Antiretroviral Drugs for Treating Pregnant
Women and Preventing HIV Infection in Infants
in Resource-Limited Settings
WHO recommendations
6th Asia Pacific UN PMTCT Task Force meeting
6 – 10 November 2006
Tin Tin Sint
Medical Officer, PMTCT
Department of HIV/AIDS
WHO
Outline
• Global overview
• Comprehensive strategy and goals
• 2006 Revised WHO PMTCT guidelines
2
Global overview
3
Estimated number of adults and children
living with HIV by region, 1986–2005
Number of people in millions
45
Oceania
40
North Africa & Middle East
35
Eastern Europe & Central Asia
30
Latin America and Caribbean
25
20
15
North America and Western Europe
Asia
Sub-Saharan Africa
10
5
0
1985
1990
1995
Year
Source: UNAIDS 2006 Report on the global AIDS epidemic
2000
2005
ARV therapy, global need, June 2006
Number of people in millions
5
4
Unmet need
Receiving ARV therapy
3
2
1
Sub-Saharan Latin America and
the Caribbean
Africa
East, South and
South-East Asia
Europe and
Central Asia
North Africa and
the Middle East
5
Comparison of 2003 and 2005 data on the coverage
of ART, access to MTCT services and coverage of HIV-infected
mothers who received ARV-prophylaxis
Coverage of antiretroviral
therapy
Access to mother-to-child
prevention services (all
pregnant women)
25
25
25
20
20
15
15
20.0
20
15
%
%
10
Coverage of HIV-infected mothers
who received antiretroviral
prophylaxis
10
7.0
5
7.6
9.0
5
0
2003
2005
%
5
0
9.2
10
3.3
0
2003
2005
2003
Sources: WHO/UNAIDS (2006). Progress on global access to HIV antiretroviral therapy: a report on “3 by 5” and beyond;
USAID et al. (2006). Coverage of selected services for HIV/AIDS prevention, care and support in low and middle income
countries in 2003 and 2005.
2005
3.2
Comprehensive
Strategy and Goals
7
Comprehensive approach to prevent HIV infection in
infants
Prevention of
HIV in
parents to
be
Prevention of
unintended
pregnancies
among HIVinfected
women
Prevention of
transmission
from an HIVinfected
woman to her
infant
Care and support for HIV-infected women, their
infants and their families
8
Universal Access
2005 G8 Summit at Gleneagles, Final Communiqué:
“…working with WHO, UNAIDS and other international
bodies to develop and implement a package of HIV
prevention, treatment and care, with the aim of as
close as possible to universal access to treatment for
all those who need it by 2010.”
9
Call for an AIDS-free generation
Global Partners Forum, Abuja, December 2005
Call to Action
“ Called upon governments , development partners, civil society
and private sector to join and move swiftly towards supporting
measures needed to eliminate HIV in infants and young children
and clear the way for a worldwide HIV- and AIDS-free generation”.
10
2006 Revised WHO
PMTCT Guidelines
11
Objectives of the Guidelines
To provide guidance to assist
national ministries of health in
the selection and the
provision of ART and ARV
prophylaxis for women and
their infants in the context of
PMTCT, taking into account
the needs of and constraints
on health systems in various
settings.
12
Guiding principles of the Guidelines
WHO comprehensive strategic
approach to the prevention of HIV
in infants and young children
Integrated delivery of PMTCT
interventions within MCH
services
A public health approach
for increasing access
to PMTCT services
Women's health as the overarching
priority in decisions about ARV
treatment during pregnancy
Necessity for highly effective ARV
regimens for eliminating HIV infection
13
in infants and young children
I. Antiretroviral treatment for HIV-infected pregnant
women
Evidence
ƒ Estimated 20-30% of HIV-infected pregnant women meet WHO
criteria for initiating ARV treatment for their own health
ƒ Advanced disease with low CD4 is associated with higher rate
of transmission, even in those receiving short course ARV
prophylaxis
ƒ Risk of NVP resistance following Sd-NVP (alone or in
combination) is significantly higher in women eligible for ART
Recommendation
ƒ All HIV-infected pregnant women eligible for antiretroviral
therapy should receive ART
14
Criteria for initiating ART in pregnant women based
on clinical stage and availability of immunological
markers
WHO clinical
staging
1
2
3
4
CD4 testing not
CD4 testing
available
available
Do not treat
