Matthew J. Kuehnert, M.D.

1. Final Revision Process for thePHS Guideline for Reducing HIV, HBV and HCV Transmission through Organ Transplantation Matthew J. Kuehnert, M.D. Office of Blood, Organ and other Tissue Safety Advisory Committee on Organ Transplantation August 28. 2012 National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion

2. PHS Guideline Development “Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs” published in 1994 by the Public Health Service (PHS) Agreement that PHS guidelines need revision • Association for Organ Procurement Organizations (AOPO), followed by other transplant organizations, sent letters to CDC suggesting guideline revision in 2008 Objective process developed for PHS guideline revision and update

3. Important Differences in Focus –1994 versus Revised Draft Guideline 1994: PHS Guideline for Preventing Transmission of Human Immunodeficiency Virus through Transplantation of Human Tissue and Organs • Organs and tissues; banked breast milk and semen • Transmission of HIV only Revised Draft: PHS Guideline for Reducing HIV, HBV and HCV Transmission through Organ Transplantation • Organs only • Transmission of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) • Evidence-based process

4. Evidence-based Process for Revision HHS agencies and external experts from transplant community provided input CDC lead for PHS agencies in developing a draft Recommendations based on systematic review of the best available evidence Evidence review conducted by: • Center for Evidence-based Practice (CEP) at University of Pennsylvania • ECRI Institute/Evidence-based Practice Center (EPC)

5. Advisors for Guideline Development Expert Panel (EP) Experts in Consent Issues, Hepatitis and HIV Content, and Laboratory Medicine; OPO Representative; Physicians in Transplant, Transplant ID, and Transplant Surgery Review Committee (RC) Representatives from AOPO, AST, ASTS, CSTE, NATCO, UNOS, Industry; and Ad Hoc Members PHS representatives from CMS, FDA, HHS/OPHS, HRSA,and NIH 5 National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion 5

6. PHS Guideline Development Methodology Five Phases Phase 1: Organize Advisors for Guideline Development 2008 Phase 2: Preliminary Literature Search in Support of Questions for Systematic Review Phase 3: Development of Questions for Systematic Review and Analytic Framework Phase 4: Production of Evidence Report Phase 5: Guideline Development 2012 National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion

7. Categories of PHS Guideline Recommendations • Donor Risk Assessment • Donor Screening • Includes Table of risk factors for recent infection of HIV, HBV, HCV • HBV-Infected Donors and Transplantation • HCV-Infected Donors and Transplantation • Recipient Informed Consent • Recipient Testing • Donor and Recipient Specimen Collection and Storage • Tracking and Reporting of HIV, HBV and HCV

8. Process for Revision of PHS Guideline • HHS offices and agencies, including CDC, HRSA, FDA, and CMS, reviewed and approved the draft Guideline • Federal Register Notice • Draft guideline accessed at www.regulations.gov • 90-day public comment period - ended 12/23/11 • Approximately 100 comments were received • All comments were reviewed • PHS Guideline Revision Work Group convened to review and discuss changes to recommendations • Agreed on changes to the guideline

9. Next Steps For Finalizing the PHS Guideline • Reconvene Expert Panel and Review Committee • Has reviewed revised guideline recommendations and provided input • Reviewing changes to revised guideline (recommendations and narrative) as made by PHS Revision Work Group • Submit guideline for HHS clearance • Publication as final Guideline in late 2012/early 2013* *Recommendations will not be regulation or policy

10. Questions or Comments? For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: http://www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion

11. Major Changes to PHS Guideline In Response to Public Comment and External Input • Number of recommendations decreased from 54 to 32 • Sections on HBV- and HCV-infected Donors and Transplantation were deleted • Donor testing for HIV changed from NAT for all donors to NAT or Ag/Ab for increased risk donors • Donor testing for HBV changed from NAT for increased risk donors to no recommendation • Living Donor testing changed from within 7 to within 28 days of organ recovery • Recipient testing (based on increased donor risk) reduced and changed to broader timeframes after transplant

12. Major Changes to PHS Guideline In Response to Public Comment and External Input • Regarding storing blood specimens for future testing (for the possibility of donor-derived disease transmission investigation) • Recommendations changed to limit to storing specimens from deceased donors only (no recommendations for living donors or recipients) • Recommendations on division of donor specimens into multiple aliquots for storing was deleted