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

2010; American Society of Tropical Medicine and Hygiene; Volume: 83; Issue: 2 Linguagem: Inglês

10.4269/ajtmh.2010.10-0156

1476-1645

Prabhat Kumar Sinha, Paul Roddy, Pedro Pablo Palma, Alice Kociejowski, María Angeles Lima, Vidya Nand Rabi Das, Jitendra Gupta, Nawin Kumar, Gaurab Mitra, Jean-François Saint-Sauveur, S Seena, Manica Balasegaram, Fernando Parreño, Krishna Pandey,

Research on Leishmaniasis Studies

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.