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Bases de données observationnelles AC12 Bilan 2007 et Objectifs 2008 Le modèle originel : Antiretroviral Therapy (ART) Cohort Collaboration • France • French Hospital Database on HIV (FHDH) • Aquitaine Cohort • Germany • 29 European countries • Canada • British Columbia Centre for Excellence in HIV (BCCfE-HIV) • South Alberta Clinic • USA • Italian Cohort of Antiretroviral-Naive Patients (ICONA) • Switzerland • Swiss HIV Cohort Study • Netherlands • AIDS Therapy Evaluation project Netherlands (ATHENA) • Spain • PISCIS, Catalonia and Balearic islands • United Kingdom • Royal Free Hospital Cohort, London Cohort Collaboration • The Multicenter Study Group on EuroSIDA • Frankfurt HIV Cohort • Köln / Bonn Cohort • Italy ART • Collaborations in HIV Outcomes Research US (CHORUS) • 1917 Clinic Cohort, University of Alabama, Birmingham • University of Washington HIV Cohort, Seattle • Veterans Aging Cohort Study (VACS), West Haven www.art-cohort-collaboration.org The Antiretroviral Therapy in Low-Income Countries (ART-LINC) Collaboration ANRS 12101 / 12138 & NIH/OAR Dabis, Egger, Schechter • A network of 21 HIV treatment programs and 47 clinical centers in Africa (Morocco, Senegal, Côte d’Ivoire, Nigeria, Cameroon, Uganda, Malawi, South Africa, Botswana), Latin America (Argentina, Brazil), and Asia (India, Thailand) – Sites identified through literature searches and personal contacts • Site assessments conducted through self-administered surveys and on-site assessments by ART-LINC central team (2004 and 2006) and through an electronic system DataCol ® (2008) – Pooling of existing databases with individual patient data: • Merger # 1 : 2004-2005, N = 8.700 • Merger # 2 : 2006-2007, N = 40,000 80 80 A B 60 S u b -S a h a ra n A frica 40 A sia 20 P e rce n ta g e w o m e n % o f to ta l p a tie n ts in re g io n Number of patients receiving ART (A); Proportion of women (B); Median baseline CD4 (C); Proportion with viral load (D) - Kaiser (CROI 2008) S u b -S a h a ra n A frica 60 S o u th A m e rica 40 20 A sia S o u th A m e rica 0 0 250 C S o u th A m e rica 200 150 100 A sia S u b -S a h a ra n A frica 50 2 0 0 1 2 0 0 2 2 0 0 3 2 0 0 4 0 5 -0 6 Year 2001 % w ith H IV vira l lo a d a t 6 m o n th s M e d ia n C D 4 ce ll co u n t (ce lls/u l) 2 0 0 1 2 0 0 2 2 0 0 3 2 0 0 4 0 5 -0 6 2002 2003 2 0 0 4 0 5 -0 6 80 D S o u th A m e rica 60 40 S u b -S a h a ra n A frica 20 A sia 0 2001 2002 2003 Year 2 0 0 4 0 5 -0 6 C u m u la tiv e m o rta lity (% ) Mortality over four years 15 Sub-Saharan Africa 10 5 Europe & North America 0 0 12 24 36 M o n th s a fte r sta rt o f A R T 48 CROI 2007 – Egger Plenary Sustained long-term CD4 response to ART among naïve patients in low-income countries Denis Nash - CROI 2008 450 400 395 372 350 355 376 377 366 336 300 301 263 250 230 200 150 100 114 50 0 Baseline 1 2 3 4 5 Sustained long-term CD4 response to ART among naïve patients in low-income countries D. Nash - CROI 2008 Most important determinant of CD4 trajectory after ART initiation is baseline CD4 (increasing with calendar time at most sites) 700 600 500 Missing 0-<24 25-49 50-99 100-149 150-199 200-299 300+ 400 300 200 100 0 Baseline 1 2 3 4 5 Tuberculosis in the first year after Initiation of ART in Low-Income and High-Income Countries The ART-LINC Collaboration and The ART Cohort Collaboration Higher incidence in lower-income countries(7.4 vs 1.0 per 100 PY) but relative reduction over time is comparable and low CD4 is the most important risk factor QuickTime™ et un décompresseur TIFF (non compressé) sont requis pour visionner cette image. CID 2007:45 (1 December) Probability of death or lost-to-follow-up in 2,710 adults starting ART at WHO stage 1 or 2 and CD4 >200/mm3 or unknown, according to CTX prescription (C. Lewden in progress) P=0.006 0.20 Death or loss to follow-up probability Adjusted HR: 046 (0.30-0.73) 0.16 0.12 0.08 0.04 0.00 0 6 12 Time (months) CTX+HAART Only HAART 18 24 Coût-efficacité de stratégies de rétention des patients sous ART Hapsatou Touré, Xavier Anglaret, Elena Losina François Dabis, Ken Freedberg Objectif général Comparer l’efficacité et les ratios de coût/efficacité de stratégies actives de recherche de patients, initialement sous traitement antirétroviral, perdus de vue dans des cohortes sélectionnées de pays à ressources limitées (Abidjan, Cape Town, …) QuickTime™ et un décompresseur TIFF (LZW) sont requis pour visionner cette image. ART-LINC: Box 5, P. 28-29 International epidemiological Databases to Evaluate AIDS • 7 regional networks • North America • South America / Caribbean • West Africa • Central Africa • East Africa • Southern Africa • Australia / Asia • Resource limited countries networks • ART-LINC Collaboration • Treat