Back to Search
Start Over
Long-term safety of the tafenoquine antimalarial chemoprophylaxis regimen: A 12-month, randomized, double-blind, placebo-controlled trial.
- Source :
-
Travel medicine and infectious disease [Travel Med Infect Dis] 2022 Jan-Feb; Vol. 45, pp. 102211. Date of Electronic Publication: 2021 Nov 18. - Publication Year :
- 2022
-
Abstract
- 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.<br />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.<br />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.<br />Conclusions: This study supports the safety of extended 52-week tafenoquine prophylaxis. CLINICAL TRIAL REGISTRATION NUMBER/CLINICALTRIALS.<br />Gov Identifier: NCT03320174.<br /> (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Details
- Language :
- English
- ISSN :
- 1873-0442
- Volume :
- 45
- Database :
- MEDLINE
- Journal :
- Travel medicine and infectious disease
- Publication Type :
- Academic Journal
- Accession number :
- 34801714
- Full Text :
- https://doi.org/10.1016/j.tmaid.2021.102211