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Table 3 TCP-3

From: Designing the next generation of medicines for malaria control and eradication

TCP-3: general considerations Minimum essential Ideal
Dosing regimen Oral, once a day for up to 3 days - for use with existing artemisinin-combination therapies (ACTs) Oral, single dose
Efficacy: TCP3aa Prevents 90% of relapses over a six month period. Human adult dose <1,000 mg Prevents 90% of relapses over a year. Human adult dose < 100 mg
Efficacy TCP3b Prevents transmission to mosquito >90% on day 7 post oral dose. Human adult dose <1,000 mg Prevents transmission to mosquito >90% between 12 h and 7 days post oral dose. Human adult dose <100 mg
Safety Acceptable therapeutic ratio based on human volunteer studies between exposure at human effective dose and NOAEL, dependent on nature of toxicity) Therapeutic ratio >50 fold based on human volunteer studies between exposure at human effective dose and NOAEL; benign safety signal
G6PD (Glucose-6-phosphate dehydrogenase) deficiency status Therapeutic dose identified with change in hemoglobin concentration at day 7 of < 2.5 g/l patients with moderate G6PD activity (60%) Therapeutic dose shows no significant change in hemoglobin concentration
Drug-drug interactions No unmanageable risks No interactions with other anti-malarial, anti-retroviral or TB medicines
Formulation Acceptable clinical formulation identified  
Cost of single treatmentb Similar to current medication: $0.50 for adults, $0.12 for infants for relapse and $0.05 for adults, $0.01 for infants for transmission blocking Better than current medication: < $0.50 for adults, $0.12 for infants under two years for relapse and < $0.05 for adults, $0.01 for infants for transmission blocking
Projected stability of final product under Zone IVb conditions (37°C 75% humidity) ≥ 24 months ≥ 5 years
  1. Notes:
  2. a Better precision on the clinical efficacy of the gold standard, primaquine in relapse prevention should be available from the phase II comparison with tafenoquine, which will be available in the summer of 2013.
  3. b Estimates of the price elasticity of an anti-relapse therapy are extremely challenging. The price range varies from the cost of treating relapses should they occur and the current treatment costs with primaquine (currently USD $0.04 per 15 mg tablet, so $1.12 for 14 days treatment).