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Early vs. deferred ART in HIV infected infants : a European Collaborative Cohort Study European Infant Collaboration Study question Is there a benefit.

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Presentation on theme: "Early vs. deferred ART in HIV infected infants : a European Collaborative Cohort Study European Infant Collaboration Study question Is there a benefit."— Presentation transcript:

1 Early vs. deferred ART in HIV infected infants : a European Collaborative Cohort Study European Infant Collaboration Study question Is there a benefit to treat all infants who are vertically infected with HIV and followed up from birth, even if they are asymptomatic?

2 STUDY POPULATION 327 infants No neonatal prophylaxis 68 Neonatal prophylaxis 259 HIV infected diagnosed < 3 months 216 Diagnosed HIV > 3 months 43 AIDS < 3 months 4 Lost FU < 3 months 2 AIDS free at 3 months 210 EIC, 2007

3 DATA COLLECTION CohortsNumber of centres in cohort Number of childrenNumber of children included France369683 Italy215323 UK and Ireland165238 Spain83117 ECS & PENTA52010 Belgium42016 Poland1178 Switzerland6157 Romania191 Netherland (Amsterdam) 163 Germany (Munich) 152 Netherland (Rotterdam) 132 Total101327210 EIC, 2007

4 AGE AT INITIATION OF ART (n=210) EIC, 2007 124 86

5 AGE AT FIRST ART TREATMENT BY COHORT

6 Early treatment (n=124) Deferred treatment (n=86) P Sub Saharan African ethnicity56%57%0.9 Gender female61% 0.9 ART during pregnancy51 %62 %0.08 Caesarean delivery55% 0.94 Birth weight <2500g31%23%0.21 Premature delivery (<37 wk)21%22%0.82 Breast feeding2%6%0.12 Number of drugs in the first ART 1 or 2 3 4 23% 69% 9% 13% 73% 14% 0.17 Class of drugs in 1st ART 1 or 2 NRTI PI + NNRTI + other 22% 42% 25% 11% 14% 50% 31% 5% 0.11 CHARACTERISTICS OF INFANTS BY GROUP EIC, 2007

7 crude HR= 5.0 95% CI: 2.0-12.6 p<0.001 KAPLAN MEIER AIDS/DEATH FREE SURVIVAL IN INFANTS ON EARLY AND DEFERRED ART EIC, 2007

8 CUMULATIVE RISK OF AIDS/DEATH BY COHORT (24 EVENTS)

9 CONCLUSIONS Etude collaborative européenne multicentrique Période détude : Enfants nés entre 1996 et 2004 Parmi les 210 nourrissons, suivis depuis la naissance ayant bénéficié dune prophylaxie néonatale, chez qui un diagnostic dinfection à VIH a été porté avant lâge de 3 mois et qui à 3 mois navaient pas présenté de symptômes, moins de 2 % des 124 enfants traités avant 3 mois versus près de 12 % des 86 enfants traités après 3 mois ont évolué vers SIDA ou décès avant lâge de 12 mois (HR de 5).

10 EIC COLLABORATORS Madrid, Spain Brussels, Belgium EPF INSERM, France J. Warszawski, J. Le Chenadec C. Dollfus MRC CTU, UK K. Boyd, A.Judd, H. Green S. Walker DM. Gibb, Italian Register L. Galli, C. Gabiano PA. Tovo M. De Martino J.Ramos S. Guillen Martin ECS, UK C. Thorne, D.Patell C. Giaquinto Warsaw, Poland M. Marczynska J. Popielska Swiss HIV Cohort O. Keiser C. Rudin D. Nadal Bucharest, Romania L. Ene D. Duiculescu Amsterdam, The Netherlands: H. Scherpbier E. Le Poole Munich, Germany U. Wintergerst G. Nothiers Liège, Belgium V. Schmitz Rotterdam, The Netherlands G. Verweel R. De Groot N. Hartwig Padova, Italy T. Goetghebuer, E. Haelterman, M.Hainaut, B. Brichard J. Levy

11 CHER TRIAL Part A n= 375 HIV infection diagnosed before 12 weeks and CD4% >25% Arm 1 Deferred treatment N=125 Arm 2 Short course (to first birthday) N=125 Arm 3 Long course ( to second birthday) N=125 FOLLOW UP For a minimum of 3.5 years ART (start or re-start) when CD4% <20% or clinical event (<25% from August 2006)

12 BASELINE CHARACTERISTICS VariableArm 2 & 3Arm 1 Number of participants enrolled252125 Sex: Female (%)147(58.3 %)74(59 %) Age (weeks, median (IQR)7.4(6.6 - 8.9)7.1(6.4 - 8.9) Mother receiving ART for PMTCT No Therapy26(10.3 %)15(12 %) NVP (%)162(64.3 %)72(58 %) AZT (%)8(3.2 %)5(4 %) AZT + NVP (%)51(20.2 %)26(21 %) HAART (%)2(0.8 %)5(4 %) Weight (Median IQR (kg)4.4(4.0 - 4.9)4.5(4.0 - 5.0) CDC Classification Class N & A (%)237(94.0 %)121(96.8 %) Class B (%)11(4.4 %)3(2.4 %) CD4 % (median (IQR)35.1(29.1 - 40.8)35.6(29 -43.8) CD4 Count (cells/mm 3 ) median (IQR)2035(1519-2754)2044(1585-2960) 5985 babies were screened using DNA PCR to enrol 377 HIV pos infants

13 MORTALITY RATES VariableArm 2 & 3 n = 252 Arm 1 n = 125 Total n = 377 Died (%) 10 (4%) 20 (16%) 30 (8%) Person Years of follow- up 167 79 246 Rate per 100 PY (95% CI) 6.0 (2.9; 10)25.3 (15.5; 39.0) 12.2 (8.2; 17.4) Hazard Ratio 0.24 (0.11; 0.51) P - value 0.0002

14 DISEASE PROGRESSION IN ALL PATIENTS VariableArm 2 & 3 n = 252 Arm 1 n = 125 Total Failure to thrive181937 Developmental delay088 PCP055 Oesophageal candidiasis022 Extrapulmonary TB111 CMV colitis011 CMV pneumonia022 CMV Hepatitis Pneumococcal disease 0000 1212 1212 Number Events Number patients 19 41 38 60 57

15 SUMMARY & CONCLUSIONS Starting ART before 12 weeks of age reduces early mortality by 75% Findings have implications for guidelines on timing of ART in early infancy These results support the need for enhanced pMTCT programmes, early infant diagnosis and effective transition to care.


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