Evaluation of HIV-1 viral load among mothers under PTMCT program with lymphocytes T CD4 count above 350 cells/µl

Transcription

1 Evaluation of HIV-1 viral load among mothers under PTMCT program with lymphocytes T CD4 count above 350 cells/µl W. M. Christelle Nadembèga 1,3, Justin Konaté 1, Désiré Néboua 1, Arsène Zongo 1, Hugues Traoré 1, Eric Somé 1, Kassoum Bansé 2, Firmin Yonli 2, Mamadou Barry 2, Eléonore Kafando, 2,3, Nicolas Méda 1,3, Rasmata Ouédraogo/Traoré 1,2,3, Mamadou Sawadogo 1,3, Valérie Maréchal 4, Nicolas Nagot 4 and Philippe Van de Perre 4, for the Promise-Pep ANRS study group 1: Promise-Pep ANRS study group, Ouagadougou, Burkina Faso. 2: Centre Universitaire Pédiatrique Charles de Gaulle, Ouagadougou, Burkina Faso. 3: Université de Ouagadougou, Burkina Faso. 4: INSERM U1058, Université Montpellier 1, Montpellier, France.

2 Introduction Outline What is Promise-PEP study? The PMTCT program in Burkina Faso Materials and methods Population Materials and methods Results and discussion Results and comments Conclusion 2

3 What is Promise-Pep, study? Randomised controlled trial comparing the efficacy of infant peri-exposure prophylaxis with Lopinavir/ Ritonavir (LPV/r) versus Lamivudine to prevent HIV-1 transmission by breastfeeding. Phase III study. Four (04) countries : Burkina Faso South Africa Uganda Zambia 3

4 Promise-Pep, Burkina Faso Site: Ouagadougou Staff: 20 persons (multidisciplinary) Study Clinic and laboratory: Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle (CHUP- CDG), Ouagadougou. Study recruitment sites: 52 sites in Ouagadougou and around Activities beginning: August

5 The PTMCT in Burkina Faso HIV prevalence : 2008 UNAIDS report 1.6% adults ( women) children Prevention of Mother-to-child Transmission (PMTCT) All the country health districts 81% ilegible sites for PMTCT HIV prevalence is 1.5% (2009) 5

6 Materials and methods Population Antenatal clinics Pregnant women HIV infection diagnosis (rapid tests) Study clinic Screening 1 Pregnant women HIV infected meet eligibilty criteria At least 18 years old 28 weeks of pregnancy HIV-1 infection post-vct Not eligible for HAART Intention to breasfeed CD4 above 350 cells/ul Intention to participate Antenatal screening consent NO Pregnant woman HIV infected non eligible Routine national PMTCT Pregnant woman is not HIV infected Regular ANC care YES 6

7 Materials and methods Population Study clinic Day 1-6 Study clinic and laboratory Screening 2 Newborn HIV-1 diagnosis Clinical examination Biological parameters Mothers Screening 2 consent 7

8 Materials and methods Population Study clinic Day 7 ±2 days Newborn/Mother fill inclusion criteria NO Regular postnatal care or peadiatric referral if required YES Enrolment and Randomisation From August 2009 to February 2011: 114 pairs mother/babies enrolled 8

9 Materials and methods Prophylaxis (WHO 2006 recommendations) Antiretroviral prophylaxis for pregnant women Starting at 28 weeks of pregnancy AZT during pregnancy Sd-NVP + AZT + 3TC during labour and delivery AZT + 3TC for 7 days postpartum Prophylaxis regimens for exposed infants Sd-NVP at birth AZT for 7 days 9

10 Materials and methods Prophylaxis during pregnancy Enrolled N=114 AZT alone N=107 AZT + 3TC N= 1 None N= 6 10

11 Materials and methods Prophylaxis at labour and delivery Enrolled N=114 AZT or NVP alone N =10 AZT+3TC AZT+NVP N=4 AZT+3TC +NVP N=89 None N =11 11

12 Materials and methods Prophylaxis pospartum Enrolled N=114 AZT alone N=10 AZT + 3TC N=

13 Materials and methods Mothers HIV serology (Screening 1: 28 weekds of pregnancy) Determine HIV1/2 (Abbot) ImmunoComb II HIV 1&2 Bispot (Orgenics) CD4 count (Screening 1: 28 weeks of pregnancy) FACScount (Becton Dickinson) Cyflow (Partec) HIV-1Viral Load (at Enrolment,3 months and 9 months) Manual Qiagen extraction Detection with Real Time PCR reagents, HIV Viral Load kit (Biocentric, France) and MiniOpticon (Biorad) 13

14 Materials and methods Infants HIV diagnosis using DBS (Screening 2, 6, 14, 26, 38 and 50 weeks) Manual DNA extraction with Qiagen Detection with Real Time PCR reagents, HIV DNA cell (Biocentric, France) and MiniOpticon (Biorad) 14

15 Results Enrolled N =114 Mean Age: 27.9 CD4 mean: HIV-1 Viral load undetectable (<300 copies/ml) N=35 (30.7%) Mean age: CD4 mean: Low HIV-1 Viral load (<5000 copies/ml) N=66 (57.9%) Mean age: CD4 mean: Moderate HIV-1 Viral load ( copies/ml) N=13 (11.4%) Mean age: CD4 mean: No infant born from enrolled mothers was HIV-1 infected at birth 15

16 Results and comments Normal prophylaxy At least 2 prophylaxyis with AZT Irregular prophylaxy VL undetectable (N=35) Low VL (N=66) Moderate VL (N=13) Total 72 (63.15%) 40 (35.08%) 2 (1.75%) 16

17 Conclusion A simple regimen based mainly on AZT alone during pregnancy acheived a low or indetectable viral load soon after delivery No HIV-1 transmission among newborn. 17

18 CRIS Acknowledgements ANRS GROUP (Promise-Pep) EDCTP UM1 (INSERM U1058) CHUP/CDG UNIVERSITY OF OUAGADOUGOU (Burkina Faso) Mothers and infants 18

19 THANK YOU! MERCI!