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Thursday, May 11, 2023

Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products | FDA

Historical perspective:

During the 1980s HIV presented a major public health problem.  There were no successful treatments for patients with HIV. It was determined that HIV was prevalent in the 'gay' population.  Their blood was 'tainted' with the Human Immunodeficiency Virus (HIV).  Blood banks were advised to not accept blood donations from anyone who was gay or had sexual encounters with those of the same sex, especially those who engaged in anal sex.


HIV and. AIDS attacks the CD4 white blood cells which form part of the protective immune system of the body.  When these cells are destroyed the immune system is no longer able to recognize and protect against bacterial fungal and protozoa infection. These resulting infections are what kill AIDs patients.

In the last five decades pharmacologic advances produced effective treatments for HIV. A fulminant case of AIDs does occur until well after a person is infected with HIV.  It lies dormant, gradually reducing the CD4 cell count until the immune system is overwhelmed by infectious agents.

The Clinical Guideline for Prevention and Treatment have eliminated AID and HIV as a fatal illness.

Blood Banks have used the above criteria for preventing blood donation by HIV/AIDS patients. 

Changes in FDA Guidance for Blood Donation by Gay Persons
 
US Food and Drug Administration on Thursday paved the way for more gay and bisexual men to donate blood by finalizing new risk-based rules for blood donation. Going forward, prospective donors will be asked the same set of questions regardless of their sex or sexual orientation.


The new criteria are risk-based questions, rather than discriminating against a group of people labeled as gay. This ruling comes as gay people are now in a protected class of people

The new questions are designed to reduce the risk of transmission of HIV, or human immunodeficiency virus, through blood donation. The FDA says it made the changes after reviewing data from other countries that have similar rates of HIV and have already implemented risk-based eligibility for blood donations, information on the accuracy of tests to detect HIV, surveillance information from a system that monitors infections passed by transfusions, and information on individual risk factors gleaned from a government-funded study.

Under the new rules, anyone reporting a new sexual partner, more than one sexual partner, or recent anal sex will be told to wait at least three months to donate blood. This reduces the likelihood that someone with a new or recent infection could donate during a window of time when their infection would not be picked up by lab tests.

Anyone taking medications to treat or prevent HIV, such as PrEP, would also be deferred from donation. The FDA says that while HIV is not transmitted during sex in people whose viral levels are undetectable, the same does not apply to blood donation. Blood is transfused directly into a vein, and involves a larger volume of fluid, making it inherently riskier than sexual contact.







Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products | FDA

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