The New DOH PMTCTPolicy

Challenges and Opportunities

A H CoovadiaECHO

Enhancing Childhood HIV Outcomes Department of Paediatrics and Child HealthCoronation Women and Children Hospital

University of The Witwatersrand

Overview PMTCT - Background The Old PMTCT Policy Where are we with PMTCT today ? The NSP (2007-2011) The New Revised PMTCT Policy PMTCT – The ‘Gateway Programme’ Challenges and Opportunities

Background 55% of all HIV-1 positive adults are

women of child bearing age. Seroprevalence rates among

pregnant women exceeds 30% in many urban populations in sub-Saharan Africa

MTCT Rates ~10 - 30% in non-breastfeeding

population of HIV-1 positive women in more developed countries

25 -45% in breast-feeding populations in Africa

intrapartum67%

in utero33%

Timing of transmission in Non breast-feeding

Transmission in Children

breastfeeding30%

intrapartum60%

in utero10%

Timing of transmission Breastfeeding

Risk Factors for Mother-to-child-transmission

High maternal viral load

Low maternal CD4 count

Vaginal delivery

Premature rupture of membranes

Breast milk

Risk Factors for Mother-to-child-transmission

chorioamnionitis low birth weight of the baby the first twin born unprotected intercourse with an HIV-

infected partner IV drug abuse STI’s

History of PMTCT and ARV interventions

ACTG 076 1994, AZT to mother from 2nd trimester,

IV during labour and delivery, 6 weeks to infant; transmission reduced from 25%-8%

Shorter course therapies sought Thai regimen PETRA

HIVNET 012 Nevirapine one dose to mother and one

dose to baby (transmission reduced to 13%)

Number of cases

PACTG 076 USPHS AZT Recommendations

80% declin

e

What did we know and when did we know it? Perinatal HIV Clinical Trial Results

1994 U.S. AZT Trial ACTG 076• 67% reduction in transmission

1998 Thai Bangkok short AP/IP AZT trial

• 50% reduction in transmission

1998 Cote d‘Ivoire short AP/IP AZT trials

• 37% reduction in transmission (breastfeeding)

1999 PETRA AZT/3TC trial (6 wk results)• 50% reduction with longest arm. • 38% reduction with the IP/PP arm

1999 Uganda 2-dose IP/PP NVP trial (HIVNET 012)• 47% reduction in transmission (breastfeeding)

1994 2004

2000 ThailandLong vs short AZT regimens

• 4% TR in LL (non BF)

2002 Cote d’Ivoire DITRAME +

• 6.2% TR with AZT & IP/PP NVP

2004 Thailand PHPT• 1.9% AZT + NVP

2003 DITRAME + 1201.1• 4.7% TR with AZT/3TC &

IP/PP NVP

PMTCT: The four-pronged strategy

• Primary prevention of HIV in parents-to-be

• Prevention of unwanted pregnancies

• Prevention of transmission from HIV-infected mother to infant

• Appropriate treatment and care

SA pMTCT Programme2001 - 2007

Nevirapine as single dose (sd) administration Dose= 1 tablet to mum at onset of labour

and a dose to baby within 72 hours after birth

Provision of infant formula for six months to mothers choosing this option.

NVP prevents MTCT by ~50% (Transmission Rates of approximately 10%)

Non-pregnancy related infections mainly HIV, TB and Pneumonia were the leadingcause of death in 38% of women

However probably an underestimate asonly 46% of women who died were tested for HIV, and 78% of those tested were HIV positivePMTCT is an opportunity to save the

lives of mothers and not only babies !

