Align OPTN Policy with U.S. Public Health Service Guideline, 2020

At a glance

What is current policy and why change it?

In June 2020, the U.S. Public Health Service (PHS) updated the Guideline for assessing solid organ donors and monitoring transplant recipients for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection due to improved testing and risk assessment methods. The OPTN must change its policies to be consistent with the updated Guideline.

Align OPTN Policy with U.S. Public Health Service Guideline, 2020

Dr. Marian Michaels, past Chair of the Ad Hoc Disease Transmission Advisory Committee, reviews the policy proposal to Align OPTN Policy with the 2020 U.S. Public Health Service Guideline.

Terms you need to know

Hepatitis B Virus (HBV): Hepatitis B is a vaccine-preventable liver infection caused by the hepatitis B virus (HBV).
Hepatitis C Virus (HCV): Hepatitis C is a liver infection caused by the hepatitis C virus (HCV).
Human Immunodeficiency Virus (HIV): Human Immunodeficiency Virus (HIV) is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to Acquired Immunodeficiency Syndrome (AIDS).
U.S. Public Health Service (PHS) Guideline: Updated in 2020 from the 2013 revision, the Guideline provides recommendations for organ transplantation related to Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV).

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What’s the proposal?

Remove terms that label an organ donor “increased risk” in OPTN policy.
Shorten the length of time organ donors with risk criteria would be considered for acute HIV, HBV and HCV from 12 months to 1 month.
Remove medical and social donor risk criteria that have not been associated with risk of organ donor transmission of HIV, HBV, and HCV.
Add testing for all transplant recipients at 4-8 weeks post-transplant for HIV, HBV, and HCV.
Add liver recipient testing at 11-13 months post-transplant for HBV.
Remove requirement for separate recipient informed consent to accept an organ from a donor that meets any risk criteria. Promote patient education and require providers to inform candidates if the donor has any risk criteria.
During candidate evaluation, add a requirement to assess the need to provide HBV vaccination. Add requirement to report vaccination status.
Require transplant hospitals to store pre-transplant living donor samples for 10 years. This aligns with current policy for deceased donor samples.

What’s the anticipated impact of this change?

What it’s expected to do
- Increase number of transplants and minimize risk of transmission of HIV, HBV and HCV
- Provide a framework for discussion of risks and benefits of accepting and declining organs from donors with risk criteria for acute HIV, HBV, and HCV infection
- Promote early identification and treatment for HIV, HBV and HCV
What it won’t do
- This will not eliminate the need to inform candidates that organs have risk criteria for HIV, HBV, and HCV transmission
- This will not eliminate the absolute risk of disease transmission events