Pan American Health Organization · 2nd edition, 2022
PAHO evidence-based recommendations for cutaneous, mucosal and visceral leishmaniasis treatment tailored to Leishmania species in the Americas.
- Issuer
- Pan American Health Organization
- Edition
- 2nd edition, 2022
- Audience
- General practitioners, internists, dermatologists, infectious disease specialists, nurses, ministry of health officials, national leishmaniasis programme managers
- Evidence
- GRADE-rated systematic reviews and randomized controlled trials; best practice statements by expert consensus where evidence unavailable
- Reviewed
- 18 Oct 2026 · GMJ
What this guideline says
GMJ summary
This second edition provides updated, GRADE-based recommendations for treating cutaneous, mucosal and visceral leishmaniasis in the Americas, where approximately 54,000 cases of cutaneous and 3,500 cases of visceral leishmaniasis occur annually across 18 endemic countries. The guideline addresses 15 Leishmania species and reflects the distinct epidemiology and therapeutic responses observed in the Americas compared to other continents.
For localized cutaneous leishmaniasis, intralesional pentavalent antimonials and miltefosine receive strong recommendations, with thermotherapy and paromomycin as conditional alternatives. For mucosal leishmaniasis, pentavalent antimonials with or without pentoxifylline are strongly recommended. Liposomal amphotericin B is the strongly recommended first-line treatment for visceral leishmaniasis in both immunocompetent and immunocompromised patients, with pentavalent antimonials as a conditional alternative only in non-immunocompromised cases.
The guideline emphasizes shared decision-making with patients, considers special populations (pregnancy, immunosuppression, cardiac disease), and provides detailed dosing regimens stratified by level of care complexity. Implementation focuses on access through PAHO’s Strategic Fund and training of health professionals in endemic areas.
Key points
For clinicians — doses and thresholds as stated in the guideline
- Intralesional pentavalent antimonials: 3–5 infiltrations of 1–5 ml per lesion at 3–7 day intervals for localized cutaneous leishmaniasis caused by L. braziliensis and L. amazonensis (strong recommendation)
- Miltefosine: 2.5 mg/kg/day (max 150 mg/day) orally for 28 days for cutaneous leishmaniasis caused by L. panamensis, L. mexicana, L. guyanensis and L. braziliensis in adults; contraindicated in pregnancy (strong recommendation)
- Pentavalent antimonials: 20 mg Sb⁺⁵/kg/day IV or IM for 30 days (max 1,215 mg Sb⁺⁵/day) for mucosal leishmaniasis, optionally combined with pentoxifylline 400 mg every 8 hours (strong recommendation)
- Liposomal amphotericin B: 3 mg/kg/day IV for 7 days (total 20 mg/kg) for visceral leishmaniasis in non-immunocompromised patients (strong recommendation)
- Liposomal amphotericin B: 3 mg/kg/day IV up to 20–40 mg/kg total dose for visceral leishmaniasis in immunocompromised patients; pentavalent antimonials contraindicated in this population (strong recommendation)
- Secondary prophylaxis for HIV–VL coinfection: liposomal amphotericin B 3 mg/kg every 2–3 weeks for all patients with CD4 <350 cells/mm³ after first episode (strong recommendation)
- Pentavalent antimonials should be avoided in patients >50 years, those with cardiac/renal disease, pregnancy, and immunosuppression; thermotherapy and liposomal amphotericin B are preferred alternatives
- Local treatment (intralesional antimonials, thermotherapy) indicated only for 1–3 lesions ≤900 mm², not on head or periarticular regions, in non-immunosuppressed patients with follow-up possibility
Systemic treatments for the management of adult patients with cutaneous leishmaniasis
Table extracted from the guideline
| Intervention | Route | Scheme | Species | Evidence certainty |
|---|---|---|---|---|
| Miltefosine | Oral | 2.5 mg/kg/day (max 150 mg/day) × 28 days, divided doses after meals | L. panamensis, L. guyanensis, L. mexicana, L. braziliensis | Low |
| Pentamidine isethionate | IM | 4–7 mg/kg/day in 3 doses every 72 hours | L. guyanensis | Low |
| Pentavalent antimonials (20 days) | IV or IM | 20 mg Sb⁺⁵/kg/day × 20 days (max 1,215 mg Sb⁺⁵/day) | L. braziliensis, L. panamensis, L. amazonensis, L. peruviana, L. mexicana | Moderate to low |
| Pentavalent antimonials (10 days) | IV or IM | 20 mg Sb⁺⁵/kg/day × 10 days (max 1,215 mg Sb⁺⁵/day) | L. braziliensis, L. panamensis | Very low |
Source: Pan American Health Organization, Guideline for the Treatment of Leishmaniasis in the Americas. Reproduced in summary form.
