Post on 25-Feb-2016
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A Call to Action
Children – The missing face of AIDS
Paediatric Care and treatment:
What do we know and what needs to be done?
Dr Helene Möller, (M.Pharm, PhD)Field Support Officer HIV/AIDSUNICEF Supply DivisionCopenhagen
Dr Chewe Luo, (MD(Pead), MTropPead, PhD)Senior Program AdviserUNICEF Programme DivisionNew York
The growing numbers of adults and children* living with HIV (UNAIDS
2005)
0
5
10
15
20
25
30
35
40
45
19861987198819891990199119921993199419951996199719981999200020012002200320042005
Oceania
North Africa & Middle East
Eastern Europe & Central Asia
Western and Central Europe and North America
Latin America and Caribbean
Asia
Sub-Saharan Africa
Millions
Number of people living with HIV
* under 15 years old
2001 United Nations Global Assembly Special Session on HIV/AIDS: PMTCT Targets
Reduce the proportion of infants infected with HIV by 20% by 2005 and 50% by 2010, by:
• Ensuring that 80% of pregnant women accessing antenatal care receive information, counseling and other HIV prevention services
• Increasing the availability of and providing access for HIV-infected women and babies to effective treatment to reduce MTCT of HIV…
Global PMTCT Response (2004)Countries with PMTCT programs per region
101
39
25
16
15
6
16
2
6
6
2
0
0 20 40 60 80 100 120
Total
Sub-Saharan Africa
Latin America and Caribbean
CEE/CIS
Asia South, East and Pacific
North Africa & Middle East
Countries with PMTCT Programs National Service Coverage
Source: United Nations Children Fund Annual Reports, 2004
10% of women giving birth annually are counseled / tested for HIV: Data from 53 high
burden countries (UNICEF December 2005 PMTCT Report Card)
8,403,718
7,896,717
Women counseled on PMTCT Women tested for HIVUNICEF PMTCT Report Card 2005
Only 9% of HIV-positive women globally receive ARV prophylaxis
(UNICEF December 2005 PMTCT Report Card)
92%
45%
17%11%
3%
78%
27%
11%7%
1%0%
10%20%30%40%50%60%70%80%90%
100%
Central andEastern Europe
Latin America East andSouthern Africa
Asia West andcentral Africa
HIV-positive women identified HIV-positive women given ARVs
Figure 4: Proportion of women receiving ARV prophylaxis in 10 highest burden countries accounting for two thirds of all MTCT infections in
2004
0%
20%
40%
60%
80%
100%
Nigeri
a (0.1
%)
DR Co
ngo (0
.8%)
Ethiop
ia (1%
)
Tanza
nia (2
%)
Mozam
bique
(3.2%
)
India (
3.5%)
Zimbab
we (5%
)
Zambia
(16%
)
Keny
a (20
%)
SouthA
frica (
22%)
Perc
enta
ge
Received ARV prophylaxis Did not receive ARVs
2.3 million HIV-infected women give birth every year…
Western & Central Europe
200200[< 400][< 400]
North Africa & Middle East8 9008 900
[2 600 – 30 000][2 600 – 30 000]
Sub-Saharan Africa630 000630 000
[560 000 – 740 000][560 000 – 740 000](90%)(90%)
Eastern Europe & Central Asia3 7003 700[2 600 – 6 400][2 600 – 6 400] East Asia
2 3002 300[840 – 6 300][840 – 6 300]South
& South-East Asia44 00044 000[25 000 – 83 000][25 000 – 83 000]
(6%)(6%)Oceania1 1001 100
[230 – 4 800][230 – 4 800]
North America500500
[<1 000][<1 000]
Caribbean3 8003 800
[2 000 – 8 000][2 000 – 8 000]
Latin America7 7007 700
[5 600 – 14 000][5 600 – 14 000]
Total: 700 000 (630 000 – 820 000) Source: UNAIDS, 2005 Report on the global AIDS Epidemic, UNAIDS,
Geneva, 2005
Estimated number of children (<15) newly infected in 2005
Estimates of children in need of ARV treatment and cotrimoxazole
(UNAIDS/UNICEF 2005; Boerma et al, WHO Bulletin 2006)
2005 estimates
Child (0-14 years) deaths due to AIDS
Children (0-14 years) in need of ART
Children (0-18 months) in need of ART
Children (0-14 years) in need of cotrimoxazole - diagnosis at 18 months
Children (0-14 years) in need of cotrimoxazole - diagnosis before 18 months
Global 410,000 660,000 270,000 4,000,000 2,100,000
Caribbean 3,100 5,100 1,800 29,000 15,000
East Asia 1,500 1,900 1,700 17,000 7,600
Eastern Europe & Central Asia 1,100 1,600 1,100 18,000 6,200
Latin America 6,000 8,600 400 70,000 35,000
North Africa & Middle East 5,300 7,600 4,400 59,000 18,000
Oceania <500 <500 <500 2,000 <1000
South & South East Asia 26,000 37,000 21,000 290,000 130,000
Sub-Saharan Africa 370,000 600,000 240,000 3,500,000 1,900,000
PEPFAR countries 250,000 410,000 200,000 2,400,000 1,300,000
Asia 28,000 39000 23000 310,000 140,000
Latin America & Caribbean 9,200 14,000 5,800 100,000 50,000
Paediatric Care and treatment:
What do we know What needs to be done?
