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

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

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

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

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

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

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

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

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

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

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

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

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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.

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