1. Recent, Five-Year HCV Sero-prevalence Trend Among Deceased Organ Donors in California Marek Nowicki 1, Dem Brucal 1, Claudia Chinchila 1, Steven Takemoto 1, Wayne Babcock 2, Helen Nelson 4, Tom Mone 3, Robert Mendez 1 1 National Institute of Transplantation, 2 California Transplant Donor Network, 3 OneLegacy, 4 Golden State Donor Service

2. Estimated Incidence of Acute HCV Infection, United States, 1960-2001 Decline in transfusion recipients Decline in injection drug users Source: Hepatology 2000;31:777-82; Hepatology 1997;26:62S-65S; CDC, unpublished data

3. Prevalence of HCV Infection by Age and Gender, United States Males Females Total

4. The impact of HCV (US) 20002010202020302040 HCV+ (Millions) 2.942.872.682.432.18 Cirrhosis (thousands) 472721859880828 Decomp C (thousands) 65103135146143 HCC (thousands) 71113 12 Deaths (thousands) 1328364039 (Davis, LT 2003)

5. Background After successful introduction of screening for antibodies to the hepatitis C virus (HCV) in early 90’s, and more recently, also for HCV RNA, several authors reported a dramatic decrease of new acute HCV infections in the US (Hepatology 2000;31:777-82; Hepatology 1997;26:62S-65S; CDC) Others published predictions of HCV epidemic trajectories, showing steady decline of the number of infected individuals in the next 30 years (Davis, LT, 2003) Since ‘02 our laboratory has been evaluating HCV serostatus of approx 850 cadaveric organ donors/year. Recently (’05) our testing algorithm was supplemented by the sensitive TMA-based NAT assay detecting HCV RNA.

6. First results

7. Aim To evaluate longitudinal trends in HCV prevalence among cadaveric organ donors from southern and northern California.

8. Specific Questions Is there a significant change or decrease in HCV sero-prevalence among transplant donors? What factors are associated with HCV positivity?

9. Material and Methods We tested 4,032 consecutive donors from 3 CA OPOs (2 from N. Cal and 1 from S. Cal) Testing period: 2002-2007 –EIA (Ortho), confirmed with RIBA (Chiron) –After 2005 HCV RNA NAT (Procleix, Chiron) Statistical Methods –Chi-square and logistic regression

10. %HCV+ Donors in 3 CA OPOs Increase in OPO1, trend not significant in OPO 2 & 3 Year P=0.01 P=NS

11. %HCV+ Donors by Donor Age >80% HCV donors were between age 41-60 P<0.001 for both OPOs

12. %HCV+ Donors with other Serology P<0.001P=0.001 N=21N=218N=467N=1169N=3319 P=0.048P=0.012 P<0.001

13. Factors Associated with HCV FactorReferenceOdds Ratio, 95% CIP 2004-052002-031.61, 0.97-2.690.065 2006-072.03, 1.26-3.300.004 Age 41-60 601.77, 1.20-2.610.004 HBcAb+HBcAb-9.06, 6.17-13.3<0.001 Prevalence of HCV+ increased HCV is almost twice as likely in 41-60 age group 9 times more likely when HBcAb positive

14. Conclusions Our data suggest a significant variability from year-to-year of HCV seroprevalance. There seems to be significant differences of HCV rates among OPOs in California. Contrary to US-wide trends in HCV’s sero-incident rates, we observed no decrease of HCV sero-prevalence among cadaveric donors in California over past 5 years. Our results suggest that due to still high numbers of HCV+ cadaveric donors HCV NAT screening is highly desirable to prevent the HCV “window” donations and possible transmissions.

15. “Take home Message” HCV+ rates differ among CA OPOs Rates were highest for age 41-60 Rates overall increased in 2006-2007 –Change in targeted donor population? –More stringent testing (NAT)? –Increased use of non-optimal donors? Further studies are needed to examine factors associated with outcomes for HCV+ donors

16. Acknowledgments This presentation will not be possible without: California Transplant Donor Network Donors and their families Golden State Donor Service National Institute of Transplantation OneLegacy

18. Prevalence of antibody to hepatitis C virus among populations of US military Personnel ( Hyamas et al, A. J. f Epidemiology, 2001)