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Pediatric HAART in Kwa Zulu Natal 2008 update

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evidence from the Children with HIV Early Antiretroviral Therapy (CHER) Study9 ... CHER Trial. Part A n= 375. HIV infection diagnosed before 12 weeks and CD4 ... – PowerPoint PPT presentation

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Title: Pediatric HAART in Kwa Zulu Natal 2008 update


1
Pediatric HAART in Kwa- Zulu Natal 2008-
update
  • Kimesh L Naidoo
  • Principal Specialist King Edward VIII Hospital

2
Format of presentation
  • What we know for sure
  • Burden of disease in KZN amongst children-
    Mortality statistics from King Edward VIII
    Hospital
  • The Pediatric HAART program- how are we doing in
    Kwa Zulu Natal!
  • 2. What we think we know
  • Focus on PMTCT should be the most important
    will we succeed with this current program
  • Early treatment of Infants start HAART as soon
    as possible lt 1Year
  • 3. What we really dont knowyet !
  • Late treatment should we wait in older children
  • Exclusion criteria and the need for Palliative
    care

3
Age of children who are dying in King Edward VIII
Hospital Pediatric wards ()1 n309(2006) and
252(2007)
1.King Edward VIII Hospital Mortality statistics
Saving Babies Report 2007
4
HIV test results documented in children who died
in King Edward VIII Pediatric wards () 1
n309(2006) and 252(2007)
1.King Edward VIII Hospital Mortality statistics
Saving Babies Report 2007
5
Documented WHO clinical staging of children who
died () 1 n309(2006) and 252(2007)
1.King Edward VIII Hospital Mortality statistics
Saving Babies Report 2007
6
Access to HAART amongstchildren who died () 1
n309(2006) and 252(2007)
1.King Edward VIII Hospital Mortality statistics
Saving Babies Report 2007
7
Mothers well being of those children who died ()
1 n309(2006) and 252(2007)
1.King Edward VIII Hospital Mortality statistics
Saving Babies Report 2007
8
2008 interventions
9
Format of presentation
  • What we know for sure
  • Burden of disease in KZN amongst children-
    Mortality statistics from King Edward VIII
    Hospital
  • The Pediatric HAART program- how are we doing in
    Kwa Zulu Natal!
  • 2. What we think we know
  • Focus on PMTCT should be the most important
    will we succeed with this current program
  • Early treatment of Infants start HAART as soon
    as possible lt 1Year
  • 3. What we really dont knowyet !
  • Late treatment should we wait in older children
  • Exclusion criteria and the need for Palliative
    care

10
Pediatric ART numbers 2
Viral loads done in IALCH3
11
Format of presentation
  • What we know for sure
  • Burden of disease in KZN amongst children-
    Mortality statistics from King Edward VIII
    Hospital
  • The Pediatric HAART program- how are we doing in
    Kwa Zulu Natal!
  • 2. What we think we know
  • Focus on PMTCT should be the most important
    will we succeed with this current program
  • Early treatment of Infants start HAART as soon
    as possible lt 1Year
  • 3. What we really dont knowyet !
  • Late treatment should we wait in older children
  • Exclusion criteria and the need for Palliative
    care

12
The Transmission Story4
13
PMTCT Expectations4 (perfect performance)
14
Reliability what does it mean5
Reliability 100 90
90
90 50
Example 22 tested 10 HIV 9 CD4
Test 8 DT 7
DT 4 PCR tested
Overall Reliability 40
15
Format of presentation
  • What we know for sure
  • Burden of disease in KZN amongst children-
    Mortality statistics from King Edward VIII
    Hospital
  • The Pediatric HAART program- how are we doing in
    Kwa Zulu Natal!
  • 2. What we think we know
  • Focus on PMTCT should be the most important
    will we succeed with this current program
  • Early treatment of Infants start HAART as soon
    as possible lt 1Year
  • 3. What we really dont knowyet !
  • Late treatment should we wait in older children
  • Exclusion criteria and the need for Palliative
    care

