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Effectiveness and Safety of Liposomal Amphotericin B for Visceral Leishmaniasis under Routine Program Conditions in Bihar, India
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.
Author Notes
Financial support: The Médecins Sans Frontières Visceral Leishmaniasis Treatment Program and patient-monitoring initiatives were funded by Médecins Sans Frontières, Operational Centre Barcelona–Athens.
Authors' addresses: Prabhat K. Sinha, Vidya Nand Rabi Das, Nawin Kumar, and Krishna Pandey, Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Agamkuan Patna, Bihar, India, E-mails: pksinha18@yahoo.com, drvnrdas@yahoo.com, drnawinkumar@gmail.com, and drkrishnapandey@yahoo.com. Paul Roddy, Pedro Pablo Palma, and María Angeles (Nines) Lima, Médecins Sans Frontières, Medical Department, Operational Centre Barcelona–Athens, Barcelona, Spain, E-mails: paul.roddy@barcelona.msf.org, pedropablo.palma@barcelona.msf.org, and nines.lima@barcelona.msf.org. Alice Kociejowski, Médecins Sans Frontières–London, London, United Kingdom, E-mail: alice.kociejowski@london.msf.org. Jitendra Gupta, Gaurab Mitra, and Siju Seena, Médecins Sans Frontières–India, Operational Centre Barcelona–Athens, New Delhi, India, E-mails: jiteninsea@yahoo.co.uk, gaurabmitra12@yahoo.co.in, and sijuseena@gmail.com. Jean-François Saint-Sauveur, Médecins Sans Frontières, Operational Centre Barcelona–Athens, Belgravia, Harare, Zimbabwe, E-mail: msfe-harare-medco@barcelona.msf.org. Manica Balasegaram, Drugs for Neglected Diseases Initiative, Geneva, Switzerland, E-mail: mbalasegaram@dndi.org. Fernando Parreño, Centre d'Atenció Primária Florida Nord, L'Hopitalet del Llobregat, Barcelona, Spain, E-mail: fernandoparre@yahoo.com.