WHO Drug Information Vol. 16, No. 2, 2002
(2002; 91 pages) View the PDF document
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Open this folder and view contentsHerbal Medicines
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View the documentMiltefosine registered for visceral leishmaniasis in India
View the documentTetanus vaccine pre-filled injection device
View the documentNonoxinol 9 ineffective in preventing HIV infection
View the documentNew formula oral rehydration salts
View the documentInternational AIDS Society recommendations for antiretroviral treatment: adult HIV infection
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View the documentProposed International Nonproprietary Names: List 87

Miltefosine registered for visceral leishmaniasis in India

Scientists have developed a new treatment for visceral leishmaniasis - a disease also known as "black fever" and "kala azar". The new drug, milte-fosine (Impavido®) could potentially save most of the 60 000 people who die from the disease every year. Miltefosine is likely to cost less and is much easier to deliver than all current therapies. In clinical trials, it cured 95% of treated patients.

Miltefosine is the first oral drug against leishmania-sis. It moved from the laboratory bench through to registration in 6 years (most medicines take twice as long) thanks to collaboration between the Government of India, the drug's manufacturer, German biopharmaceutical company Zentaris, and TDR (Tropical Diseases Research), a programme cosponsored by UNDP, the World Bank, and WHO. Miltefosine has now been approved for use in India, which has 50% of the global burden of visceral leishmaniasis. With this drug, the Government of India hopes to reach its goal of eliminating leishma-niasis by 2010.

Leishmaniasis is a parasitic disease transmitted through the bite of the sandfly. The disease is found in 88 countries. While the 350 million people living in these areas are the most vulnerable, others at risk are travellers, vacationers, missionaries, development workers and soldiers. The regions where leishmaniasis is endemic have expanded significantly since 1993. Mass population movements are fuelling the growing epidemic. Major outbreaks in Brazil, for example, were triggered by large migrations of rural populations to the suburbs of the country’s largest cities. An outbreak in Sudan killed 100 000 in an area with a population of less than 1 million. More recently, co-infections of leishmania-sis and HIV are becoming more common. The interaction of the two diseases makes each more destructive, accelerating the onset of AIDS and shortening the life of HIV-infected people.

Until now, all treatments for the disease have had substantial drawbacks. Some are toxic and can cause permanent damage such as diabetes. Up to 60% of cases in India are now resistant to the first-line drug. Other drugs trigger dangerous reactions that can be lethal in about 9% of patients. Some treatments require injections while others need to be provided intravenously over a period of 15 to 30 days in hospital. And all are so expensive that the people infected are unable to afford them.

Asta Medica originally developed miltefosine to fight breast cancer, but TDR scientists discovered that it also had an effect on the leishmaniasis parasite. No drug is without some side effects. The drug can induce vomiting, but this is not strong and usually limited to a few days. Due to a potential danger to the foetus, care must be taken when administering the drug to women of child-bearing age. Studies are under way in India to assess how well the drug performs in a real life situations and its potential long term impact on the control of leishmaniasis.

Researchers hope the future will yield better methods of diagnosing visceral leishmaniasis. In many tropical settings, the high fever brought on by the disease is easily confused with malaria. An easy to use test would greatly facilitate visceral leishmania-sis control. Trials, supported by TDR, of such diagnostic kits are now under way in Ethiopia, Kenya and Sudan.

Reference: Weekly Epidemiological Record, 77: 210-212 (2002) and http://www.who.int/tdr

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