Lifelong ART for Pregnant Women: Benefits, trade‐offs, and the research needed to optimize maternal, perinatal,
and community health outcomes
Resource and programmatic considerations
Karusa KiraguUNAIDS Secretariat, Geneva
June 11, 2013
The creation of the Global Plan to eliminate new HIV infections among children by 2015 and keep mothers alive
High Level Global Task Team co-chaired by Michel Sidibé and Ambassador Eric Goosby
Membership of 40 countries, 30 civil society and private sector organizations, and 15
international and regional bodies/organizations.
Global Plan launched at UN High Level Meeting on AIDS in the presence of UN Secretary General
Ban Ki-moon, President Goodluck Jonathan of Nigeria, Former United States President Bill
Clinton
Member states set target to eliminate new HIV infections among children and reduce AIDS
related maternal mortality by half in the Political Declaration on AIDS adopted at UN High Level
Meeting on AIDS.
/Insert picture of Clinton, EXD and Ebube
Baseline 0.5% Baseliine
28%
34%
6%
16%19%
Baseline
24%21% 21%
61%
29%
48%
28%33%*
90%
50% 50%
0%5%
90% 90% 90%
100%
50%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Reduction innew pediatricHIV infections
Reduction inHIV‐associatedmaternal deaths
Reduction inHIV incidenceamong women
15‐49
Reduction inunmet need forfamily planning
MTCT rate Maternal ARVprophylaxis
ARV coverageduring
breastfeeding
ART coveragefor mothersown health
ART coveragefor children
Reduction in <5HIV attributable
deaths
2009 Baseline 2011 2015 Target
Progress Toward Global Plan Targets
Source: Towards the Elimination of Mother‐to‐child Transmission of HIV and Keeping Their Mothers Alive Abbreviated Progress Report 2012; UNAIDS
Rationale:Percent of eligible receiving ART for their own health, 21 priority
countries, 2011
48
26
0
10
20
30
40
50
60
Pregnant women Children
Percen
t
Source: UNAIDS Global Plan Progress Report, 2012
• Over half the women who needed treatment were not receiving it
• ¾ of eligible kids who needed treatment were not receiving it
Rationale: Percent of pregnant women eligible for treatment receiving it, 2011
15
24
25
27
40
42
45
51
51
61
69
71
77
84
88
0 20 40 60 80 100
Uganda
Ethiopia
Mozambique
Nigeria
Tanzania
Cameroon
Lesotho
Malawi
Zimbabwe
Kenya
S. Africa
Swaziland
Botswana
Namibia
Zambia
PercentSource: UNAIDS: Global Plan Progress Report,
2015 goal: 90% coverage
Data: Hargrove AIDS 2010; Model: Williams JID 2006
0.001
0.010
0.100
1.0000 500 1000 1500 2000
CD4+ cell count
Mor
talit
y at
one
yea
r
HIV-positive
HIV+ and HIV- post-partum women in Harare (1997-2000)
2.5x3.9x100xHIV-negative
Excess mortality for mothers in Zimbabwe even when CD4 cell counts are at higher level (ZIVTAMBO study)
Number of childhood infections averted because of ARVs since 2009
0
50,000
100,000
150,000
200,000
250,000
300,000
2009 2010 2011 2012
UNAIDS estimates, 2013
Rationale:New child infections in 2012 by mode of transmission, 21
priority countries, preliminary
0
50000
100000
150000
200000
250000
Total new infections Infections duringpregnancy and delivery
Infections duringbreastfeeding
Num
ber o
f new
infections
Proportionately more children acquiring HIV during breastfeeding
Simplicity 5 Pillars of Treatment 2.0
TREATMENT2.0
Adapt delivery systems
Mobilize communities
POC and other simplified monitoring
Optimize drug regimens
Reduce costs
2013 WHO Guidelines Development Groups
Adult(n=37)
Marco Vitoria
Elie Akl
Gisela Schneider, Luis Adriean Quiroz
Stefano VellaSerge Ehoile
6 WHO staff
GDG (n)
WHO Facilitator
Co‐chairs
Community
Methodologist
WHO HQ
4 WHO staffWHO RO
MCH (n=41)
Nathan Shaffer/Lulu Muhe
Jörg Meerpohl
Evgenia Maron, Babalwa Mbono
Elaine AbramsDenis Tindyebwa
5 WHO staff
5 WHO staff
Operational (n=38)
Eyerusalem Negussie
Holger J Schünemann
Anupam K. Pathni, Anna Zakowicz, Kenly Sikwese
Kevin de Cock Yogan Pillay
6 WHO staff
3 WHO staff
Programmatic (n=36)
Joseph Perriens
Kenly Sikwese, Asia Russell, Sergey Filippovych
Irene MukuiAdeeba bte Kamarulzaman
8 WHO staff
3 WHO staff
Current ARV Regimen for PMTCT, April 2013
Option A Option B Option B+ (life‐long ARVs for pregnant women)
High level Discussions
MOH approved
Implementing
Cameroon Cote d'Ivoire Kenya Namibia MalawiGhana Botswana Tanzania UgandaNigeria* Burundi AngolaSwaziland* India Mozambique
Chad Zambia
South Africa EthiopiaLesotho ZimbabweDRC
* Piloting Option B+ in some regions or districts
Approximate cost of 12‐month supply of life‐long ART
$364
$110
$0
$50
$100
$150
$200
$250
$300
$350
$400
2012 2013
US Dollars
TDF/3TC (or FTC)/EFV International transaction prices, and not those paid by end-users at country levelSource: WHO 2013 Global Price Reporting Mechanism
Over-reliance on Aid for AIDS
In 35% of countries, donor support accounts for >50% of the AIDS response
Lifelong ART for Pregnant Women
Benefits, trade-offs, and research needed
Benefits of Life-long Treatment
• Treatment benefits for women• Simpler regimen – one pill, once a day• Simpler message – treatment for life• Simpler determination of eligibility – only
voluntary and confidential HCT• Prevention benefits for child and partner• Simpler supply chain• Integration: Opportunity for better platform
Operational issues Planning and preparation of the MNCH system Infrastructure, HRH including task sharing, supply
chain, community systems Expansion and decentralization to primary services Integration (MNCH clinics into ART clinics) Services integration (e.g. TB, ANC/MCH and IDU
settings, FP, pediatric HIV) Monitoring for toxicity and resistance Quality assurance Client retention ART Adherence
Research gaps to improve efficiency and effectiveness
Impact of earlier ART initiation Optimal monitoring of ART response B+ feasibility, acceptability, field efficacy, and safety
especially long-term use Toxicity and resistance monitoring (what, how and
frequency) Strategies to improve retention and adherence Implementation on service delivery models – linkage
to care, service integration, decentralisation, retention ….
Optimizing partnerships with community
Source: Adapted from WHO, 2013
Acknowledgements
• Mary Mahy• Reuben Granich• Patrick Brenny• Mitch Besser• Bernhard Schwartlander
For more information:
Global Plan: zero‐HIV.orgIATT: emtct‐iatt.org