Long-term safety of the tafenoquine antimalarial chemoprophylaxis regimen: A 12-month, randomized, double-blind, placebo-controlled trial.

Autor: Novitt-Moreno A; Fast-Track Drugs & Biologics, Poolesville, MD, 20878, USA., Martidis A; Retina Consultants of Southern Colorado, Colorado Springs, CO, 80909, USA., Gonzalez V; Valley Retina Institute, McAllen, TX, 78503, USA., Ransom J; Fast-Track Drugs & Biologics, Poolesville, MD, 20878, USA., Scott CB; Fast-Track Drugs & Biologics, Poolesville, MD, 20878, USA., Dow G; 60°Pharmaceuticals LLC, Washington, DC, 20036, USA. Electronic address: geoffdow@60degreespharma.com., Reid M; Graythan Regulatory Services Pty Ltd, Brisbane, QLD, 4000, Australia., Smith B; 60°Pharmaceuticals LLC, Washington, DC, 20036, USA., Zottig VE; United States Army Medical Materiel Development Activity (USAMMDA), Ft Detrick, MD, 21702, USA., Read LT; United States Army Medical Materiel Development Activity (USAMMDA), Ft Detrick, MD, 21702, USA., Garver Baldwin LS; United States Army Medical Materiel Development Activity (USAMMDA), Ft Detrick, MD, 21702, USA., Chen FK; Centre for Ophthalmology and Visual Sciences (incorporating Lions Eye Institute), The University of Western Australia, Nedlands, WA, 6009, Australia; Linear Clinical Research, Nedlands, WA, 6009, Australia.
Jazyk: angličtina
Zdroj: Travel medicine and infectious disease [Travel Med Infect Dis] 2022 Jan-Feb; Vol. 45, pp. 102211. Date of Electronic Publication: 2021 Nov 18.
DOI: 10.1016/j.tmaid.2021.102211
Abstrakt: Background: Tafenoquine is a long-acting 8-aminoquinoline approved for antimalarial prophylaxis for ≤6 months. Additional data is needed to establish the drug's longer-term safety profile, including potential ophthalmic or neuropsychiatric effects.
Method: This was a randomized, double-blind, placebo-controlled trial in 600 healthy adults. Eligible subjects were randomized 1:1 to receive tafenoquine 200 mg weekly (antimalarial prophylactic regimen) or placebo for 52 weeks. Scheduled safety visits occurred at Weeks 4, 12, 24, 52 (dosing completed), and 64 (final follow-up). Safety assessments included ophthalmic changes, general and neuropsychiatric adverse events (AEs), and laboratory value changes.
Results: The percentage of subjects with a protocol-defined Serious Ophthalmic Safety Event was lower in the Tafenoquine Group (18.2%) versus the Placebo Group (19%, p = 0.308). There was no significant difference between the percentages of subjects with at least one AE in the Tafenoquine Group (91.0%) versus Placebo (89.9%, p = 0.65). Common AEs seen at a significantly higher incidence for tafenoquine included reversible cornea verticillata (54.5%) and nausea (13.0%), leading to 0.0% and 0.7% discontinuations. Psychiatric AEs occurred at similar percentages in both study groups. Reversible changes in hemoglobin, methemoglobin, creatinine, and blood urea nitrogen (BUN) were noted.
Conclusions: This study supports the safety of extended 52-week tafenoquine prophylaxis. CLINICAL TRIAL REGISTRATION NUMBER/CLINICALTRIALS.
Gov Identifier: NCT03320174.
(Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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