Sodium stibogluconate and paromomycin for treating visceral leishmaniasis under routine conditions in eastern Sudan

Abstract Objectives 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. Conclusion 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.