World Health Organization · 2026 edition · 55 pages
Evidence-based treatment recommendations for VL and PKDL in eastern Africa and South-East Asia, with new combination regimens and safety guidance.
- Issuer
- World Health Organization
- Edition
- 2026 edition
- Audience
- National leishmaniasis and NTD programme managers, infectious disease clinicians, health-care providers, policy-makers in ministries of health, drug regulatory authorities, pharmacovigilance programmes, implementing partners, international agencies
- Evidence
- GRADE methodology; systematic reviews with low to very low certainty evidence; conditional recommendations based on limited RCTs and observational studies; expert opinion for VL relapse management
- Reviewed
- 15 Oct 2026 · GMJ
What this guideline says
GMJ summary
These guidelines provide updated, evidence-based treatment recommendations for visceral leishmaniasis (VL) and post-kala-azar dermal leishmaniasis (PKDL) in eastern Africa and South-East Asia. VL, also known as kala-azar, is a fatal parasitic disease if untreated, with eastern Africa accounting for 73% of global cases in 2023. PKDL is a skin manifestation that can occur after VL treatment and serves as a reservoir for transmission.
The guidelines introduce new combination regimens: for primary VL in eastern Africa, paromomycin plus miltefosine for 14 days is suggested as an alternative to sodium stibogluconate (SSG) plus paromomycin for 17 days. For PKDL in eastern Africa, paromomycin plus miltefosine is recommended over liposomal amphotericin B (LAmB) plus miltefosine. In South-East Asia, LAmB regimens are preferred over extended miltefosine monotherapy for PKDL, with important safety warnings about ocular adverse events associated with prolonged miltefosine use.
The recommendations are conditional with low to very low certainty evidence, reflecting the limited trial data available. The guidelines emphasize the importance of pharmacovigilance, particularly ocular monitoring with miltefosine, contraception counselling due to teratogenic risks, and potassium monitoring with high-dose LAmB. Implementation considerations address feasibility, equity, and resource requirements in resource-limited endemic settings.
Key points
For clinicians — doses and thresholds as stated in the guideline
- For primary VL in eastern Africa: paromomycin 20 mg/kg IM once daily plus miltefosine (allometric dose) orally twice daily for 14 days is suggested as alternative to SSG 20 mg/kg plus paromomycin 15 mg/kg daily for 17 days
- SSG 20 mg/kg plus paromomycin 15 mg/kg for 17 days is suggested over SSG monotherapy (30 days) in patients who cannot receive paromomycin-miltefosine combination
- LAmB 3–5 mg/kg per day (total 30 mg/kg over 6–10 days) suggested for patients with contraindications to other regimens, including pregnant women and severely malnourished patients
- For VL relapse in South-East Asia: do not re-treat with single-dose LAmB (10 mg/kg); use combination therapy or higher LAmB doses (15–20 mg/kg total)
- For PKDL in eastern Africa: paromomycin 20 mg/kg IM for 14 days plus miltefosine (allometric dose) for 42 days suggested over LAmB plus miltefosine regimen
- For PKDL in South-East Asia: LAmB 30 mg/kg total (6 doses of 5 mg/kg over 3 weeks) suggested over miltefosine 100 mg/day for 12 weeks due to ocular safety concerns
- Miltefosine is contraindicated in pregnancy; women of childbearing age require contraception during and for 5 months after treatment (2 months for regimens <28 days)
- Regular eye examinations (every 2 weeks) mandatory during and after miltefosine treatment; serum potassium monitoring essential with high-dose LAmB (≥30 mg/kg)
Distinct features of PKDL in Sudan and on the Indian subcontinent
Table extracted from the guideline
| Feature | Eastern Africa | Indian subcontinent |
|---|---|---|
| Highest rate reported | 4.8/100 | 4.8/1,000 |
| Maximum PKDL rate after VL | 3–20% (6-months follow-up) | 2–17% |
| Interval after VL (majority) | 0–6 months | 2–3 years |
| Most common presentation | Polymorphic, papular | Polymorphic, papulonodular, macular |
| Spontaneous cure | Yes | No |
| May occur with visceral disease | Yes | Uncommon |
| May occur without previous VL | Yes | Yes |
| Mucosal lesions | Rare | Not uncommon |
Source: World Health Organization, Guidelines on leishmaniases: treatment of visceral leishmaniasis and post-kala-azar dermal leishmaniasis in eastern Africa and South-East Asia. Reproduced in summary form.
What changed in this edition
Versus the previous edition
- New combination regimen for VL in eastern Africa: paromomycin plus miltefosine for 14 days as alternative to SSG plus paromomycin
- Updated safety profile of miltefosine with acknowledgment of reasonable possibility of causal relationship with ocular adverse events
- Risk mitigation measures for miltefosine-related ocular toxicity, including mandatory pre- and post-treatment eye examinations
- New treatment recommendations for PKDL in both eastern Africa and South-East Asia based on recent clinical trials
- Guidance on VL relapse management in South-East Asia (not previously covered)
- Weight-band-based allometric dosing tables for miltefosine, particularly for patients <30 kg
- Extended contraception period after miltefosine: 5 months for regimens ≥28 days, 2 months for shorter regimens
- Specific monitoring indicators for VL and PKDL programmes
From the guideline
Verbatim
“Use of a combination of paromomycin (20 mg [15 mg base]/kg per day IM once a day for 14 days) plus miltefosine (allometric dose, orally BID for 14 days) is suggested as an alternative to a combination of SSG (20 mg/kg per day IM/IV) plus paromomycin (15 mg [11 mg base]/kg per day IM for 17 days).”
