Treatment of Leishmaniasis
The recommended treatment for leishmaniasis depends on the clinical form (visceral, cutaneous, or mucosal) and should be tailored based on the infecting Leishmania species, geographic region, and patient factors, with liposomal amphotericin B (L-AmB) being the first-line therapy for visceral leishmaniasis in immunocompetent persons. 1
Visceral Leishmaniasis (VL) Treatment
First-line Treatment
- For immunocompetent persons with VL, liposomal amphotericin B (L-AmB) is recommended with an FDA-approved dosage regimen of 3 mg/kg/day IV on days 1-5,14, and 21 (total dose: 21 mg/kg) 1
- Higher doses (≥40 mg/kg) may be necessary for VL acquired in East Africa 1
- For immunosuppressed persons with VL (including HIV/AIDS), L-AmB is recommended at 4 mg/kg/day IV on days 1-5,10,17,24,31, and 38 (total dose: 40 mg/kg) 1
- Single-dose L-AmB (10 mg/kg) has shown 97% final cure rate in Bangladesh, demonstrating its potential use in resource-limited settings 2
Alternative Treatments
- For VL caused by L. donovani acquired in South Asia in patients ≥12 years, weighing ≥30 kg, and not pregnant/breastfeeding, oral miltefosine (2.5 mg/kg/day, maximum 150 mg in 3 divided doses for 28 days) is an alternative 1, 3
- Pentavalent antimonial therapy (20 mg SbV/kg/day IV or IM for 28 days) is recommended for VL in areas with low antimony resistance (<10%) 1, 4
- Amphotericin B lipid complex may be considered for patients who develop liposome-induced complement activation-related pseudoallergy to L-AmB 1
Cutaneous Leishmaniasis (CL) Treatment
- Treatment choice depends on Leishmania species, lesion location, number and size of lesions, and risk of mucosal involvement 1
- Miltefosine is FDA-approved for CL caused by L. braziliensis, L. guyanensis, and L. panamensis 3
- Pentavalent antimonials remain effective in many regions at 20 mg SbV/kg/day for 20 days 4
- Treatment success should be monitored by clinical parameters: lesion flattening, >50% size decrease by 4-6 weeks, and reepithelization of ulcerative lesions by approximately 3 months 1
Mucosal Leishmaniasis (ML) Treatment
- All persons with clinically manifest, metastatic American ML should receive systemic antileishmanial therapy 1
- Treatment options include:
- Pentavalent antimonials (20 mg SbV/kg daily, IV or IM, for 28-30 days) 1
- Amphotericin B deoxycholate (0.5-1.0 mg/kg per dose, IV, daily or every other day, for a cumulative total of 20-45 mg/kg) 1
- Liposomal amphotericin B (cumulative total dose ranging from 20-60 mg/kg) 1
- Miltefosine (approximately 2.5 mg/kg/day, maximum 150 mg/day for 28 days) 1, 3
Special Considerations
Therapeutic Failure
- Monitor CL lesions for 6-12 months after treatment 1
- Additional therapy is recommended when new lesions develop, existing lesions worsen, or incomplete healing occurs by 3 months after treatment completion 1
- For VL that doesn't respond to L-AmB, consider an alternative drug, higher dose, or longer course of L-AmB 1
HIV Co-infection
- Initiate or optimize antiretroviral therapy as soon as the patient is stable enough to tolerate it 1
- Consider combination therapy (e.g., L-AmB plus miltefosine) for refractory cases 1
- Higher doses and longer durations of therapy may be needed depending on immunosuppression level 1
Pregnancy
- Miltefosine is contraindicated in pregnancy due to embryo-fetal toxicity 3
- Obtain a serum or urine pregnancy test before prescribing miltefosine to females of reproductive potential 3
- Females should use effective contraception during miltefosine therapy and for 5 months after completion 3
Monitoring Treatment Response
- For VL, clinical parameters correlate well with parasitologic responses and should be used to monitor treatment 1
- For CL, the first sign of healing is usually flattening of the skin lesion 1
- By 4-6 weeks after treatment, lesion size should decrease by >50%, ulcerative lesions should be reepithelializing, and no new lesions should appear 1
- Ulcerative lesions are generally fully epithelialized and clinically healed by approximately 3 months after treatment 1