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

      Prabhat K. Sinha; Paul Roddy; Pedro Pablo Palma; Alice Kociejowski; María Angeles (Nines) Lima; Vidya Nand Rabi Das; Jitendra Gupta; Nawin Kumar; Gaurab Mitra; Jean-François Saint-Sauveur; et al. (The American Society of Tropical Medicine and Hygiene, 2010-08)
      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.