title: Unresponsiveness to AmBisome in some Sudanese patients with kala-azar.
abstract: In Sudan, two treatments are currently registered for visceral leishmaniasis: sodium stibogluconate (SSG) as first line and liposomal amphotericin B (AmBisome) as second line. We present 64 patients (52 relapse cases to SSG, 12 new but complicated cases) treated with AmBisome in eastern Sudan. AmBisome was administered at 2.5-8.2mg/kg (15-49mg/kg in total) per dose six times (days 1, 2, 3, 5, 10, 15) as an intravenous infusion. We measured outcome according to clinical response and parasitological clearance (lymph node aspiration). Patient outcomes fell into three groups: group 1, clinical responders (cured) with a negative test of cure (n=35); group 2, clinical responders with a positive test of cure (n=19); group 3, clinical non-responders (failures) with a positive test of cure (n=10). Of the 10 failures, six were already relapse cases. All of group 3, and 15 from group 2, were also treated with additional SSG (20mg/kg intramuscularly daily for 30-50 d) with resulting clinical and parasitological improvement. Parasite persistence and clinical failure were associated with a higher parasite density on admission (P<0.002) and underlying immunosuppressive disease: tuberculosis (three cases) or HIV (two cases). Because AmBisome monotherapy may fail in Sudan, a combination of AmBisome and SSG is recommended for relapse cases.
authors.affiliation: Medécins Sans Frontières, Plantage Middenlaan 14, 1018 DD Amsterdam, The Netherlands.
authors.forename: Marius
authors.initials: M
authors.lastname: Mueller
authors.forename: Koert
authors.initials: K
authors.lastname: Ritmeijer
authors.forename: Manica
authors.initials: M
authors.lastname: Balasegaram
authors.forename: Youssif
authors.initials: Y
authors.lastname: Koummuki
authors.forename: Muriel Ramirez
authors.initials: MR
authors.lastname: Santana
authors.forename: Robert
authors.initials: R
authors.lastname: Davidson
mesh_terms: D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage*; D000981:Antiprotozoal Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D015658:HIV Infections / Q000150:complications; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D007898:Leishmaniasis, Visceral / Q000150:complications / Q000188:drug therapy*; D008297:Male; D012307:Risk Factors; D017211:Treatment Failure; D014376:Tuberculosis / Q000150:complications
chemical_list: D000981:Antiprotozoal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B