Eastern Africa: Clinical Trial Finds New Treatment for Post-kala-azar Dermal Leishmaniasis
By Thuku Kariuki
Clinical trials have shown that a new treatment for people with post-kala-azar dermal leishmaniasis (PKDL), a serious skin disease is safer, shorter, and more effective than the current treatment.
The trial was conducted in Sudan by the non-profit medical research organization Drugs for Neglected Diseases Initiative (DNDi) and the Institute of Endemic Diseases at the University of Khartoum, and whose results were published in PLOS Neglected Tropical Diseases.
PKDL can develop after one is treated for visceral leishmaniasis (VL), and is common in Eastern Africa and South Asia. The condition, transmitted by sandflies, is usually detected when a rash around the mouth appears. It can then spread to the arms and upper body, and eventually to the entire body, depending on the severity.
In Sudan, nearly 20% of VL patients will develop PKDL within six months post-treatment, the highest rate worldwide.
The new medication will cut the amount of hospital time for PKDL patients in half. It also cuts the amount of time that patients will have to take drugs, something that poses risks in toxicity.
Currently, the standard treatment for PKDL is sodium stibogluconate (SSG), an injectable drug that is given for a lengthy 60-90 days. It carries life-threatening toxicity when used for an extended period and requires hospital admission, as it must be administered under close supervision.
“Treatment for PKDL in Sudan is currently only recommended for patients with severe or persistent disease, mainly because SSG is prolonged, toxic, and expensive,” explains Professor Ahmed Musa, Senior Investigator for Leishmaniasis from the Institute of Endemic Diseases, University of Khartoum, hoping that the new regimen will encourage an exponential rise in those who seek help.
“We have now found a safer and better treatment option where patients only need to be admitted to hospital for 14 days and then complete the oral treatment at home. This makes it more patient-friendly, which is important since most people affected by this terrible disease are children.”
The financial support for the trial came from the World Health Organization (WHO) and several international non-governmental organizations (NGOs).
Most of the participants (90%) in the Phase II trial conducted in 2018 were children, 12 years old and younger. It consisted of two testing arms.
The first arm saw patients receive a combination of oral miltefosine and injectable paromomycin (MF+PM) for 42 days. They were only hospitalized for 14 days while receiving the medicine. 98% of them were completely cured.
The second arm only required patients to be hospitalized for seven days, while they received a regimen of miltefosine and injectable liposomal amphotericin B (MF+LAmB) for 28 days. These saw an 80% rate of being cured. Both groups were required to take medicine at home after their hospital stays.
“For a long time, patients with PKDL in Eastern Africa have been left behind by medical research because the disease is not considered life-threatening. Many have had to endure not only stigma but expensive, lengthy treatments exposing them to toxicity,” declares Dr Fabiana Alves, Director of the Leishmaniasis Cluster at DNDi. “This new, shorter, and better treatment will improve the lives of these neglected patients and also help reduce VL transmission on our road to elimination.”
To defeat the disease, the reporting regime for new cases in affected areas needs to be strengthened. The WHO and its partners are trying to ensure that all PKDL cases are detected, reported, and managed by 2030. Complete eradication of the disease could still be decades away, but thousands of patients can now find safe, affordable help.