Small studies show good outcomes for previously uninfected recipients who receive kidneys from donors infected with hepatitis.
Given a choice between dialysis and a kidney transplant, a transplant is the clear choice to make due to longer survival odds. But for the roughly 95,000 patients currently waiting on transplant lists, dialysis is the only option due to a dearth of suitable donor kidneys. However, the definition of “suitable” may be changing as researchers discover the potential in donor kidneys that previously would have been discarded because they’re infected with hepatitis C virus (HCV).
Recent studies have confirmed that placing HCV-infected kidneys into recipients with HCV often results in positive outcomes and few complications. Now, a team led by Peter P. Reese, MD, MSCE and David S. Goldberg, MD, MSCE, epidemiologists and transplant surgeons at Penn Medicine in Philadelphia, Pennsylvania, has found that implanting HCV-infected kidneys into recipients who don’t have HCV also leads to positive outcomes.
The team conducted a trial known as THINKER (Transplanting Hepatitis C kidneys Into Negative KidnEy Recipients), which involved transplanting HCV-positive kidneys into 10 uninfected donors. After the transplants, tests revealed that all 10 had detectable levels of HCV in their blood; however, 12 weeks after receiving treatment for HCV, not 1 of the 10 had any detectable virus in their systems, and their new kidneys functioned well. Wanting more data, the team implanted HCV-infected kidneys into 10 more uninfected patients. The expanded trial allowed the researchers to take a more long-term look at the results, including how well the new kidneys continued to function, whether participants remained free of HCV, and how good their quality of life was.
All 20 participants had undetectable levels of hepatitis in their blood 12 weeks after finishing a treatment course, with the first 10 participants still free of the virus 1 year later. None of the 20 rejected the transplanted kidneys, although a few did develop antibodies. As far as quality of life, the average physical component score did decrease somewhat for the first 4 weeks post-transplant but then rose higher than before transplantation.
Could using HCV-infected kidneys in uninfected recipients be a turning point for patients whose only option so far has been hours of dialysis every week? Dr Reese and other experts think so. The THINKER study’s results were similar to an earlier study conducted at Johns Hopkins known as EXPANDER (Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients), which transplanted HCV-infected kidneys into 10 uninfected donors. Dr Reese and his team have proposed a trial to the National Institutes of Health that would involve 200 transplant recipients, although he’s unsure yet how large any future trials would be.
The Penn team is optimistic, however, that any results will generally be positive. “We do not know the probability of HCV cure, but so far from the THINKER and EXPANDER trials and other work, it appears as if the probability of cure is very high,” Dr Reese told Contagion®. Complication rates, on the other hand, cannot be predicted. “We need a larger study to determine how many patients will need a second round of antiviral treatment to be cured, how many may develop immunological complications, etc. There is some evidence from prior studies that patients with hepatitis C after transplantation are at greater risk of immunological responses like antibodies against the donor organ (which can cause rejection), problems with the vasculature, or diabetes.” Dr. Reese would like to see Medicare and other insurance providers cover post-transplant hepatitis medications; without this coverage, he says, recipients may not be able to be cured of hepatitis after receiving an HCV-positive kidney.
Ironically, the positive results of the THINKER study were possible partly as a result of a national tragedy: rising rates of opioid use among young individuals. “[M]any of these donors are young people who became addicted to drugs, contracted hepatitis C [from needle use] and died of an overdose,” said Dr Reese. “As a result of their young age, they often were otherwise in quite good health and their organs function very well. Their organs may provide particular benefit to young transplant recipients. [They] should not go to waste.”
Ms. Saloman is a health writer with more than 20 years of experience working for both consumer-and physician-focused publications. She is a graduate of Brandeis University and the Medill School of Journalism at Northwestern University. She lives in New Jersey with her family.