Abstract
Liposomal amphotericin B (LAmB) is the drug of choice in Bangladesh to eliminate the burden of visceral leishmaniasis, also known as kala-azar, a fatal protozoan parasitic disease if left untreated. We aimed to assess efficacy and safety of a single-dose (10 mg/kg) LAmB in visceral leishmaniasis (VL) treatment among the visiting children and adults in a tertiary care setting. This prospective study includes 11 children and 19 adults with a confirmed diagnosis of kala-azar (total 30 cases). Intravenous infusion of LAmB (10 mg/kg body weight) was given to all of the patients. Clinical assessments were conducted during treatment, before hospital discharge, and on days 30 and 180 after treatment. Efficacy was estimated in terms of initial cure (at day 30) and the final cure (at 180 days). All information was recorded in a preformed case record form and analysis was performed in SPSS 22. The mean age was 27.13 ± 18.04 years (3–65) with male predominance (60%). Significant regression of spleen size was found following treatment with LAmB at 30 days and 180 days follow up visit (p < 0.05 for all). Overall, rate of initial cure was 90% (n = 27) (child 90.9% vs 89.47% adult) and final cure was 96.66% (n = 29) (child 100% vs 94.73% adult). Fourteen adverse events were recorded mostly including fever and/or shivering (85.71%). No case relapsed or were referred either due to management or Severe Adverse Event (SAE). In real-life experience, the LAmB treatment for visceral leishmaniasis is as safe and effective for treatment of kala-azar patients.
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Acknowledgements
We thank NKEP for giving the investigations facility including rK39 and ensuring on demand supply of standard liposomal amphotericin B to carry out the management and research. We greatly appreciate the kind support of the Disease Control Unit, Directorate General of Health Services, and the Government of Bangladesh in conducting this study in the DMCH. We are grateful to the management team- doctors, and nurses of the DMCH for diagnosis and treatment of study patients. We are also grateful to the study participants who gave us consent to conduct the study. We are also thankful to DSMB boards and teams who carried out GCP training to carry out the research. The authors also showed their gratitude to the Pi Research Consultancy Center, Bangladesh (www.pircc.org) for their constant support during journal selection and overall, the study process. Also, thanks Dr Noor-E-Ambia and Dr Tamanna Tabassum for language help.
Funding
This trial received no external fund or grant. However, LAmB (Gilead pharmaceuticals) was collected from the National Kala-azar elimination program (NKEP) which was also provided by World Health Organization.
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MRE and RA conceive and developed the concept of the study. Conception and design of this Research were made by RA, MJH, and RN and PKM. Data collection was done MRE, RN and PKM. MJH wrote the first draft of the manuscript and ASK, AB, RA, MR, AL, reviewed the draft. Data analysis was done by conjointly MRR, MJH and ASK. All authors read and revised the article and MJH works as a corresponding author.
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The study was approved by the ethical review committee of Dhaka Medical College Hospital (Memo no. MEU-DMC/ECC/2016/53-D) and the study conformed to the current Declaration of Helsinki. Moreover, confidentiality and anonymity were maintained in all over the study.
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The researcher was duly concerned about the ethical issues related to the study. Formal ethical clearance was taken from the Ethical Review Committee (ERC) of the DMC for conducting the study as well as formal permission was taken from the responders. Confidentiality was maintained properly.
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Informed written consent was taken from the subject informing the nature & purpose of the study, the procedure of the study, the right to refuse, accept & withdraw to participate in the study as well as the participants didn't gain financial benefit from this study.
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Md. Rezaul Ekram, Mohammad Robed Amin and Mohammad Jahid Hasan Joint first authors.
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Ekram, M.R., Amin, M.R., Hasan, M.J. et al. Efficacy and safety of single-dose liposomal amphotericin B in patients with visceral leishmaniasis in Bangladesh: a real-life experience. J Parasit Dis 45, 903–911 (2021). https://doi.org/10.1007/s12639-021-01379-w
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DOI: https://doi.org/10.1007/s12639-021-01379-w