A new clinical trial has found a safer, shorter, and more effective treatment for post-kala-azar dermal leishmaniasis (PKDL), a debilitating skin condition that affects thousands in East Africa. The study, conducted by the non-profit Drugs for Neglected Diseases initiative (DNDi) and the University of Khartoum in Sudan, was published in the journal PLOS Neglected Tropical Diseases.
PKDL is a complication that can develop after treatment for visceral leishmaniasis (VL), also known as kala-azar. The skin condition, which is most prevalent in Sudan, causes unsightly rashes that can spread across the body. Up to 20% of VL patients in the country go on to develop PKDL within six months of treatment.
The current standard treatment for PKDL involves long courses of injectable medications that can be highly toxic. But the new trial has identified a superior treatment regimen that reduces hospital stays by over 50% and improves safety.
“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,” said Dr. Fabiana Alves, Director of the Leishmaniasis Cluster at DNDi. “Many have had to endure not only stigma but expensive, lengthy treatments exposing them to toxicity. But this new, shorter, and better treatment will improve the lives of these neglected patients.”
The Phase II trial tested two treatment arms. The first group received a combination of oral miltefosine and injectable paromomycin (MF+PM) for 42 days, but only needed to stay in the hospital for 14 days. After discharge, they continued the oral treatment at home. This regimen achieved a 98% cure rate at 12 months.
The second arm received miltefosine and injectable liposomal amphotericin B (MF+LAmB) for 28 days, with just a 7-day hospital stay. This alternative treatment had an 80% cure rate.
“Treatment for PKDL in Sudan is currently only recommended for patients with severe or persistent disease, mainly because the standard treatment is prolonged, toxic, and expensive,” said Professor Ahmed Musa from the University of Khartoum. “But we have now found a safer and better treatment option where patients only need to be admitted to the hospital for 2 weeks.”
Detecting and treating PKDL is crucial for eliminating visceral leishmaniasis as a public health problem in the region, as people with PKDL lesions can transmit the disease to sand flies. The new findings support efforts by the World Health Organization to ensure all PKDL cases are detected and managed by 2030.
“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,” added Dr. Alves.
