Paediatric HIV
Target product profile for paediatric HIV
Paediatric HIV
Target product profile for paediatric HIV
Target product profile for a ‘4-in-1’ for paediatric HIV
DNDi aims to develop a once-daily, pleasant-tasting 4-in-1 fixed-dose antiretroviral treatment for HIV in all children under three years, including neonates, that is easily swallowed and does not require a cold-chain.
| Ideal | Acceptable | |
|---|---|---|
| Target population | Both nevirapine (NVP)-exposed and non-exposed HIV+ and HIV-exposed children under 3 years of age, including neonates | Both NVP-exposed and non-exposed HIV+ children under 3 years of age and above 3 months of age |
| Treatment regimen | Once-daily Dosing based on weight band | Twice-daily Dosing based on weight band |
| Formulation | Fixed-dose formulation of abacavir, lamivudine, lopinavir, and ritonavir. Dosage form suitable for sprinkling on age-appropriate food or liquid, suitable for infants and young children, with very small particle sizes enabling easy swallowing by very young infants and neonates. | Fixed-dose formulation of abacavir, lamivudine, lopinavir, and ritonavir. Dosage form suitable for sprinkling on age-appropriate food or liquid, suitable for infants and young children. |
| Durability | High genetic barrier, protease inhibitor-like. Long plasma half-life. | High genetic barrier, protease inhibitor-like. Long plasma half-life. |
| Efficacy | Same as for adults | Same as for adults |
| Safety/tolerability | Well tolerated and no laboratory monitoring needed | No laboratory monitoring needed |
| Palatability | No taste or pleasant taste for children | Acceptable taste for children |
| Drug-drug interactions | No drug-drug interaction with TB medicines, particularly rifampicin or rifabutin | Some drug-drug interaction with TB medicines, but can be used with proper dose adjustments |
| Stability | No cold chain requirement, minimum 2 years shelf life in Zone IVb conditions | No cold chain requirement, minimum 18 months shelf life in Zone IVb conditions |
| Cost | Similar to average public cost of an adult antiretroviral therapy | Not more expensive than the public cost of the paediatric formulations of the separate drugs |
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