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

Anne Novitt-Moreno, Adam Martidis, Victor Gonzalez, Janet Ransom, Charles B. Scott, Geoffrey Dow, Mark Reid, Bryan Smith, Victor E. Zottig, Lisa Thomas Read, Lindsey S. Garver Baldwin, Fred K. Chen

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

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. 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.

Original languageEnglish
Article number102211
JournalTravel Medicine and Infectious Disease
Volume45
DOIs
Publication statusPublished - 1 Jan 2022

Fingerprint

Dive into the research topics of 'Long-term safety of the tafenoquine antimalarial chemoprophylaxis regimen: A 12-month, randomized, double-blind, placebo-controlled trial'. Together they form a unique fingerprint.

Cite this