Lack of attention to children- What do we need to consider in this consultation?
• Children are not little adults and the guidelines need that specificity
• Disease more aggressive in children – 30% mortality at yr 1, 50% at yr 2 and 60% at yr 5 – aspects of early diagnosis to be considered• HIV Diagnosis for children below 18 months problematic:
• Clinical disease presentation non-specific• PCR expensive and requires sophisticated labs and expertise
• Laboratory monitoring in children under 6 years difficult –CD4% required for children below 6 years
• Capacities and expertise on care and treatment underdeveloped
• Lack of infrastructure for chronic care management of children
Early diagnosis of HIV infection
Ensure reliable early diagnosis of HIV infected children:- Ensure specialized care for infected children- Discontinue PCP prophylaxis in uninfected children- DNA PCR (real time PCR) on Dried Blood Spots (on filter
paper) performed in regional/national centers?
A pilot program to make available early HIV diagnosis in all hospitals in northern Thailand (collaboration Faculty of Associated Medical Science - PHPT - CDC Region 10; support: Sidaction)
Children do well on ART: Evidence from a randomised trial
P Fassinou et al AIDS 2004, 18:1905 -1913
Children do well on treatment:Evidence from the Brazilian National Program
(Matida L et al, 2002)Kaplan-Meier survival estimates, by anodiag
analysis time0 50 100 150
0.00
0.25
0.50
0.75
1.00
1997 - 19981995 - 19961993 - 19941988 - 1992Before 1988
Years from randomisation
Systematic delivery of cotrimoxazole prophylaxis can improve children’s lives-
CHAP Trial (Chintu et al Lancet 2004)
Prop
ortio
n al
ive
Cotrimoxazole
Placebo
0.40
0.60
0.80
1.00
0 .5 1 1.5 2
232 177 106 47211 143 72 29
HR=0.57[0.43-0.77] p=0.0002
Global causes of U5 Mortality: How do Global causes of U5 Mortality: How do we address Paed HIV Care within the we address Paed HIV Care within the
broader context of child survival ?broader context of child survival ?
Under-nutrition is an underlying cause of 53% of deaths of children under five years of age
Source WHR 2005
What should be our guiding principles?
• Urgency. There is an immediate need to scale up diagnosis and treatment. To achieve this guidelines should consider what can be delivered at the lower levels and different practitioners.
• Equity of Access. All children in need of treatment, care, and support, including the hard to reach will receive it.
• The Centrality of the needs Children Living with HIV/AIDS. The needs of children living with HIV/AIDS and their caregivers within the broader context of child survival.
• Delivery of Life-Long Care and Support. Once started, antiretroviral therapy is for life. Recommendations should be realistic to ensure uninterrupted medicine supply.
Procurement and Supplies Management
PMTCT Scale UpWhat tools do we have ?
WHO PMTCT guidelines: Discussions in Montreaux June
2005…. SUPPLY OPTIONS
MOTHER BABY
nvp 200mg - single dose
zdv 300mg - from 28 weeks
zdv/3TC - intrapartum and then for 7 days
nvp susp 0,6ml single dose
zdv oral liquid for 7 days
zdv oral liquid for 28 days
FORMULATIONS TO PROVIDE PMTCT SERVICES : Key challenges
• Nevirapine tablets: • Commercially available as pack of 60 tablets• Blister packs facilitate dispensing to some extent• For PMTCT, need 1 tablet stat, often to take home ?
• Nevirapine suspension (10mg/ml):• Commercially available as 240ml• Donation programmes supply 20ml or 25ml• For PMTCT, need 0,6ml per day ?
• Commercial bottles are adapted with fitted caps to facilitate dispensing, donation to decant ?
• Dispensing syringe : BAXA Donation
FORMULATIONS TO PROVIDE PMTCT SERVICES : Key challenges
• zidovudine tablets: bd from 28 weeks• Commercially available as pack of 60 tablets• Blister packs facilitate dispensing to some extent
• zdv 300mg/3TC 150mg tablets: intrapartum, bd 7 days• Commercially available as pack of 60 tablets• Blister packs facilitate dispensing to some extent• For PMTCT, need 16 – 18 tablets per week, 20’s pack ?
• zidovudine oral liquid (10mg/ml)• Commercially available as 100ml, 200ml, 240ml bottle• For PMTCT, need approximately 35 – 50 ml per week, or• 150ml per month ( if mom had no ART ) ?
Procurement and Supplies Management
Paediatric HIC Care and Support
Global technical tools available ..
