Revised Recommendations for Reducing the Risk of HIV Transmission by Blood (Donation) - FDA

The FDA ^ | 2015

[Faith Presses On]

Full title: "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products"

My note: Some Democrats in Congress and the mainstream and left-wing media have been pushing for the FDA to lift its ban on sexually active gay men donating blood since the Orlando terrorist attack (the White House responded that the ban will stay). The dozens of "lift the ban" articles published everywhere from Time and the New York Times and Washington Post to Salon and Cosmopolitan have either twisted or omitted facts and issues. This is despite the fact that when the FDA moved last year to reduce the ban from "indefinite deferral" - lifetime - to one year for gay men who have abstained from sex during that period, they issued an extensive report on how and why they made that decision. Below are some key excerpts from that report. Note that I've broken apart long paragraphs and also highlighted certain words and phrases with bolding to make the text more easy to read. - FPO

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products (FDA, 2015)

Background

The emergence of Acquired Immune Deficiency Syndrome (AIDS) in the early 1980s and the recognition that it could be transmitted by blood and blood products had profound effects on the United States (U.S.) blood system (Refs. 2, 3, 4).

Although initially identified in men who have sex with men (MSM) and associated with male-to-male sexual contact, AIDS was soon noted to be transmitted by transfusion of blood products, and by infusion of clotting factor concentrates in individuals with hemophilia (Refs. 5, 6).

Subsequently, AIDS was also found to be associated with heterosexual transmission through commercial sex work and with intravenous drug use (Refs. 7, 8).

The understanding of risk factors for AIDS in 1983 informed the first blood donor deferral policy, which at that time was the only way to reduce the chance of transmission of AIDS through blood product transfusion. In 1984, AIDS was reported to be associated with the virus now known as HIV, opening the door to development of donor screening tests.


*  *  *

History of Efforts to Reduce HIV Transmission by Blood Products

Beginning in 1983, the FDA issued recommendations for providing donors with educational material on risk factors for AIDS and for deferring donors with such risk factors in an effort to prevent transmission of the agent responsible for AIDS (later understood to be caused by HIV) by blood and blood products (Refs. 2, 9, 10, 11).

Providing donor educational material and asking at-risk donors not to donate was demonstrated to have a significant impact on preventing HIV transmission prior to the availability of testing (Ref. 12).

However, thousands of recipients of blood and blood components for transfusion and recipients of plasma-derived clotting factors became infected with HIV before the causative virus was identified and the first screening tests for HIV were approved in 1985 (Refs. 2, 4, 10).

*  *  *

The use of donor educational material, specific deferral questions, and advances in HIV donor testing (e.g., HIV antibody assays, p24 antigen assays, and nucleic acid tests (NAT)) have reduced the risk of HIV transmission from blood transfusion from about 1 in 2500 units prior to HIV testing to a current estimated residual risk of about 1 in 1.47 million transfusions (Refs. 14, 15).

The development of pathogen inactivation procedures for products manufactured from pooled plasma in the 1980s improved the safety of these products by inactivating lipid-enveloped viruses. No transmissions of HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) have been documented through U.S.-licensed plasma-derived products in the past two decades (Ref. 16).

Relating in large part to the development of more sensitive HIV testing methodologies, there have been calls in the social and scientific literature to revisit the blood donor deferral policies that were established about three decades ago, in particular, with regard to the deferral of MSM.

During the period from 1997 to 2010, FDA held a number of public meetings, including workshops and Blood Product Advisory Committee (BPAC) meetings to further review evidence and to discuss its blood donor deferral policies to help prevent the transmission of HIV (Refs. 17, 18, 19, 20).

In June 2010, the Department of Health and Human Services (HHS) brought the issue of deferral of men who have had sex with another man, even one time, since 1977, for public discussion at a meeting of the Advisory Committee on Blood Safety and Availability (the Committee).

The Committee heard presentations of currently available scientific data as well as comments from the public. The Committee recommended to the HHS Secretary “that the current MSM deferral policy, while suboptimal, should be retained pending the completion of targeted research studies that might support a safe alternative policy” (Ref. 21).

*  *  *

. . . (I)n September 2010, an Interagency Blood, Organ & Tissue Safety Working Group on MSM (BOTS Working Group), consisting of representatives from the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), National Institutes of Health (NIH), HHS Office of Civil Rights, Office of the Assistant Secretary for Health (OASH), and FDA, was charged by the Assistant Secretary for Health with exploring the feasibility of a data and science-driven policy change.

