World Health Organization phases out painful injections in new leishmaniasis guidelines

SWITZERLAND—The World Health Organization (WHO) has released updated treatment guidelines for leishmaniasis, introducing shorter, safer, and more effective therapies for patients in eastern Africa and Southeast Asia.

The recommendations apply to visceral leishmaniasis (VL), commonly known as kala-azar, and post-kala-azar dermal leishmaniasis (PKDL), offering significant improvements in patient care.

New treatment options for a deadly disease

Visceral leishmaniasis is one of the world’s deadliest parasitic diseases after malaria.

Transmitted through the bite of infected sandflies, it causes prolonged fever, weight loss, anaemia, and enlargement of the spleen and liver.

Without prompt treatment, the disease is often fatal.

Leishmaniasis is endemic in 80 countries, with an estimated 50,000 to 90,000 new cases reported annually, although WHO estimates that only 25% to 45% of infections are officially documented.

PKDL is a skin condition that can develop after treatment for kala-azar.

Although it is not fatal, the disease can serve as a reservoir for ongoing transmission while exposing patients to stigma, social isolation, and mental health challenges.

The revised guidelines recommend alternative treatment regimens for primary VL in eastern Africa, shorter and safer therapies for PKDL in both eastern Africa and Southeast Asia, and updated approaches for managing relapsed VL among immunocompetent patients in Southeast Asia.

WHO also revised the safety guidance for miltefosine by incorporating recommendations from its Advisory Committee on the Safety of Medicinal Products and introducing allometric dosing to improve treatment accuracy.

Replacing lengthy and toxic regimens

For decades, VL treatment in Africa relied heavily on sodium stibogluconate (SSG), an injectable medicine that required painful daily injections over several weeks and frequently caused severe side effects.

For the first time, WHO recommends SSG-free treatment regimens for eligible patients. In eastern Africa, the organization now recommends oral miltefosine combined with paromomycin injections to treat both VL and PKDL.

The updated VL regimen lasts 14 days and reduces the number of injections compared with the previous 17-day treatment using sodium stibogluconate and paromomycin.

Meanwhile, in Southeast Asia, WHO now recommends shorter combination therapies using liposomal amphotericin B alone or together with oral miltefosine for patients with PKDL.

Previously, PKDL patients in eastern Africa often received sodium stibogluconate for 30 to 60 days or liposomal amphotericin B for 20 days, while patients in South-East Asia commonly underwent a 12-week course of miltefosine.

The updated recommendations replace these lengthy regimens with more patient-friendly alternatives.

WHO estimates that nearly half of all primary VL patients and all PKDL patients could benefit from the new therapies.

Patients experiencing VL relapse in Southeast Asia will also receive clearer treatment guidance, while those in Africa who are not eligible for miltefosine combinations will continue using existing regimens until additional therapies become available.

Global collaboration drives progress

Dr. Daniel Ngamije Madandi, WHO Director of Malaria and Neglected Tropical Diseases, said the updated guidelines represent a major step forward after years of difficult treatment options, particularly for patients in Africa.

He noted that safer, shorter, and more convenient regimens will improve patient care while accelerating efforts to eliminate leishmaniasis across Africa and Asia.

Many of the newly recommended therapies were developed by the non-profit Drugs for Neglected Diseases initiative (DNDi) and its partners.

Dr. Fabiana Alves, Director of DNDi’s Leishmaniasis-Mycetoma Cluster, welcomed WHO’s endorsement, adding that the organization is collaborating with Novartis to develop LXE408, an oral drug candidate that could eventually replace injectable treatments.

Following WHO’s recommendations, endemic countries are expected to update their national treatment guidelines.

Wyckliff Omondi, Head of the Division of Vector Borne and Neglected Tropical Diseases at Kenya’s Ministry of Health, said Kenya has already begun incorporating the new therapies into its national protocols.

He added that the country’s participation in the Leishmaniasis East Africa Platform (LEAP) has helped advance these treatments and strengthen regional efforts to combat the disease.