E-DRUG: Leishmaniasis (Kala-Azar) treatment (2)
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Dear e-druggers,
The message of Mian Imran Masood reflects the typical situation for many
countries where leishmaniasis is endemic, in its cutaneous (CL),
muco-cutaneous (MCL) and/or visceral manifestation (VL, or kala azar).
Pentavolent antimonials, in the form of sodium stibogluconate (SSG) or
meglumine antimoniate, are the mainstay of treatment for all leishmaniases
for the last 70 years. However, in most endemic countries, they are still
either not accesssible at all, or priced beyond the reach of most.
Sodium stibogluconate (SSG) was originally developed in the 1940s by
GlaxoWellcome, now gsk (Pentostam). A few years later, meglumine
antimoniate (Glucantime) was developed and is now produced by Aventis.
Both are expensive despite some recent price changes. Gsk recently reduced
the price of Pentostam to €126 per adult treatment* for the non profit
sector in developing countries (communication to MSF, November 2005),
while the price of Glucantime was considerably reduced in 2005 to €43 per
adult treatment for less developed countries and non-governmental
organizations (communication to MSF, December 2005). Much cheaper generic
forms are available, as the one distributed by IDA foundation in
Amsterdam, and manufactured by Albert David in India. This generic form of
SSG costs €23 per adult treatment and is now used widely in India,
Ethiopia, Bangladesh, Sudan and Nepal. Generic SSG is currently the only
affordable therapy for leishmaniasis in any country. Other treatment
options for leishmaniasis exists but are either not yet available
(paromomycin for VL), or expensive, such as miltefosine for CL and VL, and
amphotericinB liposomal (Ambisome). Ambisome is highly effective in VL and
far preferable over conventional amphotericinB because of its quick
action, lack of side effects and easier administration. For Africa, the
manufacturer Gilead made it available for €22,30 per vial for the
treatment of VL in the public sector. For non African countries, the price
per vial is about 10 times higher. There are currently very few new drugs
in development. Paromomycin will be licenced for VL towards the end of
2006 and will then become a new affordable therapy (see www.iowh.org).
*an adult of 35 kg
Overview of manufacturers and prices per treatment of an adult of 35 kg
Albert David, India, via IDA: sodium stibogluconate; €23
Aventis: meglumine antimoniate (Glucantime); ~€120 (private sector) and
€43 for less developed countries and NGO's
gsk: sodium stibogluconate (Pentostam); ~ €200 (private sector) and
€126 for governments and NGO's in low income countries
Bristol Meyer Squibb: amphotericin B (Fungizone); €57
Gilead: liposomal amphotericinB (Ambisome); ~ €3400 (private sector)
and €290 for the non profit sector in Africa (only for treatment of VL)
Gland Pharma, India, via IDA: paromomycin; €4,20
Zentaris: miltefosine (Impavido); ~ €120 (private sector), €70 (public
sector)
While CL and MCL can be severe and disabilitating diseases, only VL is
fatal when left untreated. VL is second only to malaria as a parasitic
cause of death. It is prevalent in 88 countries, with 200 million people
at risk. Experts estimate are that there are ~500,000 new cases annually,
of which 90% occur in Brazil, Bangladesh, India, Nepal and Sudan, and 50%
in Asia alone. MSF has VL projects in Sudan, Ethiopia and Uganda, and has
up
to date treated >60.000 patients with VL.
References:
Ritmeijer K, Veeken H, Melaku Y, Leal G, Amsalu R, Seaman J. Ethiopian
visceral leishmaniasis: generic and proprietary sodium stibogluconate are
equivalent; HIV co-infected patients have a poor outcome. Trans R Soc Trop
Med Hyg 95, 1-5 (2001).
Moore E, O’Flaherty D, Heuvelmans H, Seaman J, Veeken H, de Wit et al.
Comparison of generic and proprietary sodium stibogluconate for the
treatment of visceral leishmaniasis in Kenya. Bull WHO, 79 (5), 388-93
(2001).
Veeken H, Ritmeijer K, Seaman J, Davidson RN. A randomized comparison of
branded sodium stibogluconate and generic sodium stibogluconate for the
treatment of visceral leishmaniasis under field conditions in Sudan. Trop
Med Int Health 5, 312-17(2000).
Margriet den Boer
Pharmacist Campaign for Access to Essential Medicines
Medecins Sans Frontieres (MSF)