HHS eases organ donation restrictions on HIV, hepatitis-infected donors

HHS on Thursday recommended removing some terms from its organ transplant guidelines that specifically characterize donors with HIV, and hepatitis B or C as a higher health risks in an effort to expand the pool of viable organ donors.

The change marks the first update to the guidelines involving the assessment and selection of organs for transplant since 2013.

HHS Secretary Alex Azar said the updated recommendations reflected advances in testing and treatment for HIV and hepatitis B and C viruses over the last several years. Those improvements have significantly lowered the infection risk to organ recipients.

“Updating our transplant guidelines to match the latest science will complement the other efforts the Trump administration is making to expand the supply of donated organs and incentivize transplants, allowing more Americans to live longer, healthier lives,” Azar said in a written statement.

The new guidance recommends organ transplant recipients receive a hepatitis B vaccination, and suggests changing the term “increased risk donor” to reduce the potential for bias by clinicians and patients against selecting organs from donors with HIV or hepatitis B and C.

“This guideline brings us one step closer to shortening the national transplant waiting list and saving more lives,” said Admiral Dr. Brett Giroir, assistant secretary for health in a written statement. “It reflects the impressive advances in testing and treatment over the last seven years and provides actionable steps that will protect transplant patients from HIV and hepatitis B and C viruses.”

The use of HIV-positive organs for transplant has only been allowed since 2013 with the passage of the HOPE Act, which allowed for kidneys and livers to be transplanted from HIV donors to HIV-positive recipients.

Over the years, transplant patients who were negative for HIV or hepatitis B and C were informed if a potential donor had certain factors that posed an increased risk for the organ recipient to contract those infections. Improvements in anti-retroviral therapies as well as the development of an effective cure for hepatitis C has made the prospect of using organs from infected donors less of a health risk.

In many ways, last year marked a milestone for advancing organ transplantation among both donors and recipients infected with those diseases. In March 2019, surgeons from Johns Hopkins University became the first in the world to transplant a kidney from one living donor living with HIV to a recipient also living with the virus.

And a study published last December found no significant differences in outcomes between heart transplant recipients who received organs from hepatitis C-positive donors and those who got organs from uninfected donors. Using hepatitis C-positive organs in non-infected patients has greatly expanded donor pools in the handful of transplant centers that have begun the practice. A sharp spike in hepatitis C rates over the past decade due to the opioid epidemic has increased the number of hepatitis C-infected donor organs.

Health officials are hopeful the new guidelines will help to alleviate some of the demand for viable organs. Currently, more than 110,000 patients in the United States are waiting for an organ transplant.

Since the start of the COVID-19 pandemic, organ transplants performed in the U.S. has dropped sharply, with the number of procedures falling by as much as 50% as of April, according to an analysis published last month in Lancet. While there has been a decrease in procedures, health officials claim the number of organ transplants has begun to increase.

“This is an important step forward for individuals in need of solid organ transplants,” said Dr. Robert Redfield, Centers for Disease Control and Prevention Director, in a written statement. “Today’s guideline is grounded in scientific evidence and advancements in testing technologies. These recommendations further expand the availability of life changing organs for those in need.”

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