What changed in this edition
Versus the previous edition
- Strong recommendation for liposomal amphotericin B as first-line treatment for visceral leishmaniasis (previously conditional)
- Strong recommendation against miltefosine for visceral leishmaniasis in the Americas due to natural resistance documented in Brazilian populations
- Strong recommendation for intralesional pentavalent antimonials for localized cutaneous leishmaniasis (upgraded from conditional)
- Strong recommendation for miltefosine in cutaneous leishmaniasis caused by specific species (L. panamensis, L. mexicana, L. guyanensis, L. braziliensis)
- New specific recommendations for secondary prophylaxis in HIV–VL coinfection with CD4 <350 cells/mm³
- Detailed best practice statements for special populations including pregnancy, breastfeeding, cardiac disease, and immunosuppression
- Stratification of treatment recommendations by level of care complexity (primary, secondary, tertiary/reference centers)
- Updated dosing tables reflecting maximum doses to reduce adverse effects (e.g., max 1,215 mg Sb⁺⁵/day for pentavalent antimonials)
From the guideline
Verbatim
“The use of liposomal amphotericin B is recommended in pediatric and adult non-immunocompromised patients to treat visceral leishmaniasis.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As a WHO consultant who has worked extensively on health systems strengthening in the South Caucasus, I find this guideline exemplary in its rigorous adaptation of global evidence to regional epidemiology—a principle highly relevant for Georgia's own guideline development under the UHC programme launched in 2013. Although Georgia is not leishmaniasis-endemic, we do see imported cases, and the guideline's stratification by level of care and emphasis on liposomal amphotericin B access through pooled procurement (PAHO Strategic Fund) offers a clear model for Georgia's engagement with WHO prequalified suppliers and the Medicines Transparency Initiative. Georgian clinicians should particularly note the strong recommendation for liposomal amphotericin B in visceral leishmaniasis (3 mg/kg/day for 7 days, total 20 mg/kg) and the absolute contraindication of pentavalent antimonials in immunocompromised patients—critical given Georgia's HIV programme data. The realistic implementation caveat is cost: liposomal amphotericin B remains expensive even at WHO-negotiated prices (US$16.50 per 50 mg vial through PAHO), and a full treatment course would require budget allocation beyond the standard State Programme for Infectious Diseases; Georgian infectious disease specialists should establish advance procurement agreements for the rare but serious imported visceral leishmaniasis case requiring 20–40 vials per patient.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 18 Oct 2026
Applicability
Georgia and the South Caucasus
Georgia is not endemic for leishmaniasis but occasionally sees imported cases in travellers, migrants and military personnel returning from endemic regions (Middle East, Central Asia). This guideline is directly relevant for Georgian clinicians because: (1) liposomal amphotericin B and pentavalent antimonials are available through the Georgian national formulary and hospital pharmacies; (2) the GRADE methodology and species-specific approach models best practice for adapting international evidence to local epidemiology; (3) the emphasis on shared decision-making, toxicity monitoring and stratification by level of care aligns with Georgia’s ongoing health system reforms under the Universal Healthcare Programme. For the rare imported visceral leishmaniasis case, Georgian infectious disease specialists should note the strong recommendation for liposomal amphotericin B (3 mg/kg/day for 7 days) and the contraindication of pentavalent antimonials in immunocompromised patients. National programmes would need to establish referral pathways to tertiary centres (e.g., Tbilisi Infectious Diseases Hospital) and ensure access to liposomal amphotericin B through international procurement mechanisms.
Questions this guideline answers
Quick answers
Which treatment is first-line for localized cutaneous leishmaniasis?
For 1–3 lesions ≤900 mm² (not on head/joints), intralesional pentavalent antimonials (3–5 infiltrations of 1–5 ml per lesion every 3–7 days) are strongly recommended for L. braziliensis and L. amazonensis. Alternatively, oral miltefosine 2.5 mg/kg/day for 28 days is strongly recommended for L. panamensis, L. mexicana, L. guyanensis and L. braziliensis. Thermotherapy (50°C for 30 seconds) is a conditional alternative.
What is the recommended treatment for visceral leishmaniasis?
Liposomal amphotericin B 3 mg/kg/day IV for 7 days (total 20 mg/kg) is strongly recommended for non-immunocompromised patients. For immunocompromised patients, use 3 mg/kg/day up to 20–40 mg/kg total dose. Pentavalent antimonials (20 mg Sb⁺⁵/kg/day for 20 days) or amphotericin B deoxycholate are conditional alternatives only in non-immunocompromised patients. Pentavalent antimonials are contraindicated in immunosuppression.
Can miltefosine be used for visceral leishmaniasis in the Americas?
No. A strong recommendation against miltefosine for visceral leishmaniasis in the Americas was issued based on a phase II study showing only 42% cure at 28 days and 68% at 42 days, and evidence of natural resistance in Brazilian (Leishmania infantum) populations. This contrasts with Indian subcontinent experience. Miltefosine remains a valid option for cutaneous leishmaniasis.
What treatments are safe in pregnancy?
For cutaneous leishmaniasis: thermotherapy or liposomal amphotericin B (2–3 mg/kg/day up to 20–40 mg/kg total). Pentavalent antimonials, miltefosine and pentamidine are contraindicated. For mucosal or visceral leishmaniasis: liposomal amphotericin B or other amphotericin B formulations. Pregnant patients should be referred to reference centres. Treatment should not be delayed if clinically indicated.
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- Issuer
- Pan American Health Organization
- Type
- Procedures, manuals, guidelines
- Edition
- 2nd edition, 2022
- Replaces
- Leishmaniasis in the Americas: Treatment Recommendations, 2013
- Status
- Current
- Published
- 2022-01-01
- Languages
- English, Spanish, Portuguese
- Scope
- Pharmacological treatment of cutaneous, mucosal, disseminated, diffuse and visceral leishmaniasis; secondary prophylaxis in immunocompromised patients; special populations (pregnancy, HIV, paediatrics, elderly)
- Audience
- General practitioners, internists, dermatologists, infectious disease specialists, nurses, ministry of health officials, national leishmaniasis programme managers
- Licence
- CC BY-NC-SA 3.0 IGO
- ISBN
- 978-92-75-12504-5 (print versi
- Evidence
- GRADE-rated systematic reviews and randomized controlled trials; best practice statements by expert consensus where evidence unavailable
- Record history
- Created 18 Oct 2026 · updated 18 Oct 2026 · next check Apr 2027
Pan American Health Organization. Guideline for the treatment of leishmaniasis in the Americas. Second edition. Washington, DC: PAHO; 2022. Available from: https://doi.org/10.37774/9789275125038GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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