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First New Treatment for Neglected Disease in 70 Years Brings Hope

After nearly a century in which the only treatment for leishmaniasis was painful, toxic and lengthy, a new combination therapy has finally been developed.
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Leishmaniasis patients in Kimalel Hospital. Photograph by Geoffrey Kamadi.

Nairobi, Kenya:

Hundreds of kilometres from the capital Nairobi in the remote district of Baringo in Western Kenya, Yego Longorchoto, a 24 year-old herdsman, is being treated for a disease called visceral leishmaniasis.

“I used to have back and joint pains and often felt fatigued”, he says, “I also felt hungry shortly after taking a meal”. Also known as Kala Azar or Black Fever, visceral leishmaniasis is spread by sand flies and can be fatal if left untreated. Symptoms include weight loss, fever, enlarged spleen and anaemia, with the liver and bone marrow also affected.

Longorchoto has been in hospital for 16 days now and is preparing to be discharged tomorrow. He has had to endure two painful injections a day. But things could be much worse. Lonogorchoto is lucky in that he is getting a newly-developed treatment, the first breakthrough in 70 years.

A new hope

Kala Azar is especially prevalent in hard-to-reach, semi-arid regions. To get to Kimalel Hospital, Longorchoto had to walk nearly 70 km just to get to the nearest road, then hitch a ride for the remaining 30 km.

This hospital sees around 50 patients a day, and treats approximately 20 leishmaniasis patients each month. In Kenya as a whole, around 4,000 cases of the disease are reported each year. And according to the Drugs for Neglected Diseases initiative (DNDi), up to 300,000 new cases are reported every year around the world.

However, despite the spread of the disease and fatalities related to it, a long-standing lack of interest from pharmaceutical companies has meant that medication developed seven decades ago is still in use today. This traditional treatment – the use of Sodium Stibogluconate (SSG) on its own – has been linked with the development of drug-resistance and its high toxicity levels can prove fatal.

But now, it seems this status quo could be about to end. A new research effort has seen the identification of a potentially effective combination treatment. This treatment first came into use in 2010, and studies into its safety are soon to be concluded.

The first new treatment in seventy years

This new combination treatment for visceral leishmaniasis involves the use of SSG along with a drug called Paromomycin (PM). According to tests, this treatment has a 93% success rate. It has now been registered in Kenya and the World Health Organization (WHO) recognises it as the first-line treatment against the disease.

“We have not had new drugs coming in to treat Kala Azar for the last 70 years, but the combination therapy is proving quite effective”, says Monique Wasunna, head of the Drugs for Neglected Tropical Diseases initiative (DNDi) in Africa and part of the research team that came up with the treatment.

Njoroge Njenga, a researcher at the Kenya Medical Research Institute (KEMRI), who was also involved in the leishmaniasis study, explains that the combination therapy drastically reduces the number of days patients needed to spend in hospital. “Whereas a patient would spend up to 30 days receiving treatment before, they are now only required to spend 17 days thanks to the new treatment”, he says, adding “The more days spent receiving treatment, the more the patient has to endure painful injections”.

Njenga also explains that the costs of treatment have also come down from KSH 22,000 ($250) to KSH 15,000 ($170) under the combination therapy.

A long way to go

Meanwhile, a phase II research of yet another study involving two more drugs to be taken in combination – AmBisome and Miltefosine – has also just been completed with the results to be published soon. This will inform researchers on whether or not to proceed to the next phase.

AmBisome by itself has been tried in Asia and shown to be safe and have a cure rate of up to 96.4%. The drawback is its prohibitively high costs. Miltefosine by itself meanwhile cannot be used by women of child-bearing age, because of what Wasunna refers to as its “geno-toxic properties”, meaning that there is a risk of it causing cancer by damaging genetic information within a cell. Furthermore, Wasunna explains, “The drug has been shown to cause abnormalities to unborn babies”. The hope is that a combination therapy of the two drugs will lead to a safe, low cost and effective alternative.

When it comes to leishmaniasis then, the DNDi’s support for research without the need for profit has yielded promising results. However, the initiative is well aware that many challenges still remain.

“DNDi has developed six new treatments for four neglected diseases in the past decade, but there are still other neglected diseases that continue to lack good treatment options”, emphasises Bernard Pécoul, Executive Director of DNDi. “While this progress is a good start, the treatments delivered are far from optimal. We have not yet developed new modern drugs which could change the history of certain neglected diseases.”

Indeed, there is a still a long way to go and many are still suffering from diseases that for too long have been ignored and forgotten. But in the meantime, patients like Longorchoto in the remote Baringo district will be thankful that, after decades of toxic and potentially hazardous medicines being the only option for treatment, any breakthroughs are occurring.

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