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Hydroxyurea For the Management of Childhood SCD in Kenyan County Hospitals

Hydroxyurea For the Management of Childhood SCD in Kenyan County Hospitals Hydroxyurea for SCD Panel. Objectives. To understand the background to the emergence of hydroxyurea as a therapy for SCD and review the evidence available to inform decision making

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Hydroxyurea For the Management of Childhood SCD in Kenyan County Hospitals

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  1. Hydroxyurea For the Management of Childhood SCD in Kenyan County Hospitals Hydroxyurea for SCD Panel

  2. Objectives • To understand the background to the emergence of hydroxyurea as a therapy for SCD and review the evidence available to inform decision making • Should Hydroxyurea be promoted for prophylactic treatment of SCD in children aged <5 years being managed in County hospitals • At what stage of disease might introduction be considered • Are there any specific conditions for using the drug • To provide preliminary recommendations to MoH on use of HU

  3. Outline • Background • Evidence • Summary on quality of evidence (as per panel discussions) • Panel deliberations

  4. Burden of SCD • It is estimated 312 000 neonates globally are born yearly with SCD (HbS) homozygous type (Piel FB 2013). • 75% of the burden is in sub-Saharan Africa (WHO 2006) • Mortality is high in children aged between 6 months and 3 years (Leikin SL 1998,Rogers DW 1978) • High mortality rate of 7.3 (4.8-11.0)per 100 Patient years Of Observation in <5 years in Tanzania (Makani J 2011)

  5. Existing guidelines GOK Clinical Guidelines 2009 (expert meeting): • Hydroxyurea only for (adult) patients with more than 3 painful crises in a year • Supportive care (analgesics, supplementary folic , malaria prophylaxis when travelling to malaria endemic zone, penicillin prophylaxis)

  6. Guideline relevant question

  7. Study selection IDENTIFICATION (Pubmed,clinical trials web, Cochrane Lib.) N=98 SCREENING (Titles and abstracts) N=44 ELIGIBILITY (full articles assessment) N=19 N=19 1 Syst. review 2 RCT 14 observational studies 2 NIH reports INCLUDED (Studies included for analysis)

  8. BABY-HUG TRIAL 2011

  9. Results (secondary outcomes)

  10. Summary

  11. Consensus on balance of benefits versus harms: Hydroxyurea vs no HU

  12. Panel proposed definition of severe disease as possible indication for initiating HU • Pain crises ( >3 /year) • Primary stroke • Transfusions( ≥2/year) • Acute chest syndrome • Hospitalizations which are Sickle cell Disease related(to be specified further) • Splenic sequestration

  13. Panel proposed Monitoring Requirement Where monitoring comprises: • Monthly monitoring at the minimum Monitoring includes: • Complete blood count • Hemoglobin • White blood cell count especially the neutrophils • Platelet counts

  14. Panel view on formulations of HU • Currently 500mg available • Recommendation: Appropriate capsules should be procured of different strengths (200mg, 300mg, 400mg) prior to widespread implementation of HU in GoK hospitals able to provide minimum monitoring.

  15. Areas for research • Need to get better data on the burden of SCD in the country • Studies on effect of Hydroxyurea on morbidity and mortality (including harms) are required • Data on long term effects of HU are required

  16. Draft Recommendation ‘Hydroxyurea at a standard dose of 20mg/kg/day should be considered for use in children below 5 years for management of severe form of sickle cell disease where minimum monitoring conditions and appropriate formulation are available’

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