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Where Are We Headed with Paediatric Prevention and Treatment
Shaffiq EssajeeMelbourne, July 25 2014
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 20130
100,000
200,000
300,000
400,000
500,000
600,000
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Trends in new HIV infections among children (aged 0-14) and coverage of maternal ARVs form PMTCT in all
low- and middle-income countries, 2001-2012
Maternal ARVs for PMTCTNew HIV infections in children (0-4)
Ne
w H
IV in
fec
tio
ns
(#
) PM
TC
T c
ov
era
ge
Source: UNAIDS 2013 HIV and AIDS estimates, 2014, and UNAIDS/WHO/UNICEF Global AIDS Response Progress Reporting (GARPR)/Universal Access data, 2006-2014
Global progress on PMTCT continues despite shrinking resources for HIV scale up
As maternal ARV access has increased, so the estimated number of new child infections has fallen to 240,000
Source: UNAIDS 2013 HIV and AIDS estimates, 2014, and UNAIDS/WHO/UNICEF Global AIDS Response Progress Report Universal Access data, 2006-14
Option B or B+ has now been adopted in all the 22 priority Global Plan countries, but the pace of implementation needs to increase
Globally close to 80% of countries have adopted Option B or B+ in their national program
Data
Option BB+ planning, piloting, early implementationB+ scale-upB+ national implementation
Missing Value
Source: lATT/WHO Global Update on the Health Sector Response to HIV, 2014.
There are 60% fewer new infections in children but there has not been a commensurate decline in child deaths
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 20130
100000
200000
300000
400000
500000
600000
700000
HIV-related child deaths
New Child infections from MTCT
60% reduction in new infections from peak of 580,000 per year 40% reduction in mortality from peak of 330,000 per year
Source: UNAIDS 2013 HIV and AIDS estimates, 2014, and UNAIDS/WHO/UNICEF Global AIDS Response Progress Report /Universal Access data, 2006-14
Unlike paediatric prevention, paediatric treatment efforts are stagnating especially when compared with adult coverage
• The denominator has increased – now “All people living with HIV” not “People in need of ART”
• Coverage for The gap between adult and child coverage has widened.
2007 2008 2009 2010 2011 2012 20130%
10%
20%
30%
40%
50%Paediatric ARTAdult ART
Percent (%)
Source: UNAIDS/WHO/UNICEF 2008-2014 GARPR/Universal Access reporting and UNAIDS 2013 HIV and AIDS estimates
38%
24%
We have been failing to achieve equity for children for a long time, but the situation today is different to the past
We don’t have the right drugs and formulations to treat children…
We still need a child friendly heat stable form of lopinavir/ritonavir but this is coming soon…
FDA approval
WHO PQ approval
Cost pppy
d4T/3TC 6/30mg 2008 2011 $46
d4T/3TC/NVP 6/30/50mg 2007 2008 $55
AZT/3TC 60/30mg 2007 2009 $72
AZT/3TC/NVP 60/30/50mg 2010 2009 $96
ABC/3TC 60/30mg 2011 2014 $168
EFV 200mg tab 2010 2009 $37
Yes we do!
Source: CHAI Ceiling Price 2013
We have been failing to achieve equity for children for a long time, but the situation today is different to the past
It’s too complicated to treat children, you need specialists just to do the dosing….
WHO guidelines offer simplified harmonized weight band doses for all ages and all forms
No it isn’t
Drug
Children 6 weeks of age and aboveNumber of tablets by weight band
3-5.9kg 6-9.9kg 10-13.9kg
14-19.9kg
20-24.9kg
am pm am pm am pm am pm am pm
AZT dual 1 1 2 1 2 2 3 2 3 3AZT triple 1 1 2 1 2 2 3 2 3 3ABC dual 1 1 2 1 2 2 3 2 3 3d4T dual 1 1 2 1 2 2 3 2 3 3d4T triple 1 1 2 1 2 2 3 2 3 3Triple nucl 1 1 2 1 2 2 3 2 3 3LPV/r NR NR 2 1 2 2 3 2
Source: Adapted from WHO Consolidated guidelines 2013
We cant make an HIV diagnosis in infants because virological testing is too difficult
We have been failing to achieve equity for children for a long time, but the situation today is different to the past
80,000
1,200,00015x increase
Year -
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
2007 2008 2009 2010 2011
Number of PCR tests each year
Global AIDS Report notes that 44% of infants are accessing an EID test within 2 months of life and in many countries this is above 90%
Source: CHAI UNITAID Program data 2012
Yes we can!
Five issues stand out as key bottlenecks across the continuum of care from diagnosis to treatment
We are not looking in the right places to identify HIV infected children.
