B+ The Evidence WHO programmatic Update PMTCT WHO update EFV Challenges for implementation of B+ Steps in making B+ operational.

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Presentation transcript:

B+ The Evidence WHO programmatic Update PMTCT WHO update EFV Challenges for implementation of B+ Steps in making B+ operational

Is elimination of MTCT possible? Source: Mahy, Stover, Kiragu et al, Sex Transm Infect : ii48-ii55, 2011

2010 WHO Antiretroviral Drugs Use for Treating Pregnant Women and Preventing MTCT Time-Limited Provision of ARV Prophylaxis if CD4 >350 and WHO Stage 1/2 to Prevent MTCT Maternal Lifelong ARV Treatment (ART) for Maternal Health if CD4 <350 or WHO Stage 3/4  No debate about policy for women with CD4 <350  Scientific/policy issues revolve around women with CD4 >350 >28 wks Labor- Delivery 35-40% 1-6 mos6-24 mos0-1 mo Pregnancy 10-25% <28 wks Breastfeeding 35-40% EarlyLate AntenatalPostpartum EarlyLate

In Utero Prevention

Delivery6.5 months28-36 weeks(1 wk) AZT AZT/3TCAZT/3TC sdNVPAZTAZT Mom Baby AZT/3TC/LPV-r AZTAZT sdNVP Mom Baby Kesho Bora: AZT/sdNVP vs Triple ARV to Prevent In Utero MTCT (Birth-1 Wk) The Kesho Bora Study Group, deVincenzi I. Lancet Infect Dis 2011;11: HIV-infected pregnant women with CD (stratified by CD4 350) Prevent IU/IP MTCT AZT/sdNVP Triple HIV-free survival All women CD No significant difference in in utero MTCT between triple vs AZT/sdNVP (1.8 vs 2.5%)

Evidence for prevention during breast feeding

ZDV/3TC x1 wk ZDV/3TC sdNVP x1 BAN STUDY-ARV intervention* NVP x 28 wks to infant Enhanced Control Maternal HAART Infant NVP ZDV/3TC/NVP x 28 wks to mother ZDV/3TC sdNVP x1 ZDV/3TC sdNVP x1 ZDV/3TC X 1 wk ZDV/3TC x1 wk *Exclusive Breastfeeding for 24 weeks with weaning over 4 weeks. Weaning food “plumpy nut” provided until week 48 Mother and Infant

Breastfeeding, Antiretrovirals and Nutrition (BAN) Study: Postpartum Infant NVP vs Maternal Triple ARV to Prevent BF MTCT Chasela C et al. NEJM 2010;362: Maternal Triple Drugs Infant NVP Control vs Maternal Triple Drugs: p= Control vs Infant NVP: p <0.001 Maternal Triple Drugs vs Infant NVP: p= % decrease 70% decrease 5.7% 2.9% 1.7% Probability MTCT in Infants Uninfected at 2 Wks In women with higher CD4, infant NVP vs maternal ARV results in similar PP MTCT

A B B+

TDF/EFV more efficacious EFV less side effects than NVP Available with TDF /3TC as once a day FDC Above risks outweigh any risk of teratogenicity In public health approach EFV NNRTI of choice For women CD4 < 350 regimen of choice TDF /3TC/EFV

B+ operational Challenges Sudden massive scale up in those on ART Pregnant and lactating women at high risk of poor adherence Pregnant and lactating women at high risk of loss to follow up

Malawi: “Option B+” Scale Up Source: Courtesy of Dr Erik Schouten, unpublished data, Malawi

ART Adherence During and After Pregnancy in Low-, Mid- and High Income Countries: Systematic Review and Meta-Analysis of 48 Studies Nachega J (unpublished data, submitted to CROI 2012) Antepartum (38 studies): 69.1% (63-75%) Postpartum (10 studies): 50.3% (34-66%) Overall Adherence65.2% (59.3, 71.0)

Role of VL in detecting poor adherence in B+ – 24% of routinely tested pregnant women in Kenya have detectable viral loads after median of 2 years on treatment (Nganga TUPDE205 Washington 2012)

Loss to follow-up and mortality among pregnant and non-pregnant women initiating ART across South Africa Landon Myer, Morna Cornell, Matthew Fox, Daniela Garone, Robin Wood, Hans Prozesky, James Ndirangu, Olivia Keiser, Matthias Egger, Andrew Boulle, for the IeDEA- Southern Africa Collaboration University of Cape Town, South Africa; Boston University; University of the Witwatersrand, Johannesburg; Medecins sans Frontières; Stellenbosch University; Africa Centre for Health and Population Studies, Hlabisa; University of Bern

LTFU on ART By 12 months after ART initiation – 19% of pregnant women LTFU – 11% of non- pregnant women LTFU – We don't know if pre or post partum Trend consistent across all sites p<0.001

Differences in LTFU over time Excess LTFU in pregnant women greatest in first 3 months after ART initiation – Differences diminish over time

Caution Study from Botswana showed increased rates of pre term delivery, low for birth weight and still birth No large scale studies on safety of TDF on child development and bone safety ( Promise study awaited)

Steps in making B+ Operational Task shifting ART initiation Decentralising PMTCT and ART initiation Fully integrated ANC / PMTCT one stop services Improved PMTCT counselling tools and training of counsellors Improved appointment systems and defaulter tracing mechanisms ( ? Role of M-health) Role of VL?