Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis

Travel Medicine and Infectious Disease
Anne Novitt-MorenoStephen Toovey

Abstract

Tafenoquine is a new prophylactic antimalarial drug. The current analysis presents an integrated safety assessment of the Tafenoquine Anticipated Clinical Regimen (Tafenoquine ACR) from 5 clinical trials, including 1 conducted in deployed military personnel and 4 in non-deployed residents, which also incorporated placebo and mefloquine comparator groups. Adverse events (AEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA®, Version 15.0) and summarized. Among all subjects who had received the Tafenoquine ACR, safety findings were compared for subjects who were deployed military personnel from the Australian Defence Force (Deployed ADF) versus non-deployed residents (Resident Non-ADF). The incidence of at least one AE was 80.6%, 64.1%, 67.6% and 94.9% in the mefloquine, placebo, tafenoquine Resident Non-ADF and tafenoquine Deployed ADF groups, respectively. The latter group had a higher incidence of AEs related to military deployment. AEs that occurred at ≥ 1% incidence in both tafenoquine sub-groups and at a higher frequency than placebo included diarrhea, nausea, vomiting, gastroenteritis, nasopharyngeal tract infections, and back/neck pain. Weekly administration of tafenoquine for up to six mo...Continue Reading

Citations

Nov 1, 2018·Journal of Travel Medicine·J Kevin Baird
Feb 21, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Martin P GrobuschPatricia Schlagenhauf
Jun 22, 2019·Transactions of the Royal Society of Tropical Medicine and Hygiene·Chaturaka RodrigoSumadhya Deepika Fernando
Nov 30, 2019·Journal of Travel Medicine·Jelena LewisJeff Goad
Jul 16, 2019·Current Opinion in Infectious Diseases·Victor Chen, Johanna P Daily
Feb 2, 2019·Archives of Disease in Childhood·Lucy Jane Bock
Sep 20, 2018·Drugs·James E Frampton
Dec 12, 2020·Expert Opinion on Drug Safety·Cindy S Chu, Jimee Hwang
Nov 24, 2020·Travel Medicine and Infectious Disease·Julian D MaierPatricia Schlagenhauf

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