Target Product Profile
Target Product Profile
| Acceptable | Ideal | |
| Target label | Chronic Indeterminate CD | Chronic Indeterminate + Reactivations (Immunocompromised) |
| Spp. | TcI+TcII | TcI+TcII |
| Distribution | All areas | All areas |
| Target population | Immunocompetent | Immunocompetent + immunocompromised |
| Adult/children | Adult | All |
| Clinical efficacy | Superiority over benznidazole in all endemic regions (parasitological) | 70% (parasitological and serological) > 95% cure for reactivated patients (parasitological and serological) |
| Resistance | Active against nitrofuran- and nitroimidazole-resistant T. cruzi strains | Active against nitrofuran- and nitroimidazole-resistant T. cruzi strains |
| Safety | Superiority to benznidazole 3 CE plus 2 standa LE during treatment | Superiority to benznidazole No CE or LE needed during treatment |
| Contraindications | Pregnancy/lactation | None |
| Precautions | No genotoxicity; No prolongation of QTc interval | No genotoxicity; No teratogenicity; No negative inotropic effect; No prolongation of QTc interval |
| Interactions | No clinically significant interaction with anti-hypertensive, anti-arrythmic and anticoagulants drugs | None |
| Presentation | Oral | Oral |
| Stability | 3 years, climatic zone IV | 5 years, climatic zone IV |
| Dosing regime | Comparable to systemic antifungal treatments | b.i.d./60 days |
Chagas
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