National Antenatal Testing Rate was 75%

compared with 45% (2005/6)HIV prevalence rate

amongst ANC attendees = 29%

Compared with 30.2% (2005/6)Percentage of Women

receiving Nevirapine was 61%

Compared with 52% (2005/6)Percentage of Babies

receiving Nevirapine was 45%

Lower than 2005/6 BUT more likely reflecting better quality data

29.5

30.229.1

National HIV and Syphilis Prevalence Survey 2006

The National Strategic Plan2007 - 2011

NSP GoalsKEY Priority Area 1 – PREVENTION

Reduce the rate of new infections by 50% by 2011

Section 3 of the Key Priority area 13.1 Broaden existing mother to child transmission

services to include other related services and target groups3.2 Scale up coverage and improve quality of PMTCT to reduce MTCT to less than 5%”

NSP TargetsObjective Intervention 5-year target Lead

Agency

2007 2008 2009 2010 2011

3.2:Scale up coverage and improve quality of PMTCT to reduce MTCT to less than 5 %

Increase the proportion of public sector antenatal services providing PMTCT

85 % 95 %

100 % 100 % 100 % DOH

Increase proportion of pregnant women tested through implementation of provider initiated VCT for all pregnant women

70 % 85 % 90 % 95 % 95 % DOH

Develop an policy and guidelines on VCT in pregnancy including consideration of provider initiated testing, and frequency of testing

Develop & implement

Annual review

Annual review

Annual review

Annual review

DOH, NGOs,DoE

Increase the proportion of the estimated population of HIV-infected pregnant women in need who receive PMTCT services

60 % 70 % 80 % 90 % 95 % DOH

The New Revised PMTCT Policy2008

‘Routine offer of VCT’ (Provider Initiated) Addition of AZT (Dual Therapy) Emphasis on getting CD4 counts on all

pregnant women to start HAART in pregnancy (CD4 < 200 OR WHO stage 4)

Infant Feeding Options – better guidance Emphasis on infant diagnosis at 6 weeks

SA pMTCT Programme2008 DUAL THERAPY

Women who need ARVs – get put onto this ASAP (CD4 count less than 200)

FOR WOMEN WITH CD4 COUNTS ABOVE 200 OR IF NOT YET ON ARVs (I.E ALL WOMEN)

Mother - AZT during pregnancy from 28 weeks gestation + single tablet Nevirapine in Labour

Baby – Single dose Nevirapine + AZT for 7 days (and in some cases upto 28 days)

Able to reduce MTCT to 5% with new policy !

AZT TO BABY FOR 4 WEEKS IF:

Mother received no PMTCT

Mother received only nevirapine for PMTCT

Less than 4 weeks of AZT/HAART taken by mother

Mother diagnosed for the first time in labour or postpartum – AZT to baby best given within 12 hours of birth

One out of four babies (25%) born to all HIV positive mothers will acquire HIV from their mother ( if no intervention is offered )

That means at least 75% of babies are uninfected at birth!

Mother to Child Transmission

5% Infected

PMTCT RATESOf all HIV Infected Women

75 % HIV Negative Babies

25 % HIV Infected BabiesWhere no intervention

10% Infected Old policySd NVPNew policyAZT + Sd NVP

95 % HIV Negative Babies !

First StepTesting

Testing

SCREENING HIV TEST

SCREENING POSITIVE

SCREENINGNEGATIVE

NEGATIVECONFIRMATORY HIV TEST

CONFIRMATORYPOSITIVE

CONFIRMATORY NEGATIVE

INDETERMINATEFINAL RESULTPOSITIVE

SEND FOR HIV ELISA

POSITIVE / NEGATIVE ELISA

FINAL RESULT

INDETERMINATE ELISASEND FOR HIV DNA PCR

(diagnostic PCR)

REPEAT TEST AT AROUND 34 WEEKS

HbCD4

GestationWeek ?

Management of HIV infected Pregnant WomanFirst Visit (WHO stage I-III)

If < 28 weeksOr

Hb <8g/dlDo NOT Start

AZT

If 28 wks or more

Hb ≥8g/dlStart AZT300mg BD

CD4WHOStage

Assessment of HIV infected Pregnant WomanSecond Visit

CD4 < 200 OR

WHO Stage IV

HAARTIf previously on AZTSwitch to 3TC/d4T/NVP

CD4 > 200 OR

WHO Stage I-III

PMTCT RegimenIf ≥ 28weeksAZT until Delivery

LABOUR AND DELIVERY At onset of labour, woman to take 600mg AZT (2

tablets) stat plus 200mg sd (1 tablet) nevirapine. If Nevirapine already taken previously with false

labour, do not repeat nevirapine dose and neonate receives standard post exposure prophylaxis.

Continue AZT 300mg 12 hourly at the usual times until the neonate is delivered.