[A-III]
Treat if CD4 cell count < 200/mm3
Do not treat
[A-III]
[B-III]
Treat
Treat if CD4 cell count < 350/mm3
[A-III]
[A-III]
Treat
[A-III]
Treat irrespective of CD4 cell count
[A-III]
15
Recommended ART for HIV-infected pregnant
women
Mother
Antepartum
AZT + 3TC + NVP Twice Daily
Intrapartum
AZT + 3TC + NVP Twice Daily
Postpartum
AZT + 3TC + NVP Twice Daily
Infant
From day 1
AZT x 7 Days*
* If the mother receives less than 4 weeks of ART during pregnancy, give 4 weeks of infant AZT
16
II. Antiretroviral prophylaxis for HIV-infected
pregnant women
Evidence
ƒ Efficacy of AZT alone or AZT/3TC regimens decrease with
breastfeeding, especially with prolonged feeding
ƒ Efficacy of Sd NVP is less affected by breastfeeding
ƒ Combination of AZT + Sd NVP is more effective than single drug
regimens
ƒ AZT + Sd NVP is equally effective as the more complex AZT+3TC+Sd
NVP and AZT+3TC regimen
ƒ The AZT/3TC "tail" given during the postpartum period reduced
development of NVP resistance
Recommendation
ƒ All HIV-infected pregnant women not needing ARV treatment should
ideally receive AZT + 3TC + Sd NVP as MTCT prophylaxis, and the
infant should get Sd NVP + AZT
17
ARV prophylactic regimens for HIV-infected pregnant
women
Ranking
Time of administration
Pregnancy
Labour
Postpartum
Maternal
Recommended
AZT
(>28 wks)
Alternative
AZT
(>28 wks)
Minimum
Minimum
Sd-NVP *
+
AZT/3TC
AZT/3TC
x 7 days*
Sd-NVP
--
Sd-NVP +
AZT/3TC
--
Sd-NVP
Infant
Sd NVP
+
AZT x 7 days *
Sd NVP
+ AZT x 7 days **
AZT/3TC
x 7 days
Sd NVP
Sd NVP
* If the woman receives at least 4 wks of AZT during pregnancy: omission of maternal NVP dose may be
considered in which case infant should receive 4 wks of AZT; and women do not require 7-day tail of AZT
and 3TC.
** If the mother receives < 4 wks of AZT during pregnancy, 4 weeks of infant AZT recommended
18
The infant NVP dose must be given immediately at birth
ARV prophylaxis for HIV-infected women presenting
in labour
Ranking
Time of administration
Postpartum
Labour
Maternal
Infant
Recommended
Sd-NVP +
AZT/3TC
AZT/3TC
x7 days
Sd NVP
+ AZT x 4 wks
Alternative
AZT + 3TC
AZT/3TC
x 7 days
AZT/3TC
x 7 days
AZT/3TC x7
days
Sd NVP
Minimum
Minimum
Sd-NVP +
AZT/3TC
Sd-NVP
Sd NVP
19
ARV prophylaxis for infants born to HIV-infected
mothers who did not receive ARV
Ranking
Time of administration
Infant Postpartum
Recommended
Sd-NVP* + AZT x 4 weeks
Alternative
Sd-NVP* + AZT x 1 week
Minimum
Sd NVP*
* NVP administered within 12 hours of birth is more effective for PMTCT
20
ARV for preventing HIV postnatal transmission
through breastfeeding
ƒ Current UN recommendations on HIV and infant feeding remain
valid, irrespective of whether a woman is receiving ART
ƒ Women receiving ART who are breastfeeding should continue
their ARV regimen
ƒ The use of ARV drugs in the mother and/or infant solely to
prevent MTCT through breastfeeding is currently not
recommended
21
Comprehensive Continuum of Care
For Mothers
ƒ HIV services need to be
integrated into MCH care
ƒ Counselling and care related to
nutrition, infant feeding, and
psychosocial support
ƒ Co-trimoxazole prophylaxis
ƒ Access to sexual health and
family planning services
ƒ HIV/AIDS care, treatment and
support services
ƒ Primary prevention services for
HIV-negative women
For Children
• Immunization
• Growth Monitoring
• Co-trimoxazole prophylaxis
• Postnatal longitudinal follow
up, including diagnosis:
-- Early diagnosis of HIV for HIVexposed children
-- Nutritional support as
necessary
• HIV/AIDS care, treatment and
support services, including ART
22
Acknowledgements
WHO
PMTCT Guidelines Group
René Ekpini
Charles Gilks
Philippe Gaillard
Matthew Chersich
Tin Tin Sint
Kim Dickson
Annette Verster
Peggy Henderson
Ekaterina Filatova
Isabelle de Vincenzi
Tim Farley
Siobhan Crowley
Marco Vitoria
Silvia Bertagnolio
Inam Chitsike
Lynn Mofenson
James McIntyre
Dorothy Mbori-Ngacha
Roger Shapiro
Graham Taylor
François Dabis
Elaine Abrams
Lynn Elizabeth Collins
Ellen Piwoz
Ngashi Ngongo
Catherine Wilfert
Anne Esther Njom Nlend
George P’Odwon Obita
Gangakhedkar Raman
Valdiléa G. Veloso
Nathan Shaffer
Moazzem Hossain
Siripon Kanshana
Mary-Glenn Fowler
Marc Lallemant
Leonardo Palombi
Elisabeth Madraa
23
Let us eliminate Paediatric HIV and AIDS!
24