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