Efficacy and Safety of Liposomal Amphotericin B for Visceral Leishmaniasis in Children and Adolescents at a Tertiary Care Center in Bihar, India

Krishna Pandey Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian, Council of Medical Research), Patna, Bihar, India;

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Biplab Pal Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India;

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Niyamat Ali Siddiqui Department of Biostatistics, Rajendra Memorial Research Institute of Medical Sciences (Indian Council, of Medical Research), Patna, Bihar, India;

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Vidya Nand Rabi Das Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian, Council of Medical Research), Patna, Bihar, India;

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Krishna Murti Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India;

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Chandra Shekhar Lal Department of Biochemistry, Rajendra Memorial Research Institute of Medical Sciences, (Indian Council of Medical Research), Patna, Bihar, India;

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Neena Verma Department of Pathology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of, Medical Research), Patna, Bihar, India;

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Rajendra Babu Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India;

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Vahab Ali Department of Biochemistry, Rajendra Memorial Research Institute of Medical Sciences, (Indian Council of Medical Research), Patna, Bihar, India;

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Rakesh Kumar Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian, Council of Medical Research), Patna, Bihar, India;

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Pradeep Das Department of Molecular Biology, Rajendra Memorial Research Institute of Medical Sciences (Indian, Council of Medical Research), Patna, Bihar, India

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DOI:
https://doi.org/10.4269/ajtmh.17-0094
Volume/Issue:
Volume 97: Issue 5
Page(s):
1498–1502
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Liposomal amphotericin B is being used increasingly to reduce the burden of kala-azar from the Indian subcontinent. There are studies which have evaluated efficacy and safety of liposomal amphotericin B for visceral leishmaniasis in all age groups. However, the only study that specifically addressed treatment of childhood visceral leishmaniasis did not include all ages or document renal and liver function. We, therefore, felt it was important to reassess the efficacy and safety of single dose liposomal amphotericin B in children and adolescents. A total of 100 parasitologically confirmed visceral leishmaniasis patients aged < 15 years were included in this study. Participants consisted of 65 males and 35 females. All of them had come from the endemic region of Bihar. They were administered one dose intravenous infusion of liposomal amphptericin B at 10 mg/kg body weight. Efficacy was assessed as initial and final cure at 1 and 6 months, respectively, and safety of all participants who were recruited in the study. The initial and final cure rate by per protocol analysis was 100% and 97.9%, respectively. Chills and rigors were the most commonly occurring adverse events (AEs). All the AEs were mild in intensity, and none of the patients experienced any serious AEs. No patients developed nephrotoxicity. Our finding indicates that liposomal amphotericin B at 10 mg/kg body weight is safe and effective in children. Results of our study support the use of single dose liposomal amphotericin B in all age group populations for elimination of kala-azar from the Indian subcontinent.

Author Notes

Address correspondence to Krishna Pandey, Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences, Agamkuan, Patna 800007, Bihar, India. E-mail: drkrishnapandey@yahoo.com

Authors’ addresses: Krishna Pandey, Vidya Nand Rabi Das, and Rakesh Kumar, Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian, Council of Medical Research), Patna, Bihar, India, E-mails: drkrishnapandey@yahoo.com, drvnrdas@yahoo.com, and drrakeshkmr@gmail.com. Biplab Pal, Krishna Murti, and Rajendra Babu, Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India, E-mails: biplab2006pal@gmail.com, krishnamurti74@gmail.com, and rajendra.veeri@gmail.com. Niyamat Ali Siddiqui, Department of Biostatistics, Rajendra Memorial Research Institute of Medical Sciences (Indian Council, of Medical Research), Patna, Bihar, India, E-mail: niyamatalisiddiqui@yahoo.com. Chandra Shekhar Lal and Vahab Ali, Department of Biochemistry, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Patna, Bihar, India, E-mails: drcslal@gmail.com and vahab_ali@yahoo.com. Neena Verma, Department of Pathology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Patna, Bihar, India, E-mail: verma_neena@yahoo.com. Pradeep Das, Department of Molecular Biology, Rajendra Memorial Research Institute of Medical Sciences (Indian, Council of Medical Research), Patna, Bihar, India, E-mail: Drpradeep.das@gmail.com.

Copyright:
© The American Society of Tropical Medicine and Hygiene 2017
Received:
08 Feb 2017
|
Accepted:
05 Jul 2017
|
Published Online:
05 Sep 2017
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
  • 1.

    Alvar J, Vélez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M, 2012. Leishmaniasis worldwide and global estimates of its incidence. PLoS One 7: e35671.

    • Search Google Scholar
    • Export Citation
  • 2.

    Sundar S, Chatterjee M, 2006. Visceral leishmaniasis—current therapeutic modalities. Indian J Med Res 123: 345–352.

  • 3.

    Zijlstra EE, Musa AM, Khalil EA, el-Hassan IM, el-Hassan AM, 2003. Post-kala-azar dermal leishmaniasis. Lancet Infect Dis 3: 87–98.

  • 4.

