Patient needs driven Research and Development Agenda

in HIVDr. Felipe Garcia de la Vega

MSF Campaign for Access to Essential Medicines

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.

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

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

Paediatric Formulations• More expensive than adult formulations

• Almost all available formulations: liquids

• No fixed dose combinations

• Complex dosing schedules mg/kg or mg/m2

• Some need cold storage, shipment

• Distributing/dispensing glass bottles

• Taste of formulations

Evolution on price for pediatric treatment according to the weight

0

500

1000

1500

7 kg 10 kg 14 kg 20 kg 25 kg 30 kg 60 kg

Weight (Kg)

US$/

year best generic

originator

ART IN FIXED DOSE COMBINATIONS: ADULT AND PAEDIATRIC FORMULATIONS

Adult Tablet Children Tablets

Adult Tablet Children 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

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