Newborn Screening for Sickle Cell Disease in Africa: Public health meets reality

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1 13 th September 2016 Newborn Screening for Sickle Cell Disease in Africa: Public health meets reality Kwaku Ohene-Frempong. MD Children s Hospital of Philadelphia Sickle Cell Foundation of Ghana

2 Disclosure of Conflict No personal conflict

3 Weatherall, British J Haematol, 2011, 154, Annual Global Births of Severe Disorders of Hemoglobin Total number of births* 464,590 SCD SS 333,929 (83.3) SC 54,736 (13.6) S β thal 12,321 (3.1) 400,986 (86.31) Thalassemia β thal α thal β thal major 23,329 (53.1) 43,917 E β thal 20,588 (46.9) (69.0) Hb H disease 14,504 (73.7) 19,687 Hb Bart s hydrops 5,183 (26.3) (31.0) 63,604 (13.69) *80 % born in low and middle income countries

4 What is sickle cell disease?

5 Sickle Cells Wright-Giemsa stained blood smear

6 What is sickle cell disease? A. Normal red cell B. Sickled red cell Scanning Electron Micrographs

7 What is sickle cell disease? Sickle cell disease (SCD) is a group of inherited disorders of red blood cells (RBC) characterized by anemia, vaso-occlusive complications, chronic organ damage, and reduced survival. SCD is caused by the predominant presence in RBC of sickle hemoglobin (Hb S), instead of the regular Hb A. Hb S results from a mutation in the beta- (hemo)globin gene.

8 SCD: Dactylitis ( hand-foot syndrome )

9 Pain!. the hallmark of sickle cell disease 10 redefined Hertz Nazaire

10 Causes of mortality in sickle cell disease Mortality is usually due to acute complications such as infection, acute chest syndrome, stroke, acute multiorgan failure, and chronic organ failure. The leading cause of death in SCD, especially in young children, is infection.

11 Infection in Sickle Cell Disease Development of Functional Asplenia Infant with SCD-SS Age 3 months Age 8 months 99 Tc Sulfur colloid Liver-Spleen Scan

12 Infection in Sickle Cell Disease Development of Functional Asplenia Infant with SCD-SS Age 3 months Age 8 months 99 Tc Sulfur colloid Liver-Spleen Scan

13 Why screen newborns for sickle cell disease?

14 Causes of Death in SCD-SS (0-10 yr) Overall incidence: 1.1/100 person-yrs (Gill FM, et al, CSSCD: 1995)

15 Infection in SCD Bacteremia in SCD-SS Disease, CSSCD Age (yr) < >20 No. pts Person-yr No. events Incidence/ 7,979 2,536 1, Pr-yr Deaths (Zarkowsky,et al. CSSCD; J Pediatr 1986: )

16 Incidence of Strep. pneumoniae Bacteremia in SCD-SS Disease Age (yr) <1* No. pts Pt.yrs No. events Incidence 10 5 Pr-yr US children < 5y (98-99)^ Infection in SCD 6,382 6,343 4, ,445 1, * 3 patients were younger than 6 months of age (Zarkowsky,et al. CSSCD; J Pediatr 1986: )

17 Newborn Screening for SCD

18 Effect of Newborn Screening for SCD Improved Survival in Children with SCD

19 Global Burden of Sickle Cell Disease How many babies are born with SCD? Estimate of Global Frequency of Sickle Cell Gene Piel et al Lancet 381:142 51

20 Global Burden of Sickle Cell Disease Estimated Annual Sickle Cell Disease Births Total number of births 400,986 SS 333,929 (83.3) SC 54,736 (13.6) S β thal 12,321 (3.1) Weatherall, British J Haematol, 2011, 154,

21 Newborns with SCD Increasing Globally Estimated Newborns with SCD-SS Sickle Region SS % SS % % change Global 305, , Americas 11, , Arab-India 47, , Eurasia 5, , Southeast Asia Sub-Saharan Africa 242, , Piel et al. (2013) PLoS Med 10(7): e doi: /journal.pmed

22 Incidence of SCD in Newborns in sub-saharan Africa Country No. tested FAS (AS) % FAC (AC) % FS (SS) % FSC (SC) % SCD (ALL) Authors (Year) Burkina Faso 2, :57 Kafando et al, 05 Togo :43 North et al, 88 Congo (DRC) 31, :71 Tshilolo, 09 Nigeria * 0.2 1:33* Odunvbun, 09 Ghana 255, :55 Ohene-Frempong MOH, 08 USA 1:2,474 Therrell, 08 * Probable overestimate due to low number tested

23 African Countries with Past or Ongoing Pilot Newborn Screening for SCD 1. Angola 2. Benin (selected) 3. Burkina Faso (past) 4. Cameroon 5. Congo DR 6. Congo Republic 7. Gabon 8. Ghana 9. Kenya 10. Liberia 11. Mali 12. Nigeria 13. Tanzania 14. Togo (past) 15. Uganda 16. Zambia

24 What happens to all those babies with SCD? sickle-cell anemia contributes the equivalent of 5% of under 5 deaths on the African continent, more than 9% of such deaths in West Africa, and up to 16% of under-5 deaths in individual West African countries.

