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Diseases Leishmaniasis Target Product Profile
Diseases Leishmaniasis Target Product Profile
Target Product Profile
Target Product Profile
| As a prerequisite to building the strategy, the target product (treatment) profile (TPP) has been established. It is based on discussions with various VL experts, consultation with VL national control programmes in endemic countries, and specifically with leading physicians and health workers who deal with this disease on a daily basis. Our TPP is reviewed and revised annually, and shared with other investigators openly (see Tables 3 and 4 for TPP of combination therapy and NCE’s, respectively). The priority is to develop a safe, effective, oral, short-course (11 days maximum) VL drug to replace current treatments. This will improve and simplify current case management. The aim is to develop combinations of drugs that are effective against VL in all foci of the disease. |
Target Profile for Developing Combinations
from Existing Visceral Leishmaniasis Treatments
| Target | Minimum Acceptable | |
| Spp | All species | L. donavani (Covers most endemic areas) |
| Distribution | All areas | ≥ One region (India or Africa or Latin America) |
| Target Population | Immunocompetent and immunosuppressed, Adults and children | Immunocompetent Primary VL Children |
| Treatment Regimen | ≤10 day treatment regimen | 14 day treatment regimen |
| Feasibility | Most of treatment given as outpatient (e.g. oral treatment) | Daily ambulatory care possible (e.g. daily im injections) |
| Clinical Efficacy | > 95% (phase 3) | > 90% (phase 3) |
| Resistance | Active against resistant strains | Active against resistant strains |
| Safety and Tolerability | No AEs requiring in patient monitoring | CFR during treatment < 1% (phase 3) |
| Contraindications | None | Pregnancy/lactating |
| Cost per treatment (2008 prices) | < $75 / course | < $175 / course (only if other cost saving possible through reduction in opportunity costs to patient & hospital care) |
Target Product Profile for VL NCEs
| Optimal Target Profile | Minimal Target Profile | |
| Target Label | VL and PKDL | VL |
| Spp | All species | L. donavani |
| Distribution | All areas | Either India or Africa |
| Target Population | Immunocompetent and immunosuppressed | Immunocompetent |
| Clinical Efficacy | > 95% | > 90% |
| Resistance | Active against resistant strains | |
| Safety and Tolerability | No AEs requiring monitoring | 1 monitoring visit in mid/end - point |
| Contraindications | None | Pregnancy/lactation |
| Interactions | None - Compatible for combination therapy | None for malaria, TB, and HIV therapies |
| Formulation | Oral / im depot | Oral / im depot |
| Treatment Regimen | 1/day for 10 days po/ 3 shots over 10 days | bid for <10 days po; or <3 shots over 10 days |
| Stability | 3 yrs in zone 4 | Stable under conditions that can be reasonably achieved in the target region (> 2 yr) |
| Cost | < $10 / course | < $125 / course |
Leishmaniasis
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