Table 2.

Target product profile of a new treatment against both stage 1 and 2 gambiense human African trypanosomiasis.

Ideal	Acceptable	NECT (current first-line treatment)
Effective against stage 1 and 2	Effective against stage 1 and 2 (used against stage 2 only)	Stage 1 and 2 (used against stage 2 only)
Broad spectrum (gambiense and rhodesiense)	Efficacy against gambiense only	Gambiense
Clinical efficacy >95% at 18 months follow-up	To be determined in an expert consultation	Clinical efficacy 96.5% [34]
Effective in melarsoprol refractory patients		Effective
<0.1% drug-related mortality	<1% drug possibly related mortality	1.2% possibly related mortality [49]
Safe also during pregnancy, for breast-feeding women and children		No specific adverse event found in babies born or being breast-fed after treatment [49]
Adult and pediatric formulations (rectal?)		Eflornithine pediatric dosing available + nifurtimox 120 mg tablets to be cut
No monitoring for adverse events	Weekly simple laboratory testing	Hospitalization required
<7 days p.o. once daily	10 days p.o. (up to t.i.d.)	7 days iv. infusion (b.i.d.) + 10 days p.o. (t.i.d.)
<7 days im. once daily	<10 days im. once daily
Stability in zone 4 for >3 years	Stability in zone 4 for >12 months	Stability in zone 4 for >24 months
Trypanocidal	Trypanostatic	Trypanostatic (eflornithine) and trypanocidal (nifurtimox)
Multi-target	Unique target (but not uptake via P2-transporter only)
<€30/course† (only drug cost)	<€100†/course	€288†/course (in 4 treatments kits; WHO) [53]
	<€200†/course if very good on other criteria

Definition: zone 4: hot and humid climate; temperature: 30°C, relative humidity: 60%.

^†Includes transport to the clinical site.

b.i.d.: Twice daily; im.: Intramuscular; NECT: Nifurtimox-eflornithine combination therapy; p.o.: Per os; t.i.d.: Three-times daily.

Adapted from [70].