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 Editor-in-Chief of the Georgian Medical Journal and a WHO consultant on health and migration, I recognize that while visceral leishmaniasis is not endemic in Georgia, our position as a transit and destination country for migrants from endemic regions—particularly from conflict-affected areas of the Middle East and Central Asia—means Georgian infectious disease specialists must maintain diagnostic vigilance for this potentially fatal disease. The most clinically important recommendation for our context is the emphasis on parasitological confirmation before treatment and the availability of liposomal amphotericin B as a critical reserve option for complicated cases, pregnant women, and patients with contraindications to other regimens. The realistic implementation challenge for Georgia is ensuring that reference laboratories maintain capacity for Leishmania microscopy and that university hospitals stock essential anti-leishmanial medicines despite infrequent use, which requires coordination between the National Center for Disease Control and Public Health, the Ministry of Health, and WHO country office to establish clear diagnostic and treatment pathways for these rare but serious imported infections. The updated pharmacovigilance requirements—particularly mandatory ocular monitoring with miltefosine and extended contraception periods—align with Georgia's strengthening post-market surveillance system and our commitments under Universal Health Coverage to provide safe, effective treatment for all residents regardless of disease rarity.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 15 Oct 2026
Applicability
Georgia and the South Caucasus
While visceral leishmaniasis is not endemic in Georgia or the broader South Caucasus, sporadic imported cases may occur through travel or migration from endemic regions, particularly from neighbouring countries where L. infantum (zoonotic form) is present in the Mediterranean Basin and Middle East. Georgian clinicians should maintain awareness of VL as a differential diagnosis in patients with prolonged fever, splenomegaly, and pancytopenia who have travelled to endemic areas. The WHO donation programme for liposomal amphotericin B (AmBisome) covers low- and middle-income countries, which may facilitate access if needed. National reference laboratories should have capacity for parasitological diagnosis, and infectious disease specialists should be familiar with these treatment protocols. For public health authorities, this guideline underscores the importance of surveillance systems that can detect imported cases and the need for established referral pathways to centres with expertise and essential medicines for leishmaniasis management.
Questions this guideline answers
Quick answers
What is the recommended first-line treatment for primary VL in eastern Africa?
Paromomycin 20 mg/kg IM once daily plus miltefosine (allometric dose) orally twice daily for 14 days is now suggested as an alternative to the previous standard of SSG 20 mg/kg plus paromomycin 15 mg/kg for 17 days. The paromomycin-miltefosine regimen is 3 days shorter, requires one fewer painful injection daily, and avoids SSG-related cardiotoxicity. However, miltefosine requires contraception in women of childbearing age and ocular monitoring.
Why are ocular examinations required for patients receiving miltefosine?
Recent reports have documented ocular adverse events in PKDL patients treated with miltefosine, including potentially irreversible panophthalmic manifestations. The WHO Advisory Committee on the Safety of Medicinal Products has acknowledged a reasonable possibility of causal relationship between miltefosine and ocular toxicity. Eye examinations should be conducted before treatment, every 2 weeks during treatment, and after completion. Patients should be educated to report visual symptoms immediately.
How should VL relapse be managed in South-East Asia?
Relapse should be confirmed parasitologically. Do not re-treat with single-dose LAmB (10 mg/kg) if that was the primary treatment. Preferred options include combination regimens: miltefosine plus paromomycin for 10 days, LAmB 5 mg/kg single dose plus miltefosine for 7 days, or LAmB 5 mg/kg plus paromomycin for 10 days. If combinations are not feasible, give higher total doses of LAmB (15–20 mg/kg) in 3–4 administrations.
What are the contraception requirements for miltefosine treatment?
Miltefosine is teratogenic and contraindicated in pregnancy. Women of childbearing potential must have a negative pregnancy test before treatment and use adequate contraception during treatment and for 5 months after completion for regimens ≥28 days, or 2 months for shorter regimens (5–10 days). Long-acting reversible contraceptives or depot preparations are preferred over oral methods, as vomiting or diarrhoea during miltefosine therapy may reduce oral contraceptive absorption.
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- Issuer
- World Health Organization
- Type
- Guidance (normative)
- Edition
- 2026 edition
- Replaces
- Control of the leishmaniases: report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22-26 March 2010 (WHO Technical Report Series 949)
- Status
- Current
- Published
- 2026-07-28
- Languages
- English
- Scope
- Pharmacological treatment of visceral leishmaniasis and post-kala-azar dermal leishmaniasis in HIV-negative patients in eastern Africa (Chad, Djibouti, Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan, Uganda) and South-East Asia (Bangladesh, India, Nepal). Does not cover cutaneous or mucocutaneous leishmaniasis, VL in HIV co-infected patients, or other endemic regions.
- Audience
- National leishmaniasis and NTD programme managers, infectious disease clinicians, health-care providers, policy-makers in ministries of health, drug regulatory authorities, pharmacovigilance programmes, implementing partners, international agencies
- Pages
- 55
- Licence
- CC BY-NC-SA 3.0 IGO
- ISBN
- 978-92-4-012329-8
- Evidence
- GRADE methodology; systematic reviews with low to very low certainty evidence; conditional recommendations based on limited RCTs and observational studies; expert opinion for VL relapse management
- Next review
- Not specified; will be updated when new evidence becomes available from ongoing clinical trials
- Record history
- Created 15 Oct 2026 · updated 15 Oct 2026 · next check Apr 2027
World Health Organization. WHO guidelines on leishmaniases: treatment of visceral leishmaniasis and post-kala-azar dermal leishmaniasis in eastern Africa and South-East Asia. Geneva: World Health Organization; 2026. Licence: CC BY-NC-SA 3.0 IGO.GMJ 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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