Study Results Support WHO Recommendations for Safe and Effective Kala-azar Treatments in Bangladesh

[Dhaka, Bangladesh and Geneva, Switzerland, 15 October 2014]
Today in Dhaka, Bangladesh, results of a four year-long clinical study to test the safety and efficacy of new combination treatments for kala-azar (visceral leishmaniasis) were presented to the Ministry of Health (MoH) of Bangladesh in the presence of Health Minister, Mr Mohammed Nasim. The treatments tested had been recommended by the World Health Organization in 2010 and form part of the treatment arsenal to support the targets for controlling this parasitic disease that infects up to 300,000 people and kills up to 40,000 people worldwide each year. The disease burden in the Indian sub-continent is particularly high, but is currently declining with efforts exerted within the regional elimination programme.

The study, a Phase III, open label, randomized, non-inferiority study of three short-course combination regimens (with AmBisome®, miltefosine, paromomycin) compared to AmBisome® alone for the treatment of kala-azar in Bangladesh, produced results from over 600 patients that were followed 6 months after treatment. The study was conducted in primary and secondary healthcare facilities in the public healthcare sector of the country.

The results, presented by Shaheed Suhrawardy Medical College (SHSMC), Bangladesh and the Drugs for Neglected Diseases initiative (DNDi) (trial sponsor), and analysis show that all tested treatments demonstrated excellent cure rates, and were well tolerated by patients. The combination treatments (AmBisome® + miltefosine; AmBisome® + paromomycin; paromomycin + miltefosine) were non-inferior to AmBisome® monotherapy: the combinations of AmBisome® + paromomycin and paromomycin + miltefosine demonstrated excellent cure rates of above 98%, thus comparable with AmBisome® monotherapy. The combination of AmBisome® + miltefosine demonstrated a slightly less than 95% cure rate.

The Shaheed Suhrawardy Medical College (SHSMC) and the International Centre for Diarrhoeal Disease Research, (ICDDR Bangladesh) worked closely with DNDi to carry out this trial that constitutes an important contribution to the MoH elimination strategy. The results presented today provide a vital impetus to move from research to implementation of first and second-line treatments for this disease as they provide the evidence needed to support the WHO recommendations for kala-azar treatment and elimination in the region.

About kala-azar (visceral leishmaniasis, VL)
Visceral leishmaniasisis a neglected tropical disease caused by Leishmania donovani or L. infantum. There are an estimated 300,000 new cases of VL per annum. Fatal if left untreated, the disease kills approximately 40,000 people every year, and 90% of cases occur in Bangladesh, Brazil, Ethiopia, India, South Sudan, and Sudan. VL is characterized by prolonged fever and splenomegaly. The current therapies administered include pentavalent antimonials (sodium stibogluconate and meglumine antimoniate), AmBisome®, miltefosine, and paromomycin.

About Drugs for Neglected Diseases initiative (DNDi)
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development organization working to deliver new treatments for neglected diseases, in particular sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, specific filarial diseases, paediatric HIV, and malaria. DNDi was established in 2003 by Médecins Sans Frontières/Doctors Without Borders (MSF), Oswaldo Cruz Foundation (FIOCRUZ) from Brazil, Indian Council for Medical Research (ICMR), Kenya Medical Research Institute (KEMRI), Ministry of Health of Malaysia, and Pasteur Institute of France. The Special Programme for Tropical Disease Research (TDR) serves as a permanent observer. Since its inception, DNDi has delivered six new treatments for neglected patients: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease.