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DTAC and Zika Virus Update

This update examines potential donor-derived transmission events in organ transplantation, with a focus on the Zika virus. The analysis discusses the current knowledge and areas of uncertainty regarding Zika transmission in immunosuppressed hosts, as well as the need for testing and appropriate protocols for potential organ donors.

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DTAC and Zika Virus Update

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  1. DTAC and Zika Virus Update Aneesh K Mehta, MD Associate Professor Emory Transplant Center Assistant Director of Transplant Infectious Diseases Member-at-large OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC)

  2. Acknowledgement This analysis reflects, in part, work performed on behalf of the OPTN Ad Hoc Disease Transmission Advisory Committee. Data and Slides were provided by Marian Michaels, Susan Tlusty, and the DTAC This work was supported wholly or in part by HRSA contract 234-2005-370011C. The content is the responsibility of the authors alone and does not necessarily reflect the views or policies of the Department of HHS, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government

  3. Disclosures • I have no relevant financial relationships to disclose

  4. Ad Hoc Disease Transmission Advisory Committee (DTAC) • Part of OPTN patient safety program • Examine unexpected potential donor-derived transmission events mainly consisting of infection or malignancy • Categorize as to whether or not they are donor derived • Evaluate aggregate data to enhance patient safety • Inform policy change and improve existing processes • Educate transplant community

  5. Potential Donor Derived Transmission Events (PDDTE) *Additional reports are submitted, but not reviewed by full DTAC (duplicates, expected transmissions and other unnecessary reporting, etc). Kaul et al ATC 2015

  6. Current Works of DTAC • Guidance on Explaining Risk Related to Use of Increased Risk Donor Organs When Considering Organ Offers • In progress • Reviewing increased reports of Cryptococcus cases to DTAC • Toxoplasma testing of deceased donors • Update to Zika guidance in progress (expected early summer)

  7. Toxoplasmosis Talking Points • Toxoplasmosis screening will soon be mandatory testing for all deceased donors • Risk of transmitting the disease to seronegative recipients can be greatly reduced by giving the recipient prophylactic antibiotics • Thus, the benefits of using toxoplasmosis-positive organs in toxoplasmosis-negative recipients often outweigh the risks. • If a deceased donor screens positive for Toxoplasma gondii, remember: • Despite the known risk, organs from donors who test positive for toxoplasmosis can be used in seronegative recipients • • The risk of transmitting toxoplasmosis from a positive donor to a negative recipient can be reduced markedly by giving the recipient prophylactic antibiotics • • Prophylactic treatment has been demonstrated to be very effective for seronegative cardiac recipients of seropositive donors but, in the absence of prophylaxis, 50-75% of recipients will develop symptomatic disease (T. gondii can go to any tissue or organ but has a predilection for the heart, skeletal muscle and brain) • • Trimethoprim/sulfamethoxazole (TMP/SMX) is the main prophylaxis against toxoplasmosis

  8. Zika Virus • Flavivirus • Transmitted to humans mainly by bite of infected Aedes mosquito • Closely related to other arboviruses • Dengue, yellow fever, Japanese encephalitis, and West Nile viruses

  9. Zika Virus Epidemiology • First recognized 1947 • Isolated from monkey in Uganda • After 1952 sporadic human cases reported • 2007 outbreak Yap Island, Micronesia • Naïve population • Est 70% infection rate • 2015 outbreak in Brazil recognized • Finding microcephaly in infants born to women who had viral illnesses suggestive of Zika during pregnancy

  10. Zika: Transmission Routes • Blood meal: • Infected mosquito to human • Viremic human to mosquito • Sexual transmission thru semen • Woman to fetus in utero • Less common • Blood transfusion • Laboratory exposure • Possibility: organs/tissues

  11. Zika Clinical Course • Most asymptomatic (80%) • When symptomatic • Usually mild and self limited • Lasts several days to a week • Symptoms • Non specific red raised rash • Fever • Conjunctivitis (pink eye) • Joint and muscle aches • More severe disease rare: • Guillain-Barré

  12. Peterson LR et al. Zika Virus. NEJM 2016; 374:1552

  13. Zika Cases Reported in the United StatesLaboratory-confirmed Zika cases reported to ArboNET (as of March 22, 2017) https://www.cdc.gov/zika/intheus/maps-zika-us.html#zika-cases-us

  14. Zika virus (ZIKV) and Organ Transplantation: What We Don’t Know • The consequence of ZIKV in immunosuppressed hosts? • How long does infectious ZIKV persist in different organs? • Will testing be appropriate and practical for potential organ donors?

  15. Zika Virus and TransplantationWhat do we know so far? • Thus far organ transmission has not been reported • Other flaviviruses have been donor transmitted • West Nile Virus (WNV) well recognized to be donor transmitted with more severe consequences compared to WNV in healthy hosts • Anecdotal case reports of Dengue transmission in endemic countries Liver Transpl 2013;19:1413; Emerg Inf Dis 2014;20:1366

  16. ZIKV and Immunosuppressed Patients: What do we know so far? • Zika virus is found in blood • 2013: Outbreak in French Polynesia: 42/1,505 (3%) blood donors test (+) • European Communicable Disease Bulletin. 19(14), 2014 • Brazil: 2 transfusion associated cases • http://www.cdc.gov/zika/transmission/blood-transfusion.html • Genome Announcements March/April 2016 • Transplant patients may be at risk from blood transfusions • Zika virus reported in 3 HIV + people without significant disease • Calvet GA, et al. J ClinVirol 2016;74:1-3 • http://www.cdc.gov/zika/hc-providers/hiv-zika.html

  17. 36-year-old man heart transplant recipient was admitted to Clinic Hospital of Ribeirão Preto, Sao Paulo, Brazil • 2-day history of high-grade fever (2-3 times a day), malaise, headache, and seizures. • Wife and his son also presented with fever and malaise, both of whom had a maculopapular rash but no neurologic symptoms • Tacrolimus, prednisone, and mycophenolate mofetil • Generalized seizure, transitory left-sided hemiplegia • After 1 week of hospitalization still had 3 to 4 daily episodes of fever (37.8°C-38.4°C) and had progressive worsening of neurologic symptoms • Immunosuppression was reduced • Atrial fibrillation, cardiac rejection was suspected • Cardiac arrest with pulseless electrical activity and died • Autopsy acute cardiac allograft rejection and Zika encephalitis, possible CNS pseudotumor

  18. Zika Virus (ZIKV) Laboratory Testing Options and Limitations MMWR 6/3/16 - http://www.cdc.gov/mmwr/volumes/65/wr/mm6521e1.htm

  19. Timing of Viremia and Antibody Blood

  20. Zika Virus (ZIKV) by NAT Finding in Different Body Components

  21. Zika Virus in Urine by PCRN=70 people [---Serum ---] Bingham et al.. MMWR Morb Mortal Wkly Rep 2016;65. DOI: http://dx.doi.org/10.15585/mmwr.mm6518e2

  22. Interim Guidance for Interpretation of Zika Virus Antibody Test Results: MMWR June 3, 2016 MMWR 6/3/16 - http://www.cdc.gov/mmwr/volumes/65/wr/mm6521e1.htm

  23. FDA Recommendations - Blood Donors • Defer for 4 weeks if travel to area with ZIKV transmission • Defer for 4 weeks after last sexual contact with a man with ZIKV exposure or ZIKV in past 3 months

  24. FDA Recommendations for Human Cells, Tissues, & Cellular/Tissue based Products

  25. Guidance for Living Donation https://www.transplantpro.org/news/guidance-for-organ-donation-and-transplantation-professionals-regarding-the-zika-virus/

  26. Guidance for Deceased Donor https://www.transplantpro.org/news/guidance-for-organ-donation-and-transplantation-professionals-regarding-the-zika-virus/

  27. Thank you • CDC www.cdc.gov/zika/ • WHO www.int/emergencies/zika/en/ • CDC http://www.cdc.gov/zika/ • AATB http://aatb.org/Zika-Virus-Zika virus-Infection-Addenda-and-Flowcharts • OPTN https://optn.transplant.hrsa.gov/news/guidance-on-zika-virus/ https://optn.transplant.hrsa.gov/resources/patient-safety • FDA http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMIssues/ucm485199.htm

  28. Learning from Experience: LifeLink of Puerto Rico

  29. Donor Highlights Information Implemented February 9, 2016

  30. Addendum Implemented Implemented March 28, 2016

  31. Newest Addendum Implemented, Sept 6, 2016

  32. LifeLink Addendum Implemented Implemented March 28, 2016

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