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 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 have been nonetheless, in our personal method, forging higher science.”
On this case, the would-be volunteers have been in a position to contribute antibodies, not entire blood – that’s, blood that hasn’t but been divided into its part components, akin 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 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 provide blood in the event that they’d been abstinent for 12 months. After which, in 2020, contemplating the COVID-19 pandemic’s impression 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together with officers on the White Home, have not too long ago argued that the present blood donation coverage is outdated and unscientific.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 consists of every part from medical and prescription histories to a slew of questions on current conduct. 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 way of all these hurdles, workers at blood facilities like Impression Life, which gives 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 every part 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 drugs and pathology on the College of Minnesota Medical Faculty.
Whereas all blood can now be screened, McCullough stated that blood banks desire to begin with a clear pattern reasonably than take away issues later within the course of.
“We need 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 center of the difficulty: Is an extended abstinence interval actually required, or is there a greater, extra scientific technique to minimize down on danger?
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 way of the blood provide is so uncommon that scientists should estimate it utilizing fashions.
As HIV testing and therapy 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 advised 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 Faculty, describes these because the “hypocrisies” within the present system.
“In heterosexuals, we tolerate a excessive stage of danger and it’s nearly like zero tolerance with homosexual males,” he stated of the unique lifetime deferral coverage. “In case you have 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 in case you’re attempting to guard individuals.”
So what protects the utmost variety of individuals most effectively, with the least danger and least quantity of discrimination? Right here’s what science says.
In response to CDC knowledge, receptive condomless anal intercourse carries the best danger of HIV transmission, adopted by being the insertive accomplice in condomless anal intercourse. Then receptive companions in vaginal intercourse have the following highest danger. The bottom danger is for 2 girls having non-insertive intercourse. And whereas homosexual males are most certainly 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 latest HIV diagnoses in American girls have been the results of condomless anal intercourse. There’s additionally some knowledge that recommend that, for unknown causes, cisgender girls’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, almost 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 accordance with the CDC. Proper now, the FDA isn’t learning deferral insurance policies for heterosexuals at increased danger 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 conduct. 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 easy methods to decide when homosexual and bisexual males can provide blood. The research asks homosexual and bisexual males questions on their sexual conduct, akin to what number of companions males have had not too long ago and in the event that they use condoms or HIV prevention drugs, referred to as pre-exposure prophylaxis (PrEP), stated Custer. The research received’t be testing these questions amongst heterosexuals.
“These are the questions which may at some point 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 might 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 might be proven to be secure” 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 shouldn’t give blood,” he stated. “Present coverage doesn’t account for that.”
There may be one glitch in that suggestion, stated 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 checks would catch that, he stated.
That’s the place the ADVANCE research is available in. Along with asking questions on males’s sexual conduct and testing blood for HIV, researchers can even check blood for concentrations of some of the widespread PrEP medication, tenofovir. After 2 weeks, members return to seek out out the outcomes of the HIV check and fill out one other, longer questionnaire on private conduct. By correlating concentrations of the drug to HIV testing, they hope to determine whether or not that theoretical danger is an actual danger. Custer stated they hope to have research outcomes early subsequent yr.
It’s additionally doable, he stated, that individuals who take PrEP are at decrease danger 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 way of a mixture of testing biomarkers for an infection and PrEP use, in addition to self-reported behaviors, we’re going to come back as shut as we are able to to having the proof.”
However possibly it doesn’t must 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 this point, researchers haven’t analyzed that knowledge, however they anticipate 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 conduct, not id. That would make 4.2 million individuals eligible. Based mostly on the proportion of eligible individuals who really donate, that could possibly be an extra 615,300 pints of blood.
No matter occurs, Katz stated it’s clear the FDA will want new knowledge to make its resolution.
In response to 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 may decide up a brand new an infection, after which base donations on precise particular person conduct as a substitute of a blanket deferral based mostly on id.
“There’s no cause we are able to’t do higher,” he stated. “Backside line, we don’t have sense but for the very best behavioral approaches, and that’s what the analysis is asking.”
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