Efficacy And Safety Of Combination Of Sodium Stibogluconate And Paromomycin For Treatment Of Visceral Leishmaniasis And Factors Associated With Poor Treatment Outcomes. A Retrospective Study North West Ethiopia

Background: Visceral leishmaniasis is among the most neglected tropical infectiousrndisease caused by the protozoan parasite of the genius lesihmania. The incidence of VL isrnestimated to be 0.2 to 0.4 million cases /year worldwide. It is fatal if left untreated. rnObjective: The objective of this study was to assess efficacy and safety of combinationrnof SSG (20mg/kg/day) and paromomycin (15mg/kg/day) and associated factors for poorrntreatment outcomes. rnMethods: A retrospective cohort study design was used. Medical record review of VLrnpatients treated with combination of sodium stibogluconate and Paromomycin betweenrn2012 and 2019 was conducted. rnResults: In total, 1000 VL patients were included. The overall initial cure was achievedrnin 924 (92.4%). Treatment failure, treatment interruptions, default and deaths respectivelyrnwere noted in 30(3%), 25 (2.5%), 13 (1.3%) and 8(0.8%). The efficacy of SSG/PMrn(186/208, 89.4%) Vs (738/792, 93.2%) was not different respectively for patients withrnweight ≤ 42.5kg and >42.5kg (p=0.07). The most common adverse events were raisedrnliver transaminases 351(35.1%), injection site pain 291(29.1%) and increased in serumrnalpha-amylase 291 (29.1%). The frequency of cardiac arrhythmia 6(0.6%) and clinicalrnpancreatitis 21(2.1%) were low. Factors associated with poor treatment outcomes werernsepsis (OR= 7.6, 95% CI: 1.86 - 31.03, P = 0.005), clinical pancreatitis (OR= 4, 95% CI:rn1.21 – 13.43, P= 0.02), and cardiac arrhythmia (OR=13, 95% CI: 2.30 – 84.34, P: 0.004).rnPatients’ body weight had no effect on poor treatment outcome (OR = 1.6, 95% CI: 0.89rn– 3.06). Of patients who attended six-month visit, cure was achieved in 259/276 (93.8%). rnPost kala-azar dermal leishmaniasis was 13 (1.3%). rn Conclusion and Recommendations. The efficacy of SSG at 20mg/kg with upperrnmaximum dose limit (850mg/day) and PM at 15mg/kg was 92.4%. Our data affirmsrneffectiveness of SSG/PM, as presently used in Eastern African countries, and no issues ofrnconcern have been identified. The continued use of the combination therapy is warranted.rnSimilar studies are recommended in the countries affected by the disease. Sepsis,rnpancreatitis and cardiac arrhythmias should be identified and managed as per VLrnmanagement protocol to prevent poor treatment outcomes .

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