title: Effectiveness and safety of liposomal amphotericin B for visceral leishmaniasis under routine program conditions in Bihar, India.
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.
authors.affiliation: Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India.
authors.forename: Prabhat K
authors.initials: PK
authors.lastname: Sinha
authors.forename: Paul
authors.initials: P
authors.lastname: Roddy
authors.forename: Pedro Pablo
authors.initials: PP
authors.lastname: Palma
authors.forename: Alice
authors.initials: A
authors.lastname: Kociejowski
authors.forename: María Angeles
authors.initials: MA
authors.lastname: Lima
authors.forename: Vidya Nand
authors.initials: VN
authors.lastname: Rabi Das
authors.forename: Jitendra
authors.initials: J
authors.lastname: Gupta
authors.forename: Nawin
authors.initials: N
authors.lastname: Kumar
authors.forename: Gaurab
authors.initials: G
authors.lastname: Mitra
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Saint-Sauveur
authors.forename: Siju
authors.initials: S
authors.lastname: Seena
authors.forename: Manica
authors.initials: M
authors.lastname: Balasegaram
authors.forename: Fernando
authors.initials: F
authors.lastname: Parreño
authors.forename: Krishna
authors.initials: K
authors.lastname: Pandey
mesh_terms: D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007194:India; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; D008081:Liposomes; C068538:liposomal amphotericin B; D000666:Amphotericin B