Gaps & obstacles Priorities & Solutions

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Group 4 Gaps & obstacles.
Presentation transcript:

Gaps & obstacles Priorities & Solutions 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 NVP-exposed infants (& mothers) – develop a strategy now ?4drugs ABC & TFV More work on PI’s D4T endgame? – long term toxicity?

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

Programmatic: Longitudinal outcome cohorts in 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

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

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

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