Asia HIV Observational Database (TAHOD) www.iedea-hiv.org www.art-linc.org www.amfar.org International epidemiological Database to Evaluate AIDS (IeDEA) IeDEA – West Africa Coordinating Investigators François DABIS (France) Emmanuel BISSAGNENE (Côte d’Ivoire) Project Manager Didier K. EKOUEVI Progress report - February 2008 Adult clinical centers in West Africa (N = 16,945) Name USAC Location Côte d’Ivoire Number of patients on HAART 2442 CePReF MTCT-Plus SMIT CIRBA CNTS Toure Hospital Point G CNHU ANRS 1215 MRC Côte d’Ivoire Côte d’Ivoire Côte d’Ivoire Côte d’Ivoire Côte d’Ivoire Mali Mali Benin Senegal Gambia 3393 461 4608 2272 716 1113 431 872 404 233 Death probability in the first 12 months after ART initiation for 11 adult cohorts in West Africa according to baseline CD4 count (N = 14,832) 9.4% 4.6% 2.1% Retention of the patients in the 11 participating adult clinics in West Africa in the first 12 months after ART initiation (N = 14,832 adults) 81.0% [81.3-82.6] International epidemiological Database to evaluate AIDS (IeDEA) in West Africa Cancer research proposal #1 - 2008 Prevalence of tobacco, alcohol and other recreational drugs use within HIV-infected adult cohorts International epidemiological Database to evaluate AIDS (IeDEA) in West Africa Cancer research proposal #2 - 2008 HIV prevalence among patients hospitalized for malignancy in Abidjan (Côte d’Ivoire) Paediatric ART in Sub-Saharan Africa: the multi-center KIDS-ART-LINC collaboration Dabis, Mbori-Ngacha ANRS 12147 & NIH/OAR To define prognosis of children treated with ART in sub-Saharan Africa in relation to the type of treatment program http://www.rcqhc.org/kids-art-linc Scientific Output 2006-2007 • Site assessment and organization of collaboration published in Cohort Profile section of Int J Epidemiol 2007;doi:10.1093/ije/dym216 • First data merger completed (individual clinical data from 8 sites, 3644 children, 2.666 on ART) • Two-year survival analysis done and results presented o CROI 2007 (Los Angeles) – February 2007 o PEPFAR 2007 (Kigali) – June 2007 o Manuscript submitted Delay in start ART until immunodeficiency results in excess mortality, most in 1st six months treatment Arrive CROI 2007 (cité par Mofenson - CROI 2008) Meta-analysis 1,195 children from 8 African data bases 53% >5 years of age, 66% severe age-related immune deficiency ARV: NNRTI-based 58%, PI-based 37% Months from ART start Probability of death after starting ART Immune Deficient at Start ART 6 months 12 months 0.4% after 6 mos 7.8% 8.2% Not Immune Deficient at Start ART 6% excess mortality 1.8% 2.2% 0.4% after 6 mos QuickTime™ et un décompresseur TIFF (LZW) sont requis pour visionner cette image. KIDS-ART-LINC: Box 3, P. 24-25 Scientific perspectives 2008 • More analyses of the first merger : – Sustained response to first-line ART regimens (durability, tolerance) – Growth abnormalities and response to ART – Incidence of tuberculosis, opportunistic infections, ART response in relation to prior PMTCT exposure cannot be investigated with the currently available data • Repeat site assessment within IeDEA framework and/or specific survey on the practice of virological testing and viral resistance • Initiate the development of a medico-economic model of pediatric care in Africa (“à la Freedberg”) using the KIDS-ART-LINC data set and network • No new merger outside of very specific objectives International epidemiological Databases to Evaluate AIDS • 7 regional networks • North America • South America / Caribbean • West Africa • Central Africa • East Africa • Southern Africa • Australia / Asia • Resource limited countries networks • KIDS-ART-LINC Collaboration • Treat Asia HIV Observational Database (TAHOD) www.iedea-hiv.org www.anecca.org www.amfar.org International epidemiological Database to Evaluate AIDS (IeDEA) West Africa Pediatric Working group Valériane Leroy, Alain Azondékon Study population (N = 2204 children on HAART) Country Center Number of Children under HAART % Bénin UPEIV 71 3 Côte d’Ivoire CePReF 309 14 Côte d’Ivoire CHU Yopougon 669 31 Côte d’Ivoire CIRBA 141 6 Côte d’Ivoire MTCT-Plus 74 3 Gambie FAJARA 23 1 Ghana Korle BU Hosp 128 6 Mali Hop G. Touré 674 31 Sénégal Hop A Royer 115 5 2204 100 Total Bases de données observationnelles Conclusions (février 2008) • L’ANRS seule ne peut pas maintenir des bases de données internationales dans les pays à resources limitées : quid de la politique de sites ? • Le partenariat avec les NIH est possible, mais : – La collaboration IeDEA est le nouveau cadre de référence – On ne pourra constituer de nouveaux “mergers” de données inter-régionales (adultes ou pédiatriques) qu’en rapport avec des objectifs très spécifiques • Réorienter les demandes de soutien à l’ANRS en fonction de ce nouveau contexte