*  *  *

Current Risk of HIV Infection Associated with Specific Behaviors

Although MSM represent a small percentage of the U.S. male population (approximately 7% of men report that they have ever participated in MSM activity and approximately 4% of men report that they engaged in MSM activity in the last 5 years 1 ) (Ref. 26), they comprise a large proportion of adults in the United States with existing and newly diagnosed HIV infections. Among persons living with HIV in 2012, CDC estimates that 56% were MSM (including MSM who were also IDU) (Ref. 27).

MSM remain at increased risk of HIV infection. In 2010, the majority of new HIV infections were attributed to male-to-male sexual contact: 63% among all adults and 78% among men, indicating that male-to-male sexual contact remains associated with high risk of HIV exposure (Ref. 28).

*  *  *

Recent Data Relevant to the Deferral for MSM

The Donor History Questionnaire (DHQ) Study involved cognitive interviews with potential donors. After receiving donor educational materials, the potential donors completed the donor history questionnaire, and were then interviewed regarding their responses (Ref. 31).

The key result of this study, which was highly consistent for both individuals who only have sex with partners of the opposite sex and MSM, was that individuals respond to questions posed by the questionnaire as if they were answering the more general and subjective question in the self-assessed
context of “is my blood safe,” rather than providing an answer to the literal questions as asked...

*  *  *

The REDS-II Transfusion-Transmitted Retrovirus and Hepatitis Virus Rates and Risk Factors Study 2011-2013 was a pilot blood donor surveillance study that evaluated four viral markers (HBV, HCV, human T cell lymphotrophic virus (HTLV), and HIV) in just over 50% of the nation’s blood supply (Ref. 32). It also determined behavioral risk factors that were associated with donations of blood that tested positive for one of these viruses compared with control donations.

In addition to demonstrating the feasibility of conducting such a surveillance program, there were several key findings. These included the finding that for each of these viral infections, the primary behavioral risk factors were consistent with the known epidemiology for each infection in the United States and validated the current blood donor deferral criteria.

Sex with an HIV-positive partner and a history of male-to-male sexual contact remained the two leading independent risk factors for HIV infection in blood donors as originally observed in CDC-funded studies from the early 1990’s.

Sex with an HIV-positive partner was associated with a 132-fold increase in risk (multivariable adjusted odds ratio) for being HIV-positive, and a history of male-to-male sexual contact was associated with a 62-fold increase in risk.

By comparison, the increase in risk for a history of multiple sexual partners of the opposite sex in the last year was 2.3-fold.

*  *  *

BloodDROPS examined the opinions of MSM regarding the blood donor deferral policy through web-based surveys of the MSM community and non-compliant MSM who donated blood (Ref. 33).

A key finding of particular note was that MSM, who comprise approximately 7% (Ref. 26) of the U.S. male population, represented an estimated 2.6% of male blood donors. Although the data were determined by different methodologies, they suggest an increase in the proportion of blood donors reporting MSM behavior from 0.6% in 1993 and 1.2% in 1998.

The qualitative responses by both donating and non-donating groups of MSM revealed that these individuals view the current policy as discriminatory and stigmatizing, and that some individuals knowingly donate despite the deferral...

The web-based community survey revealed that approximately 90% of MSM think the MSM blood donation deferral should change, and 59% of MSM reported they would comply with a change to a one-year deferral ...

*  *  *

Some epidemiologic data are available from countries that have changed their deferral policy for MSM (Refs. 34, 35). The most robust data measuring the impact of these policy changes are available from Australia (Ref. 36).

Australia also has a voluntary blood donor system and has a similar percentage of men reporting male-to-male sexual contact at some time during their lives (5% compared with 7% in the United States (Ref. 26).

During the five years before and five years after a change from a lifetime deferral to a one-year deferral in Australia, there was no change in risk to the blood supply, defined by the number of HIV positive donations per year and the proportion of HIV-positive donors with male-to-male sex as a risk factor.

In addition, the compliance rate with the one-year MSM deferral among male donors in Australia following the policy change was >99.7% (Ref. 37).

Of note, donors in Australia must sign a declaration in the presence of blood center staff that they understand that there are penalties, including fines and imprisonment, for providing false or misleading information. No such declaration is required in the United States, nor are donors advised of penalties for providing false or misleading information.

To comply with global regulatory requirements on deferral policies, manufacturers of blood and blood components, including Source Plasma, collected in the U.S. and intended for further manufacturing use in other countries, may not be able to implement FDA’s recommended 12 month donor deferral policy for MSM and instead may maintain longer deferral policies.


