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By NewsDesk @ bactiman63
GSK and Medicines for Malaria Venture (MMV) today presented positive data from the TEACH study of tafenoquine, an 8-aminoquinoline, for the prevention of relapse (radical cure) of Plasmodium vivax (P. vivax) malaria in children and adolescents.
The results of the evaluation of exposure to tafenoquine in children (TEACH) were presented during the Virtual Annual Meeting of the American Society of Tropical Medicine & Hygiene 2020.
TEACH evaluated tafenoquine doses based on weight in children and adolescents aged 6 months to 15 years. The safety profile was consistent with previous clinical studies with the exception of early post-dose vomiting. Ninety-five percent of the 60 study subjects had no recurrence of P. vivax malaria during four months of follow-up.
The current standard of care for the prevention of P. vivax relapse requires a 7 or 14 day treatment cycle and there is currently no age-specific pediatric formulation. Tafenoquine is a single dose treatment for radical healing and is already licensed for people over 16 years of age. TEACH investigated the use of a new 50 mg dispersible tablet, which was developed to facilitate its use in children. The study also used the approved 150 mg tablet.
Pauline Williams, GSK Director of Global Health R&D, said: “The results presented today represent an encouraging step forward in the fight against P. vivax malaria in children, providing evidence to support a pediatric formulation of tafenoquine. Poor compliance with the current standard of care may allow P. vivax Malaria relapses from its dormant state, causing terrible suffering in young people disproportionately affected by the disease and allowing the continued transmission of malaria, undermining malaria elimination efforts. This data underscores GSK’s dedication to fighting infectious diseases, especially in children, and our commitment to discovering and developing interventions to combat malaria. “
David Reddy, CEO of MMV, said: “Children are particularly at risk of P. vivax malaria, which is why the development of a pediatric formulation of tafenoquine was essential. At MMV our goal is to offer treatment to the most vulnerable populations and we are proud to have worked together with GSK to meet this unmet need with a single dose treatment for relapse prevention in children 6 months of age and older. “
The TEACH study evaluated tafenoquine in children and adolescents with P. vivax malaria weighing at least 10 kilograms. All subjects received a single dose of taphenoquine and a course of chloroquine administered according to local or national treatment guidelines to treat the acute blood stage of the disease.
Different doses of tafenoquine were administered based on weight. The TEACH data show that subjects weighing between 10 kg and 20 kg should receive 100 mg dispersible tablets; and those between 20 kg and 35 kg should receive 200 mg in dispersible tablets. Those who weigh more than 35 kg should receive 300 mg in the form of two 150 mg tablets, currently approved for older populations. Although no subjects were included in the lowest weight range (≥6 months to <2 years, weighing ≥5 kg to ≤10 kg), data from the TEACH pharmacokinetic model (PK) indicate that a child in that weight range you should receive a dose of 50 mg. taphenoquine dosage.
The 95 percent relapse-free efficacy rate at four months is in line with studies of tafenoquine in adults and older adolescents. The safety profile was consistent with previous clinical studies, with the exception of early post-dose vomiting. No serious drug-related adverse events were reported.
TEACH data will support regulatory filings in Australia and malaria endemic countries.
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