Journal article
Liver Function Test Abnormalities in Experimental and Clinical Plasmodium vivax Infection
Anand Odedra, Lachlan Webb, Louise Marquart, Laurence J Britton, Stephan Chalon, Joerg J Moehrle, Nicholas M Anstey, Timothy William, Matthew J Grigg, David G Lalloo, Bridget E Barber, James S McCarthy
American Journal of Tropical Medicine and Hygiene | American Society of Tropical Medicine and Hygiene | Published : 2020
Abstract
Liver transaminase elevations after treatment in malaria volunteer infection studies (VISs) have raised safety concerns. We investigated transaminase elevations from two human Plasmodium vivax VISs where subjects were treated with chloroquine (n = 24) or artefenomel (n = 8) and compared them with studies in Thailand (n = 41) and Malaysia (n = 76). In the VISs, alanine transaminase (ALT) increased to 3 2.5 × upper limit of normal (ULN) in 11/32 (34%) volunteers, peaking 5-8 days post-treatment. Transaminase elevations were asymptomatic, were not associated with elevated bilirubin, and resolved by day 42. The risk of an ALT 3 2.5 × ULN increased more than 4-fold (odds ratio [OR] 4.28; 95% CI: ..
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Grants
Awarded by Bill & Melinda Gates Foundation
Awarded by Malaysian Ministry of Health
Awarded by National Institutes of Health (USA)
Awarded by Australian NHMRC
Funding Acknowledgements
IBSM studies were supported by a grant from the Bill & Melinda Gates Foundation (OPP1059029). The study in Thailand was supported by a grant from the Bill & Melinda Gates Foundation (OPP1111147). The study in Malaysia was supported by a grant from the Malaysian Ministry of Health (BP00500420), the National Institutes of Health (USA) (R01AI116472-01), and the Australian NHMRC (program grants 1037304 and 1132975; Project grant 1045156; fellowships to J. S. M. [1135955], N. M. A. [1135820], and M. J. G. [1138860]).