Treatment of Visceral Leishmaniasis in an Immunocompetent Host

This protocol applies to patients presenting with clinical and laboratory evidence of visceral leishmaniasis (VL) who are immunocompetent — that is, without any identified congenital or acquired immune defect, including HIV/AIDS.

Clinical Scenario

Patient Profile

The patient meets clinical and laboratory criteria for VL and has no underlying immunodeficiency. Treatment is indicated when both clinical abnormalities compatible with VL and laboratory evidence of VL are present. An immunocompetent host is specifically one without a congenital or acquired immune defect such as HIV/AIDS.

Treatment Approach

For an immunocompetent patient, the recommended first-line treatment involves a parenteral antifungal agent, with select alternative agents — oral or parenteral — available based on the geographic region where infection was acquired and individual patient characteristics.

Full regimen details — including agent selection, sequencing, and alternatives — are in the complete structured protocol.

References

DOI: 10.4269/ajtmh.16-84256

We recommend that persons with clinical abnormalities compatible with VL and laboratory evidence of VL be treated (Table 3).
An immunocompetent person is defined as someone without an identified congenital or acquired immune defect (eg, HIV/AIDS).
For an immunocompetent person with VL, treatment with liposomal amphotericin B (L-AmB) is recommended. The FDA-approved dosage regimen is 3 mg/kg/day IV on days 1–5, 14, and 21 (total dose, 21 mg/kg) (Table 3).
For an immunocompetent person with VL caused by L. donovani, acquired in the Indian subcontinent (South Asia), who is ≥12 years of age, weighs ≥30 kg, and is not pregnant or breastfeeding, treatment with the oral agent miltefosine, 2.5 mg/kg per day (maximum, 150 mg, in 3 divided doses) for 28 days, is a possible alternative to L-AmB, particularly in persons weighing <75 kg (see XXVI and Table 3).
Pentavalent antimonial therapy (20 mg SbV/kg/day IV or IM for 28 days) is a recommended therapy for immunocompetent persons with VL acquired in areas where the prevalence of antimony-resistant Leishmania species is low (<10%).

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