Mother on HAART, continue treatment as usual during labour.

POSTNATAL CAREBaby: Nevirapine 0.6 ml as soon as possible after

delivery (under 2.5kg give 0.2ml/kg), plus

AZT 4mg/kg 12 hourly for 7 days or 28 days (premature <35 weeks 2mg/kg) Above the same for women on AZT or on

HAART

Enquire about feeding options from the mother

Babies Requiring 28 days ofAZT

Where mother had no ARVS at all during antenatal period or labour i.e unbooked

Mother had < 4 weeks of AZT or Mother had < 4 weeks of HAART Mother received only sd NVP

What about the women testing Negative ?

Repeat HIV testing at or around 34 weeks of gestation

About 5% of women will seroconvert during pregnancyHIV NEG ----------------- HIV POS

What about the women who haven’t been tested ?

No women should leave a healthcare facility without beingoffered an HIV test.

Not doing so is tantamount to being negligentRemember too our responsibility to both mother and the child

Labour Ward Postnatal Ward

Challenges to Success of the Programme

Political leadership Testing rates below target Adequacy of human resources (e.g trained counsellors) Information transfer between facilities. Stigma Drug supply – NVP + AZT (no stock outs) No widespread campaign explaining benefits of programme Lack of integration with other services such as family

planning/CCMT/EPI Community and NGO involvement largely lacking Not seen as priority programme by healthcare facilities that

have other competing demands Public sector focussed rather than larger public health concern,

where only addressing attendees to the public health service

Which Services need integration ? VCT – Family Planning VCT – PMTCT PMTCT – CCMT (ARV sites) PMTCT – Infant Diagnosis and Follow up

(IDFU) Infant Diagnosis and Paediatric ARV site EPI – IDFU TB - CCMT STI - CCMT

Meeting the challenges Political Commitment Increase effective coverage - PMTCT programme in 100% of healthcare facilities

providing ANC Testing strategy needs revisiting – Provider initiated TC Adequate staffing with role clarification and systems improvement to enable

better coverage of all women. Prioritization of programme within healthcare facility. All staff at facilities must

understand importance of the programme. Programme leadership with dedicated and responsible team who monitor

progress in on-going manner i.e M&E at local level. Integration of PMTCT with CCMT services to enable smooth transfer of patients

needing treatment Community education and involvement in getting testing rates up. Mass media and educational campaigns to raise awareness of the programme and

it’s benefits. INFANTS - Need to ensure that ALL HIV exposed infants reap the benefits of an

enhanced PMTCT programme, which would include Abandoned infants (upto 50% have been noted to have had HIV exposure) Infants whose mothers are indisposed – death, coma, serious post-partum illness, mental

confusion Infants whose mothers refuse testing - Infants whose mothers refuse any intervention despite knowing their status

Opportunities Improve overall maternal antenatal care and outcomes

Through training on basic ANC Reduction in maternal mortality (NCCEMD) Improvement in basic infrastructure/equipment

Improve HIV testing rates amongst adults (women and men)

Expedited entry onto ARVs for women with low CD4 counts

Increasing access points for ARVs for patients Drastically reducing numbers of infected infants Establishing follow up for infants with early diagnosis

and treatment if needed Decreasing orphanhood

PMTCT‘The Gateway Programme’

Thesaurus Entry Opening Access First step Opportunity Chance

Longman Dictionary An opening in a fence or way etc, across which a

gate may be put A way of finding e.g Hardwork is the gateway to

success

5% Infected

95 % HIV Negative Babies

What are we aiming for ?

PMTCT95% HIV negatives

+ves

Early IdentificationOf all infected infants

Early initiation of HAARTin infants

Decreasenumberof infectedChildrenIn SA

Decrease morbidity And mortality in HIVinfected Children in

SA

Early IdentificationOf Sick Women

Decrease morbidity

And mortality in HIV

infected Women in SA

Decrease number of infected

WomenIn SA

References SA National DOH PMTCT Policy (2008) District Health Barometer (HST 2006/7) Every Death Counts Report Lancet – Every Death Counts

Would like to thank Prof James McIntyre for use of some slides.

Ashraf.Coovadia@wits.ac.za