Combination therapy shows high efficacy in treating people with leishmaniasis and HIV

Results of clinical trials conducted in Ethiopia by the group of drugs for neglected diseases initiative (DNDI), in partnership with Médecins Sans Frontières (MSF), the University of Gondar and the University of Addis Ababa, are paving the way for more effective and safer treatments for people with the disease. once of HIV and visceral leishmaniasis (LV), group of patients suffered from poor treatment options. The results were published today in PLOS Neglected Tropical Diseases.

Visceral leishmaniasis (also known as kala-azar), with nearly 90,000 cases estimated in Asia, Africa and South America, is the second leading cause of parasite mortality after malaria, with 20,000 to 30,000 deaths per year. HIV affects visceral leishmaniasis by modifying its severity, worsening treatment outcomes and recurrence rates, and increasing the risk of death. Co-infection remains widespread in many parts of the world, particularly in northwestern Ethiopia, where 20-40% of cases of visceral leishmaniasis occur in people living with HIV.

"The region is the most visceral leishmaniasis country in the world in people living with HIV." Young Ethiopian workers, who migrated to the lowlands for seasonal work and are at risk of contracting HIV, are also vulnerable to HIV. to the bites of sandflies that cause them to sleep in makeshift shelters, "said Dr. Jorge Alvar, Senior Counselor for Leishmaniasis at DND.I. "There is an urgent need to improve treatment and outcomes for this critically ill and neglected population."

The current World Health Organization (WHO) guidelines recommend the treatment of HIV / LV co-infection with liposomal amphotericin B (often better known as AmBisome, the name). commercial drug manufactured by Gilead), but the recommendations are not properly evaluated in most endemic areas. .

Between 2011 and 2014, the international medical humanitarian organization MSF began using a compbadionate use regime, badociating AmBisome with miltefosine, an oral drug, in the Abdurafi health center, in the north-west of l & # 39; Ethiopia.

"The medical imperative being to reduce the alarming rate of therapeutic failures, we tried something new," said Dr. Koert Ritmeijer, counselor for neglected tropical diseases at MSF. "After our routine treatment experience of more than 150 patients at the Abdurafi Center, the results were very encouraging, but had to be confirmed by controlled clinical studies."

To provide the necessary scientific evidence, DNDI started a phase III study starting in 2014, testing both an AmBisome monotherapy (40 mg / kg) in accordance with current WHO recommendations and international recommendations, as well as the following. a combination infusion of AmBisome (30 mg / kg) and miltefosine orally for 28 days (100 mg / kg). day) in 58 HIV / LV patients at two sites in Ethiopia.

The results demonstrated the high efficacy of the combination, with a cure rate of 67% when the treatment lasted 28 days and a cure rate of 88% when the non-cured patients were given a second treatment to eliminate the parasite Leishmania, with a full treatment period. 58 days.

"Given the benefits to individual and public health, there is a strong case for early adoption of this treatment in international and national guidelines," said Dr. Alvar. "The findings also suggest that a new case management strategy is needed, according to which the use of one or two cycles of treatment depends on the achievement of negative parasitology."