Background: 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.
Methods: 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).
Results: 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.
Conclusions: Weekly administration of tafenoquine for up to six months increased the incidence of gastrointestinal AEs, certain infections, and back/neck pain, but not the overall incidence of AEs versus placebo. CLINICAL TRIAL REGISTRATION NUMBERS/CLINICALTRIALS.
Keywords: 8-aminoquinoline; Adverse events; Malaria; Safety; Tafenoquine; Tolerability.
Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.