16
The natural history of peri-natal HIV differs
from that of adult HIV infection6
106
Viral load
Adults
3 6 9 12 24
36 48 60
Months following primary infection
17
(No Transcript)
18
Infant Immunity6
  • Physiological immunodeficiency
  • Humoral immunity
  • Lower IgG/A
  • Cell-mediated immunity
  • TH2 skewed response until 12 months (?
    IL-2,4,6,10)
  • Poorer CTL responses lt6 months
  • Innate immunity
  • ? NK cells
  • chemokines

19
8.Mphatswe et al .High frequency of rapid
immunological progresion in African infants
infected in the era of perinatal HIV prophylaxis
.AIDS (London,England)200721(10)1253-61
20
  • Objective Determine the natural history of HIV
    infection following peri-partum sd-NVP and
    implications for ARV roll-out programs8

21
(No Transcript)
22
  • Post sd-NVP8
  • MTCT 69 Intrauterine / 31 Intra-partum
  • Using a CD cut-off for ARV eligibility of-
  • lt20 - 35 of patients were eligible by 3 months
    and 70 by 6 months.
  • lt25 - 55 of patients were eligible by 3 months
    and 85 by 6 months.

23
ART initiated before 12 weeks reduces early
mortality in young HIV-infected infants
evidence from the Children with HIV Early
Antiretroviral Therapy (CHER) Study9
  • Avy Violari, Mark Cotton, Di Gibb, Abdel Babiker,
    Jan Steyn, Patrick Jean-Philippe, James McIntyre
  • PHRU, University of Witwatersrand KID-CRU,
    Stellenbosch University MRC-CTU UK DAIDS NIAID,
    NIH

24
CHER Trial Part A n 375







ART (start or re-start) when CD4 lt20 or
clinical event (lt25 from August 2006)

















25
Baseline characteristics9
5985 babies were screened using DNA PCR to enrol
377 HIV pos infants
26
Follow-up and use of ART9
27
Mortality Rates9
28
Risk of death9
  • Death rate per 100 person-years (Arm 23 vs. 1)
  • 3 months 10 vs. 41
  • 3 to 6 months 4 vs. 23
  • 6 to 12 months 3 vs. 9

29
Disease progression in all patients9

30
WHO Criteria June 2006
31
(No Transcript)
32
Format of presentation
  • What we know for sure
  • Burden of disease in KZN amongst children-
    Mortality statistics from King Edward VIII
    Hospital
  • The Pediatric HAART program- how are we doing in
    Kwa Zulu Natal!
  • 2. What we think we know
  • Focus on PMTCT should be the most important
    will we succeed with this current program
  • Early treatment of Infants start HAART as soon
    as possible lt 1Year
  • 3. What we really dont knowyet !
  • Late treatment should we wait in older children
  • Exclusion criteria and the need for Palliative
    care

33
Dilemma
  • When should Children with HIV infection be
    started on Antiretroviral therapy?10

Welch SB,Gibb D (2008) When Should Children with
HIV infection Be Started on Antiretroviral
Therapy? PLoS Med 5(3)e73
doi10.1371/journal.pmed.0050073
34
After 1 year when should children with HIV
infection be started on HAART10
  • Beyond infancy should we delay treatment until it
    is really needed for these children progression
    without detectable clinical changes or a fall in
    CD4 count is less likely
  • No RCT
  • Side-effect profile dys-lipidaemias and
    Cardiovascular risk depend on duration
  • Adherence issues at risk families
  • Drug resistant virus
  • No long-term outcome studies on starting ART at
    different CD4 counts
  • Suggest
  • CONSIDER SOCIAL CIRCUMSTANCES AS WELL AS RISK OF
    DISEASE PROGRESSION rather than rigidly set CD4
    threshold

35
The case for earlier intervention10
  • New evidence shows that progression to AIDS,
    especially serious non-AIDS events (cardiac,
    renal, hepatic )occur at higher CD4 thresholds
    especially middle income and resource limited
    settings
  • Long term drug toxicity overplayed
  • Simpler drug regimens available
  • Triple-class drug resistance appears less common
  • Two new classes with no cross resistance available

