Leishmaniasis medical therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Medical Therapy

• Treatment decisions should be individualized, with expert consultation.
• In general, all clinically manifest cases of visceral leishmaniasis and mucosal leishmaniasis should be treated, whereas not all cases of cutaneous leishmaniasis require treatment.
• The treatment approach depends in part on host and parasite factors.
• Some approaches/regimens are effective only against certain Leishmania species/strains and only in particular geographic regions.
• Even data from well-conducted clinical trials are not necessarily generalizable to other settings. Of particular note, data from the many clinical trials of therapy for visceral leishmaniasis in parts of India are not necessarily directly applicable to visceral leishmaniasis caused by L. donovani in other areas, to visceral leishmaniasis caused by other species, or to treatment of cutaneous and mucosal leishmaniasis.
• Special groups (such as young children, elderly persons, pregnant/lactating women, and persons who are immunocompromised or who have other comorbidities) may need different medications or dosage regimens.

Cutaneous Leishmaniasis

• Decisions about whether and how to treat should be individualized.
• The treatment approach depends in part on the Leishmania species/strain and the geographic area in which infection was acquired; the natural history of infection, the risk for mucosal dissemination/disease, and the drug susceptibilities in the pertinent setting; and the number, size, location, evolution, and other clinical characteristics of the patient's skin lesions.
• In general, the first sign of a therapeutic response to adequate treatment is decreasing induration (lesion flattening).
• The healing process for large, ulcerative lesions often continues after the end of therapy.
• Relapse (clinical reactivation) typically is noticed first at the margin of the lesion.

Indications

Therapy of cutaneous leishmaniasis may be indicated to:

• decrease the risk for mucosal dissemination/disease (particularly for New World species in the Viannia subgenus)
• accelerate healing of the skin lesions
• decrease the risk for relapse (clinical reactivation) of the skin lesions
• decrease the local morbidity caused by large or persistent skin lesions, particularly those on the face or ears or near joints
• decrease the reservoir of infection in geographic areas where infected persons (vs. non-human animals) serve as reservoir hosts (such as in Kabul, Afghanistan, and other Leishmania tropica-endemic areas, where transmission is anthroponotic)

Medical Therapy

▸ Click on the following categories to expand treatment regimens.

Cutaneous Leishmaniasis   ▸  Systemic Therapy (Parenteral)   ▸  Systemic Therapy (Oral)   ▸  Local Therapy

Systemic Therapy (Parenteral) Preferred Regimen ▸ [[ Systemic Therapy (Oral) Preferred Regimen ▸ [[ Local Therapy Preferred Regimen ▸ [[

Systemic therapy (parenteral) For pentavalent antimonial (SbV) therapy, see above about CDC's IND protocol for sodium stibogluconate (Pentostam®). The standard daily dose is 20 mg of SbV per kg, administered IV or IM. The traditional duration of therapy is 20 days for cutaneous leishmaniasis (10 days may suffice in some settings) and 28 days for mucosal (and visceral) leishmaniasis. For some patients, adjustment of the daily dose or the duration of therapy may be indicated. Conventional amphotericin B deoxycholate traditionally has been used as rescue therapy for cutaneous (and mucosal) leishmaniasis. Lipid formulations of amphotericin B typically are better tolerated than conventional amphotericin B. However, the data supporting their use for treatment of cutaneous (and mucosal) leishmaniasis are anecdotal; standard dosage regimens have not been established. When lipid formulations (e.g., liposomal amphotericin B) have been used for treatment of cutaneous leishmaniasis, patients typically have received 3 mg per kg daily, by IV infusion, for a total of 6 to 10 or more doses. In the United States, pentamidine isethionate is uncommonly used for treatment of cutaneous leishmaniasis. Its limitations include the potential for irreversible toxicity and variable effectiveness. Systemic therapy (oral) In March 2014, FDA approved the oral agent miltefosine for treatment of cutaneous leishmaniasis in adults and adolescents who are not pregnant or breastfeeding. The FDA-approved indications are limited to infection caused by three particular species, all three of which are New World species in the Viannia subgenus—namely, Leishmania (V.) braziliensis, L. (V.) panamensis, and L. (V.) guyanensis. Even for these species, the effectiveness of miltefosine has been variable in different geographic regions. Use of miltefosine for treatment of infection caused by other Leishmania species in the New World or by any species in the Old World would constitute off-label use, as would treatment of children less than 12 years of age. See above for additional perspective and considerations regarding miltefosine.

The "azoles" ketoconazole, itraconazole, and fluconazole—administered orally—have been used with mixed results, in various settings. For example: Ketoconazole (adult regimen: 600 mg daily for 28 days) showed modest activity against L. mexicana and L. (V.) panamensis infection in small studies in Guatemala and Panama, respectively. However, itraconazole (adult regimen: 200 mg twice daily for 28 days) was ineffective against L. (V.) panamensis infection in a clinical trial in Colombia. Use of fluconazole (adult regimen: 200 mg daily for 6 weeks) for treatment of L. major infection in various countries in the Old World has been associated with mixed results. Preliminary data from Iran suggest that a higher daily dose (400 vs. 200 mg) might be more effective against L. major infection. Preliminary, uncontrolled data from northeastern Brazil suggest that a regimen of 8 mg per kg daily for 4 to 6 weeks might be effective against L. (V.) braziliensis infection in that region. Local therapy Some cases of cutaneous leishmaniasis without risk for mucosal dissemination/disease might be candidates for local therapy, in part depending on the number, location, and characteristics of the skin lesions. Examples of local therapies that might have utility in some settings include cryotherapy (with liquid nitrogen), thermotherapy (use of localized current field radiofrequency heat), intralesional administration of SbV (to date, not covered by CDC's IND protocol for Pentostam®), and topical application of paromomycin (such as an ointment containing 15% paromomycin/12% methylbenzethonium chloride in soft white paraffin; not commercially available in the United States).

References

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