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Access to Paediatric ARV Formulations The plight of Children

Access to Paediatric ARV Formulations The plight of Children. UNICEF SUPPLY DIVISION ARV formulations available …………. Product portfolio include: ARVS 42 formulations in 75 different presentations, 30 - 40% can be used for children HIV tests, CD4, CD8, Viral load including

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Access to Paediatric ARV Formulations The plight of Children

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  1. Access to Paediatric ARV FormulationsThe plight of Children Access to Paediatric ARV formulations

  2. UNICEF SUPPLY DIVISIONARV formulations available ………… Product portfolio include: • ARVS 42 formulations in 75 different presentations, 30 - 40% can be used for children • HIV tests, CD4, CD8, Viral load including • PCR equipment ( 2 suppliers ) Access to Paediatric ARV formulations

  3. Access to paediatric ARV formulations depends on effective supply chain management Demand Monitoring Product Selection Effective Use Forecasting Receipt, Storage, Distribution Financing Product Procurement Quality Assurance Supplier Agreements Access to Paediatric ARV formulations

  4. DEMAND : When to start ; What to start with …. WHO Guidelines exist • For Prevention of Mother to Child Transmission: • Guideline for mothers with indications for initiation of treatment who may become pregnant • Mothers on ART who become pregnant, and infants • HIV infected pregnant women with or without indications for ART, and infants etc • For Treatment and Care: First Line • Preferred option for children (zdv or d4T) + 3TC + NVP • Guideline for children on TB treatment regiments containing rifampicin, substitute NVP for EFV • For Treatment and Care: Second Line • Guidelines for children with treatment failure ABC + ddI + PI Access to Paediatric ARV formulations

  5. FIRST LINE / PMTCT:ARV Formulations available... Access to Paediatric ARV formulations

  6. FIRST LINE / PMTCTOperational Characteristics of available ARV Formulations Access to Paediatric ARV formulations

  7. PRODUCT SELECTION : When to start ; What to start with …. • For Prevention of Mother to Child Transmission: For infant: Nevirapine (NVP) single dose 0,6ml Zidovudine (ZDV) 4mg/kg 2x daily, for 1 week Lamivudine (3TC) 2mg/kg 2x daily, for 1 week See http://www.who.int/hiv/pub/mtct/guidelines/en/ Access to Paediatric ARV formulations

  8. FORMULATIONS TO PROVIDE PMTCT SERVICESKey challenges …. • Nevirapine suspension (10mg/ml): • Commercially available as 240ml • Donation programmes supply 20ml or 25ml • Bottles are adapted with fitted caps to facilitate dispensing • For PMTCT, need 0,6ml per day ? • Dispensing syringe : BAXA Donation • Zidovudine oral liquid (10mg/ml) • Commercially available as 100ml, 200ml, 240ml bottle • For PMTCT, need approximately 35ml per week ? • Lamivudine oral liquid (10mg/ml) • Commercially available as 100ml, 240ml • For PMTCT, need approximately 25ml per week ? Access to Paediatric ARV formulations

  9. SECOND LINE / PMTCTARV Formulations are available …… Access to Paediatric ARV formulations

  10. SECOND LINEOperational Characteristics of available ARV Formulations Access to Paediatric ARV formulations

  11. FORECASTING : When to start ; What to start with …. • For Treatment and Care: First Line Variations of Zidovudine (ZDV) < 4 weeks: 4mg/kg 2x daily 4 wks – 13 years: 180mg/m2/dose 2x daily Stavudine (d4T) < 30kg: 1mg/kg/dose 2x daily Lamivudine (3TC) < 30 days: 2mg/kg 2x daily, then 4mg/kg 2x daily Nevirapine (NVP) 15 – 30 days: once daily dose 5mg/kg 30 days – 13 years: 120mg/m2/dose once a day for 2 weeks, then 120-200mg/m2/dose 2x daily Efavirenz (EFV) Only > 3 years, > 10kg Access to Paediatric ARV formulations

