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CHS position on HIV-O deferral in Africa


ISSUE DOCUMENT: DEFERRAL OF DONORS WHO LIVED IN OR VISITED AFRICA SINCE 1977

ISSUE
The deferral of donors who have lived in or travelled to certain African countries (Cameroon, Central African Republic, Chad, Congo, Equitorial Guinea, Gabon, Niger or Nigeria) since 1977 and the sexual partners of these potential blood donors.

BACKGROUND: INTERNATIONAL
Residence in or visits to Africa were not a reason for donor deferral until the mid-1990s. At that time a new strain of HIV (called HIV-O for outlier) emerged in central Africa. Since then, two cases were identified in the U.S.; none in Canada. As the HIV test kits had not been validated for this strain, the FDA began to defer donors who had lived in or visited these African countries. Health Canada followed suit.

By 2009, suppliers of test kits had demonstrated that their test kits were effective to detect all known strains of HIV. The FDA issued a 'Final Guidance' allowing blood operators using a laboratory test approved for the screening of HIV-O to withdraw the questions related to HIV-O risk. Questions on specific African country of origin were dropped. France did the same.

In countries where the questions were dropped (e.g. U.S. and France), there have been no reports of HIV transmission through blood due to undetected strains of HIV.

These countries have not published studies of transfusion transmissible infection (TTI) rates among donors from the countries from where donors were previously deferred because of HIV-O.


BACKGROUND: CANADA
Despite tests in Canada being licensed to detect HIV-O, Health Canada has been slow to follow the FDA actions.

Question 31 of the CBS Record of Donation asks:
  1. Were you born in or have you lived in Africa since 1977?
  2. Since 1977, did you receive a blood transfusion or blood product in Africa?
  3. Have you had sexual contact with anyone who was born in or lived in Africa since 1977?
Note: If potential donors answer yes, other questions are asked about specific countries.
 
Question 20 of the Héma-Québec Record of Donation asks:
  1. Êtes-vous né(e) ou avez-vous habité depuis 1977 dans un des pays suivants : Cameroun, République centrafricaine, Tchad, Congo, Guinée équatoriale, Gabon, Niger ou Nigéria?
  2. Si vous avez voyagé dans un de ces pays depuis 1977, avez-vous reçu une transfusion sanguine ou tout autre traitement médical comportant un produit fait à partir de sang?
  3. Avez-vous eu des relations sexuelles avec une personne qui est née ou qui a habité depuis 1977 dans un de ces pays?
Those who answer “yes” to these questions are permanently deferred.

Both CBS and Héma-Québec have asked Health Canada to drop the HIV-O deferral. Health Canada has recently agreed to allow this question to be dropped; however, Health Canada indicated it intended to require that the sexual partners of these visitors to Africa would continue to be deferred for 12 months after the latest sexual contact. Health Canada was unable to satisfactorily explain the logic of this decision.

Former residents or visitors to certain central African countries would nevertheless continue to be deferred for 12 months after their return as all these countries are endemic for malaria. (There is a 12-month deferral for visits to countries where malaria is endemic.) This effectively covers the window period for HIV.

Removal of the questions would help address the increasing demand for phenotyped blood for sickle cell disease patients and thereby prevent alloimmunization in multiply transfused sickle cell disease patients. While red blood cells are not in short supply, phenotyped red blood cells for this particular group of patients are. The issue is particularly critical in Quebec where the need for these phenotypes of blood is higher. A larger number of recent immigrants come from these central African countries where French is widely spoken.

Neither CBS nor Héma-Québec has implemented the change proposed by Health Canada as they are unable to explain to donors why the person who actually lived in these central Africa countries would not be deferred but the sexual partner would be. In practice, this would mean that two people who are single would be allowed to donate but, if they married, they would both be deferred.

The extremely low risk posed by HIV in blood donors from these African countries (window period, test failure, processing error) needs to be balanced against the real risk of failing to provide an adequate supply of phenotyped blood to sickle cell patients.

The Recipient Advisory Committee of the Sickle Cell Society of Québec has asked to have the questions removed. The Network of Rare Blood Disorder Organizations, at its last meeting in June, recommended that each member association consider writing to Health Canada to urge it to remove the deferral question relating to Africa and HIV entirely. The malaria deferral would remain.

Both Canadian Blood Services and Héma-Québec support removing the deferral.

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Canadian Hemophilia Society Policy on Deferral of Donors
Who Lived in or Visited Africa Since 1977


Given the proven effectiveness of current HIV tests to detect all known strains of HIV;

Given the benefits of providing an adequate supply of phenotyped blood from Black donors to sickle cell disease patients;

Given the continuing 12-month deferral of blood donors based on residency or visits to certain central African countries because of the risk of malaria;

Be it moved that the Canadian Hemophilia Society recommends to Health Canada that the deferral regarding HIV of persons who resided or visited certain African countries be removed, as should the deferral of their sexual partners.

Adopted by the Canadian Hemophilia Society Board of Directors, September 29, 2012