1. Management of Risk and Blood Availability in Donor Populations with High Prevalence of Blood Borne Pathogens Ravi Reddy IBSF Meeting 20 March 2015

2. SANBS Blood Supply Model SANBS is a private not for profit company operating on a fee for service basis Provides a vein to vein blood transfusion service in 8 of the 9 provinces in SA. – WPBTS in Western Cape 823,000 units of blood collected annually (100% voluntary) – 2 800 units bled daily – 90 Fixed site donor centres as well as mobile drives daily 2 testing centres - Johannesburg and Durban ( business continuity) 7 blood processing centres strategically located in major cities 84 blood banks managed by SANBS staff, serving > 600 hospitals and clinics. Significant transport and cold chain logistics infrastructure for distribution of blood Accredited by external agency - SANAS

3. Maintaining a Safe Blood Supply In South Africa HIV prevalence began increasing significantly among SA population in mid 1990’s Prevalence in antenatal clinic attendees rose from 1.7% in 1991 to 22.8% by 1998 The increase in HIV prevalence varied significantly among the different ethnic groups, likely as a result of socio economic conditions at the time – Prevalence in blood donors rose from 0.06% to 0.26% in this period – The prevalence among Black first time donors ranged from 3.5 to 6 % (male and female respectively) Significant risk of window period HIV transmission Risk model implemented to place donors in risk categories based on ethnic group, gender and donation status – Limited collections and blood product issued from high risk categories

4. Impact of Risk Policy based on Donor Selection Significant decrease in HIV in the donor population despite increasing prevalence in the antenatal and general population

5. Challenges with Risk Policy (1998 -2005) 86% of population is Black and majority of Black donors fell into high risk categories and cellular products not used – Black donor base decreased significantly Not sustainable – Diminishing donor base, and in medium term, insufficient donors to meet demand Significant political pressure and public outcry in December 2004 Needed to revise the current policy and testing strategy while maintaining a safe blood supply

6. New Risk Management Strategy Implemented in 2005 Ethnic group was removed as a marker for risk Implemented individual donation nucleic acid testing (ID-NAT) using the ULTRIO ® assay on the TIGRIS ® platform for: – HIV-1 RNA, HCV RNA and HBV DNA Serology testing with Abbott Prism assay continued but stopped HIV p24 Ag testing Quarantine system for FFP maintained – donor retested plasma for therapeutic use Pooled platelets and paediatric cellular products made from very regular repeat donors.

7. HIV infections in 8 years of ID-NAT screening of 6,237,803 donations in South Africa 11377 (96.8%) HIV RNA +, anti-HIV– window period 362 (3.05%) HIV RNA +, anti-HIV + concordant HIV RNA –, anti-HIV + elite controller 112 (0.95%) HIV-RNA anti-HIV 131/362 (36.2%) HIV-Ag + 216 HIV-Ag-, RNA+ infections avoided (1:28,879) 15 not tested

8. Analysis of Recent infections (anti-HIV negative, ID NAT positive Donations) NAT Yields NAT yield Rate in New Donors is 2.85 times higher than in Repeat Donors YearRepeat1:xNew1:xLapsed1:xTotal1:x Year 1 101:5896841:1607821:3727616 1:45652 Year 2 211:2759851:1502751:1444431 1:23470 Year 3 191:30367131:653441:1923036 1:20535 Year 4 221:27268141:725341:2160440 1:19701 Year 5 241:26196161:617521:4420942 1:19427 Year 6 451:13859141:720731:2982362 1:13130 Year 7 381:16300131:780661:1521657 1:14249 Year 8 511:11857211:513861:1628478 1:10389 Total2301:209681001:7350321:211563621:17232

9. HBV infections in 8 years of ID-NAT screening of 6,237,803 donations in South Africa 5767 (82%) HBV DNA +, HBsAg– 1104 (15.7%) HBV DNA +, HBsAg + concordant HBV DNA –, HBsAg + 182 (2.6%) (significant decrease annually after Ultrio Plus implementation HBV-DNA HBsAg WP= 450 (40.1%) OBI= 641 (58.1%) Unk=13

10. Blood Safety in SANBS Implementation of new technology and donor education by SANBS ensured: – Improved blood safety (no reported cases of HIV transmission through blood transfusion since 2005, compared to an average of 2 cases a year prior to that) Increased blood supply to meet increasing demand by collecting blood from previously excluded communities – Black donors now comprise 37% of the blood donors in SANBS Major public health success story in South Africa – high confidence in safety of blood.

11. Challenges in Africa Inadequate blood donor panel ( low % of voluntary non remunerated repeat donors) – Insufficient blood collected, higher discard rates Poorly defined donation testing strategies – most sensitive assays not utilised Lack of External quality assurance and audits Inefficient processes (collection, transport, production, storage) No or very poor IT infrastructure

12. Challenges in Africa (cont’d) Lack of Government commitment (regulatory framework, funding, compliance) Significant financial and human resource challenges Not meeting Country Needs for Blood products and plasma derived medicinal products (PDMP’s) No or very poorly developed haemovigilance programmes

13. Country GroupCountries (n)Total Blood Donations (n) Population (n)Donation Rate (units/1000 people) Group A (at least 80% VNRBD) 191,980,349*437,286,1284.5 (2.8 if SA excluded) Group B (50 to 79% VNRBD) 7 666,783 91,255,9897.3 Group C (<50% VNRBD 17 839,060285,264,8672.9 All Countries433,486,192*813,806,9844.3 Source - WHO: Blood Safety in the Africa Region_ 2010 survey * South Africa contributes over 900,000 donations with 52 million people 13 Number of Blood Donations and Donation Rates per Groups of Countries in Africa

14. HIV prevalence among Blood Donors Table 2- MMWR / November 25, 2011 / Vol. 60 / No. 46 Mostly repeat reactive unconfirmed – When HBV, HCV and Syphilis positives added = large percentage of discards 14

15. TTI Testing Strategy 17/43 (39.5%) Countries performed confirmatory testing for TTI’s – Algorithms lacking for repeat testing in many countries – No confirmatory testing in 26 Countries Significant percentage of blood donations with false positive results discarded – Contributes further to the shortages Donor deferral and counselling challenges – Loss of donors 15

16. What is Required Commitment, led by Government, for a sustainable Blood Service in many African Countries Resources to develop the various key elements of the Blood Supply Chain – Sustainable financial model (less reliance on donor funding) – Programmes to strengthen and retain human capital – Integrated IT systems, quality systems, M&E

17. Thank You