Quantitative estimate of the risks and benefits of possible alternative blood donor deferral strategies for men who have had sex with men
Steven A. Anderson
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorHong Yang
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorLou M. Gallagher
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorSharon O'Callaghan
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorRichard A. Forshee
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorMichael P. Busch
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorMatthew T. McKenna
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorIan Williams
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorAlan Williams
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorMatthew J. Kuehnert
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorSusan Stramer
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorSteve Kleinman
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorJay Epstein
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorAndrew I. Dayton
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorSteven A. Anderson
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorHong Yang
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorLou M. Gallagher
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorSharon O'Callaghan
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorRichard A. Forshee
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorMichael P. Busch
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorMatthew T. McKenna
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorIan Williams
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorAlan Williams
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorMatthew J. Kuehnert
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorSusan Stramer
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorSteve Kleinman
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorJay Epstein
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorAndrew I. Dayton
From the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland; the Institute for Environmental Science and Research Ltd, Kenepuru, New Zealand; the Office of the Australian Safety and Compensation Council, Civic, Canberra, Australia; the University of California at San Francisco and Blood Centers of the Pacific, San Francisco, California; the Centers for Disease Control and Prevention, Atlanta, Georgia; the National Testing and Reference Laboratories, American Red Cross, Gaithersburg, Maryland; and the University of British Columbia, Vancouver, British Columbia, Canada.
Search for more papers by this authorThis project was supported in part by an appointment to the Research Participation Program at the Center for Biologics Evaluation and Research administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration (L.M.G.). Funding for travel and support were provided by the Institute for Environmental Science and Research Limited, Kenepuru, New Zealand (L.M.G.).
Disclaimer: The findings and conclusions in this article have not been formally disseminated by the Department of Health and Human Services and should not be construed to represent any Department determination or policy.
Abstract
BACKGROUND: Implementation of sensitive screening methods for human immunodeficiency virus (HIV) and hepatitis viruses prompts the question of what quantitative risks may result from altered deferral strategies for donation of blood by men who have had sex with men (MSM).
STUDY DESIGN AND METHODS: Quantitative probabilistic models were developed to assess changes in the residual risk of transfusion-transmitted HIV and hepatitis B virus (HBV) associated with blood testing and quarantine release errors (QREs) in the initial year of two hypothetical policy scenarios that would allow donations from donors who have abstained from MSM behavior for at least 5 years (MSM5) or at least 1 year (MSM1).
RESULTS: The MSM5 and MSM1 models, respectively, predicted annual increases in units of HIV-infected blood of 0.5% (0.03 mean additional units; 95% confidence interval [CI], 0-1) and 3.0% (0.18 mean additional units; 95% CI, 0-1) over current estimated HIV residual risk using recent, nationwide biologic product deviation reports to estimate QRE rates. These estimates are approximately 10-fold lower than estimates based on New York State QRE data from the previous decade. The models predicted smaller increases in infectious HBV donations.
CONCLUSIONS: QREs remain the most significant preventable source of risk. More accurate inputs, including the percentage of MSM in the population, the percentage of MSM who have abstained from MSM activity for 1 or 5 years, the prevalence of HIV and HBV in MSM who have abstained from MSM activity for 1 or 5 years, the rate of self-deferral, and QRE rates, are required before making more precise predictions.
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Citing Literature