*  *  *

Considerations of the BOTS Working Group

Over the course of its deliberations, the BOTS Working Group reviewed and discussed several different options for the MSM policy:

• no change,

• change to a five-year deferral,

• change to a one-year deferral,

• change to a deferral less than one year,

• pre-testing of potential donors, and

• deferral based upon individual risk assessment.

Although not making a change would maintain the current level of safety of the blood supply, as noted above, there is evidence that the indefinite deferral policy is becoming less effective over time.

In addition, the indefinite policy is perceived by some as discriminatory. The data that a five-year deferral would be safer than a one-year deferral are not compelling.

However, some have argued that a five-year deferral would, in theory, add a safeguard by allowing time for intervention against an emerging infectious disease that might spread rapidly among MSM and be transmitted through blood transfusion.

Sufficient data are not available to assess the effectiveness of selecting MSM with low HIV risk based on deferral times of less than one year since last exposure.

The individual risk-based options were not determined to be viable options for a policy change at this time for a number of reasons: pretesting would be logistically challenging, and would likely also be viewed as discriminatory by some individuals, and individual risk assessment by trained medical professionals would be very difficult to validate and implement in our current blood donor system due to resource constraints.

Additionally, the available epidemiologic data in the published literature do not support the concept that MSM who report mutual monogamy with a partner or who report routine use of safe sex practices are at low risk for HIV.

Specifically, the rate of partner infidelity in ostensibly monogamous heterosexual couples and same-sex male couples is estimated to be about 25%, and condom use is associated with a 1 to 2% failure rate per episode of anal intercourse (Refs. 38, 39, 40, 41).

In addition, the prevalence of HIV infection is significantly higher in MSM with multiple male partners compared with individuals who have only multiple opposite sex partners (Ref. 28).

Change to a one-year deferral is also supported by other evidence, including the experience in countries that have already changed their policies to a one-year deferral (Argentina, Australia, Brazil, Hungary, Japan, Sweden and United Kingdom).

In addition, this change would potentially better harmonize the deferral for MSM with the one-year deferral in place for both men and women who engage in certain other sexual behaviors associated with an increased risk of HIV exposure (e.g., sex with an HIVpositive partner, sex with a commercial sex worker).

Thus, following careful review, the BOTS Working Group was supportive of a policy change to a one-year deferral for MSM.

*  *  *

Evaluating Alternative Policy Options Using Available Evidence

FDA is responsible for maintaining the safety of the blood supply in the U.S. FDA recognizes that the current indefinite deferrals for certain groups are not optimal. However, changes to the existing deferral policies must be made in the context of maintaining the high level of safety of the U.S. blood supply achieved to date.

The following is a summary of the practical and scientific considerations associated with various potential options regarding changing the blood donor deferral policy for reducing the risk of HIV transmission.

1. No change in policy, continue indefinite deferral.

Evidence indicates that the indefinite deferral policy for men who have had sex with other men, even once, since 1977 has become less effective over time. Similar data are not available for CSW and IDU.

The rate of non-compliance of MSM under the indefinite deferral policy appears to be increasing because the percentage of male donors estimated to be MSM has risen from 0.6% in 1993, to 1.2% in 1998, and to 2.6% in 2013. Therefore, it is appropriate to consider alternatives.

2. Eliminate any deferral related to HIV for all donors and rely on laboratory testing alone.

HIV testing on blood donated in the United States is currently implemented by assays including nucleic acid testing. Nucleic acid testing is generally performed on pools of 6 to 16 donor samples. Pooling of samples both markedly reduces the cost of testing and is associated with a reduced number of false positive samples.

The window period when recent HIV infection might be missed using this testing strategy is approximately 9 days. Given this, it has been suggested that no donor deferral is necessary, given the relatively low likelihood that a recently infected individual would give blood.

However, in the setting of the approximately 50,000 new HIV infections per year in the United States, conservative calculations performed by FDA estimate that this approach could potentially be associated with an approximately four-fold increase in HIV transmissions resulting from blood transfusions each year.

Such a policy, increasing the potential for the transmission of HIV infection, is not aligned with maintaining or improving the safety of the blood supply in the U.S.

3. Eliminate any deferral related to HIV for all donors and implement laboratory pre-testing.

Rapid tests for HIV infection have been approved, and could potentially be used at blood collection centers to prescreen potential donors in order to reduce collection of HIV-positive units.

