Who Should Be Allowed to Donate Blood?

On the top of the pre-Delta variant COVID-19 pandemic, Stephen Rawlings, MD, PhD, was doing HIV and SARS-CoV-2 analysis when a pair of males, a pair, got here to him. Each of them had had COVID-19. Each wished to donate convalescent plasma or in any other case contribute to stopping the virus. Rawlings needed to inform them no.

For Rawlings and his principal investigator (PI), it was a weird second.

“Right here the PI was a homosexual man, I used to be a homosexual man, and there have been these two males – and all of us couldn’t donate,” Rawlings mentioned. “However we had been nonetheless, in our personal manner, forging higher science.”

On this case, the would-be volunteers had been capable of contribute antibodies, not entire blood – that’s, blood that hasn’t but been divided into its element components, resembling platelets and plasma. That’s as a result of because the early HIV epidemic, homosexual, bisexual, and different males who’ve intercourse with males (MSM) couldn’t donate entire blood. At first, it was ever, even when they’d had intercourse with one man in 1978 and by no means once more. In 2018, the U.S. Meals and Drug Administration (FDA) allowed homosexual males to present blood in the event that they’d been abstinent for 12 months. After which, in 2020, contemplating the COVID-19 pandemic’s affect on the blood provide, the FDA modified the coverage once more to cut back the abstinence interval to three months.

Many, together with officers on the White Home, have not too long ago argued that the present blood donation coverage is old-fashioned and unscientific. However what may a extra science-based blood donation coverage appear like?

Danger of buying HIV by means of blood merchandise has dropped within the final 35 years

What we name the U.S. blood donation coverage is definitely an amalgam of standards that folks should meet earlier than they’re allowed to donate. It consists of every thing from medical and prescription histories to a slew of questions on latest habits. These embrace questions on having had sexually transmitted ailments, nonprescription injection drug use, and up to date tattoos, amongst others. As well as, males additionally should not have had intercourse with one other man within the final 3 months, and girls should not have had intercourse with a person who’s had intercourse with one other man within the final 3 months. As soon as an individual will get by means of all these hurdles, employees at blood facilities like Influence Life, which supplies blood to a number of dozen hospitals within the U.S., will examine an individual’s arms for needle tracks.

Discovering none, the customer “lays down and bleeds,” mentioned Louis Katz, MD, appearing chief medical director for Influence Life. Blood vials then go down the corridor, the place they bear blood typing and testing for every thing from cytomegalovirus to West Nile virus to Zika to hepatitis B and C.

After which, in fact, there’s HIV, “the poster-child an infection that we fear about,” mentioned international blood advisor Jeffrey McCullough, MD, professor emeritus of laboratory drugs and pathology on the College of Minnesota Medical College.

Whereas all blood can now be screened, McCullough mentioned that blood banks want to begin with a clear pattern quite than take away issues later within the course of.

“We need to begin with the highest-quality product,” he mentioned. And whereas seven HIV assessments can be found now to check the blood provide, together with PCR, antigen, antibody, and nucleic acid assessments, assessments are by no means 100% correct, mentioned McCullough. The query of how clear is clear sufficient is the guts of the difficulty: Is a protracted abstinence interval actually required, or is there a greater, extra scientific option to minimize down on threat?

McCullough mentioned that the present blood provide is the most secure it is ever been – even with the now 3-month deferral in homosexual and bisexual males giving blood. And Katz mentioned that getting HIV by means of the blood provide is so uncommon that scientists must estimate it utilizing fashions.

As HIV testing and remedy have developed over time, these fashions present that the danger of HIV making it into the blood provide has additionally dropped, mentioned Brian Custer, PhD, director of epidemiology and coverage science on the Vitalant Analysis Institute. In 1986, fashions advised that one unit of blood in 22,000 may comprise HIV. Extra not too long ago, these fashions estimate the danger of HIV making it into the blood provide at 1 in 1.5 million to three million.

However the U.S. blood donation coverage is filled with contradictions, mentioned Jeff Crowley, former director of the White Home Workplace of Nationwide AIDS Coverage. Crowley, now a professor at Georgetown College Regulation College, describes these because the “hypocrisies” within the present system.

“In heterosexuals, we tolerate a excessive degree of threat and it’s virtually like zero tolerance with homosexual males,” he mentioned of the unique lifetime deferral coverage. “Should you had been a heterosexual man who had condomless intercourse with a intercourse employee, you may get deferred for six months. However it was a lifetime deferral for homosexual males. It simply doesn’t make any sense when you’re making an attempt to guard folks.”

So what protects the utmost variety of folks most effectively, with the least threat and least quantity of discrimination? Right here’s what science says.

Homosexual males aren’t the one ones who’ve anal intercourse, and so they’re not the one ones who get HIV

In accordance with CDC knowledge, receptive condomless anal intercourse carries the best threat of HIV transmission, adopted by being the insertive accomplice in condomless anal intercourse. Then receptive companions in vaginal intercourse have the subsequent highest threat. The bottom threat is for 2 ladies having non-insertive intercourse. And whereas homosexual males are most definitely to have receptive anal intercourse, they aren’t the one ones who do. A 2020 modeling research within the American Journal of Reproductive Immunology advised that 41% of recent HIV diagnoses in American ladies had been the results of condomless anal intercourse. There’s additionally some knowledge that counsel that, for unknown causes, cisgender ladies’s rectal lining could also be more vulnerable to HIV than males’s.

