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[e-drug] Large-Scale Kala-Azar Treatment Results in Eastern Africa, urgency in South Sudan

E-DRUG: Large-Scale Kala-Azar Treatment Results in Eastern Africa, urgency in 
South Sudan

Results of Large-Scale Roll Out of Combination Treatment for Kala-Azar in 
Eastern Africa Points to Urgency to Treat Disease Victims as Outbreak Surges in 
South Sudan


On 1 October 2014 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 were 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 first-line 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.

'Visceral Leishmaniasis or Kala-Azar is one of the deadliest parasitic diseases 
worldwide: it causes prolonged fever, malnutrition, opportunistic infections, 
skin rash and disfiguration, and rapid death if untreated. In East Africa 
specifically, Kala-Azar disables and kills in very poor and remote communities. 
Access to effective drugs is extremely difficult due to their price, and 
complex supply. The 17-day SSG&PM combination therapy is a very good progress 
compared to the 30 days SSG mono-therapy.  While we need to continue the search 
for a better treatment, these results show a real progress', says Micaela 
Serafini, Medical Director of Médecins Sans Frontières (MSF).

Gabrielle Landry Chappuis
Head of Communication and Advocacy
Drugs for Neglected Diseases initiative - DNDi
15 Chemin Louis-Dunant, 1202 Geneva, Switzerland
tel. +41 22 906 9249 / mobile: +41 79 309 3910

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