International Blood Safety Forum Washington, DC Confronting Emerging Pathogens with Limited Resources José Eduardo Levi MARCH 20th, 2015 MANDATORY TESTING IN BRAZIL Hepatitis B – anti-HBc + HBsAg + HBV-DNA Hepatitis C – anti-HCV + HCV-RNA HIV– anti-HIV (1, 2 and O) + HIV-RNA Chagas Disease – anti-T. cruzi Syphilis – Treponemic or non-treponemic assay HTLV-1 and HTLV-2 – anti-HTLV 1 and 2 Malaria – In endemic areas (Amazon) CMV – Selected recipients Abnormal hemoglobin – Sickle cell trait DENGUE Dengue Cases Brazil 1990 - 2014 1500000 1450000 1400000 1350000 1300000 1250000 1200000 1150000 1100000 1050000 1000000 950000 900000 850000 800000 750000 700000 650000 600000 550000 500000 450000 400000 350000 300000 250000 200000 150000 100000 50000 0 Year 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Affected municipalities and Incidence Sao Paulo 15,000,000 inhabitants < 1,000 dengue cases in 2010 60 km Santos 800,000 inhabitants > 20,000 dengue cases in 2010 DENGUE LABORATORY MARKERS AMONG BLOOD DONORS FROM SANTOS, BRAZIL. LEVI, UNPUBLISHED IgG MONTH/YEAR JAN/2010 FEB/2010 MARCH/2010 APRIL/2010 JULY/2010 JULY/2011 N= 500 493 495 500 500 500 IgM IgG + IgM TMA Tabela 1 – Número de casos de dengue comprovados e incidência por 100.000 habitantes em municípios da baixada santista. Fonte: Secretaria do estado da Saúde (Grupo de Vigilância Epidemiológica) e IBGE. MEAN 74,0% 64,5% 68,7% 70,2% 71,6% 74,4% 7,2% 8,5% 15,2% 24,4% 17,8% 8,6% 5,8% 6,9% 13,7% 23,8% 17,8% 7,8% 0,0% 1,4% 1,2% 0,8% 0,0% 0,0% 70,6% 13,6% 12,6% 0,6% Rate symptomatic/ asymptomatic = 1:3 EVIDENCE OF TRANSFUSION-TRANSMITTED DENGUE VIREMIC DONOR (RNA+) RECIPIENT PRE-TX NEGATIVE AND POST-TX NEGATIVE SIGNS, SYMPTOMS AND LABORATORY MARKERS COMPATIBLE WIH DENGUE OCCURRING 1-14 DAYS POST-TRANSFUSION STRAMER SL, TRANSFUSION 2012, IN PRESS Transfusion. 2015 Jan 21. doi: 10.1111/trf.12944. [Epub ahead of print HYPOTHESIS FOR THE LOW NUMBER OF TT CASES REPORTED: 1) Hemovigilance may be deficient 2) Presence of protective immunity in recipients in endemic areas 3) Frequent cotransfusion of antibody-positive units which neutralize infectivity of viremic donations 4) Clinical outcomes may not be as severe in immunosuppressed patients infected with dengue 5) Need for mosquito saliva to enhance dengue replication and virulence; ? HYPOTHESIS FOR THE LOW NUMBER OF TT CASES REPORTED: 1) Hemovigilance may be deficient 2) Presence of protective immunity in recipients in endemic areas 3) Frequent cotransfusion of antibody-positive units which neutralize infectivity of viremic donations 4) Clinical outcomes may not be as severe in immunosuppressed patients infected with dengue 5) Need for mosquito saliva to enhance dengue replication and virulence; DENGUE LABORATORY MARKERS AMONG BLOOD DONORS FROM SANTOS, BRAZIL. LEVI, UNPUBLISHED IgG MONTH/YEAR JAN/2010 FEB/2010 MARCH/2010 APRIL/2010 JULY/2010 JULY/2011 N= 500 493 495 500 500 500 IgM IgG + IgM TMA Tabela 1 – Número de casos de dengue comprovados e incidência por 100.000 habitantes em municípios da baixada santista. Fonte: Secretaria do estado da Saúde (Grupo de Vigilância Epidemiológica) e IBGE. MEAN 74,0% 64,5% 68,7% 70,2% 71,6% 74,4% 7,2% 8,5% 15,2% 24,4% 17,8% 8,6% 5,8% 6,9% 13,7% 23,8% 17,8% 7,8% 0,0% 1,4% 1,2% 0,8% 0,0% 0,0% 70,6% 13,6% 12,6% 0,6% DENGUE SEROTYPES CIRCULATING IN BRAZIL, 2012 HYPOTHESIS FOR THE LOW NUMBER OF TT CASES REPORTED: 1) Hemovigilance may be deficient 2) Presence of protective immunity in recipients in endemic areas 3) Frequent cotransfusion of antibody-positive units which neutralize infectivity of viremic donations 4) Clinical outcomes may not be as severe in immunosuppressed patients infected with dengue 5) Need for mosquito saliva to enhance dengue replication and virulence; 2 casos de dengue, 1 DF e 1 DSS, ambos transplante de fígado cerca de 8 meses pós-transplante. HYPOTHESIS FOR THE LOW NUMBER OF TT CASES REPORTED: 1) Hemovigilance may be deficient 2) Presence of protective immunity in recipients in endemic areas 3) Frequent cotransfusion of antibody-positive units which neutralize infectivity of viremic donations 4) Clinical outcomes may not be as severe in immunosuppressed patients infected with dengue 5) Need for mosquito saliva to enhance dengue replication and virulence; DONOR`S SCREENING: IF AND HOW -EPIDEMIOLOGY Important negative impact on donor availability -CLINICAL SIGNS Low efficiency -LABORATORIAL ? PROOF OF TT WNV - USA WNV INTRODUCTION IN SOUTH AMERICA CHIKUNGUNYA CASES – BRAZIL NOVEMBER 2014 No cases Imported(38) Autoctonous (850) NEW/EMERGING AGENTS A. albopictus A. aegypti MEASURES TAKEN AT SÃO PAULO BLOOD BANK: - DEVELOPMENT OF A DENGUE/CHKV REAL-TIME PCR ASSAY FOR APHERESIS PLATELET UNITS - EMERGENCY PLAN TO STOP BLOOD COLLECTION AT AREAS OF HIGH INCIDENCE - MOBILIZATION OF FIDELIZED BLOOD DONORS FROM NON-AFFECTED AREAS - ESTABLISHMENT OF EPIDEMIOLOGICAL CRITERIA FOR RESTARTING BLOOD COLLECTION (TRIGGERS) ACKNOWLEDGMENTS Dr Ésper G. Kallas and team - Immunology Dept., São Paulo University Medical School Eliana Perroud – Santos Blood Center Dr Cláudio Pannuti and team – Virology Lab, tropical medicine Institute, University of São Paulo Dr Ester Sabino – Infectious Diseases Dept., São Paulo University Medical School Dr Alfredo Mendrone and team – Fundação Pró-Sangue Dr Michael P. Busch - Blood Systems Research Institute, EUA Novartis (Grifols) – Sponsor, Santos Dengue Blood Donors Study