Q&A: Updated guidance expands access to transplants
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In June, HHS and U.S. Public Health Service issued updated guidance on solid organ transplants to increase the number organs available for transplantation.
Healio spoke with Infectious Disease News Editorial Board Member Peter Chin-Hong, MD, professor of medicine and director of the transplant infectious disease program at University of California, San Francisco, about the updated guidance and transplant medicine in general in the time of COVID-19.
Q: Which updates are most noteworthy?
A: The main thing is that all donors are going to be tested regardless of perceived risk factors for the big three — HIV, hepatitis B and hepatitis C — as opposed to before, when you would only follow-up on people considered at high risk or increased risk according to the CDC definition. Who is being perceived as "at risk" has changed in this document. There is no longer a designation of increased risk — everyone is considered at risk, so everybody will be tested both from the donor side and the recipient.
The section on hepatitis B immunization is also useful. Everything in the document appears to be "as advertised" and expected.
Q: What effect will the guidance have for patients in need of a transplant?
A: Overall, it is a good thing. I know that patients get scared by the term "increased risk." They think of somebody on a street corner with a needle stuck in their arm and imagine taking an organ from that person. Although we have done a lot of education over the years, there is still negative stigma for the big three. The chance of dying on the waitlist and not taking that organ is several-fold higher than taking that organ with the chance that you may have a false negative.
I think that observation has led to people turning down organs — not necessarily in big urban centers like San Francisco, where almost everybody is high risk in terms of donors, but in many other parts of the country where the term "increased risk" has a bad connotation to the patient. If you remove that term and inform them that everyone is being tested and followed up on after their transplant, then it potentially will increase the acceptability of organs and avoid having people throw away organs.
Q: What measures can be taken to improve the public’s understanding of the risk for acquiring an infection via a transplant?
A: I think people who are on the transplant list know about the risk for dying on the list based on the time to organ availability. What is really hard for people to understand, and this based on a lot of different studies of patient perceptions, is that people have no sense of comparing that risk with the risk for a false-negative test. Of course, there is a potential window period, but that is why I think the flip side of recommendation is to standardize repeat testing of recipients.
The other aspect that we should educate patients on is that we are in a completely different era than we were when these guidelines were last revised in 2013. If you have hepatitis C, we can effectively cure you. HIV is a chronic disease — even with the very unlikely chance that you get it via a transplant — and hepatitis B can be controlled, as well, albeit not as easily as you can cure hepatitis C. Your risk for dying on the transplant list is much higher than any of these perceived risks from infections.
Another thing we can educate patients about is that there is a lot of stigma with these labels of having HIV. I think that drove a lot of people to turn down these organs.
There is no comparison between how much more likely it is that you will die if you don't take the organ vs. the unlikely chance that you will experience a false negative and unknowingly get HIV, hepatitis B or hepatitis C.
Q: Are there areas of our transplant system that could use further revision?
A: Some of the room for improvement is in how we talk to patients. Not everybody is comfortable talking about risk and therapy. Understanding very old-fashioned things such as how you talk to patients about risk is important. They have to believe it themselves first. What we also understand from patient communication data is that patients trust what their physicians say to them, and if that physician is not convinced, there is no way that patient will be convinced. It has to start with that. Usually, that infectious disease doctor has not had that discussion of risk up front or has not sent them to someone else who is really sure. Communication can always be improved.
Hepatitis B , if you read through the documentation, probably has the longest potential window for a false negative. You can consider repeating the hepatitis B [nucleic acid testing (NAT)] in 1 year, whereas everybody gets the big three NATs at 1 month. But hepatitis B can sometimes have a bit of a longer window. I think that hepatitis B is still something that people can work on.
A lot of people’s behavior is driven by potential litigation. They haven't been successful, but there has been some litigation around increased-risk organs. One of the items in the guidelines would do away with specific informed consent around disease transmission. General consent will remain, and there used to be a specific consent that you gave to increased-risk donors. They did away with that.
People will continue to discuss risk with patients, which I still think they should. That may hold true if people do not discuss it, because they may not remember to discuss that far. In the old days, when you knew you were going to get an increased-risk donor, you had to get a separate patient consent. Now, you are not going to have to do that.
Some programs will continue their consent because they think it is safer and they don't have that many organs being turned down when they have done consent in that way. It all comes down to communication. I think consent is an interesting issue. The current guidelines say you don't have to do the second consent, but you should incorporate it in the discussion. I am worried that people won't include it in the discussion because they won't be prompted to do so.
Q: Will there need to be special considerations for COVID-19 and transplant recipients going forward?
A: Yes, I think it is important to reassure patients about what measures are being taken. In the hospital, we notice that patients are not coming in because they are afraid of COVID-19. Some do not come to the hospital even for transplant-related issues. Some discussion about the safety of the hospital and increased testing could be useful. When you get a transplant, even if you have no symptoms you are tested before your transplant. All potential donors are being tested, as well. That will help reassure patients that things are safe.
Part of the HHS document talks about reporting the rise in COVID-19 infections, but there has not been convincing COVID-19 transmission specifically among transplant patients. I think we are being considerate of COVID-19 because we do not know enough, but I don't think that blood-borne COVID transmission will be a common issue.
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