title: Quantitative estimate of the risks and benefits of possible alternative blood donor deferral strategies for men who have had sex with men.
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).
  
  
  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.
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852-1448, USA.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Anderson
authors.forename: Hong
authors.initials: H
authors.lastname: Yang
authors.forename: Lou M
authors.initials: LM
authors.lastname: Gallagher
authors.forename: Sharon
authors.initials: S
authors.lastname: O'Callaghan
authors.forename: Richard A
authors.initials: RA
authors.lastname: Forshee
authors.forename: Michael P
authors.initials: MP
authors.lastname: Busch
authors.forename: Matthew T
authors.initials: MT
authors.lastname: McKenna
authors.forename: Ian
authors.initials: I
authors.lastname: Williams
authors.forename: Alan
authors.initials: A
authors.lastname: Williams
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Kuehnert
authors.forename: Susan
authors.initials: S
authors.lastname: Stramer
authors.forename: Steve
authors.initials: S
authors.lastname: Kleinman
authors.forename: Jay
authors.initials: J
authors.lastname: Epstein
authors.forename: Andrew I
authors.initials: AI
authors.lastname: Dayton