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 |