Wednesday, January 7, 2015

FDA Reevaluates Gay Blood Donor Eligibility

By Meredith A. Reyes, MD
Houston pathologist

The Food and Drug Administration (FDA) has announced it will revise the current lifetime ban on blood donation from men who have had sex with other men (MSM), even once, since 1977. Many patients may wish to understand the reasoning behind the longstanding deferral of these potential blood donors, or the scientific and medical evidence that supports the change in this policy.

The policy of deferring MSM donors has been in place since the early 1980s, early in the AIDS epidemic and before the HIV virus had been discovered. It has remained in place because MSM are, as a group, at increased risk for HIV, hepatitis B, and other infections that may be transmitted to those who receive blood transfusions. MSM represent about 4 percent of the men in the United States4. In 2010, however, they accounted for 78 percent of new HIV infections among males and 63 percent of all new infections2. MSM accounted for 54 percent of all people living with HIV infection in 2011. The estimated number of new HIV infections was greatest among MSM aged 13-24 years.

Improvements in blood donation screening have been made since the ban was put in place. Today blood is screened for multiple infectious agents, including two different tests for HIV. Despite those improvements, the risk of acquiring HIV from transfusion is approximately 1 per 2 million units transfused. This very small risk remains because of a “window period” between the time an individual is infected and the time laboratory tests will detect infection – approximately 9 days for HIV. The lifetime deferral has remained in place because of this “window period” and because MSM remain at high risk for HIV .

The strict, lifetime deferral policy means many healthy blood donors are turned away. The new FDA policy would change the deferral period for men who have had sex with men to a temporary, 12 month period. This is consistent with policies for other populations considered at high risk for HIV infection (accidental needlestick/blood exposure, sexual contact with an individual with HIV, or viral hepatitis). This 12- month deferral far exceeds any known “window period” for detectability of infection. It has also been discussed that certain members of the MSM population (those with low numbers of partners or in long-term relationships with only one partner) might be at a lower risk of HIV infection. However, no donor screening standards or questions have been devised that can reliably identify a potentially lower risk group of donors. The UK, Australia, Sweden, Hungary, and Japan all have instituted 12- month deferral periods; Canada and New Zealand have 5-year deferrals; and South Africa has a 6 month deferral. Italy and Spain assess the risk of all donors with a questionnaire, regardless of their sexual orientation.

It has been documented, both within and outside of the US, that MSM who otherwise would not be allowed to donate blood, have violated the current lifetime deferral. A recent study found that this practice may be increasing. That study interviewed those who had not complied with the lifetime ban. Many of those interviewed said they would, however, comply with a 12-month deferral period. It is estimated the change to a 12-month deferral would allow about 180,000 new U.S. men to be eligible for donation.

Doctors and patients want confirmation that the blood supply is safe. The FDA has concluded that there is no scientific or medical evidence supporting an indefinite deferral of MSM donors. Changing the deferral to 12 months after last sexual contact with another male is similar to the standards used for others at increased risk of transfusion-transmitted infections. The FDA is expected to issue national guidelines in the future, and will require increased surveillance of all transfusion-transmitted diseases to evaluate this new policy.

Meredith A. Reyes, MD, is chair of the TMA Committee on Blood and Tissue Usage. She is also Associate Director of Transfusion Services at Houston Methodist Hospital.

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