What is the recommended treatment for leishmaniasis?

Treatment of Leishmaniasis

The recommended treatment for leishmaniasis should be individualized based on the clinical syndrome (cutaneous, mucosal, or visceral), infecting Leishmania species, and host factors, with systemic therapy required for visceral and mucosal forms, while cutaneous leishmaniasis may be managed with local or systemic approaches depending on complexity. 1

Treatment Options by Clinical Syndrome

Visceral Leishmaniasis (VL)

• Liposomal amphotericin B (L-AmB) is the first-line therapy for visceral leishmaniasis in immunocompetent persons, with an FDA-approved dosage regimen of 3 mg/kg/day IV on days 1-5,14, and 21 (total dose: 21 mg/kg) 2
• For immunosuppressed persons with VL, including those with 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) 2
• In areas with low antimony resistance (<10%), pentavalent antimonials such as sodium stibogluconate (SSG) may be used at 20 mg SbV/kg/day IV or IM for 28 days 2
• Higher doses (≥40 mg/kg) of L-AmB may be necessary for VL acquired in East Africa 2

Cutaneous Leishmaniasis (CL)

• Treatment approach depends on whether the case is classified as simple or complex:

  • Simple CL: Local therapy is preferred for Old World CL and may be useful for localized New World CL caused by species not associated with mucosal leishmaniasis risk 3
  • Complex CL: Systemic treatment is recommended 3

• Local therapy options include:

  • Heat and cryotherapy
  • Topical paromomycin ointments/creams
  • Intralesional injections of pentavalent antimonial drugs (with or without cryotherapy)
  • Photodynamic or laser treatment 3

• Systemic therapy options include:

  • Miltefosine: FDA-approved for CL caused by L. braziliensis, L. guyanensis, and L. panamensis in persons ≥12 years weighing ≥30 kg; dosage is 2.5 mg/kg/day (maximum 150 mg/day) for 28 days 4
  • Pentavalent antimonials: 20 mg SbV/kg/day for 20 days 3
  • Amphotericin B formulations: Used when other options fail or are contraindicated 3

Mucosal Leishmaniasis (ML)

• All persons with clinically manifest, metastatic, American ML should receive systemic antileishmanial therapy 3
• Traditional options include:
  • Pentavalent antimonial (SbV) compound (20 mg SbV/kg daily, IV or IM, for 28–30 days) 3
  • Amphotericin B deoxycholate (0.5–1.0 mg/kg per dose, IV, daily or every other day, for a cumulative total of approximately 20–45 mg/kg) 3
  • Liposomal amphotericin B (L-AmB, with a cumulative total dose ranging from approximately 20 to 60 mg/kg) 3
  • Miltefosine (approximately 2.5 mg/kg per day, maximum 150 mg/day, for 28 days) 3, 4

Treatment Algorithm

Step 1: Determine Clinical Form and Complexity

• Identify whether the patient has cutaneous, mucosal, or visceral leishmaniasis 1
• For cutaneous leishmaniasis, determine if it's simple or complex (see Table 1 in guidelines) 3

Step 2: Consider Leishmania Species and Geographic Origin

• Attempt species identification as treatment response varies by species 1
• Consider geographic region where infection was acquired, as resistance patterns differ 3

Step 3: Evaluate Host Factors

• Assess immune status (immunocompromised patients may require longer treatment courses) 5
• Consider comorbidities, pregnancy status, and age 3

Step 4: Select Appropriate Treatment

• For visceral leishmaniasis: L-AmB as first-line therapy 2
• For simple cutaneous leishmaniasis: Local therapy if appropriate 3
• For complex cutaneous leishmaniasis or mucosal leishmaniasis: Systemic therapy 3

Special Considerations

• Immunocompromised patients: Higher relapse rates, may require longer treatment courses and secondary prophylaxis 5
• Pregnancy: Many antileishmanial drugs are contraindicated during pregnancy; treatment decisions should be individualized 3
• Treatment failure: Monitor lesions for 6-12 months after treatment; consider additional therapy when new lesions develop, existing lesions worsen, or incomplete healing occurs by 3 months 2
• Drug administration: Convenience and adherence are important considerations; amphotericin compounds require saline loading and premedication, with infusions taking up to 4 hours per dose 3

Common Pitfalls and Caveats

• Misidentification of species: Failure to identify the infecting Leishmania species may lead to inappropriate treatment selection 1
• Inadequate dosing: Doses <2 mg/kg/day of miltefosine are associated with lower response rates 3
• Confusing inflammatory response with treatment failure: A paradoxical increase in local inflammation may occur in the first 2-3 weeks of treatment 1
• Neglecting mucosal involvement risk: Local therapies should not be used for infections with Leishmania species associated with mucosal leishmaniasis risk 1
• Premature assessment of treatment response: Healing process may continue after treatment completion, especially for large ulcerative lesions 3