patient needs driven research and development agenda in hiv dr. felipe garcia de la vega msf...

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