    Thakur CP, Narayan S, Ranjan A, 2004. Epidemiological, clinical and pharmacological study of antimony-resistant visceral leishmaniasis in Bihar, India. Indian J Med Res 120: 166–172.

    • Search Google Scholar
    • Export Citation
  • 5.

    Sundar S, Singh A, Rai M, Prajapati VK, Singh AK, Ostyn B, Boelaert M, Dujardin JC, Chakravarty J, 2012. Efficacy of miltefosine in the treatment of visceral leishmaniasis in India after a decade of use. Clin Infect Dis 55: 543–550.

    • Search Google Scholar
    • Export Citation
  • 6.

    Jamil KM et al. 2015. Effectiveness study of paromomycin IM injection (PMIM) for the treatment of visceral leishmaniasis (VL) in Bangladesh. PLoS Negl Trop Dis 9: e0004118.

    • Search Google Scholar
    • Export Citation
  • 7.

    Sundar S, Mehta H, Suresh AV, Singh SP, Rai M, Murray HW, 2004. Amphotericin B treatment for Indian visceral leishmaniasis: conventional versus lipid formulations. Clin Infect Dis 38: 377–383.

    • Search Google Scholar
    • Export Citation
  • 8.

    Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW, 2010. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 362: 504–512.

    • Search Google Scholar
    • Export Citation
  • 9.

    Mondal D, Alvar J, Hasnain MG, Hossain MS, Ghosh D, Huda MM, Nabi SG, Sundar S, Matlashewski G, Arana B, 2014. 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 2: e51–e57.

    • Search Google Scholar
    • Export Citation
  • 10.

    National Cancer Institute Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0. DCTD, NCI, NIH, DHHS. 2006. Available at: http://ctep.cancer.gov. Accessed February 2, 2016.

  • 11.

    Health Ministers Committed to Eliminate Kala-azar (media advisory), 2014. New Delhi: WHO Regional Office for South-East Asia. Available at: http://www.searo.who.int/mediacentre/releases/2014/pr1580/en/.

  • 12.

    Syriopoulou V, Daikos GL, Theodoridou M, Pavlopoulou I, Manolaki AG, Sereti E, Karamboula A, Papathanasiou D, Xenophon KGS, 2003. Two doses of a lipid formulation of amphotericin B for the treatment of mediterranean visceral leishmaniasis. Clin Infect Dis 36: 560–566.

    • Search Google Scholar
    • Export Citation
  • 13.

    Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW, 2008. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis 47: 1000–1006.

    • Search Google Scholar
    • Export Citation
  • 14.

    Sundar S et al. 2011. Comparison of short-course multidrug treatment with standard therapy for visceral leishmaniasis in India: an open-label, non-inferiority, randomised controlled trial. Lancet 377: 477–486.

    • Search Google Scholar
    • Export Citation
  • 15.

    Thakur CP, Kanyok TP, Pandey AK, Sinha GP, Messick C, Olliaro P, 2000. Treatment of visceral leishmaniasis with injectable paromomycin (aminosidine). An open-label randomized phase-II clinical study. Trans R Soc Trop Med Hyg 94: 432–433.

    • Search Google Scholar
    • Export Citation
  • 16.

    Pagliano P, Carannante N, Rossi M, Gramiccia M, Gradoni L, Faella FS, Gaeta GB, 2005. Visceral leishmaniasis in pregnancy: a case series and a systematic review of the literature. J Antimicrob Chemother 55: 229–233.

    • Search Google Scholar
    • Export Citation
  • 17.

    Sundar S, Pandey K, Thakur CP, Jha TK, Rabidas VN, Verma N, Lal CS, Verma D, Alam S, Das P, 2014. Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, Open-Label Study. PLoS Negl Trop Dis 8: e3169.

    • Search Google Scholar
    • Export Citation
  • 18.

    Sundar S, Jha TK, Thakur CP, Mishra M, Singh VP, Buffels R, 2003. R Single-dose liposomal amphotericin B in the treatment of visceral leishmaniasis in India: a multicenter study. Clin Infect Dis 37: 800–804.

    • Search Google Scholar
    • Export Citation
  • 19.

    Sinha PK et al. 2010. Effectiveness and safety of liposomal amphotericin b for visceral leishmaniasis under routine program conditions in Bihar, India. Am J Trop Med Hyg 83: 357–364.

    • Search Google Scholar
    • Export Citation
  • 20.

    Thakur CP, 2001. A single high dose treatment of kala-azar with Ambisome (amphotericin B lipid complex): a pilot study. Int J Antimicrob Agents 17: 67–70.

    • Search Google Scholar
    • Export Citation
  • 21.

    Sundar S, Agrawal G, Rai M, Makharia MK, Murray HW, 2001. Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trial. BMJ 323: 419–422.

    • Search Google Scholar
    • Export Citation
  • 22.

    Sundar S, Jha TK, Thakur CP, Mishra M, Singh VR, Buffels R, 2002. Low-dose liposomal amphotericin B in refractory Indian visceral leishmaniasis: a multicenter study. Am J Trop Med Hyg 66: 143–146.

    • Search Google Scholar
    • Export Citation
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