And homosexual males aren’t the one individuals who get HIV. As an example, practically 1 in 4 new HIV transmissions within the U.S. occurred in heterosexual adults in 2019. Individuals who inject medication made up 7% of recent diagnoses, in line with the CDC. Proper now, the FDA isn’t finding out deferral insurance policies for heterosexuals at greater threat of HIV, although, mentioned Custer.

Blood facilities do defer folks from donating blood if they’ve a historical past within the final 3 months of intercourse work or injecting medication, nonetheless.

A extra science-based method could also be to ask everybody about their sexual habits. However that’s not what the Assessing Donor Variability And New Ideas in Eligibility (ADVANCE) research is doing. Designed and funded by the FDA, the research is contemplating different choices for the way to decide when homosexual and bisexual males may give blood. The research asks homosexual and bisexual males questions on their sexual habits, resembling what number of companions males have had not too long ago and in the event that they use condoms or HIV prevention medicines, referred to as pre-exposure prophylaxis (PrEP), mentioned Custer. The research gained’t be testing these questions amongst heterosexuals.

“These are the questions that may in the future be on a future blood donor historical past questionnaire,” mentioned Custer. “A up to date, science-based method to coverage is strictly what we’re making an attempt to do.”

HIV assessments can detect an infection sooner and with extra precision

Again when the ban on homosexual males donating blood got here out, there have been no assessments for HIV. A ban was a blunt instrument. However it has lengthy since been changed by correct HIV assessments, mentioned Katz.

“By the late Nineties, we had nucleic acid assessments – PCR, principally – that would detect HIV inside 7 to 10 days,” he mentioned.

And that ought to imply, Rawlings mentioned, {that a} homosexual man in a mutually monogamous relationship for the final 10 years the place neither accomplice has HIV ought to have the ability to donate the identical as anybody else. “I’m pretty assured that monogamous homosexual males will be proven to be secure” donating blood, mentioned Katz.

Rawlings is himself one such man.

“If I’d had a brand new intercourse accomplice and it was unprotected and within the final 7 days, I shouldn’t give blood,” he mentioned. “Present coverage doesn’t account for that.”

HIV prevention medicines could complicate the effectiveness of testing, although

There is likely to be one glitch in that suggestion, mentioned Custer, of the Vitalant Analysis Institute: HIV transmissions whereas somebody is utilizing HIV prevention meds inconsistently, although uncommon, may end in simply sufficient medicine within the blood to maintain the extent of virus within the blood very low. It’s unclear whether or not present assessments would catch that, he mentioned.

That’s the place the ADVANCE research is available in. Along with asking questions on males’s sexual habits and testing blood for HIV, researchers can even take a look at blood for concentrations of one of the vital widespread PrEP medication, tenofovir. After 2 weeks, members return to search out out the outcomes of the HIV take a look at and fill out one other, longer questionnaire on private habits. By correlating concentrations of the drug to HIV testing, they hope to determine whether or not that theoretical threat is an actual threat. Custer mentioned they hope to have research outcomes early subsequent yr.

It’s additionally potential, he mentioned, that individuals who take PrEP are at decrease threat of donating blood containing HIV as a result of the medicine is 99% efficient in stopping HIV. Proper now it’s a paradox.

“I don’t know if it will likely be sufficient,” he mentioned of the info they’ll be gathering. “By means of a mixture of testing biomarkers for an infection and PrEP use, in addition to self-reported behaviors, we’re going to return as shut as we will to having the proof.”

However perhaps it doesn’t have to be sufficient. Because the FDA decreased the MSM deferral interval to three months in April 2020, the Transfusion-Transmissible An infection Monitoring System (TTIMS) has been following whether or not there’s been an uptick in donations containing HIV. To date, researchers haven’t analyzed that knowledge, however they count on to have outcomes by the tip of 2022.

It’s additionally unclear whether or not the ADVANCE research will end in adjustments to the FDA’s deferral insurance policies for homosexual males. If it does, the U.S. will be part of the U.Ok., France, and Greece, amongst others, to donate based mostly on habits, not id. That would make 4.2 million folks eligible. Primarily based on the proportion of eligible individuals who truly donate, that might be an extra 615,300 pints of blood.

No matter occurs, Katz mentioned it’s clear the FDA will want new knowledge to make its determination.

In accordance with him, a greater science-based coverage may defer non-monogamous homosexual males from giving blood for 7 to 10 days after their final sexual expertise, in order that HIV assessments may choose up a brand new an infection, after which base donations on precise particular person habits as an alternative of a blanket deferral based mostly on id.

“There’s no purpose we will’t do higher,” he mentioned. “Backside line, we shouldn’t have a great sense but for the most effective behavioral approaches, and that’s what the analysis is asking.”

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