1. Patient needs driven Research and Development Agenda in HIV Dr. Felipe Garcia de la Vega MSF Campaign for Access to Essential Medicines

2. HIV in Mozambique Mozambique is one of the poorest countries in the world. Today 1.3 m people live with HIV in Mozambique. 99,000 children In 2001 MSF started HIV treatment projects in Maputo and Lichinga.

5. The problem of HIV diagnosis in children Most common presentation is failure-to- thrive One of the most difficult diagnostic challenges in pediatrics even in western setting HIV diagnosis particularly important in <18 months because most children die during infancy

6. Diagnosis HIV Paediatric Diagnostics Viral Load, not used routinely Impossible to detect infection <12- 18 m. with serologic tests 50% of children die before 2 years

8. Paediatric Formulations More expensive than adult formulations Almost all available formulations: liquids No fixed dose combinations Complex dosing schedules mg/kg or mg/m 2 Some need cold storage, shipment Distributing/dispensing glass bottles Taste of formulations

11. ART IN FIXED DOSE COMBINATIONS: ADULT AND PAEDIATRIC FORMULATIONS Adult TabletChildren Tablets Adult TabletChildren Tablets d4T + 3TC + NVP "Baby" (3-10 Kg): d4T 6mg + 3TC 30mg + NVP 50mg "Junior" (10-30 Kg):d4T 12mg + 3TC 60mg + NVP 100 mg Adult: d4T (30 mg or 40mg) + 3TC 150mg + NVP 200 mg Children FORMULATIONS

12. Conclusions Children with AIDS have been neglected In addition to diagnostic tools and formulations other gaps exist in HIV R&D (HIV/TB, PMCT, 2nd line…) Simply relying on the market for filling these gaps is not a strategy in itself Who will take the lead in addressing these challenges and fund and manage the R&D of needed tools  R& D has to be driven by patient needs