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Prediction of Visceral Leishmaniasis Development in a Highly Exposed HIV Cohort in Ethiopia Based on Leishmania Infection Markers: Results from the Preleish Study

34 Pages Posted: 5 Mar 2024

See all articles by Johan Van Griensven

Johan Van Griensven

University of Antwerp - Institute of Tropical Medicine (ITM)

Saskia van Henten

University of Antwerp - Institute of Tropical Medicine (ITM)

Aderajew Kibret

Médecins sans Frontières

Mekibib Kassa Tessema

University of Gondar

Hailemariam Beyene

Médecins sans Frontières

Said Abdellati

University of Antwerp - Institute of Tropical Medicine (ITM)

Dagnew Mersha

Médecins sans Frontières

Kasaye Sisay

Médecins sans Frontières

Hailemicheal Seyum

Médecins sans Frontières

Hamid Eshetie

Médecins sans Frontières

Fikadu Kassa

Médecins sans Frontières

Tadfe Bogale

University of Gondar

Roma Melkamu

University of Gondar

Arega Yeshanew

University of Gondar

Bart Smekens

University of Tübingen - Institute of Tropical Medicine

Christophe Burm

University of Antwerp - Department of Clinical Sciences

Hanne Landuyt

University of Antwerp - Institute of Tropical Medicine (ITM)

Annelies de Hondt

University of Antwerp - Institute of Tropical Medicine (ITM)

Dorien Van den Bossche

University of Antwerp - Institute of Tropical Medicine (ITM)

Rezika Mohammed

University of Gondar

Myrthe Pareyn

University of Antwerp - Institute of Tropical Medicine (ITM)

Florian Vogt

Australian National University (ANU) - National Centre for Epidemiology and Population Health

Wim Adriaensen

University of Antwerp - Unit of Neglected Tropical Diseases

Koert Ritmeijer

Médecins sans Frontières

Ermias Diro

University of Gondar

More...

Abstract

Background: Targeted preventive strategies in HIV-infected individuals require markers to predict visceral leishmaniasis (VL). We conducted a longitudinal study in an HIV-cohort in VL-endemic North-West Ethiopia to 1) describe the pattern of Leishmania markers preceding VL; 2) identify Leishmania markers predictive of VL; 3) develop a clinical management algorithm according to predicted VL risk levels.

Methods: The PreLeisH study followed 490 HIV-infected adults free of VL at enrolment for upto two years (2017-2021). Blood PCR targeting Leishmania kDNA, Leishmania serology and Leishmania urine antigen test (KAtex) were performed every 3-6 months. We calculated the sensitivity/specificity of the Leishmania markers for predicting VL and developed an algorithm for distinct clinical management strategies, with VL risk categories defined based on VL history, CD4 count and Leishmania markers (rK39 RDT & PCR).

Results: At enrolment, 485 (99%) study participants were on antiretroviral treatment; 360/490 (73.5%) were male; the median baseline CD4 count was 392 (IQR 259-586) cells/µL; 135 (27.5%) had previous VL. Incident VL was diagnosed in 34 (6.9%), with 32 (94%) displaying positive Leishmania markers before VL. In those without VL history, baseline rK39 RDT had 60% sensitivity and 84% specificity to predict VL; in patients with previous VL, PCR had 71% sensitivity and 95% specificity. The algorithm defined 442 (92.3%) individuals at low VL risk (routine follow-up), 31 (6.5%) as moderate risk (secondary prophylaxis) and six (1.2%) as high risk (early treatment).

Conclusions: Leishmania infection markers can predict VL risk in HIV-patients. Interventional studies targeting those at high risk are needed.

Funding: The PreLeish study was funded by the Department of Economy, Science and Innovation of the Flemish Government, Belgium (757013) and the Directorate-General for Development Cooperation and Humanitarian Aid (DGD), Belgium (BE-BCE_KBO-0410057701-prg2022-5-ET).

Declaration of Interest: None to declare.

Ethical Approval: The study was approved by the institutional review board of the ITM-A and the ethics review committee of the University of Antwerp (Belgium), the University of Gondar (Ethiopia), MSF, the Amhara Regional Health Bureau (Ethiopia) and the national research ethics review committee in Ethiopia.

Keywords: visceral leishmaniasis, HIV, kala-azar, prediction, asymptomatic infection

Suggested Citation

Van Griensven, Johan and Henten, Saskia van and Kibret, Aderajew and Tessema, Mekibib Kassa and Beyene, Hailemariam and Abdellati, Said and Mersha, Dagnew and Sisay, Kasaye and Seyum, Hailemicheal and Eshetie, Hamid and Kassa, Fikadu and Bogale, Tadfe and Melkamu, Roma and Yeshanew, Arega and Smekens, Bart and Burm, Christophe and Landuyt, Hanne and de Hondt, Annelies and Van den Bossche, Dorien and Mohammed, Rezika and Pareyn, Myrthe and Vogt, Florian and Adriaensen, Wim and Ritmeijer, Koert and Diro, Ermias, Prediction of Visceral Leishmaniasis Development in a Highly Exposed HIV Cohort in Ethiopia Based on Leishmania Infection Markers: Results from the Preleish Study. Available at SSRN: https://ssrn.com/abstract=4743680 or http://dx.doi.org/10.2139/ssrn.4743680

Johan Van Griensven (Contact Author)

University of Antwerp - Institute of Tropical Medicine (ITM) ( email )

Saskia van Henten

University of Antwerp - Institute of Tropical Medicine (ITM) ( email )

Aderajew Kibret

Médecins sans Frontières ( email )

Mekibib Kassa Tessema

University of Gondar ( email )

Gondar, 196
Ethiopia

Hailemariam Beyene

Médecins sans Frontières ( email )

Said Abdellati

University of Antwerp - Institute of Tropical Medicine (ITM) ( email )

B-2000 Antwerp
Belgium

Dagnew Mersha

Médecins sans Frontières ( email )

Kasaye Sisay

Médecins sans Frontières ( email )

Hailemicheal Seyum

Médecins sans Frontières ( email )

Hamid Eshetie

Médecins sans Frontières ( email )

Fikadu Kassa

Médecins sans Frontières ( email )

Tadfe Bogale

University of Gondar ( email )

Roma Melkamu

University of Gondar ( email )

Arega Yeshanew

University of Gondar ( email )

Bart Smekens

University of Tübingen - Institute of Tropical Medicine ( email )

Tübingen
Germany

Christophe Burm

University of Antwerp - Department of Clinical Sciences ( email )

Hanne Landuyt

University of Antwerp - Institute of Tropical Medicine (ITM) ( email )

Annelies De Hondt

University of Antwerp - Institute of Tropical Medicine (ITM) ( email )

Dorien Van den Bossche

University of Antwerp - Institute of Tropical Medicine (ITM) ( email )

Rezika Mohammed

University of Gondar ( email )

Gondar, 196
Ethiopia

Myrthe Pareyn

University of Antwerp - Institute of Tropical Medicine (ITM) ( email )

Florian Vogt

Australian National University (ANU) - National Centre for Epidemiology and Population Health ( email )

Wim Adriaensen

University of Antwerp - Unit of Neglected Tropical Diseases ( email )

Antwerp
Belgium

Koert Ritmeijer

Médecins sans Frontières ( email )

Ermias Diro

University of Gondar ( email )

Gondar, 196
Ethiopia