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– Virological– Clinical

• Improved PMTCT interventions• Training & guidelines• Strategies

– When to start ART?– Can ART be stopped? CD4 guided STI