25 What happens to all those babies with SCD?..although current data are inadequate to support defınitive statements, they are consistent with an early-life mortality of 50% 90% among children born in Africa with SS disease. Grosse et al. Am J Prev Med 2011;41(6S4):S398 S405

26 Newborn Screening for Sickle Cell Disease in Ghana Kumasi-Tikrom Pilot Project Sickle Cell Foundation of Ghana

27 NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project Population: 26,327,649 Ghana Birth rate: births/1,000 pop. (2015 est.) Annual births: 820,000 (approx.) Kumasi Population: 2,070,000 2nd largest city in Ghana Capital of Asante Region Capital of old Asante Kingdom Sickle Cell Foundation of Ghana

28 NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project Project Funding 1. U.S. Government: National Heart, Lung, and Blood Institute (NHLBI) of National Institutes of Health (NIH), Comprehensive Sickle Cell Center Research Grant: ; ; and, (PI: Ohene- Frempong 2. Government of Ghana: Ministry of Health and Ghana Health Service Staff 3. Children s Hospital of Philadelphia (CHOP) - Staff and donations Sickle Cell Foundation of Ghana

29 Newborn Screening for SCD in Ghana NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project Development of National Newborn Screening Programme (1/2) 1. Sickle Cell Foundation of Ghana, a non-profit NGO, formed in 2004 to: lead advocacy for SCD programming and service; administer newborn screening pilot project. 2. March 2008: US-NIH three 5-year funding cycles for the pilot project ended. 3. Screening continues with funding from Ministry of Health and National Health Insurance Authority, administered by Sickle Cell Foundation of Ghana (SCFG) Sickle Cell Foundation of Ghana

30 Newborn Screening for SCD in Ghana NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project Development of National Newborn Screening Programme (2/2) 4. Nov. 2010: National Programme of Newborn Screening for SCD (NNbSP-SCD) is launched by government Technical Advisory Committee inaugurated Steering Committee to be established to oversee Programme SCFG appoint Programme Managers and Coordinating Agency 5. Nov 2011: Technical Advisory Committee presents Draft Policy and Detailed Plan for National Newborn Screening 6. 5-year national scale-up plan adopted Sickle Cell Foundation of Ghana

31 NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project National Policy on Newborn Screening As part of the Mission of the Ministry of Health to promote health and vitality for all people living in Ghana, reduce or prevent early mortality or morbidity from certain diseases detectable in newborn babies, and achieve the United Nations Millennium Development Goal (MDG) #4 - to reduce by two thirds, between 1990 and 2015, the mortality rate of children under five - the Ministry of Health has determined that all babies born in Ghana shall be offered screening for selected diseases and conditions after birth. Sickle Cell Foundation of Ghana

32 NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project National Policy on Newborn Screening Issues Addressed: 1.Programme Oversight 2.Scientific Advisory 3.Healthcare Provider Responsibilities 4.Parental Education and Right of Refusal 5.Human Samples Ownership 6.Newborn Screening Data Ownership 7.Confidentiality of Screening Data 8.Healthcare Following Newborn Screening Sickle Cell Foundation of Ghana

33 NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project Barrier to Universal Newborn Screening: Sustainability 1. Donor / Research funding for pilot and feasibility studies 2. National Health Insurance Authority Insurance Law: Healthcare for children < 5 yr FREE Insufficient revenue from Value Added Tax Insufficient funding to meet primary obligations Insufficient and irregular funding for NBS 3. Private Health Insurance - untested 4. Private corporate funding untested;?sustainability 5. Personal ($5/baby) political; under consideration Sickle Cell Foundation of Ghana

34 NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project Komfo Anokye Teaching Hospital, Kumasi Kumasi Centre for Sickle Cell Disease (KC-SCD) Established December 1992 with 10 patients - in preparation for Newborn Screening for SCD research project 1995: Newborn screening research project launched at KATH All babies started on penicillin, anti-malarial prophylaxis, folic acid. and comprehensive outpatient and inpatient clinical management. Ongoing family education with genetic counseling offered in clinic

35 NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project KC-SCD: Clinic Enrollment of Newborn-Screened Patients at End of 2015 Age Group (yrs) Active Patients SS SC 0-4 1, , ,673 1, >18 1, TOTAL 6,413 4,221 2,192 Possibly the largest number of newborn-screened cohort at a single clinical site. 4.5% babies died by age 5 years Sickle Cell Foundation of Ghana

36 Impact of Public Health Interventions on SCD Mortality 1. Implementation in 2015 of prenatal diagnosis, penicillin prophylaxis, and anti-pneumococcal vaccination for children with SCD- SS, can reduce mortality among children under-5 with SCD-SS, prolong the lives of 5,302,900 SCD-SS newborns with by Large-scale universal screening could save the lives of up to 9,806,000 newborns with SCD-SS globally, 85% of whom will be born in sub- Saharan Africa Piel et al. (2013) PLoS Med 10(7): e doi: /journal.pmed

37 Conclusions 1. Sickle cell disease is a major public health issue and among leading causes of under-5 mortality in Africa. 2. Newborn Screening for SCD is technically feasible and saves lives in Africa as it does elsewhere. 3. Newborn screening is a new public health intervention in Africa new infrastructure, development of human and technical resources needed. 4. Funding and sustainability are major challenges Sickle Cell Foundation of Ghana

38 NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project Tracking Babies with SCD in Kumasi

39 Newborn Screening for SCD in Ghana ISNS 2016: Newborn Screening for SCD in Africa NBS for SCD in Ghana: Kumasi-Tikrom Pilot Project Follow up of Children with SCD in Tikrom Sickle Cell Foundation of Ghana

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