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New PMTCT WHO Rapid Advice Guidelines- Should we go with Option A or Option B in Malawi?

New PMTCT WHO Rapid Advice Guidelines- Should we go with Option A or Option B in Malawi?. Presented to Technical Working Group January 7, 2010 Maria Kim, Baylor Children’s Foundation Malawi.

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New PMTCT WHO Rapid Advice Guidelines- Should we go with Option A or Option B in Malawi?

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  1. New PMTCT WHO Rapid Advice Guidelines- Should we go with Option A or Option B in Malawi? Presented to Technical Working Group January 7, 2010 Maria Kim, Baylor Children’s Foundation Malawi

  2. Prepared with a great amount of assistance from Dr. Lynne Mofenson, National Institutes of Health and Dr. Peter Kazembe

  3. The two options……

  4. Scientific comparisons….

  5. Comparative Efficacy Similar effectiveness to maternal triple combination prophylaxis for prevention of in utero infection in women with high CD4 count (Kesho Bora trial in women with CD4 200-500, transmission at birth 2.2% with AZT/single-dose NVP regimen vs 1.8% with maternal triple drug regimen). No study with adequate power to provide comparative efficacy of infant vs maternal postnatal prophylaxis in women with CD4 >350, although available data suggest at minimum similar efficacy. Overall seems to have similar efficacy

  6. Kesho Bora: Question 1: Prevention of AP/IP Infection de Vincenzi I et al. IAS, Capetown, South Africa, July 2009, Abs. LB PE C01 Delivery 28-36 weeks 6.5 months (1 wk) 77% breastfed, median 21 wks <50% exclusive to 3 mos sdNVP ARM 1: Short Course (N=411) AZT AZT/3TC AZT/3TC X 1 wk Mom sdNVP AZT x1 wk Baby CD4 200-500: 824 HIV+ pregnant women ® AZT/3TC/LPV-r AZT/3TC/LPV-r AZT/3TC/LPV-r ARM 2: Triple (N=413) Mom sdNVP AZT x1 wk Baby • Is administration of maternal HAART during pregnancy and labor superior • to short-course AZT/sdNVP with AZT/3TC tail in preventing in utero • transmission (transmission rate around time birth-1 week)? SLIDE from Dr. LYNNE MOFENSON

  7. Kesho Bora: HIV Infection Over Time in HAART through Breastfeeding Vs Short AZT/sdNVP Arms De Vincenzi I et al. IAS, Capetown, South Africa, July 2009 Abs LBPEC01 Birth MTCT 1.8%% 12 mo MTCT 6 mo MTCT 5.5% 2.2% 4.9% Proportion not infected 9.5% 8.5% No significant difference in AP MTCT rates in triple vs short at birth-1 week Significant difference in MTCT rates starting after age 1 month with postnatal maternal HAART vs no postnatal prophylaxis log rank p = 0.039 Age (mos) SLIDE from Dr. LYNNE MOFENSON

  8. MITRA (Infant ARV) vs MITRA-PLUS (Maternal HAART) to Prevent Postnatal MTCT, TanzaniaKilewo et al. JAIDS 2008;48:315-23; JAIDS 2009 in press No significant difference in terms of postnatal transmission between maternal or infant prophylaxis strategies SLIDE from Dr. LYNNE MOFENSON

  9. Breastfeeding, Antiretrovirals and Nutrition (BAN) Study: IP/PP Intervention Chasela C et al. IAS, Capetown, South Africa, July 2009 Abs. WE LB C103 ARM 1 control (N=668) (closed early 3/08) sdNVP Delivery 6 months All breastfed (1 week) Mother AZT/3TC ARM 2 Maternal HAART (N=851) sdNVP Baby AZT/3TC/LPV-r Mother Baby AZT/3TC X 1 wk AZT/3TC AZT/3TC AZT/3TC X 1 wk AZT/3TC X 1 wk Mother 2,637 HIV+ women at delivery (CD4 >250, Hb >7gm/dL) 1st ®: mom nutritional supplement AZT/3TC X 1 wk Baby NVP 2nd ® AZT/3TC X 1 wk ARM 3 Infant NVP (N=848) AZT/3TC X 1 wk SLIDE from Dr. LYNNE MOFENSON

  10. BAN: Probability of HIV Infection by Week 28 in Infants Uninfected at BirthChasela C et al. IAS, Capetown, South Africa, July 2009 Abs. WELBC103 Control vs Maternal HAART: p= 0.0032 0.08 Control vs Infant NVP: p <0.0001 Maternal HAART vsInfant NVP: p= 0.1203 6.4% 0.06 Control Estimated probability of being HIV positive 0.04 3.0% Maternal HAART 0.02 1.8% Infant NVP 0 1 4 8 12 16 20 24 28 SLIDE from Dr. LYNNE MOFENSON Age (weeks)

  11. Comparative Efficacy Overall seems to have similar efficacy AND Best to get mothers to come to ANC early!

  12. Safety

  13. Pregnancy Outcome Safety

  14. Mma Bana: Stillbirths, Prematurity, Low Birth Weight, and Congenital Abnormalities Shapiro R et al. IAS, Capetown, South Africa, July 2009, Abs. WeLBB101 * Gestational age determined by last menstrual period and/or ultrasound SLIDE from Dr. LYNNE MOFENSON

  15. HAART (and Longer Duration of HAART) is Associated with Prematurity (<37 Wks): Johannesburg, South Africa Van der Merwe K et al. IAS, Capetown, South Africa, July 2009, Abs. WePEB262 1,630 HIV+ women with advanced HIV disease (CD4 <250) followed 4/04-7/08 P=0.002 P<0.001 EFV-exposure was significantly associated with LBW compared to other regimens. 35% in EFV groups versus 18% and 19% in kaletra vs NVP based group. P=0.015 P=0.071 SLIDE from Dr. LYNNE MOFENSON

  16. AMATA study- Peltier, et. Al- JID 2009, Vol 23 No 18Breastfeeding with maternal antiretroviral therapy or formula feeding to prevent HIV postnatal MTCT in Rwanda • 11 (2.1%) required drug substitution due to toxicity • 7/11 due to ZDV related anemia, 2/11 due to d4T, 1/11 due to NVP rash 1/11 due to severe depression from EFV.

  17. Chance for Resistance

  18. Chance for Resistance

  19. Considerations for Malawi…

  20. Cost Projected for TWO years and based on National Programme Projections. Takes into account medications and transport and distribution costs- prepared bv Erik Schouten

  21. Feasibility

  22. Need for cd4 monitoring before and AFTER pregnancy

  23. Feasibility

  24. WHO 2010

  25. Acceptability

  26. Scalability

  27. Other Considerations

  28. Other Considerations

  29. Chaka cha Bwino!

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