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Kesho Bora Study

Study focusing on improving efficacy of MTCT prevention interventions in developing countries and preserving health of HIV-positive mothers. The goal is to use ARV drugs in antepartum, intrapartum, and postpartum periods. The main study endpoints include HIV-free infant survival and AIDS-free survival among mothers. The study population consists of women with varying CD4 counts, with sample sites in Burkina Faso, Kenya, and South Africa. The study aims to inform protocols for ARV drug usage and infant feeding practices in HIV-positive mothers.

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Kesho Bora Study

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  1. Kesho Bora Study Isabelle de Vincenzi (devincenzii@who.int)

  2. Rationale • Efficacy of MTCT prevention interventions in developing countries needs to be improved • Health of HIV-infected mothers needs more attention • Alternatives to replacement feeding for children born to HIV-infected mothers need to be identified HAART during pregnancy and breastfeeding may achieve all 3 purposes

  3. Goal • To optimize the use of ARV drugs during the antepartum, intrapartum and postpartum periods to prevent MTCT of HIV and preserve the health of the mother in settings where the majority of HIV-positive women breastfeed

  4. General Outline - Mothers • Intervention according to disease status in late pregnancy • CD4 count < 200 or HIV Stage 4 (prospective cohort) • ZDV+3TC+NVP during pregnancy, delivery and continued as long as required, potentially lifelong • CD4 count > 500 (prospective cohort) • ZDV from 34-36 wks until onset of labourand one dose NVP in labour • CD4 count 200 – 500 (randomised study) • Triple-ARV MTCT prophylaxis: ZDV+3TC+LPV/r from 28 wks until 6 mths post-partum • Short-course MTCT prophylaxis (see above) from 28 wks + ZDV+3TC (mother) Not enrolled anymore Not enrolled anymore

  5. Infants • All infants receive single-dose NVP + ZDV 1 wk • Standard WHO/UNICEF infant feeding counselling • Study implemented in sites where majority of women choose to breastfeed • Free formula offered to mother/children opting for replacement feeding • All women choosing to breastfeed counselled to breastfeed exclusively for 5½ months, followed by weaning over a 2-week period

  6. Main study endpoints • HIV-free infant survival at 6 weeks and 12 months, irrespective of mode of infant feeding • HIV-free infant survival at 12 months among infants who received any breastmilk • AIDS-free survival among mothers by 18 months postpartum • Incidence of serious adverse events in mothers and children Sample size N = 850 randomized

  7. 5 study sites • Bobo-Dioulaso, Burkina-Faso:Centre Muraz, Nicolas Meda • Mombasa, Kenya:ICRH – Stanley Luchters • Nairobi, Kenya:KNH - Ruth Nduati • Durban, South Africa:U. KwaZulu Natal - Nigel Rollins • Mtubatuba, South Africa:Africa Centre – Marie-Louise Newell Nairobi Bobo Dioulasso Mombasa Mtubatuba Durban

  8. Protocol changes * Never implemented – mother and children received short regimen** From 18 weeks if ART needed

  9. Status First interm analyis (25% 12 months follow-up) 6-weeks results 6-months results Recruitment Follow-up 12-months results Final results

  10. Kesho Bora Study12 months follow-up for women not randomized:CD4+< 200/mm3 or > 500/mm3

  11. Study Population CD4 < 200 /mm3 CD4 > 500 /mm3 119 Women enrolled 131 Lost to follow-up before delivery 1 Death before delivery - Did not initiate ARVs - Stillbirths 4 Lost to follow-up before delivery -Death before delivery 1Did not initiate ARVs 1Stillbirths 2 114 Women with live births (incl 3 multiple pregs) 127 114 Live singletons or first born 127 HIV Status unknown(4 early deaths) HIV Status unknown(1 early death, 1 lost to follow-up) 110 Live singletons or first born with known HIV status 125

  12. Characteristics of enrolled women

  13. Characteristics of live born infants

  14. Kesho Bora StudyCumulative Risk of HIV Infection at 12 months (n=110) CD4+ <200 (n=125) CD4+ >500 7.6% 5.8%

  15. Kesho Bora Study- Infant Mortality CD4+ <200 (n=114) (n=127) CD4+ >500 12.3% 8.9%

  16. 12-Months Transmission and Survival

  17. Comparative data

  18. Comparative data

  19. Preliminary comments • High CD4 counts : • Similar Tx rates with "long triple" (KiBS) and "short" (KB); • Costs of triple prophylaxis (resistance in particular) not well assessed yet: prevalence and impact of resistance? Maternal HIV progression after stopping triple prophylaxis? • Only 1 case of post-partum Tx (KB) despite only short-ARV: consider triple-proph. in ante-partum, but unclear when to stop (! viral rebound during breastfeeding) • Low CD4 counts : • Relatively high transmission rate in KB, KiBS,MITRA (~ 6%): problems of adherence when ART started during pregnancy and immediately after HIV diagnosis? Importance of starting early? Feasibility of rapid clinical/CD4 evaluation? • Much lower rates in Abidjan, AMATA, DREAM….

  20. Remaining results to be coming out • Results from randomized trials (KB, BAN, Botswana, PROMISE 2) • Trials related to infant prophylaxis (PEPI, SWEN, PROMISE 1, BAN) • How to make replacement feeding safe • Vaccines

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