2 pmtct-slides jan 2011

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WHO 2010 guidelines and

country level guidelines onantiretroviral drugs for

treatment pregnant women and

preventing HIV infection ininfants



Acknowledgments

EGPAF acknowledges the World Health

Organization for sharing these slides, which

have been adapted for use by (Facilitator

please add the name of the person whoadapted these slides).

All guidelines available at:

http://www.who.int/hiv/en/



Contents

These slides include:

1. An overview of the WHO revision process

2. The revised WHO guidelines on ARVs for PMTCT.

3. Country-specific guidelines on ARVs for

PMTCT.4. General discussion points,

implementation challenges, and a quiz to

test your knowledge.



WHO REVISION PROCESS



Prioritise Problems, establish panel, questions

Systematic Reviews

Evidence Profiles

Relative importance of outcomes

Overall quality of evidence

Benefit ± downside evaluation

Strength of recommendation

Implementation and evaluation of guidelines

Guideline development process



Preparation

~ one year of activities«

Systematic reviews

Evidence profiles

Feasibility assessment

Costing projections

PLHIV consultations Drug safety profiles

Peer consultations

Use of the GRADEmethod (seewww.gradeworkinggroup.o

rg/)

2010 update



PMTCT Study Results and GuidelinesRevisions

USA & Europe

Thailand

Africa

1998

Bangkok

AP/IP AZT

1998

Abidjan

AP/IP AZT

1999

HIVNET 012

Sd-NVP

2002

DITRAME+1

AZT+NVP

2003

DITRAME+1.1

AZT/3TC+NVP

2004

PHPT-2

AZT+NVP

1994

ACTG 076

1999

PETRA

AZT

/3TC

2009

Mma Bana

AZT/3TC/LPV-r

AZT/3TC/ABC

2009

Kesho Bora

AZT+3TC+sd-NVP

2009

PEPI-Malawi

6 wks NVP-infant

2000

PHPT

AZT

T r a n s m i s s i o n ( % )

0

5

10

15

20

25

30

35

WHO

recommendations

first issued

1st revision of

WHO

guidelines

2nd revision of

WHO

guidelines

2010 revision

2009

B AN

Maternal ARV

vs infant NVP 6

m



REVISED WHOGUIDELINES



Antiretrovirals in pregnancy

The PMTCT recommendations refer to two key

approaches:

Life-long ART for HIV-infected pregnant womenin need of treatment

Prophylaxis, or the short-term provision of

ARVs, to prevent HIV transmission from motherto child, for women who don·t require

treatment for their own health



WHO Key recommendations

1. Earlier ART for a larger group of HIV+ pregnantwomen to benefit both the health of the motherand prevent HIV transmission to her child duringpregnancy

2. Longer provision of ARV prophylaxis for HIV+pregnant women who do not need ART for theirown health to reduce the risk of HIV transmissionfrom mother to child

3. Provision of ARVs to the mother or child toreduce the risk of HIV transmission during thebreastfeeding period



Antiretroviral therapy (ART)

CD4 cell count available

CD4 < 350 cell/mm3 CD4 > 350 cell/mm3

ART

Regardless of

clinical stage

ART

If symptomatic

(stage 3 or 4)

WHO clinical stage

Stage 1 ARV prophylaxis

Stage 2 ARV prophylaxis

Stage 3 ART

Stage 4 ART

Start ART as soon as feasible regardless of gestational

age and continue for life long



ART for mother & prophylaxis forexposed infants

Mother

Preferred

AZT + 3TC + NVP or

AZT + 3TC + EFV

Alternative TDF + 3TC (or FTC) + NVP or

TDF + 3TC (or FTC) + EFV

Exposed infants (mothers on ART)

All infants

NVP for 4-6 weeks or

AZT for 4-6 weeks



13

Benef it and impact of ART in eligiblepregnant women

Pregnant women with CD4 < 350 cells/mm3:

About 40% of HIV+ pregnant women

Account for > 75% of MTCT risk

Account for >80% of postpartum transmission

Account for 85% of maternal deaths within 2years of delivery

Have strong benefit from initiating ART formaternal health and PMTCT during pregnancy,labour and delivery and breastfeeding



ARV prophylaxis to preventMTCT

For w omen not eligible f or ART or

unknow n eligibility

Beginning as early as 14 weeks of

gestation (2nd trimester) or as soon as

possible thereafter



ARV prophylaxis to give to non-eligible pregnant women

2 possible options:

A) Maternal AZT, or

B) Maternal triple ARV prophylaxis

And for the breastfeeding mother:

Provision of ARVs to the child OR the motherto reduce risk of HIV transmission during

breastfeeding (if breastfeeding is best infant

feeding option)



Prophylaxis optionsOption A Option B

Mother

Antepartum AZT (from 14 weeks)

sd-NVP at onset of labour*

AZT + 3TC during labour & delivery*

AZT + 3TC for 7 days postpartum*

Mother

Triple ARV (from 14 wks until one wk

after all exposure to breast milk has ended)

AZT + 3TC + LPV-r

AZT + 3TC + ABC

AZT + 3TC + EFV

TDF + 3TC (or FTC) + EFV

Infant

Breastfeeding population

Daily NVP (from birth until one wk after

all exposure to breast milk had ended)

Non-breastfeeding population

Sd-NVP + daily AZT for 4-6 weeks

OR

Daily NVP for 4-6 weeks

Infant

All exposed infants

AZT for 4-6 weeks OR NVP for 4-6 weeks

*sd-NVP and AZT+3TC can be omitted if mother receives > 4 wks AZT antepartum



Option A or Option B?

Both recommended options A and B providesignificant reduction of the MTCT risk

There are advantages and disadvantages of

both options, in terms of feasibility, acceptabilityand safety for mothers and infants, as well as

cost

The choice for a preferred option should bemade at a country level, after considering these

advantages and disadvantages



REVISED COUNTRYGUIDELINES



Steps on Guidelines Adaptation and Implementationat Country Level

Establishment of the National Advisory Committee

Evidence Assessment (considering the globalrecommendations)

Situational Assessment (coverage, populations, treatmenteligibility criteria, lab, delivery & procurement capacities,training needs)

Adaptation (feasibility & costing evaluations)

Decision Making & Prioritization

M&E plan



Current Status of Guidelines Adaption/Option Choice andImplementation in {Insert your country name here}

Facilitator, please include country-specific

choice, guideline summary, and

modifications



Discussion Question Guide

Do you feel the option chosen is appropriate for your country

context? Why or why not?

Discuss monitoring and evaluation of the revised PMTCT guidelines:

are there any modifications that should be made to existing forms,

registers, or data review processes?

Discuss possible barriers to implementation of the revised PMTCT guidelines and proposed solutions to these barriers.

Discuss existing community or facility-based efforts to increase

demand, access, and adherence to PMTCT, and how these might

be upscaled.

Discuss existing efforts to reach more HIV-exposed children with ARVs for PMTCT, in particular those mother-baby pairs missed by

PMTCT programs, and how these efforts might be upscaled.

Discuss how to integrate PMTCT services with other service

delivery points.



Group Quiz Questions

Instructions: Please break into your small

groups and answer the following questions

together:

Facilitator please add questions as

appropriate.

2 pmtct-slides jan 2011

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