  12. FORECASTING : When to start ; What to start with …. • For Treatment and Care: Second Line Variations of Abacavir (ABC) < 16yrs or < 37,5kg: 8mg/kg 2x daily Didanosine (ddI) < 3 months : 50mg/m2/dose 2x daily 3 months – 13 yrs : 90-120 mg/m2/dose 2x daily, or 240mg/m2/dose once a day Lopinavir/ritonavir 6 months – 13 years: 225mg/m2 LPV, plus (LPV/r) 57,5 mg/m2 ritonavir 2x daily, or weight based Nelfinavir (NFV) < 1 yr: 50mg/kg/dose 3x daily, or 75mg/kg/dose bd 1 yr - 13 yrs: 55 – 65 mg/kg/dose 2x daily Access to Paediatric ARV formulations

  13. ESTIMATING THE NUMBER OF TREATMENTS NEEDED STEP 1: Estimated number of births, existing death-rates, HIV prevalence in ANC settings STEP 2: Estimated PMTCT coverage and transmission rates = estimated HIV positive infants born STEP 3: What is the chance of survival ? Morbidity ? Mortality Coverage with cotrimoxazole prophylaxis STEP 4: Estimated number of children at different ages eligible for treatment (assumptions around disease progression) STEP 5: Reality check – who will enrol them into treatment, etc … Access to Paediatric ARV formulations

  14. NUMBER OF INFECTED CHILDREN ALIVE AT SELECTED AGES, birth cohort ± 300,000(effect of COTRIMOXAZOLE [TMP-SMX] prophylaxis and/or ART for symptomatic) Marie-Louise Newell, Kirsty Little, Madeleine Bunders (Ghent-IAS Group on HIV infection in women and children) Access to Paediatric ARV formulations

  15. NUMBER OF INFECTED CHILDREN ALIVE AND ELIGIBLE FOR ART AT SELECTED AGES(effect of COTRIMOXAZOLE [TMP-SMX] prophylaxis and/or ART for symptomatic) Marie-Louise Newell, Kirsty Little, Madeleine Bunders (Ghent-IAS Group on HIV infection in women and children) Access to Paediatric ARV formulations

  16. PUTTING IT IN CONTEXT: NUMBER OF INFECTED CHILDREN ALIVE AND ELIGIBLE FOR ART AT SELECTED AGES, BIRTH COHORT 300,000 HIV+ infants(effect of COTRIMOXAZOLE [TMP-SMX] prophylaxis and/or ART for symptomatic) Marie-Louise Newell, Kirsty Little, Madeleine Bunders (Ghent-IAS Group on HIV infection in women and children) Access to Paediatric ARV formulations

  17. ARV liquid formulations can become expensive .. Access to Paediatric ARV formulations

  18. MSF Paper: 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 $ 222 $16 Best innovator price/y $ 508 $27.24 • Managing the switch – increases complexities in resource poor settings Access to Paediatric ARV formulations

  19. ARV Formulations available, but …. • More expensive than adult formulations • No fixed dose combinations • Estimating needs are problematic • Weight guided dosing will assist care-givers • Some need cold storage, shipment • Distributing glass bottles has it’s problems • Taste of formulations, bulk of supplies Access to Paediatric ARV formulations

  20. RECOMMENDATIONS FROM NOVEMBER 2004 WHO/UNICEF CONSULTATION • With currently available formulations, children CAN and SHOULD BE treated • Simplified treatment guidelines are in progress; • weight based dosing, eligibility to treatment done, should be available soon ! • Greater advocacy is needed for access to appropriate formulations for both PMTCT and HIV Care and Treatment • Demand forecasting vs HOW MANY CHILDREN CAN WE REACH TOMORROW ? • Improved diagnostics ….. Access to Paediatric ARV formulations

  21. Access to paediatric ARV formulations depends on effective supply chain management Demand Monitoring Product Selection Effective Use Forecasting Receipt, Storage, Distribution Financing Product Procurement Quality Assurance Supplier Agreements Access to Paediatric ARV formulations

  22. Access to paediatric ARV formulations depends on effective supply chain management Demand Creation Monitoring Product Selection Effective Use Forecasting Receipt, Storage, Distribution Financing We need partners to complete the cycle Product Procurement Quality Assurance Calculating the number of bottles we should/can buy … Supplier Agreements Access to Paediatric ARV formulations

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