Effectiveness and Safety of Liposomal Amphotericin B for Visceral Leishmaniasis under Routine Program Conditions in Bihar, India

Prabhat K. Sinha Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Paul Roddy Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Pedro Pablo Palma Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Alice Kociejowski Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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María Angeles Lima Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Vidya Nand Rabi Das Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Jitendra Gupta Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Nawin Kumar Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Gaurab Mitra Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Jean-François Saint-Sauveur Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Siju Seena Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Manica Balasegaram Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Fernando Parreño Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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Krishna Pandey Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India; Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain; Médecins Sans Frontières, London, United Kingdom; Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India

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DOI:
https://doi.org/10.4269/ajtmh.2010.10-0156
Volume/Issue:
Volume 83: Issue 2
Page(s):
357–364
Restricted access
Get Permissions

We evaluated, through the prospective monitoring of 251 patients at Sadar Hospital in Bihar, India, the effectiveness and safety of 20 mg/kg body weight of liposomal amphotericin B for the treatment of visceral leishmaniasis. The treatment success rates for the intention-to-treat, per protocol, and intention-to-treat worse-case scenario analyses were 98.8%, 99.6%, and 81.3%, respectively. Nearly one-half of patients experienced mild adverse events, but only 1% developed serious but non–life-threatening lips swelling. The lost to follow-up rate was 17.5%. Our findings indicate that the 20 mg/kg body weight treatment dosage is effective and safe under routine program conditions. Given that the exorbitant cost of liposomal amphotericin B is a barrier to its widespread use, we recommend further study to monitor and evaluate a lowered dosage and a shorter treatment course.

Author Notes

*Address correspondence to Paul Roddy, Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Nou de la Rambla 26, Barcelona 08001, Spain. E-mail: paul.roddy@barcelona.msf.org

Financial support: The Médecins Sans Frontières Visceral Leishmaniasis Treatment Program and patient-monitoring initiatives were funded by Médecins Sans Frontières, Operational Centre Barcelona–Athens.

Authors' addresses: Prabhat K. Sinha, Vidya Nand Rabi Das, Nawin Kumar, and Krishna Pandey, Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Agamkuan Patna, Bihar, India, E-mails: pksinha18@yahoo.com, drvnrdas@yahoo.com, drnawinkumar@gmail.com, and drkrishnapandey@yahoo.com. Paul Roddy, Pedro Pablo Palma, and María Angeles (Nines) Lima, Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain, E-mails: paul.roddy@barcelona.msf.org, pedropablo.palma@barcelona.msf.org, and nines.lima@barcelona.msf.org. Alice Kociejowski, Médecins Sans Frontières–London, London, United Kingdom, E-mail: alice.kociejowski@london.msf.org. Jitendra Gupta, Gaurab Mitra, and Siju Seena, Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India, E-mails: jiteninsea@yahoo.co.uk, gaurabmitra12@yahoo.co.in, and sijuseena@gmail.com. Jean-François Saint-Sauveur, Médecins Sans Frontières, Operational Centre Barcelona–Athens, Belgravia, Harare, Zimbabwe, E-mail: msfe-harare-medco@barcelona.msf.org. Manica Balasegaram, Drugs for Neglected Diseases Initiative, Geneva, Switzerland, E-mail: mbalasegaram@dndi.org. Fernando Parreño, Centre d'Atenció Primária Florida Nord, L'Hopitalet del Llobregat, Barcelona, Spain, E-mail: fernandoparre@yahoo.com.

Copyright:
Copyright © 2010 by The American Society of Tropical Medicine and Hygiene 2010
Received:
12 Mar 2010
|
Accepted:
06 May 2010
|
Published Online:
05 Aug 2010
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
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