A Call to Action Children – The missing face of AIDS

1. A Call to Action Children – The missing face of AIDS

2. Paediatric Care and treatment: What do we know and what needs to be done? Dr Helene Möller, (M.Pharm, PhD) Field Support Officer HIV/AIDS UNICEF Supply Division Copenhagen Dr Chewe Luo, (MD(Pead), MTropPead, PhD) Senior Program Adviser UNICEF Programme Division New York

3. The growing numbers of adults and children* living with HIV (UNAIDS 2005) 45 Oceania 40 Millions North Africa & Middle East 35 Eastern Europe & Central Asia 30 Western and Central Europe and North America Number of people living with HIV 25 Latin America and Caribbean 20 Asia 15 Sub-Saharan Africa 10 5 0 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 AIDS epidemic update, December 2005 * under 15 years old

4. 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…

5. Global PMTCT Response (2004) Countries with PMTCT programs per region Source: United Nations Children Fund Annual Reports, 2004

6. 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 HIV UNICEF PMTCT Report Card 2005

7. Only 9% of HIV-positive women globally receive ARV prophylaxis(UNICEF December 2005 PMTCT Report Card)

9. 2.3 million HIV-infected women give birth every year… Estimated number of children (<15) newly infected in 2005 Western & Central Europe 200 [< 400] Eastern Europe & Central Asia 3 700 [2 600 – 6 400] North America 500 [<1 000] East Asia 2 300 [840 – 6 300] North Africa & Middle East 8 900 [2 600 – 30 000] Caribbean 3 800 [2 000 – 8 000] South & South-East Asia 44 000 [25 000 – 83 000] (6%) Sub-Saharan Africa 630 000 [560 000 – 740 000] (90%) Latin America 7 700 [5 600 – 14 000] 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

10. Estimates of children in need of ARV treatment and cotrimoxazole (UNAIDS/UNICEF 2005; Boerma et al, WHO Bulletin 2006)

11. Paediatric Care and treatment: What do we know What needs to be done?

12. 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

13. 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)

14. Children do well on ART: Evidence from a randomised trialP Fassinou et al AIDS 2004, 18:1905 -1913

15. Children do well on treatment:Evidence from the Brazilian National Program(Matida L et al, 2002) 1997 - 1998 1995 - 1996 1993 - 1994 1988 - 1992 Before 1988

16. Systematic delivery of cotrimoxazole prophylaxis can improve children’s lives- CHAP Trial(Chintu et al Lancet 2004) Cotrimoxazole Placebo 1.00 HR=0.57 [0.43-0.77] p=0.0002 0.80 Proportion alive 0.60 0.40 0 .5 1 1.5 2 Years from randomisation 232 177 106 47 211 143 72 29

17. 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

18. 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.

19. Procurement and Supplies Management PMTCT Scale Up What tools do we have ?

20. WHO PMTCT guidelines: Discussions in Montreaux June 2005….

21. 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

22. 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 ) ?

23. Procurement and Supplies Management Paediatric HIC Care and Support

24. Global technical tools available .. • 2006 ART treatment guidelines for paediatric and adult ART; and ARVs for PMTCT (2004) • Guidelines on care treatment and support of HIV infected women and their children(nutrition, diagnosis, care of HIV exposed and infected children) • Global strategy on infant and young child feeding (range of tools) • Expert recommendations on Appropriate Paediatric ARV Formulations

25. Global technical tools available …. • 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

27. FIRST LINE REGIMENS Operational Characteristics of available ARVs

28. SECOND LINE REGIMENSOperational Characteristics of available ARVs

29. PROPOSED REVISIONS: 1st and 2nd Line Regimens

30. 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

31. 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

32. Procurement and Supplies Management The need for Optimising Supply and Demand

33. 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

34. 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

35. 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

36. Optimising identification of children and entry into chronic paediatric care and treatment PMTCT Services In and outpatient units Pediatric HIV CST program Home Based Care Nutrition Rehabilitation Centers Referral from other units (VCT, TB units, adult ARV clinics)

37. Tiered decentralised model in Brazil: What should be delivered at what level • Universal • Regionalized • Hierarchical • Integrated Hospitals Day clinics, Outpatient clinics Home Care Primary care units

38. Thank You