1. 2006 ART treatment guidelines for paediatric and adult ART; and ARVs for PMTCT (2004)
2. Guidelines on care treatment and support of HIV infected women and their children (nutrition, diagnosis, care of HIV exposed and infected children)
3. Global strategy on infant and young child feeding (range of tools)
4. Expert recommendations on Appropriate Paediatric ARV Formulations
Global technical tools available ….
5. Recommendations on use of cotrimoxazole for HIV exposed and infected infants
6. Revised clinical staging of HIV infection for use in children (& adults)
7. Technical reference groups for paediatric HIV care, ART & PMTCT
8. Simplified standardised training tools for integrated HIV care (IMAI - ART care for children and adults, IMCI)
9. Programme indicators for paediatric HIV & ART care & PMTCT
COTRIMOXAZOLE PROPHYLAXIS
DOSE
Syrup(40mg/200mg)
Paediatric tablet
(20 mg/100 mg)
Single Strength Adult Tablet(80 mg/400mg)
Double StrengthAdult Tablet(160 mg/800 mg)
< 6 months20 mg TMP/100 mg SMX
2.5ml 1 n/a n/a
6 months – 5 years40 mgTMP/200mg SMX
5 ml 2 1/2 n/a
> 6 – 14 years80 mg TMP/400 mg SMX
10 ml 4 1 1/2
> 15 years(or >35 kg )160 mg TMP/800 mg SMX
n/a n/a 2 1
FIRST LINE REGIMENS Operational Characteristics of available ARVs
TreatmentProducts available
(volume)Storage & other considerations
1st Line Innovator GenericFridge
? Other
ZDV 240ml 100, 200ml No
d4T 200ml - Yes Supplied as pwdr
3TC 240ml 100, 240ml No
NVP 240ml20*, 25,100,
240ml NoSome non-WHO PQed formulations as powder
EFV 180ml Coming soon No Not for children under 3yrs
* Only available in donation programme, with dispensing syringe
SECOND LINE REGIMENSOperational Characteristics of available ARVs
TreatmentProducts available
(volume)Storage & other considerations
2nd Line Innovator Generic Fridge ? Other
ABC 240ml - No Abacavir Hypersensitity
ddI 237ml - NoNeed antacid,
4g in 237ml not available
LPV/r 5x60ml - Yes, new?Need cold shipment,
alcohol, new on the way
NFV 144g pwd - NoDifficult to dispense
Crushed tablets cheaper
PROPOSED REVISIONS: 1st and 2nd Line Regimens
1st Line Regimen
RTI based
2nd Line RegimenRTI PI *
ZDV/d4T + 3TC + NVP/EFV ddI + ABC
LPV/r orSQV/ror NFV
ABC + 3TC + NVP/EFV ddI + ZDV ± 3TC
ZDV/d4T + 3TC + ABC EFV or NVP ± ddI or EFV or NVP ± 3TC
MSF PAPER 2004: Current situation regarding prices and availability of specific children formulations …
• Cost of treatment drops when switching to adult formulations: Peak around 14kg bodyweight
• Using tablets for a child (20 kg) reduces the cost per treatment per year nearly 8 times:• (d4T / 3TC / NVP )
Best generic price/y $ 566 $224Best innovator price/y $1,706 $631
• Managing the switch – increases complexities in resource poor settings
WHAT IS NEW ?WHO 6th Expression of Interest spells it out
• Single formulations, adults, adolescents, paeds:• NRTIs; ABC, ddI, 3TC, d4T, TDF, ZDV• NNRTIs ; NVP, EFV• PIs; IDV, NFV, SQV, rtv
• Reduced doses, scored tablets for the young, liquid formulation
• FDC for adults and paeds, scored• Co-packaged formulations for adults and kids
Procurement and Supplies Management
The need for Optimising Supply and
Demand
Challenges affecting supply strategies supporting global
disease programmes• Product selection is driven working groups,
consultants and prequalification efforts• Lack of consideration of product specifications, e.g. expiry
dates, weights and volume• Lack of consideration of storage and distribution
requirements• Lack of consideration of performance characteristics, e.g.
refrigeration needs• Lack of consideration of costs and cost drivers, buffer stock• Push to place orders to reach programme targets
Challenges affecting supply strategies supporting global
disease programmes• Traditional planning methods are focussed on
pushing products downstream towards end users, rarely with an understanding of the true demand at the first level of care
• Push to place orders• Items move from under-stock to overstock in no
time, expire, move back to undersupply Erratic demand
• Affecting private sector as much as public
Delivery Systems & Management structures drive
supply and demand• Unclear scientific data on effective models for delivery of paediatric care in resource limited settings
• Chronic care management of sick children limited in most settings
• However, best practices from programmatic experiences are emerging
Optimising identification of children and entry into chronic paediatric care
and treatment
Pediatric HIV CST program
PMTCT Services
In and outpatient units
Home Based CareNutrition Rehabilitation Centers
Referral from other units
(VCT, TB units, adult ARV clinics)
Tiered decentralised model in Brazil: What should be delivered
at what level•Universal•Regionalized•Hierarchical•Integrated
Hom
e C
are
Hospitals
Day clinics, Outpatient clinics
Primary care units
Thank You