Correspondence www.thelancet.com/lancetgh Vol 2 April 2014 e203 Single-dose liposomal amphotericin B for visceral leishmaniasis Dinesh Mondal and colleagues (January, p e51) 1 investigated the safety and efficacy of single-dose liposomal amphotericin B for treatment of visceral leishmaniasis (also known as kala azar) in Bangladesh. The successful administration of single-dose liposomal amphotericin B at a primary health centre is heartening. In a linked Comment, Prabhat Kumar Sinha and Sujit Bhattacharya 2 discussed adverse events reported in the study. Concerns about potential risks of adverse drug reactions and resistance prompted WHO to initiate pharmacovigilance for miltefosine, 3 another drug used to treat leishmaniasis, and develop an educational manual for patients and health workers. 4 Pharmacovigilance and reporting of adverse drug reactions, especially at primary health centres, remain difficult. Efforts are needed for post-marketing surveillance of single-dose liposomal amphotericin B for cost, benefit, and safety in real life. Sinha and Bhattacharya also refer to the high cost of treatment with liposomal amphotericin B (Ambisome, Gilead, USA). An alternative low-cost formulation, developed in academic institutions in India with funding from the Indian Department of Biotechnology, 5 has been tested for leishmaniasis 6 and has been commercialised as Fungisome (Lifecare, India) by a scientist entrepreneur, and could be provided a much lower price than that of Ambisome. Post-marketing surveillance has been done with results similar to those of pre-marketing phase 1–3 studies. 7 Clinical trials funded by the Indian Government of single doses of this formulation are underway, and have shown promising initial results for safety and efficacy. We hope that this drug will further lower the cost of treatment, making therapy affordable to patients with the greatest need. I declare that I have no competing interests. Copyright © Kshirsagar. Open Access article distributed under the terms of CC BY-wNC-ND. Nilima A Kshirsagar [email protected] Indian Council of Medical Research, ESIC, Post Graduate Institute of Medical Science and Research, Government of India, Mahatma Gandhi Memorial Hospital, Parel, Mumbai, India 1 Mondal D, Alvar J, Hasnain MG, et al. Efficacy and safety of single-dose liposomal amphotericin B for visceral leishmaniasis in a rural public hospital in Bangladesh: a feasibility study. Lancet Glob Health 2014; 2: e51–57. 2 Sinha PK, Bhattacharya S. Single-dose liposomal amphotericin B: an effective treatment for visceral leishmaniasis. Lancet Glob Health 2014; 2: e7–8. 3 Kshirsagar N, Ferner R, Figueroa BA, Ghalib H, Lazdin J. Pharmacovigilance methods in public health programmes: the example of miltefosine and visceral leishmaniasis. Trans R Soc Trop Med Hyg 2011; 205: 61–67. 4 Kshirsagar N, Anwikar S, Bandekar M, Noronha S. Kala–Azar—a short educational film on pharmacovigilance for visceral leishmaniasis in India, Nepal and Bangladesh. Geneva: World Health Organization Tropical Diseases Research Programme, 2009. 5 Kshirsagar NA, Pandya SK, Kirodian GB, Sanath S. Liposomal drug delivery system from laboratory to clinic. J Postgrad Med 2005; 51 (suppl 1): S5–15. 6 Bodhe PV, Kotwani RN, Kirodian BG, et al. Dose-ranging studies on liposomal amphotericin B (L-AMP-LRC-1) in the treatment of visceral leishmaniasis. Trans R Soc Trop Med Hyg 1999; 93: 314–18. 7 Sanath SS, Gogtay NJ, Kshirsagar NA. Post-marketing study to assess the safety, tolerability and effectiveness of Fungisome: an Indian liposomal amphotericin B preparation. J Postgrad Med 2005; 51 (suppl 1): S58–63.

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Correspondence

www.thelancet.com/lancetgh Vol 2 April 2014 e203

Single-dose liposomal amphotericin B for visceral leishmaniasis

Dinesh Mondal and colleagues (January, p e51)1 investigated the safety and efficacy of single-dose liposomal amphotericin B for treatment of visceral leishmaniasis (also known as kala azar) in Bangladesh. The successful admin istration of single-dose lipo-somal amphotericin B at a primary health centre is heartening. In a linked Comment, Prabhat Kumar Sinha and Sujit Bhattacharya2 discussed adverse events reported in the study. Concerns about potential risks of adverse drug reactions and resistance prompted WHO to initiate pharmacovigilance for miltefosine,3 another drug used to treat leishmaniasis, and develop an educational manual for patients and health workers.4 Pharmacovigilance and reporting of adverse drug reactions, especially at primary health centres, remain difficult. Efforts are needed for post-marketing surveillance of single-dose liposomal amphotericin B for cost, benefi t, and safety in real life. Sinha and Bhattacharya also refer to

the high cost of treatment with liposo-mal amphotericin B (Ambisome, Gilead, USA). An alternative low-cost formulation, developed in academic institutions in India with funding from the Indian Department of Biotechnology,5 has been tested for leishmaniasis6 and has been commercialised as Fungisome (Lifecare, India) by a scientist entrepreneur, and could be provided a much lower price than that of Ambisome. Post-marketing surveillance has been done with results similar to those of pre-marketing phase 1–3 studies.7 Clinical trials funded by the Indian Government of single doses of this formulation are underway, and have shown promising initial results for safety and effi cacy. We hope that this drug will further lower the cost of treatment, making therapy aff ordable to patients with the greatest need.I declare that I have no competing interests.

Nilima A [email protected]

Indian Council of Medical Research, ESIC, Post Graduate Institute of Medical Science and Research, Government of India, Mahatma Gandhi Memorial Hospital, Parel, Mumbai, India

1 Mondal D, Alvar J, Hasnain MG, et al. Effi cacy and safety of single-dose liposomal amphotericin B for visceral leishmaniasis in a rural public hospital in Bangladesh: a feasibility study. Lancet Glob Health 2014; 2: e51–57.

2 Sinha PK, Bhattacharya S. Single-dose liposomal amphotericin B: an eff ective treatment for visceral leishmaniasis. Lancet Glob Health 2014; 2: e7–8.

3 Kshirsagar N, Ferner R, Figueroa BA, Ghalib H, Lazdin J. Pharmacovigilance methods in public health programmes: the example of miltefosine and visceral leishmaniasis. Trans R Soc Trop Med Hyg 2011; 205: 61–67.

4 Kshirsagar N, Anwikar S, Bandekar M, Noronha S. Kala–Azar—a short educational fi lm on pharmacovigilance for visceral leishmaniasis in India, Nepal and Bangladesh. Geneva: World Health Organization Tropical Diseases Research Programme, 2009.

5 Kshirsagar NA, Pandya SK, Kirodian GB, Sanath S. Liposomal drug delivery system from laboratory to clinic. J Postgrad Med 2005; 51 (suppl 1): S5–15.

6 Bodhe PV, Kotwani RN, Kirodian BG, et al. Dose-ranging studies on liposomal amphotericin B (L-AMP-LRC-1) in the treatment of visceral leishmaniasis. Trans R Soc Trop Med Hyg 1999; 93: 314–18.

7 Sanath SS, Gogtay NJ, Kshirsagar NA. Post-marketing study to assess the safety, tolerability and eff ectiveness of Fungisome: an Indian liposomal amphotericin B preparation. J Postgrad Med 2005; 51 (suppl 1): S58–63.