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Table 4 TCP-4

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

TCP-4 criteria Minimum essential Ideal
Dosing regimen; adult dosea Oral, once per week; < 1,000 mg Oral, once per month; < 100 mg
Rate of onset of action Slow onset of action (>48 h) against asexual blood stages or causal liver stage activity  
Susceptibility to loss of efficacy due to acquired resistance Very low risk for blood stage Very low; orthogonal mechanism to treatment use
Clinical protection from infection >95% protection from primary Plasmodium infection >95% protection from all Plasmodia infections (including relapses)
Transmission reduction to the mosquito vector: inhibition of oocysts via vector stage targeting at trough levels No > 90%
Bioavailability /Food Effect - human data > 30%, < 3-fold food effect >50%, no food effect
Drug-Drug Interactions No unmanageable risks No interactions with other anti-malarial, anti-retroviral or TB medicines
Safety – Clinical 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 Measured - No enhanced risk in relevant G6PD deficient animal models Measured - No enhanced risk in G6PD deficient subjects
Formulation Acceptable clinical formulation identified  
Cost of single treatmentb ≥ $0.5 for adults, $0.1 for infants under two years < $0.25 for adults, $0.05 for infants under two years
Projected stability of final product under Zone IVb conditions (37°C 75% humidity) ≥ 2 years ≥5 yr
  1. a It may be acceptable for a chemoprotectant that is clearly differentiated in other ways versus existing gold standard prophylactics to be dosed more frequently.