Long-term clinical outcomes in visceral leishmaniasis/human immunodeficiency virus-co-infected patients during and after pentamidine secondary prophylaxis in Ethiopia: a single-arm clinical trial

Ermias Diro, Koert Ritmeijer, Marleen Boelaert, Fabiana Alves, Rezika Mohammed, Charles Abongomera, Raffaella Ravinetto, Maaike De Crop, Helina Fikre, Cherinet Adera, Harry van Loen, Achilleas Tsoumanis, Wim Adriaensen, Asrat Hailu, Johan van Griensven

Research output: Contribution to journalA1: Web of Science-article

Abstract

Background: We have conducted a single-arm trial evaluating monthly pentamidine secondary prophylaxis (PSP) to prevent visceral leishmaniasis (VL) relapse in Ethiopian HIV-patients. Outcomes at 12 months of PSP have been previously reported, supporting PSP effectiveness and safety. However, remaining relapse-free after PSP discontinuation is vital. We now report outcomes and associated factors for a period of upto 2.5 years after initiating PSP, including one year follow-up after PSP discontinuation.

Methods: The trial had three phases: 1) 12 months (M12) of PSP; 2) a 6-months PSP-extension period if CD4 count ≤200cells/μl at M12; 3) 12-months follow-up after stopping PSP. The probability of relapse and risk factors were calculated using Kaplan-Meier methods and Cox regression.

Results: For the 74 patients included, final study outcomes were: 39 (53%) relapse-free, 20 (27%) relapse, five (7%) deaths, ten (14%) lost. The two-year risk of relapse was 36.9% (95% CI 23.4%-55.0%), highest for those with a history of VL relapse and low baseline CD4 counts. 45 patients were relapse-free and in follow-up at M12 of PSP. This included 28 patients with M12 CD4 counts >200cells/µl, remaining relapse-free after PSP discontinuation. Amongst the 17 with M12 CD4 counts <200 cells/µl, one relapsed and three were lost during the PSP-extension period. During one year post-PSP follow-up, two patients relapsed and one was lost. No PSP-related serious adverse events were reported during the PSP-extension/post-PSP follow-up period.

Conclusions: M12 CD4 counts >200 cells/µL seem safe to discontinue PSP. The management of those failing to reach this remains to be defined.

Original languageEnglish
JournalClinical Infectious Diseases
Volume66
Issue number3
Pages (from-to)444-451
Number of pages8
ISSN1058-4838
DOIs
Publication statusPublished - 2018

Keywords

  • Journal Article

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