A Call to Action Children The missing face of AIDS Paediatric Care and treatment: Dr Helene Mller, (M.Pharm, PhD) Field Support Officer HIV/AIDS UNICEF Supply Division Copenhagen What do we know and what needs to be done? Dr Chewe Luo, (MD(Pead), MTropPead, PhD) Senior Program Adviser UNICEF Programme Division New York Millions The growing numbers of adults and children* living with HIV (UNAIDS 2005)
Number of people living with HIV 45 40 35 Oceania North Africa & Middle East Eastern Europe & Central Asia 30 Western and Central Europe and North America 25 Latin America and Caribbean 20 Asia 15 Sub-Saharan Africa 10 5 0 1986198719881989 199019911992199319941995 199619971998199920002001 2002200320042005 * 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 North Africa & Middle East 0 6 2 Asia South, East and Pacific 15 6 CEE/CIS 16 6 Latin America and Caribbean
25 2 Sub-Saharan Africa 39 16 Total 101 0 20 40 60 Countries with PMTCT Programs 80 100 National Service Coverage Source: United Nations Children Fund Annual Reports, 2004
120 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 UNICEF PMTCT Report Card 2005 Women tested for HIV Only 9% of HIV-positive women globally receive ARV prophylaxis (UNICEF December 2005 PMTCT Report Card) 100% 90% 80% 92% 78% 70% 60% 50% 45%
40% 30% 27% 17% 20% 11% 10% 11% 7% 3% 1% 0% Central and Latin America Eastern Europe East and Southern Africa HIV-positive women identified
Asia West and central Africa 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 100% 60% 40% 20% (1 %) Et hi op ia (0 .8 %) Ta nz
an M ia oz (2 am %) bi qu e (3 .2 %) In di a (3 .5 Zi %) m ba bw e (5 %) Za m bi a
(1 6% ) Ke ny a (2 So 0% ut hA ) fr ic a (2 2% ) DR Co ng o (0 .1 %) 0%
Ni ge ri a Percentage 80% Received ARV prophylaxis Did not receive ARVs 2.3 million HIV-infected women give birth every year Estimated number of children (<15) newly infected in 2005 North America 500 Western & Central Eastern Europe Europe & Central Asia 200 [< 400] [<1 000]
Caribbean 3 800 [2 000 8 000] Latin America 7 700 [5 600 14 000] 3 700 [2 600 6 400] North Africa & Middle East 8 900 [2 600 30 000] Sub-Saharan Africa 630 000 [560 000 740 000] (90%)
East Asia 2 300 [840 6 300] South & South-East Asia 44 000 [25 000 83 000] (6%) Oceania 1 100 [230 4 800] Total: 700 000 (630 000 820 000) Source: UNAIDS, 2005 Report on the global AIDS Epidemic, UNAIDS, Geneva, 2005 Estimates of children in need of ARV treatment and cotrimoxazole Children Children Children (0-14
Children (0-14 (UNAIDS/UNICEF Boerma et al, WHO Bulletin Child (0-142005; (0-14 (0-18 years) in need of years) in need of years) years) in months) cotrimoxazole cotrimoxazole deaths due need of 2006) in need of diagnosis at 18 diagnosis before 2005 estimates Global to AIDS ART ART
months 18 months 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 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 28,000 39000 23000 310,000 140,000 9,200 14,000 5,800 100,000 50,000 South & South East Asia Asia Latin America & Caribbean
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 1.00 0.75 1997 - 1998 1995 - 1996 1993 - 1994 1988 - 1992 Before 1988 0.50 0.25 0.00 0
50 analysis time 100 150 Systematic delivery of cotrimoxazole prophylaxis can improve childrens livesCHAP Trial (Chintu et al Lancet 2004) Proportion alive 1.00 HR=0.57 [0.430.77] p=0.0002 0.80 0.60 Cotrimoxazol e Placebo 0.40
0 .5 1 1.5 2 232 211 177 143 106 72 47 29 Years from randomisation Global causes of U5 Mortality: How do we address Paed HIV Care within the 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 Up What tools do we have ? WHO PMTCT guidelines: Discussions in Montreaux June
2005. SUPPLY OPTIONS MOTHER BABY nvp 200mg - single dose nvp susp 0,6ml single dose zdv 300mg - from 28 weeks zdv oral liquid for 7 days zdv/3TC - intrapartum and then 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, 20s 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. 6. 7. 8. 9. Recommendations on use of cotrimoxazole for HIV exposed and infected infants Revised clinical staging of HIV infection for use in
children (& adults) Technical reference groups for paediatric HIV care, ART & PMTCT Simplified standardised training tools for integrated HIV care (IMAI - ART care for children and adults, IMCI) Programme indicators for paediatric HIV & ART care & PMTCT COTRIMOXAZOLE PROPHYLAXIS Syrup DOSE < 6 months Single Strength (20 mg/100 mg) Adult Tablet Double Strength Adult Tablet 2.5ml 1 n/a n/a
5 ml 2 1/2 n/a 10 ml 4 1 1/2 n/a 2 1 (40mg/ 200mg) Paediatric tablet (80 mg/400mg)
(160 mg/800 mg) 20 mg TMP/100 mg SMX 6 months 5 years 40 mgTMP/200mg SMX > 6 14 years 80 mg TMP/400 mg SMX > 15 years(or >35 kg ) n/a 160 mg TMP/800 mg SMX FIRST LINE REGIMENS Operational Characteristics of available ARVs Treatment Products available (volume) Storage & other considerations Innovator Generic Fridge ?
ZDV 240ml 100, 200ml No d4T 200ml - Yes 3TC 240ml 100, 240ml No NVP 240ml 20*, 25,100,
240ml No Some non-WHO PQed formulations as powder EFV 180ml Coming soon No Not for children under 3yrs 1st Line * Only available in donation programme, with dispensing syringe Other Supplied as pwdr SECOND LINE REGIMENS Operational Characteristics of available ARVs Products available (volume) Treatment
2nd Line ABC ddI LPV/r NFV Storage & other considerations Innovator Generic Fridge ? Other 240ml - No Abacavir Hypersensitity No Need antacid, 4g in 237ml not available
Yes, new? Need cold shipment, alcohol, new on the way No Difficult to dispense Crushed tablets cheaper 237ml 5x60ml 144g pwd - PROPOSED REVISIONS: 1st and 2nd Line Regimens 1st Line Regimen 2nd Line Regimen RTI PI * RTI based ZDV/d4T + 3TC + NVP/EFV ddI + ABC
ABC + 3TC + NVP/EFV ddI + ZDV 3TC ZDV/d4T + 3TC + ABC EFV or NVP ddI or EFV or NVP 3TC LPV/r or SQV/r or NFV 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 $224 Best 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; NNRTIs ; PIs; ABC, ddI, 3TC, d4T, TDF, ZDV NVP, EFV 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 In and outpatient units PMTCT Services Pediatric HIV CST program Home Based Care Nutrition Rehabilitation Centers Referral from other units
(VCT, TB units, adult ARV clinics Tiered decentralised model in Brazil: What should be delivered at what level Hospitals Ca re Day clinics, Outpatient clinics Primary care units Ho me Universal Regionaliz ed Hierarchic al Integrated Thank You
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