On the peak 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 needed 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 stated. “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 complete blood – that’s, blood that hasn’t but been divided into its element components, comparable to platelets and plasma. That’s as a result of for the reason that early HIV epidemic, homosexual, bisexual, and different males who’ve intercourse with males (MSM) couldn’t donate complete 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 scale 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 to be?

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 contains the whole lot 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 ladies 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 Impression 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,” stated Louis Katz, MD, performing chief medical director for Impression Life. Blood vials then go down the corridor, the place they endure blood typing and testing for the whole lot from cytomegalovirus to West Nile virus to Zika to hepatitis B and C.

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

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

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

McCullough stated 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 stated that getting HIV by means of the blood provide is so uncommon that scientists need to estimate it utilizing fashions.

As HIV testing and remedy have advanced over time, these fashions present that the chance of HIV making it into the blood provide has additionally dropped, stated Brian Custer, PhD, director of epidemiology and coverage science on the Vitalant Analysis Institute. In 1986, fashions recommended that one unit of blood in 22,000 may include HIV. Extra not too long ago, these fashions estimate the chance 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, stated 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 stage of threat and it’s nearly like zero tolerance with homosexual males,” he stated 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 if you happen to’re attempting to guard individuals.”

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

Based on CDC information, receptive condomless anal intercourse carries the very 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 more than likely to have receptive anal intercourse, they aren’t the one ones who do. A 2020 modeling research within the American Journal of Reproductive Immunology recommended that 41% of latest HIV diagnoses in American ladies had been the results of condomless anal intercourse. There’s additionally some information that counsel that, for unknown causes, cisgender ladies’s rectal lining could also be extra susceptible to HIV than males’s.

And homosexual males aren’t the one individuals who get HIV. For 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 latest diagnoses, in line with the CDC. Proper now, the FDA isn’t learning deferral insurance policies for heterosexuals at increased threat of HIV, although, stated Custer.

Blood facilities do defer individuals 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 strategy 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 methods to decide when homosexual and bisexual males can provide blood. The research asks homosexual and bisexual males questions on their sexual habits, comparable to what number of companions males have had not too long ago and in the event that they use condoms or HIV prevention medicines, often known as pre-exposure prophylaxis (PrEP), stated Custer. The research gained’t be testing these questions amongst heterosexuals.

“These are the questions which may in the future be on a future blood donor historical past questionnaire,” stated Custer. “A up to date, science-based strategy to coverage is strictly what we’re attempting to do.”

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

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

And that ought to imply, Rawlings stated, {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 protected” donating blood, stated 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 mustn’t give blood,” he stated. “Present coverage doesn’t account for that.”

There could be one glitch in that advice, stated Custer, of the Vitalant Analysis Institute: HIV transmissions whereas somebody is utilizing HIV prevention meds inconsistently, although uncommon, might 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 checks would catch that, he stated.

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 will even check blood for concentrations of some of the widespread PrEP medication, tenofovir. After 2 weeks, contributors return to seek out out the outcomes of the HIV check 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 stated they hope to have research outcomes early subsequent 12 months.

It’s additionally attainable, he stated, 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 stated of the information 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 are able to to having the proof.”

However possibly it doesn’t should be sufficient. Because the FDA diminished 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. Thus far, researchers haven’t analyzed that information, however they anticipate to have outcomes by the tip of 2022.

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

No matter occurs, Katz stated it’s clear the FDA will want new information to make its choice.

Based on 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 checks might choose up a brand new an infection, after which base donations on precise particular person habits as a substitute of a blanket deferral primarily based on id.

“There’s no purpose we are able to’t do higher,” he stated. “Backside line, we don’t have a superb sense but for the perfect behavioral approaches, and that’s what the analysis is asking.”



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