HealthDay neglects the potential harms of transplanting hepatitis-infected kidneys

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

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.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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.”

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

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.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

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.