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Access to Paediatric ARV Formulations Provisions for Children

Access to Paediatric ARV Formulations Provisions for Children. 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

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Access to Paediatric ARV Formulations Provisions for Children

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  1. Access to Paediatric ARV FormulationsProvisions for Children

  2. 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

  3. UNICEF SUPPLY DIVISIONARV formulations available ………… Product portfolio include: • ARVS 42 formulations in 75 different presentations, 30 - 40% can be used for children <14 • HIV tests, CD4, CD8, Viral load including • PCR equipment ( 2 suppliers )

  4. FIRST LINE / PMTCT:ARV Formulations available...

  5. FIRST LINE / PMTCTOperational Characteristics of available ARV Formulations(WHO prequalified/FDA approved)

  6. 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 ?

  7. SECOND LINE / PMTCTARV Formulations are available ……

  8. SECOND LINEOperational Characteristics of available ARV Formulations

  9. 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 = transmission through breast feeding 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 …

  10. 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)

  11. 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)

  12. 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)

  13. ARV liquid formulations can become expensive ..

  14. 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

  15. 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

  16. 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 …..

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