This story reported on a study that showed 20 dialysis patients who were transplanted with kidneys infected with hepatitis C virus (HCV) and subsequently treated for the virus fared as well as patients who received non-infected kidneys. The study concluded that kidneys from HCV-infected donors “may be a valuable transplant resource.”
The story explained the novelty of using organs that might otherwise get thrown away. But it skipped over questions about availability, potential risks, and study limitations. Conflicts of interest also weren’t mentioned–and they were notable in this case.
The idea of using HCV-infected kidneys to fill a gap in demand is a potential innovation that merits news coverage. A kidney transplant often offers better quality of life, lower risk of death, and lower costs compared with years of dialysis, in which a machine does the work of a healthy kidney by removing waste from the blood. But it’s important that the limitations of the emerging research on this topic are carefully communicated. New direct-acting antiviral drugs that treat HCV, as we’ve noted, carry risks and have uncertain benefits.
The story quoted the lead researcher saying the “potential cost savings could be significant,” and the alternative — dialysis — “can cost more than $88,000 a year, according to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.”
But there was no data on the cost of a transplant or of HCV treatment–which is the intervention being studied.
According to various online sources, kidney transplants in the U.S. average just over $400,000, with the cost of anti-rejection drugs at several hundred dollars a month. Anti-rejection drugs must be taken for life.
The HCV treatment used in this study, Zepatier, has a list price of $54,600 for a 12-week treatment course and $72,800 for a 16-week course. Harvoni, which was listed as the best-selling HPV treatment in 2017, cost $63,000 for an eight-week course and $189,000 for a 24-week course.
This means that in reality, the cost comparisons are complex, which the story didn’t convey.
The story reported the main benefit of using infected kidneys, which is shorter wait time for a transplant. It said that the average wait time for a non-infected kidney is more than two years, compared to eight months for an HCV-infected kidney.
The story also said transplanting infected kidneys and then treating recipients for HCV resulted in a “100 percent cure rate. Half were evaluated six months after their transplant and the others a year after.”
It quoted the lead researcher, Peter Reese, M.D.: “And we found that these kidney transplants were working as well as kidney transplants from uninfected patients.”
We’ll rate this as satisfactory. However, we’d note that the story didn’t point out that we don’t know much about long-term benefits or overall survival at this point. Do these patients live as long? Are their rates of liver problems the same as those who receive uninfected kidneys? It will take much more than one year of follow-up to learn the answers to these questions.
The story acknowledged that “some patients might not want to take the risk associated with an infected kidney,” but we think the potential risks of this strategy warranted more discussion.
Hepatitis C causes inflammation of the liver that can lead to diminished liver function or failure of that organ. According to the study, one patient in the study experienced a serious adverse event, protein in the urine, which indicated liver malfunction and could have been triggered by the HCV infection. The condition improved after treatment, according to the published study.
Modern HCV treatments are not 100% effective at curing the disease and come with “black box warnings” for side effects such as low blood cell count, nausea, flulike symptoms, feeling tired, headache, and reduced appetite.
The story didn’t mention any study limitations.
For example, researchers said the results might not extend to other patient populations for a variety of reasons including the use of different HCV treatments and variations in adherence to a treatment regime or self-care.
The researchers also said a larger trial that tracks patients over a longer time is needed to assess potential complications. That detail wasn’t in the story, which instead quoted a researcher who said the study “should prompt transplant centers to rethink use of HCV-infected kidneys.”
The story said of the “roughly a half-million patients in the United States who were on dialysis for late-stage kidney disease in 2016, only 19,000 received kidney transplants.”
The story quoted one source not involved in the study, Adnan Sharif, MD, a consultant transplant nephrologist at Queen Elizabeth Hospital and University of Birmingham in the United Kingdom, who wrote an editorial that accompanied the study.
More importantly, the story didn’t inform readers that the study was funded by Merck, maker of the HCV drug combination elbasvir/grazoprevir, which is marketed under the name Zepatier. (Merck stands to profit from HCV-infected kidney donations becoming more common.)
It also didn’t mention that six of the study’s physician authors reported relationships with drug companies that make HCV treatments and/or transplant anti-rejection drugs. That included lead researcher Peter Reese, M.D., who is quoted extensively in the story. Reese reported grants from four companies including Merck and another HCV treatment maker, Bristol-Meyers Squibb.
The story made it clear that the alternative to receiving an infected kidney is waiting more than a year on average for a healthy kidney or remaining on dialysis.
The story could have done a better job of explaining what steps would need to be taken to make kidneys and other organs from infected donors available. Who would have to approve of this protocol? And what further evidence is required to confirm that it’s safe?
Moreover, it’s not clear how much the wait would be shortened by making HCV-infected kidneys available to patients who don’t have the virus. According to data cited in an accompanying editorial, 3,562 kidneys from donors with HCV have been discarded in the U.S. since 1995; that number seems small compared to the number of people in need of a kidney.
Also, given a rise in HCV-infected kidneys from young donors due to the opioid crisis, it seems that efforts to curb opioid misuse might diminish the availability of those organs.
The story explained that more effective and safer treatments to rid the body of HCV — along with the availability of kidneys from younger donors — have made this a potentially viable strategy to increase the kidney pool.
It also mentioned related research: “Another study, published in the same journal in July, reported similar success in transplants of HCV-infected kidneys into HCV-infected patients. About 15 percent of dialysis patients have HCV, the researchers said.”
The story does not appear to rely on a news release.