However, such tests do not address the problem of identifying recently infected donors. Testing individuals 10 to 14 days in advance of blood donation and then retesting them on the day of donation could theoretically reduce the potential for window period transmission of HIV without the need for a prolonged period of sexual abstinence, so long as individuals refrain from sexual activity between the time that the initial testing is performed and the time of blood donation, when such testing would be performed again.

However, retesting donors for the millions of donations made each year would add significant burden to donors to appear for donation on two separate occasions and would add very significant logistic complexity to the blood donor system. For example, initial testing would need to be completed and the results would need to be available for review at the time individuals returned to donate during the specific time interval during which the results would be valid.

4. Individually assess donor risk.

Although individual donor assessment for risk of HIV and other infections has been implemented in a few countries, significant differences exist regarding the situation in those countries and the situation in the United States. For example, in South Africa, HIV transmission is primarily heterosexual and every unit is screened individually for HIV, given the epidemiology affecting all available blood donors.

Individual risk assessment presents significant challenges in the United States for a number of reasons. At this time there are inadequate data to support the effectiveness of the use of donor educational materials and questionnaires on safe sexual practices for the prevention of transfusion-transmitted infections through donated blood.

In addition, self-report of monogamy cannot be relied upon because of the relatively high rate of infidelity between partners in any type of sexual relationship (Ref. 38). Even if a potential donor is truthful in providing responses regarding his or her own behavior, the response may not be meaningful if a partner has not been monogamous.

Although the effectiveness of individual assessment of donor risk can be explored in the future, currently there is no validated and accepted individual risk assessment tool or questionnaire.

5. Implement a time-based deferral.

Although it might seem that any deferral longer than the 9 day window period would be effective, this assumption is incorrect because of recall bias, non-compliance, and other behavioral factors.

As a group, in the United States, MSM have the highest HIV risk: according to CDC, two-thirds of new HIV infections occur in the approximately 2% of the population who are MSM (Ref. 27). The risk of HIV among MSM is more than twenty-fold higher than that of men who have sex with multiple female partners and women who have sex with multiple male partners (Ref. 32).

Thus, absent another scientifically-validated way of identifying individuals at highest risk of transmitting HIV, a time-based deferral for MSM since last sexual encounter is the one deferral policy that has been demonstrated to be effective in a setting with similar HIV epidemiology to the United States.

The data available from the transition to a one-year deferral policy in Australia are particularly compelling because it monitored the effect of the change using a national blood surveillance program.

Data for the five years preceding and following the change from an indefinite to a one-year deferral showed no detectable decrease in safety of the blood supply.

Twenty-four HIV-positive donations were identified among 4,025,571 donations prior to the change in policy compared with 24 among 4,964,628 donations following it.

Scientifically robust data are not available for time-based deferral periods of less than one year.

[Faith Presses On]

Some highlights from the report:

* The total lifetime ban was getting less effective because a small, but growing and significant number of sexually active gay men were donating blood anyway. Many were doing so because they considered the ban discriminatory, so it seemed some change needed to be made.

* After carefully studying the matter, which is documented in the report, the FDA recommended the one-year waiting time after last sexual contact for MSM rather than completely lifting the ban for the following reasons:

- The extremely high levels of HIV infection among MSM.

- They determined that men who have a history of having sex with men still have a far greater incidence of HIV infection than do men who have many multiple partners.

- They also write that in both heterosexual and homosexual relationships considered to be monogamous, about 25% of them actually aren't, and it is the homosexual relationships that are falsely believed to be monogamous that are a much greater threat in terms of HIV infection.

They also note that a potential blood donor who is in a male homosexual relationship might truthfully report that his relationship is monogamous, even while his partner is having sexual contact with other men.

- For a variety of reasons, other options besides the one-year ban, such as simply relying on testing the blood or testing donors beforehand, aren't effective and/or practical.

* The report says that while the FDA knows that keeping this ban isn't a perfect solution, it is the best option among all the possibilities.

* The report also mentions the concern that a new infection might quickly spread among sexually active gay men and infect the blood supply before it could be detected.

[fella]

Contaminated haemophilia blood products

[JimRed]

Don’t let queers or druggies donate.

Does any one else remember an interview on a TV “news” show back in the early 80s with a homosexual who said that if AIDS was commonly spread among heterosexuals that research funding would increase dramatically, so the homosexualists were going to donate blood whenever possible?

[Thank You Rush]

Most interesting part of the whole post:

“”the White House responded that the ban will stay””

Someone goofed apparently - they couldn’t make a statement that made sense, could they?