The World Health Organization (WHO) guideline development group convened to review the evidence for new treatments for visceral leishmaniasis and PKDL in Eastern Africa and South Asia in November 2023. The process is ongoing, with the recommendations expected in 2025. In parallel, the ministries of health in the endemic countries in the region are reviewing the evidence and are expected to release revised national treatment guidelines following the release of WHO recommendations.

The Phase II clinical trial in Sudan was completed, demonstrating the suitability of two combination treatments: miltefosine and paromomycin (MF+PM), and liposomal amphotericin B and miltefosine (LAmB+MF) as safe, effective, shorter treatments for PKDL. Findings from the Phase II trial in Sudan were published in November 2023. It is expected that these alternative therapies will be recommended for patients with PKDL in Eastern Africa.

The final clinical study report for the Phase II PKDL trial in Sudan was released in January 2022 and shared with the Sudanese regulatory agency and ethical approval committees. Discussions regarding potential changes to PKDL treatment guidelines are ongoing with the Ministry of Health. The study manuscript is expected to be published in the second quarter of 2023. 

The Phase II study in Sudan testing both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM), completed enrolment and follow-up of all 110 patients in May 2021. Final study results are expected in the first quarter of 2022.  

DNDi’s Phase II study in Sudan testing both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM), completed enrolment of 110 patients in May 2020. Patient follow-up will continue through the first half of 2021; results are expected by the end of 2021. 

A Phase II study to test both liposomal amphotericin B in combination with miltefosine, and paromomycin in combination with miltefosine began in Dooka, Sudan in 2018 and had enrolled 73 patients by January 2020. Results are expected by 2021. 

Work continues at University of Gedaref in Sudan to establish a sandfly colony in preparation for infectivity studies in PKDL and visceral leishmaniasis patients. 

In Sudan, a Phase II study to test both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM) began in Dooka, Sudan in 2018 and had recruited 39 patients by January 2019. Results are expected by mid-2021. Preparation for an infectivity study to confirm whether PKDL acts as a reservoir for ongoing leishmaniasis infection is underway. 

A Phase II study to test both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM) is under preparation in Sudan. Target recruitment will be 110 patients over two years. 

Preparations for a PKDL infectivity study – studying the ability of a pathogen to establish a horizontal infection, that is not from parent to child – in Sudan began with the preparation of an insectarium. 

A Phase II study to assess the safety and efficacy of both liposomal amphotericin B in combination with miltefosine (LAmB+MF), and paromomycin in combination with miltefosine (MF+PM), is planned in Sudan. A site visit was undertaken, and the protocol and study documents are being finalized for submission to ethics and regulatory authorities. In addition, preparations began for a PKDL infectivity study with the objective to establish the infectivity of PKDL patients to sandflies, to determine if PKDL patients maintain interepidemic transmission of visceral leishmaniasis.