title: Sodium stibogluconate and paromomycin for treating visceral leishmaniasis under routine conditions in eastern Sudan.
abstract: OBJECTIVE
  Among patients with primary and relapse visceral leishmaniasis (VL) in eastern Sudan, we determined the proportion eligible for treatment with sodium stibogluconate and paromomycin (SSG/PM) and, of these, their demographic and clinical characteristics; initial treatment outcomes including adverse side effects requiring treatment discontinuation; treatment outcomes by 6 months; and risk factors associated with initial (slow responders) and late treatment failure (relapses and post-kala-azar dermal leishmaniasis, PKDL).
  
  
  METHODS
  A retrospective cohort study in Tabarak Allah Hospital, Gedaref Province, eastern Sudan, from July 2011 to January 2014.
  
  
  RESULTS
  Of 1252 individuals diagnosed with VL (1151 primary and 101 relapses), 65% were eligible for SSG/PM including 83% children, almost half of them malnourished and anaemic. About 4% of individuals discontinued treatment due to side effects; 0.7% died during treatment. Initial cure was achieved in 93% of 774 primary cases and 77% of 35 relapse cases (P < 0.001). Among the 809 patients eligible for SSG/PM, 218 (27%) were lost to follow-up. Outcomes by six months among the 591 patients with available follow-up data were: definitive cure (n = 506; 86%), relapse (n = 38; 6%), treatment discontinuation (n = 33; 6%), PKDL (n = 7; 1%) and death (n = 7; 1%). Among those completing a full course of SSG/PM, relapses and under-fives were at significantly higher risk of early and late treatment failure, respectively.
  
  
  CONCLUSIONS
  Whether SSG/PM as a first-line regimen is an undeniable progress compared to SSG monotherapy, it excluded a considerable proportion of VL patients due to drug safety concerns. We call for accelerated development of new drugs and treatment regimens to improve VL treatment in Sudan.
authors.affiliation: Médecins Sans Frontières - Switzerland, Sudan mission, Gedaref, Sudan.
authors.forename: Atia M
authors.initials: AM
authors.lastname: Atia
authors.affiliation: Médecins Sans Frontières - Switzerland, Sudan mission, Gedaref, Sudan.
authors.forename: Ann
authors.initials: A
authors.lastname: Mumina
authors.affiliation: Médecins Sans Frontières-Brussels Operational Center, Brussels, Luxembourg.
authors.forename: Katherine
authors.initials: K
authors.lastname: Tayler-Smith
authors.affiliation: Médecins Sans Frontières Switzerland, Operational Center Geneva, Geneva, Switzerland.
authors.forename: Philippa
authors.initials: P
authors.lastname: Boulle
authors.affiliation: Médecins Sans Frontières Switzerland, Operational Center Geneva, Geneva, Switzerland.|Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Alcoba
authors.affiliation: Federal Ministry of Health, Khartoum, Sudan.
authors.forename: Mousab Siddig
authors.initials: MS
authors.lastname: Elhag
authors.affiliation: Ministry of Health, Gedaref State, Gedaref, Sudan.
authors.forename: Mubarak
authors.initials: M
authors.lastname: Alnour
authors.affiliation: Médecins Sans Frontières-Brussels Operational Center, Brussels, Luxembourg.
authors.forename: Safieh
authors.initials: S
authors.lastname: Shah
authors.affiliation: Médecins Sans Frontières Switzerland, Operational Center Geneva, Geneva, Switzerland.|Geneva University Hospitals, Geneva, Switzerland.
authors.forename: François
authors.initials: F
authors.lastname: Chappuis
authors.affiliation: Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: van Griensven
authors.affiliation: Médecins Sans Frontières-Brussels Operational Center, Brussels, Luxembourg.
authors.forename: Rony
authors.initials: R
authors.lastname: Zachariah
mesh_terms: D000293:Adolescent; D000328:Adult; D000740:Anemia / Q000150:complications / Q000453:epidemiology; D000967:Antimony Sodium Gluconate / Q000009:adverse effects / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007223:Infant; D007898:Leishmaniasis, Visceral / Q000188:drug therapy* / Q000401:mortality; D059012:Lost to Follow-Up; D008297:Male; D044342:Malnutrition / Q000150:complications / Q000453:epidemiology; D010303:Paromomycin / Q000009:adverse effects / Q000627:therapeutic use*; D018579:Patient Selection; D015995:Prevalence; D012008:Recurrence; D012189:Retrospective Studies; D013397:Sudan / Q000453:epidemiology; D017211:Treatment Failure
chemical_list: D000981:Antiprotozoal Agents; D010303:Paromomycin; D000967:Antimony Sodium Gluconate
keywords: Operational Research; Sudan; kala-azar; leishmaniasis; paromomycin; sodium stibogluconate