Today in Bahir Dar, Ethiopia, at the occasion of the Leishmaniasis East Africa Platform meeting, which has gathered some 150 African and international leishmaniasis experts, results of a pharmacovigilance – or large-scale treatment safety and efficacy monitoring – plan, carried out by MSF, DNDi, and national partners in Kenya, Sudan, Uganda, and Ethiopia, were presented to key decision makers in order to boost patient access to treatment of kala-azar with the combination of Sodium Stibogluconate and Paromomycin (SSG&PM) in the region. In this large cohort of patients, treated under normal field conditions, the results confirmed the safety and high rate of efficacy of the combination treatment in the fight against this fatal neglected tropical disease.
Over 3000 patients, nearly half of which children, were treated with SSG&PM in Eastern Africa in order to provide large-scale evidence aimed at ensuring that endemic countries in the region include the treatment in their national guidelines and essential medicines lists, in addition to registering the drugs, all of which to ultimately ensure the drugs are procured and made accessible to all patients, even those in the most remote areas. SSG&PM was recommended by the World Health Organization in 2010 as firstline treatment of kala-azar in Eastern Africa following successful Phase III clinical trials carried out by the LEAP platform, DNDi, and partners.
‘The results of this pharmacovigilance plan are unambiguous: we need this treatment to reach kala-azar patients even in the most remote and unstable areas with no exception’, said Dr Daniel Argaw Dagne, Leishmaniasis Programme, Department of Control of Neglected Tropical Diseases, WHO. ‘We have more than enough data, what we need now is action from control programmes’, he added.
The study results show a 95% cure rate in a large group of patients at the end of treatment and very low mortality and failure rates, all of which are comparable to prior clinical trial results. The combination treatment importantly aims to replace the treatment of kala-azar with SSG alone, namely due to toxicity levels and cost of treatment. Without treatment, the disease is fatal, and is prone to frequent outbreaks.
Eastern Africa has one of the world’s highest kala-azar disease burdens, second only to the Indian subcontinent, and counts anywhere between 30,000 and 57,000 new cases per year. Healthcare providers addressing the outbreak in South Sudan, which began in 2009 and is currently on the verge of its highest peak, with major operational support by MSF and drug procurement support from WHO, have implemented SSG&PM to treat the majority of cases, despite political instability, population displacements, and a floundering health system. Research conducted in Sudan has proven the effectiveness of the treatment in lowering the impact of kala-azar outbreaks.
‘While we continue our collective efforts to identify better, and entirely oral new treatments for visceral leishmaniasis, especially for Africa where the disease is difficult to control, we want to see access to SSG&PM secured today by our governments’, said Dr Musa Bashir Musa, Minister of Health, Gedarif State, Sudan.
‘We have to ensure the pharmacovigilance plan immediately translates into patient access here in Ethiopia and elsewhere in Eastern Africa’, said Heran Gerba, Deputy Director General, Ethiopian Food, Medicine and Health Care Administration and Control Authority (EFMHACA), Ethiopia.
About visceral leishmaniasis (VL or kala-azar)
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 Sudan, Ethiopia, Kenya, Bangladesh, India, Nepal, and Brazil. VL is characterized by prolonged fever and splenomegaly. The current VL therapies administered include pentavalent antimonials [sodium stibogluconate (SSG) and meglumine antimoniate], AmBisome®, miltefosine, and paromomycin (PM).
Renee Olende, Regional Communications Manager, DNDi Africa
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