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Tafenoquine

Manufactured by GlaxoSmithKline
Sourced in United Kingdom

Tafenoquine is a laboratory product developed by GlaxoSmithKline. It is an antimalarial agent used for research purposes.

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4 protocols using tafenoquine

1

Comparison of Tafenoquine and Artemisinin Combinations

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Study treatments were tafenoquine (150 mg per tablet) (GlaxoSmithKline), dihydroartemisinin-piperaquine tetraphosphate (40 mg/320 mg per tablet) (Eurartesim; Sigma-Tau Industrie Farmaceutiche Riunite SPA), and artemether-lumefantrine (20 mg/120 mg per tablet) (Coartem; Novartis Pharmaceuticals). Subjects were randomized into five cohorts (n = 24 per cohort) to receive tafenoquine on day 1 (300 mg) plus once-daily dihydroartemisinin-piperaquine on days 1, 2, and 3 (120 mg/960 mg for subjects with a body weight of 36 to <75 kg and 160 mg/1,280 mg for subjects with a body weight of ≥75 to 100 kg), or plus artemether-lumefantrine (80 mg/480 mg) with the second dose administered 8 h after the first dose on day 1 and then twice daily on days 2 and 3, or each drug given alone (Fig. 1). No dose adjustments were allowed.
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2

Tafenoquine Dose Randomized Placebo-Controlled Trial

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Eligible subjects were randomized in a 2:1 ratio to receive either a single 300-mg oral dose of tafenoquine (GlaxoSmithKline, Harlow, United Kingdom) or matched placebo on day 1 of the study (Fig. 1). Treatment was directly observed, administered with 240 mL of water and given with food. The randomization schedule was generated by GlaxoSmithKline Quantitative Sciences using validated internal software. The GlaxoSmithKline online randomization system (RAMOS NG) was used to allocate subjects to treatment. Subjects were masked to treatment; as were the readers at the independent retinal reading center, who reviewed the data. Although not required by the protocol, investigators were also masked to treatment allocation, with only pharmacy staff aware of treatment allocation throughout the study.

Study schematic

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3

Comparison of Tafenoquine and Primaquine Antimalarial Treatments

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The trial drugs were chloroquine phosphate (300-mg tablets [West Ward Pharmaceuticals] or 150-mg tablets [Alliance Pharmaceuticals]), tafenoquine (150-mg film-coated tablets [GlaxoSmithKline]), and primaquine phosphate (15-mg overencapsulated tablets [Sanofi]) (dosages are given for the free-base form). All patients received 600 mg of open-label chloroquine on days 1 and 2 and 300 mg on day 3. Patients were randomly assigned, in a 2:1 ratio, to receive a single 300-mg dose of tafenoquine while hospitalized on day 1 or 2 or 15 mg of primaquine once daily for 14 days starting on day 1 or 2. All treatments were administered orally with food. To ensure that the patients and investigators were unaware of the trial-group assignments, primaquine-matched placebo was administered to patients in the tafenoquine group and tafenoquine-matched placebo was administered to patients in the primaquine group on the scheduled treatment days. Treatment was discontinued when a patient had a protocol-defined decrease in the hemoglobin level (>3.0 g per deciliter or ≥30% from baseline or to a level of <6.0 g per deciliter), clinically significant changes in the liver chemical profile, a prolongation of the QT interval (corrected with the use of Fridericia’s formula) to more than 500 msec, or a grade 4 adverse event (Table S1 in the Supplementary Appendix, available at NEJM.org).
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4

Tafenoquine versus Chloroquine for Malaria

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This was a randomized, active-control, double-blind, double-dummy study conducted from 15th September 2003 to 10th January 2005 at the Bangkok Hospital for Tropical Disease (Fig 1).
There were to be two sequential cohorts: cohort 1 was 400 mg tafenoquine for three days and comparator; cohort 2 was planned to be tafenoquine 600 mg as a single dose and comparator, but was not executed because of slow parasite clearance in cohort 1.
Treatment allocation was based on a computer generated block randomization list (block size 6). Eligible patients were randomized to active treatment with either tafenoquine 400 mg for three days (GlaxoSmithKline, two 200 mg capsules per day); or chloroquine phosphate 1000 mg for two days (AstraZeneca UK Ltd, four 250 mg capsules per day; 600 mg chloroquine base) and chloroquine phosphate 500 mg for one day (two 250 mg capsules; 300 mg chloroquine base) followed by 15 mg primaquine base for 14 days (Muir Pty Ltd, one capsule per day, given with food). Matched placebos were given as shown in Fig 2.
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