36
5 reasons why earlier ART is even more important
than for adults10
  • Faster HIV disease progression in all children
  • Significant immune recovery is better in younger
    children in whom thymus is more active
  • Bacterial infections are most common and serious
    in younger children ,including TB
  • Better growth if child is on ART ( 10cm shorter
    at 10years)
  • HIV encephalopathy appears to be reduces with
    earlier HAART

37
Format of presentation
  • What we know for sure
  • Burden of disease in KZN amongst children-
    Mortality statistics from King Edward VIII
    Hospital
  • The Pediatric HAART program- how are we doing in
    Kwa Zulu Natal!
  • 2. What we think we know
  • Focus on PMTCT should be the most important
    will we succeed with this current program
  • Early treatment of Infants start HAART as soon
    as possible lt 1Year
  • 3. What we really dont knowyet !
  • Late treatment should we wait in older children
  • Exclusion criteria and the need for Palliative
    care

38
Majority of HIV infected individuals are
categorized as WHO stage 41
39
Timing of death1
40
DEFINITION (WHO)
2008 interventions
  • An approach that improves the quality of life of
    patients and their families facing the problems
    associated with life threatening illness, through
    the prevention and relief of suffering by means
    of early identification and impeccable assessment
    and treatment of pain and other problems,
    physical, psychosocial and spiritual

41
PALLIATIVE CARE STAKEHOLDERS
2008 interventions
42
Main thrust of Palliative care in SA
  • ADVOCACY
  • INTEGRATION AND COVERAGE- case for simple
    protocol facility
  • EDUCATION AND TRAINING
  • DRUG ACCESS
  • EVALUATION

43
Proposal 3 Aspects
2008 interventions
  • Social Criteria
  • Inability to access HAART despite social support
  • Family / Guardian acceptance of provision of
    palliative care
  • Clinical criteria
  • End- organ damage non responsive to HAART or /and
  • Severe wasting non responsive to nutritional
    intervention or/and
  • Severe wasting not responding to Opportunistic
    infection treatment/s
  • Health system Requirements
  • Agreement by all health care workers in direct
    care of patient ( medical, nursing and support
    staff)
  • Provision of drugs and infrastructure
    (institutional and /or community) for palliative
    care

44
30/11/2006 8,7 KG
Reference 11
17/04/2007
17/05/2007
19/02/2007
08/08/2007 12,5 KG
22/06/2007
45
References and Acknowledgements
  • King Edward VIII Hospital Mortality statistics
    Saving Babies Report 2007
  • KZN Pediatric Figures of children lt 13 years on
    HAART supplied by Viloshini Manickum
    Principal Pharmacist 29Sep2008
  • NHLS figures 2008 March . Pravi Moodley
    .Department of Virology
  • UKZN PMTCT 20000 project ,Nigel Rollins,2007
  • UKZN PMTCT 20000 project, Brandon Bennet,2007
  • Delane Shingadia CHIVA-KZN mentoring project 2008
    March
  • H Lyall CHIVA KZN mentoring project 2007
  • Mphatswe et al .High frequency of rapid
    immunological progresion in African infants
    infected in the era of perinatal HIV prophylaxis
    .AIDS (London,England)200721(10)1253-61
  • Violari,Avy et al PHRU, University of
    Witwatersrand KID-CRU, Stellenbosch University
    MRC-CTU UK DAIDS NIAID, NIH
  • Welch SB,Gibb D (2008) When Should Children with
    HIV infection Be Started on Antiretroviral
    Therapy? PLoS Med 5(3)e73 doi10.1371/journal.
    pmed.0050073
  • Dr Graca , Appelsbosch Hospital ARV clinic
    2007pictures and case
  • Dr Moherndran Archary ,Department of Pediatrics
    ,UKZN early infant treatment slides
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