ANRS-FUNDED RESEARCH IN THE DEVELOPING WORLD

Transcription

1 ANRS-FUNDED RESEARCH IN THE DEVELOPING WORLD Brazil Burkina Faso (Bobo Dioulasso) Cambodia (Phnom Penh) Cameroon (Yaounde) Côte d Ivoire (Abidjan) Senegal (Dakar) Vietnam (Ho Chi Minh City) South Africa, Thailand

2 CURRENT PRIORITIES FOR ANRS-FUNDED RESEARCH IN THE DEVELOPING WORLD Molecular epidemiology; diversity; resistance Clinical trials in PMTCT and pediatric AIDS Prevention of sexual transmission Clinical trials in chronically-infected adults Low cost methods for monitoring CD4 cells and plasma viral load Cohorts Multidisciplinary assessment of national treatment and prevention programmes («operational research») Behavioral and sociological studies Health economics

3 Evolution from baseline of plasma HIV RNA (mean ± SD) 7 Plasma HIV RNA log ,4 1,9 1,9 2,0 2,3 0 baseline (n=40) 6 months (n=40) 12 months (n=39) 15 months (n=36) 18 months (n=38)

4 ANRS 1274 Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine and lamivudine in HIV-1-infected adults in Cameroon : open label, multicenter trial Laurent C., Kouanfack C., Koulla-Shiro S., Nkoué N., Bourgeois A., Calmy A., Lactuock B., Nzeusseu V., Mougnutou R., Peytavin G., Liégeois F., Nerrienet E., Tardy M., Peeters M., Andrieux-Meyer I., Zekeng L., Kazatchkine M.D., Mpoudi-Ngolé E., Delaporte E. Lancet 2004 : 364, 29-34

5 TRIVACAN ANRS 1269 Three arm multicentric randomized trial comparing uninterrupted HAART to scheduled therapeutic interruptions (4 mo/ 2 mo) and an therapeutic interruption regimen where treatment is resumed on the basis of CD4 cell counts N = 690 Abidjan

6 HRZE (2 months) RH (4 months) ARV Early R End of anti-tb Anti-TB Late ARV Day 1 Day 14 M2 M6 M12

7 RESEARCH NEEDS IN THE CONTEXT OF EXPANDING THE ACCESS TO ANTIRETROVIRAL THERAPY: OPTIMIZING THERAPY Search for optimal 1st, 2nd and 3rd line treatment regimens for chronically infected patients Optimize strategies Optimize regimens for specific indications, e.g. tuberculosis, pregnancy, children Generics Pharmacokinetics

8 RESEARCH NEEDS IN THE CONTEXT OF EXPANDING THE ACCESS TO ANTIRETROVIRAL THERAPY: IMPACT Efficacy, tolerance, adherence Changes in health-seeking behaviors Impact on health care workers and health system Impact on purchase/ delivery /circulation of ARVs Impact on decision-making by health authorities Economic impact and impact on country planification processes Impact on behavior, prevention, attitude towards disease

9 Observance moyenne en fonction du niveau de participation financière des patients (n= 619 mois de traitement) observance moyenne % gratuit de 1 à FCFA de à FCFA FCFA ou plus

10 Distribution des motifs d interruption prolongée de traitement (>6 jours) en fonction de l année de suivi (N=159) 60% 50% OUBLI / SOMMEIL A L'EXTERIEUR / VOYAGE 40% PB FINANCIER 30% 20% MALADIE/EI 10% 0% RUPTURE EN MEDICAMENTS ARRET VOLONTAIRE / TRADITHERAPIE AUTRES

11 CHARTE D ETHIQUE DE LA RECHERCHE DANS LES PAYS EN DEVELOPPEMENT L accès des personnes aux bénéfices attendus de la recherche constitue un droit fondamental. La recherche doit servir les intérêts de la personne au sein de sa communauté. La recherche constitue un engagement partenarial réciproque qui concerne l ANRS, l investigateur, la personne qui se prête à la recherche, les institutions des pays partenaires et les communautés.

12 Main areas of operational research Needs assessment. Optimal models for delivery of care. Drug procurement, delivery, distribution, and rational use of drugs. Human resources, healthcare infrastructure, and administrative and management capacities. Impact on the HIV-infected population and general population. Microeconomic, macroeconomic, and societal impact on development.

13 EVALUATING DRUG ACCESS INITIATIVES Côte d Ivoire (2000) Sénégal (2002) Chile (2003)

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15 MONITORING TREATMENT Low cost methods for enumerating CD4 cells Low cost methods for measuring plasma HIV-RNA, e.g. real-time PCR ; p24 antigen Restrict viral resistance studies to research and to surveillance programmes in (regional?) reference centers

16 RESEARCH NEEDS IN THE CONTEXT OF EXPANDING THE ACCESS TO ANTIRETROVIRAL THERAPY: OPPORTUNISTIC INFECTIONS Improve diagnostic procedures Establish diagnostic algorithms Improve therapeutic protocols; prophylaxis Assess changing patterns of disease with expanding availability of ARVs Focus on tuberculosis; acute pulmonary infections and enteric infections

17 Evolution from baseline of CD4 cell counts (mean ± SD) 600 CD4 cells/mm ,8 306,8 350,2 362,3 372,0 0 baseline (n=40) 6 months (n=39) 12 months (n=39) 15 months (n=38) 18 months (n=33)

18 Evolution from baseline of weight (mean ± SD) , ,4 64 Weight (kg) , baseline (n=40) 6 months (n=40) 12 months (n=39) 15 months (n=39) 18 months (n=34)

19 RESEARCH NEEDS IN THE CONTEXT OF EXPANDING THE ACCESS TO ANTIRETROVIRAL THERAPY: POLICIES Identify gaps in training, infrastructures, organization of health systems, health insurance; Identify cultural, societal, economic, political, barriers to implementation and expansion of antiretroviral programmes.