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 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 have been nonetheless, in our personal approach, forging higher science.”
On this case, the would-be volunteers have been capable of contribute antibodies, not complete blood – that’s, blood that hasn’t but been divided into its part components, reminiscent of 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 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 cut back the abstinence interval to three months.
Many, together with officers on the White Home, have lately argued that the present blood donation coverage is outdated and unscientific. However what may a extra science-based blood donation coverage appear like?
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 all the things from medical and prescription histories to a slew of questions on latest habits. These embrace questions on having had sexually transmitted illnesses, 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 Affect 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 Affect Life. Blood vials then go down the corridor, the place they bear blood typing and testing for all the things 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,” mentioned world blood advisor Jeffrey McCullough, MD, professor emeritus of laboratory medication and pathology on the College of Minnesota Medical Faculty.
Whereas all blood can now be screened, McCullough mentioned that blood banks want to start out with a clear pattern relatively than take away issues later within the course of.
“We wish to begin with the highest-quality product,” he mentioned. 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, mentioned 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 method to minimize down on danger?
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 way 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 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 prompt that one unit of blood in 22,000 may comprise HIV. Extra lately, 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 Faculty, describes these because the “hypocrisies” within the present system.
“In heterosexuals, we tolerate a excessive degree of danger and it’s nearly like zero tolerance with homosexual males,” he mentioned of the unique lifetime deferral coverage. “For those who 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 the event you’re attempting to guard folks.”
So what protects the utmost variety of folks most effectively, with the least danger and least quantity of discrimination? Right here’s what science says.
In response to CDC information, receptive condomless anal intercourse carries the best danger of HIV transmission, adopted by being the insertive associate in condomless anal intercourse. Then receptive companions in vaginal intercourse have the subsequent highest danger. The bottom danger is for 2 girls 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 examine within the American Journal of Reproductive Immunology prompt that 41% of recent HIV diagnoses in American girls have been the results of condomless anal intercourse. There’s additionally some information that recommend that, for unknown causes, cisgender girls’s rectal lining could also be extra susceptible 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 medicine made up 7% of recent diagnoses, in accordance with the CDC. Proper now, the FDA isn’t finding out deferral insurance policies for heterosexuals at larger danger 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 medicine, 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) examine is doing. Designed and funded by the FDA, the examine is contemplating different choices for find out how to decide when homosexual and bisexual males can provide blood. The examine asks homosexual and bisexual males questions on their sexual habits, reminiscent of what number of companions males have had lately and in the event that they use condoms or HIV prevention medicines, referred to as pre-exposure prophylaxis (PrEP), mentioned Custer. The examine received’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 recent, science-based method 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, mentioned Katz.
“By the late Nineties, we had nucleic acid checks – PCR, principally – that might 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 associate 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 associate and it was unprotected and within the final 7 days, I shouldn’t give blood,” he mentioned. “Present coverage doesn’t account for that.”
There may be one glitch in that advice, mentioned Custer, of the Vitalant Analysis Institute: HIV transmissions whereas somebody is utilizing HIV prevention meds inconsistently, although uncommon, may lead to simply sufficient remedy 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 mentioned.
That’s the place the ADVANCE examine is available in. Along with asking questions on males’s sexual habits and testing blood for HIV, researchers will even take a look at blood for concentrations of probably the most frequent PrEP medicine, tenofovir. After 2 weeks, individuals 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 danger is an actual danger. Custer mentioned they hope to have examine outcomes early subsequent yr.
It’s additionally doable, he mentioned, that individuals who take PrEP are at decrease danger of donating blood containing HIV as a result of the remedy is 99% efficient in stopping HIV. Proper now it’s a paradox.
“I don’t know if it is going to be sufficient,” he mentioned of the info 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 will to having the proof.”
However perhaps it doesn’t should be sufficient. Because the FDA lowered 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 information, however they anticipate to have outcomes by the tip of 2022.
It’s additionally unclear whether or not the ADVANCE examine will lead to modifications 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 primarily based on habits, not identification. That would make 4.2 million folks eligible. Primarily based on the share of eligible individuals who really donate, that might be a further 615,300 pints of blood.
No matter occurs, Katz mentioned it’s clear the FDA will want new information 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 habits as an alternative of a blanket deferral primarily based on identification.
“There’s no cause we will’t do higher,” he mentioned. “Backside line, we don’t have a great sense but for the perfect behavioral approaches, and that’s what the analysis is asking.”