Meta-Analysis Plan for 207581: Comparing the efficacy of 300 mg single dose tafenoquine with 14-day primaquine 15 mg treatment regimen for the prevention of P. vivax relapse: a non-inferiority analysis

Trial description: P. vivax represents approximately 50 percent of all malarial cases in South and South East Asia, Latin America and the horn of Africa. PQ and TQ are both 8-aminoquinolines that have demonstrated efficacy over chloroquine (CQ) only in the radical cure of P. vivax malaria. However, a clinical study to directly assess the treatment difference between PQ+CQ and TQ+CQ has not been conducted. This meta-analysis is designed to evaluate whether TQ+CQ is non-inferior to PQ+CQ for the prevention of relapse over the six month post-dosing period. The individual subject data from the PQ+CQ and CQ only arms of the DETECTIVE Part 1 study as wells as TQ+CQ and PQ+CQ arms of the DETECTIVE Part 2 and GATHER studies will be used in this study. The purpose of DETECTIVE (TAF112582) study is to test the safety and efficacy of TQ+CQ as a radical cure for P. vivax malaria relative to the control CQ. Part 1 aims to select an efficacious and well-tolerated dose that can be co-administered with CQ. Part 2 will investigate the safety and efficacy of the selected dose of TQ 300 mg in the treatment and radical cure of P. vivax malaria. A total of 851 subjects have been enrolled in DETECTIVE study. The GATHER (TAF116564) study aimed to assess the incidence of hemolysis, safety, and efficacy of TQ versus PQ in subjects with P. vivax malaria. Subjects were randomized to in 2:1 ratio to receive single dose TQ+CQ or PQ+CQ once daily for 14 days. A total of 251 subjects have been enrolled in GATHER study. All the subjects were followed-up up to six month post-dose in both the DETECTIVE and GATHER studies.