course liposomal amphotericin B for the treatment of visceral leishmaniasis obtained in the Mediterranean demonstrated safety and efficacy in children, according to a study published in The Pediatric Infectious Disease Journal.
“The FDA recommends 3 mg/kg on days 1-5, 14 and 21 up to a total dose of 21 mg/kg for imported cases in the United States,” Panagiotis Krepis, MD, from P&A Kyriakou Children’s Hospital at the National and Kapodistrian University of Athens, and colleagues wrote. “However, a diverse range of dosing schedules is used from a single injection of 10 mg/kl for L. donovani in the Indian subcontinent to a total of 20-21 mg/kg through different regimens against L. infantum in the Mediterranean basin, where a concrete dosage regimen has not been yet established.”
To observe the efficacy and safety of short-course liposomal amphotericin B among children within the Mediterranean with visceral leishmaniasis (VL), researchers retrospectively examined cases of 43 children treated in a tertiary children’s hospital. All participants received treatments within an 11-year period, and Leishmania spp was confirmed in these patients in bone marrow samples or a serological test.
Each patient included in the study was administered five different liposomal amphotericin B regimens, with dosages ranging from 18 to 22 mg/kg. Among the 43 patients, 23 were female. Overall, mean patient age was 4.6 years.
According to study results, all patients achieved an initial response to liposomal amphotericin B treatment, and 98% of patients were cured at 6 months.
Infusion reactions, electrolyte disorders and other adverse effects were observed in 14 patients. Three patients experienced self-limiting nephrotoxicity, one of which developed acute kidney injury. One patient required discontinuation of treatment after developing ventricular arrhythmias.
The toxicity among the various dosing regimens was not statistically significant, although adverse effects were most commonly noted in the 2-day treatment.
“Previous studies conducted among children in Greece have shown high cure rates up to 98% at 6 months with the use of a 2-day scheme of 10 mg/kg/24h,” Krepis and colleagues wrote. “In our analysis, a 10 mg/kg x 2 days course was administered in the majority of cases (58.1%) with high rates of initial (100%) and definitive cure (96%), comparable to other Mediterranean studies. All other [liposomal amphotericin B] L-AmB regimens used in this study also resulted in 100% successful initial and definite outcome.”— by Katherine Bortz
Disclosure: The researchers report no relevant financial disclosures.
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