When we do find infected children many are lost before enrollment into care
We are stalling in efforts to expand pediatric access though decentralization and task shifting
Diagnosis
LinkageTreatm
ent
1
2
3
4
5
We are not integrating paediatric HIV and MCH
We have failed to harness the community as a partner
for pediatric scale up
Diagnosis
We are not looking in the right places to identify HIV infected children.
When we do find infected children many are lost before enrollment into care
We are stalling in efforts to expand pediatric access though decentralization and task shifting
Diagnosis
LinkageTreatm
ent
1
2
3
4
5
We are not integrating paediatric HIV and MCH
We have failed to harness the community as a partner
for pediatric scale up
Globally paediatric testing is focused on infant diagnosis within PMTCT, but in the era of B+ are we looking in the right places? 1
Art Clinic EID Lab Maternity MCH/PMTCT/
ANC
OPD Outreach Paediatric Ward
PNC YCC/Im-munisa-
tion
Art Clinic EID Lab Maternity MCH/PMTCT/
ANC
OPD Outreach Paediatric Ward
PNC YCC/Im-munisa-
tion
No of test
2942 5972 813 1492 2372 1289 31 115 1600 1720
% Posi-tive
7 8 9 6 5 15 16 28 5 7
500
1500
2500
3500
4500
5500
6500
3
8
13
18
23
28
7 8 96 5
15 16
28
5 7
No of test % Positive
Inpatient wards
Source: Uganda national EID testing program statistics 2012
OPD testing of sick infants and outreach to infants whose mothers
were lost to follow up of from PMTCT8% of tests
16% of
pos
In Malawi, where B+ has been in place longest, National Program data confirm the shifting trend of paediatric HIV prevalence
Population Prevalence Source
HIV-exposed 6 week (DNA PCR) 2%National Supervision data, Q1 2014
HIV-exposed 12 month 6%National Supervision data, Q1 2014
Moderately malnourished children in outpatient rehabilitation
6.6%Nutrition program (5 months in 2014 in16/28 districts)
Moderate-severely malnourished children in outpatient rehabilitation
18%Nutrition program (5 months in 2014 in 16/28 districts)
Severely malnourished children in inpatient rehabilitation
23%Nutrition program (5 months in 2014 in16/28 districts)
1
Source: Malawi Ministry of Health 2014
Testing in inpatient or outpatient settings can identify older children and infants who “slip through the cracks” of PMTCT 1
Approach AcceptabilityHIV exposed or
infectedImpact
Rollins et al. AIDS 2009
Routine HIV Ab screening with follow up EID testing of infants in 3 immunization clinics in KZN
90% of mothers accepted infant testing
>40% of infants had HIV exposure9.2% were DNA PCR positive
No impact on immunization rates
McCollum et al. Plos One 2010
Routine inpatient screening in Lilongwe of mother and child
71% of mothers accepted child testing
8.5% were infected
Testing was also offered to mothers with good acceptance
Mutanga et al. PLOS One 2012
Routine inpatient in Lusaka using HIV Ab tests
98% acceptance of testing
15.5% infected >90% linkage to services as in a large general hospital
Recommendations & policy guidance exist for PITC in children in generalized epidemics, but they are rarely implemented 1
• PITC Eligibility: All children 6-15 with unknown status
• Sites: 6 primary clinics in Harare over a 4-month period
• 2,831 children eligible but only 70% were offered a test
• Reasons for not testing
• Unsuitable guardian – especially male guardians
• Lack of staff time or reagents
• Child “did not seem sick” or was “too old to have HIV”
• 90% of children tested could have received PITC earlier
Kranzer et al. PLOS one 2014
Loss to follow up and Linkage
We are not looking in the right places to identify HIV infected children.
When we do find infected children many are lost before enrollment into care
We are stalling in efforts to expand pediatric access though decentralization and task shifting
Diagnosis
LinkageTreatm
ent
1
2
3
4
5
We are not integrating paediatric HIV and MCH
We have failed to harness the community as a partner
for pediatric scale up
In this 4-country retrospective review, between 62 and 74% of positive infants could not be accounted for after 1 year
Source: Chatterjee et al. BMC Public Health, 2011. Collins et al. CROI 2014.
2
Positive
via EID
Receive
d Results
Enrolle
d in H
IV care
Initiated on ART
Alive and a
ctive
on ART0
500
1000
1500
2000
2500
3000
3500
64%
Retention of infected infants in Uganda
Each positive infant identified costs an estimated $240 to $440 depending on vertical transmission rates
Strategies such as SMS printers to return results to clinics have already been shown to improve infant retention
14 days
DBS drawn for PCR
6 wks 10 wks
Caregiver returns for
results
EID sample received at laboratory
Sample processed
Laboratory can immediately
send results via SMS printers5 -10
days
Results are available when
caregiver returns
2
POC offers “while you wait results” so may improve both clinical outcomes and reduce wastage of resources
1 2 3
• 827 HIV-exposed infants tested using Poc EID and traditional DNA PCR
• 60% of infants were between 1-2 months of age.• Overall 85 positive samples by DNA PCR, with
excellent correlation (only 2 samples were discordant) and sensitivity = 98.5%, specificity = 99.9%
• PoC gives rapid results AND is very portable allowing for use where needed – eg in labour ward or in community settings
2
Source: Jani et al. JAIDS 2014
Decentralization and Task shifting
We are not looking in the right places to identify HIV infected children.
