Treatment options for kala-azar (visceral leishmaniasis) in Bihar, India

Visceral leishmaniasis (VL) is one of the world s neglected diseases that take a huge toll on people in developing countries, but receive little attention from the Western world. It is a life-threatening disease of great medical, social and economic importance in endemic areas, for which there at present, exists no satisfactory treatment, i.e. affordable and available. VL is a vector-borne disease caused by the protozoa Leishmania donovani. It is a severe debilitating condition, characterised by prolonged fever, splenomegaly, hypergammaglobulinaemia and pancytopenia. Patients become gradually ill over a period of a few months, and the disease is 100% fatal untreated. Over 90% of the total cases of VL occur in five countries: Bangladesh, India, Nepal, Sudan and Brazil. The situation is especially grave in Bihar, India, where the disease is spreading. The parasite becoming resistant to the first-line antileishmanial agent, antimonials, has rendered this drug useless. There is an urgent need of a new first-line drug. The classical second-line treatments are unsuited: while pentamidine is inefficient, amphotericin B is effective but present serious adverse effects. Liposomal amphotericin B is very effective and safe, but unaffordable (average treatment US$ 600). The cost of this drug needs to be substantially reduced, if such formulations are to be applied meaningfully in developing countries like India. Paromomycin is effective and safe, but at present not commercially available. Miltefosine, the first oral antileishmanial drug, is now registered in India and clinical trials show promising results. We analysed clinical studies conducted in Bihar from 1980 and up to now and performed a cost-effectiveness analysis of the different treatment options. This was done in order to inform decisions-makers to make choices on how best to use limited resources in the battle against VL. We discovered that the most promising and cost-effective treatment protocol is out-patient treatment with the new drug miltefosine. For women in childbearing age miltefosine is contraindicated and lipid-associated amphotericin B and paromomycin are the best alternatives. Effort should be made to make these drugs available and affordable to the population of Bihar