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 TransplantationAugust 28. 2012

National Center for Emerging and Zoonotic Infectious DiseasesDivision of Healthcare Quality Promotion

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

2008Objective process developed for PHS guideline revision and update

Important Differences in Focus –1994 versus Revised Draft Guideline1994: 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

Evidence-based Process for Revision

HHS agencies and external experts from transplant community provided inputCDC lead for PHS agencies in developing a draftRecommendations 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)

National Center for Emerging and Zoonotic Infectious DiseasesDivision of Healthcare Quality Promotion

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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

Advisors for Guideline Development

National Center for Emerging and Zoonotic Infectious DiseasesDivision of Healthcare Quality Promotion

Phase 1: Organize Advisors for Guideline Development

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

PHS Guideline Development Methodology Five Phases

2008

2012

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

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

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

Questions or Comments?

For more information please contact Centers for Disease Control and Prevention

1600 Clifton Road NE, Atlanta, GA 30333Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-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 DiseasesDivision of Healthcare Quality Promotion

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

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