Leishmaniasis medical therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alejandro Lemor, M.D. [2]

Overview

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 depends on the form of leishmaniasis, and this include medications such as Pentavalent antimonial (SbV) compounds, liposomal amphotericin B, miltefosine, ketoconazole, and fluconazole.

Medical Therapy

• 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.

Indications for Therapy in Cutaneous Leishmaniasis

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)

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.

▸ Click on the following categories to expand treatment regimens.

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

Systemic Therapy (Parenteral) Preferred Regimen ▸ Sodium stibogluconate 20 mg/kg IV/IM once daily for 10-20 days OR ▸ Meglumine antimoniate 20 mg/kg IV/IM once daily for 10-20 days Alternative Regimen ▸ Liposomal amphotericin B† 3 mg/kg/day IV infusion for 6-10 days OR ▸ Pentamidine‡ 2-3 mg/kg/day IV/IM for 4-7 days † Data supporting the use of amphotericin B for treatment of cutaneous (and mucosal) leishmaniasis are anecdotal; standard dosage regimens have not been established. ‡ 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) Preferred Regimen Patients that weight 33-44 kg: ▸ Miltefosine † 50 mg PO q12h for 28 days Patients that weight >45 kg: ▸ Miltefosine † 50 mg PO q8h for 28 days Alternative Regimen‡ ▸ Ketoconazole 600 mg daily for 28 days OR ▸ Fluconazole 200 mg daily for 6 weeks †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. ‡ The "azoles" showed modest activity against some Leishmania species in some cases, but are not FDA approved Local Therapy List of possible local therapies ▸ Cryotherapy (with liquid nitrogen) ▸ Thermotherapy (use of localized current field radiofrequency heat) ▸ Intralesional administration of SbV † ▸ Topical application of paromomycin (such as an ointment containing 15% paromomycin/12% methylbenzethonium chloride in soft white paraffin) †To date, not covered by CDC's IND protocol for Pentostam®

Visceral Leishmaniasis

▸ Click on the following categories to expand treatment regimens.

Visceral Leishmaniasis   ▸  Systemic Therapy (Parenteral)   ▸  Systemic Therapy (Oral)

Systemic Therapy (Parenteral) Preferred Regimen ▸Liposomal amphotericin B† 3 mg/kg/day IV for 5 days, then once on day 14 and once on day 21 (Total dose: 21 mg/kg) OR ▸ Sodium stibogluconate 20 mg/kg IV/IM once daily for 28 days OR ▸ Meglumine antimoniate 20 mg/kg IV/IM once daily for 28 days Alternative Regimen ▸Amphotericin B deoxycholate 0.5-1 mg/kg IV once daily (Total dose: 15-20 mg/kg) † In immunosuppressed patients, dose is 4 mg/kg/day for 5 days, then once on day 10, 17, 24, 31, and 38 (Total dose: 40 mg/kg) Systemic Therapy (Oral) Preferred Regimen Patients that weight 33-44 kg: ▸ Miltefosine † 50 mg PO q12h for 28 days Patients that weight >45 kg: ▸ Miltefosine † 50 mg PO q8h for 28 days

Antimicrobial Regimen

• Leishmaniasis

• 1. Cutaneous Leishmaniasis

• Different Leishmania species cause Old World versus New World (American) cutaneous leishmaniasis. In the Old World (the Eastern Hemisphere), the etiologic agents include Leishmania tropica, L. major, and L. aethiopica, as well as L. infantum and L. donovani. The main species in the New World (the Western Hemisphere) are either in the L. mexicana species complex (L. mexicana, L. amazonensis, and L. venezuelensis) or the subgenus Viannia (L. [V.] braziliensis, L. [V.] guyanensis, L. [V.] panamensis, and L. [V.] peruviana). The Viannia subgenus is also referred to as the L. (V.) braziliensis species complex.
• 1.1 Systemic Therapy (Parenteral)

• Preferred Regimen (1): Sodium stibogluconate 20 mg/kg IV/IM q24h for 10-20 days
• Preferred Regimen (2): Meglumine antimoniate 20 mg/kg IV/IM q24h for 10-20 days
• Alternative Regimen (1): Liposomal amphotericin B 3 mg/kg/day IV infusion for 6-10 days
• Alternative Regimen (2): Pentamidine 2-3 mg/kg/day IV/IM for 4-7 days
• Note: Data supporting the use of amphotericin B for treatment of cutaneous (and mucosal) leishmaniasis are anecdotal; standard dosage regimens have not been established. 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.

• 1.2 Systemic Therapy (Oral)

• Adults and adolescents at least 12 years of age, who weigh from 33-44 kg
• Preferred Regimen:Miltefosine 50 mg PO q12h for 28 days
• Adults and adolescents at least 12 years of age, who weigh >45 kg

• Preferred Regimen:Miltefosine 50 mg PO q8h for 28 days
• Alternative Regimen (1): Ketoconazole 600 mg qd for 28 days OR qd for 6 weeks
• Alternative Regimen (2): Fluconazole 200 mg qd for 6 weeks
• Note: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. The "azoles" showed modest activity against some Leishmania species in some cases, but are not FDA approved

• 1.3 Local Therapy

• List of possible local therapies
• Cryotherapy (with liquid nitrogen OR Thermotherapy (use of localized current field radiofrequency heat) OR Intralesional administration of SbV OR Topical application of Paromomycin (such as an ointment containing 15% Paromomycin/12% methylbenzethonium chloride in soft white paraffin)

• 2. Visceral Leishmaniasis

• Visceral leishmaniasis usually is caused by the species L. donovani and L. infantum (L. chagasi generally is considered synonymous with L. infantum)
• 2.1 Systemic Therapy (Parenteral)

• Preferred Regimen (1): Liposomal amphotericin B 3 mg/kg/day IV for 5 days, then once on day 14 and once on day 21 (Total dose: 21 mg/kg)
• Preferred Regimen (2): Sodium stibogluconate 20 mg/kg IV/IM q24h for 28 days
• Preferred Regimen (3): Meglumine antimoniate 20 mg/kg IV/IM q24h for 28 days
• Alternative Regimen: Amphotericin B deoxycholate 0.5-1 mg/kg IV q24h (Total dose: 15-20 mg/kg)
• Note: In immunosuppressed patients, dose is 4 mg/kg/day for 5 days, then once on day 10, 17, 24, 31, and 38 (Total dose: 40 mg/kg)

• 2.2 Systemic Therapy (Oral)

• Adults and adolescents at least 12 years of age, who weigh from 33-44 kg
• Preferred Regimen: Miltefosine 50 mg PO q12h for 28 days
• Adults and adolescents at least 12 years of age, who weigh >45 kg
• Preferred Regimen: Miltefosine 50 mg PO q8h for 28 days

References

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