When we do find infected children many are lost before enrollment into care
We are stalling in efforts to expand pediatric access though decentralization and task shifting
Diagnosis
LinkageTreatm
ent
1
2
3
4
5
We are not integrating paediatric ART with MCH
We have failed to harness the community as a partner
for pediatric scale up
Among 1740 South African children on ART, 18 month outcomes were the same in all tiers of the health system
Bock et al. Trans R Soc Trop Med Hyg 2008;102:905-911
Viral suppression
Mortality
CD4 Recovery
3
While task sharing in adults is well-established, for children despite evidence, national programs have been slow to adopt
Source: Penazzato et al. JAIDS 2014
Non-physician managed ART compared with physician managed ART
Mortality and retention outcomes from 6 to 36 months of follow up were comparable
3
Integration of paed HIV and MCH
We are not looking in the right places to identify HIV infected children.
When we do find infected children many are lost before enrollment into care
We are stalling in efforts to expand pediatric access though decentralization and task shifting
Diagnosis
LinkageTreatm
ent
1
2
3
4
5
We are not integrating paediatric ART with MCH
We have failed to harness the community as a partner
for pediatric scale up
A pilot program in Uganda has had success in retaining mother-baby pairs by providing an integrated package of HIV services 4
• 22 MCH clinics at sites where ART is also available• MCH nurse-midwives trained in maternal and paediatric HIV care• Mothers and infants referred in from multiple entry points (including the ART clinic)
HIV Service packageMaternal ART (B+)
Infant CotrimoxazoleInfant NVP prophylaxis
Infant diagnosisFixed F/U appointment
MCH service packageNutritional assessment
Infant feeding counseling Immunization
Growth monitoringFP services
0%10%20%30%40%50%60%70%80%90%
100%Percentage at all 22 sites
0
500
1000
1500
309
1105
Number of mother-baby pairs seen in all 22 clinicsNumber of mother-baby pairs seen in all 22 clinics
USAID Applying Science to Strengthen and Improve SystemsSource: Nsubuga-Nyombi et al. TUSA03 AIDS 2014
COORDINATION CONTINUITY
Finding the balance between horizontal versus vertical service delivery systems 4
Involving the Community
We are not looking in the right places to identify HIV infected children.
When we do find infected children many are lost before enrollment into care
We are stalling in efforts to expand pediatric access though decentralization and task shifting
Diagnosis
LinkageTreatm
ent
1
2
3
4
5
We are not integrating paediatric ART with MCH
We have failed to harness the community as a partner
for pediatric scale up
The Tingathe Program was piloted at 3 sites between 2008 and 2011 and showed marked improvement in case-finding
Mar
-07
Jun-
07
Sep-0
7
Dec-0
7
Mar
-08
Jun-
08
Sep-0
8
Dec-0
8
Mar
-09
Jun-
09
Sep-0
9
Dec-0
9
Mar
-10
Jun-
10
Sep-1
0
Dec-1
00
500
1000
1500
2000
2500
3000
Infected ever enrolled
Exposed ever enrolled
Total ever enrolled
Start of Tingathe BASIC
Start of Tingathe PMTCT
Date of clinic enrollment
Pa
tie
nt
Nu
mb
ers
5
Community health workers specialized in HIV testing & counseling, active case identification, PMTCT support, and linkage to care
Now expanded to 6 districts in central Malawi
Source: Ahmed et al. Manuscript submitted for publication
Conclusions
• We have the tools we need we just need to shed our complacency
• Our approach to finding infected and exposed children needs to go beyond PMTCT and reinvigorate PITC for children
• Solutions are local as much as global. No one size fits all for concepts like integration, community involvement and task shifting
• Even as we push for elimination of new infections in children we must also push to treat all children in need. There can be no dichotomy between treatment and prevention.
Acknowledgements
Chewe LuoCraig McLureSubhasree RaghavanLynne MofensenElaine AbramsSaeed AhmedMartina PenazzatoNathan FordNigel RollinsNandita SugandhiCharles KiyagaAnisa GhadrshenasPolly ClaydenAshraf GrimwoodJohn MillerStuart KeanTamara Nsubuga-Nyombi