Re-Entry of Donors with History of Hepatitis On/After Age 11

Principle:

Until this guidance, everyone with hepatitis at age ≥ 11 has been permanently deferred, regardless of the type of hepatitis.  Except for confirmed cases of HCV at any age, donors with other causes may be reassessed to determine if they may be re-entered into the donor pool.  I have also included assessing levels of anti-HBs as per my previous policy at HMC Doha.

Policy:

  1. All donors with a history of HBV (confirmed HBsAg and/or HBV-NAT positive) or HCV, regardless of the age it occurred, continue to be permanently/indefinitely deferred.
  2. Donors with anti-HBc with negative HBsAg and/or HBV-NAT may be further assessed by performing anti-HBs titering.
    1. If the level of anti-HBs >= 100 IU/L (mIU/ml), then the donor may be reentered.
    1. If the donor’s antibody titer < 100 IU/L, he may be offered HBV vaccination:
      1. If the post-vaccination HBV titer >= 100 IU/L, then he may be reentered.
      1. If the donor does not receive HBV vaccination, he remains deferred.
  3. Donors with a history of HAV, CMV, or Epstein-Barr hepatitis may be reentered into the donor pool without further testing.
  4. If the donor is uncertain what type of hepatitis he had, then perform:
    1. HBV testing (HBsAg, HBcAb, HBsAb, HBV DNA NAT)
    1. HCV testing (HCV Ab, HCV LIA, HCV RNA NAT
    1. Liver enzyme testing (ALT, AST)
  5. If there is evidence of current or past HBV and/or HCV, then the donor is still permanently deferred
  6. If there is evidence of ALT or AST elevation, the donor remains indefinitely deferred.

References:

Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday, FDA-2017-D-5152–Requalification for History of Hepatitis Guidance-Final, US FDA/CBER, September 2017