Effectiveness and Safety of Liposomal Amphotericin B for Visceral Leishmaniasis under Routine Program Conditions in Bihar,India |
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Authors: | Prabhat K. Sinha Paul Roddy Pedro Pablo Palma Alice Kociejowski María Angeles Lima Vidya Nand Rabi Das Jitendra Gupta Nawin Kumar Gaurab Mitra Jean-Fran?ois Saint-Sauveur Siju Seena Manica Balasegaram Fernando Parre?o Krishna Pandey |
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Affiliation: | 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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Abstract: | 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. |
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