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Group 4

Group 4. Gaps & obstacles Priorities & Solutions. Key Issues. Ideal paediatric regimens Dosing & pharmacokinetics Programmatic evaluation. Ideal paediatric regimens. FDC-based Clinical & pK evaluation Can start with adult formulations Rapid development of paediatric formulations

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Group 4

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  1. Group 4 Gaps & obstacles Priorities & Solutions

  2. Key Issues • Ideal paediatric regimens • Dosing & pharmacokinetics • Programmatic evaluation

  3. Ideal paediatric regimens • FDC-based • Clinical & pK evaluation • Can start with adult formulations • Rapid development of paediatric formulations • NVP-exposed infants (& mothers) – develop a strategy now • ?4drugs • ABC & TFV • More work on PI’s • D4T endgame? – long term toxicity?

  4. Dosing & Pharmacokinetics • Rifampicin – NVP/EFV interactions • EFV <3y/10kg • X1 daily dosing regimens • Incl 3TC, ddI, EFV, D4T, NVP, TFV • Validating weight-band based tables • At extremes of bands • Efficacy & toxicity • Dose clarification 3TC & NVP & ZDV

  5. Programmatic:Longitudinal outcome cohortsin resource-constrained settings • Model program definition (for replication) • Decentralized • Nurse-managed • Community & family based with good referral network • Chronic care • Systems for surveillance • Clinical outcome (incl drop-out rate) • Resistance • Toxicity • Program evaluation • Forecasting evaluation

  6. Who should do & who should fund? • Should WHO, UNICEF, UNAID & partners co-ordinate process? • Support from Regulatory authorities • National programs must endorse & support appropriate research • Funding - PEPFAR, GATES, USAID, Research networks, Academic institutions • Manufacturers (Innovator & Generic) • NGO – MSF, others

  7. Other priorities • Early diagnosis • Virological • Clinical • Improved PMTCT interventions • Training & guidelines • Strategies • When to start ART? • Can ART be stopped? CD4 guided STI

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