THURSDAY, Sept. 22, 2016 (HealthDay News) — For adults with acute Plasmodium vivax or P. falciparum, KAF156 shows antimalarial activity, according to a study published in the Sept. 22 issue of the New England Journal of Medicine.
Nicholas J. White, M.D., from the Mahidol University in Bangkok, and colleagues conducted a phase 2, open-label trial at five centers in Thailand and Vietnam to examine the antimalarial efficacy, safety, and pharmacokinetic profile of KAF156. They assessed parasite clearance rates in adult patients with vivax or falciparum malaria who were treated with multiple doses (400 mg for three days), and assessed cure rate in a cohort of patients with falciparum malaria treated with a single dose (800 mg).
The researchers found that the median parasite clearance times were 45 and 24 hours for 10 patients with falciparum malaria and for 10 patients with vivax malaria, respectively, after treatment with the multiple-dose regimen, and 49 hours for the 21 patients with falciparum malaria treated with a single dose. During 28-day follow-up for patients treated with a single dose, one had reinfection and seven had recrudescent infections (cure rate, 67 percent). The mean terminal elimination half-life was 44.1 ± 8.9 hours for KAF156. No serious adverse events were seen in the study; common adverse events included sinus bradycardia, thrombocytopenia, hypokalemia, anemia, and hyperbilirubinemia.
“KAF156 showed antimalarial activity without evident safety concerns in a small number of adults with uncomplicated P. vivax or P. falciparum malaria,” the authors write.
Several authors disclosed financial ties to Novartis, which developed KAF156 and partially funded the study.
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