Penn Medicine announced today the launch of a clinical trial investigating the safety and efficacy of transplanting kidneys from deceased donors positive for hepatitis C virus infection to patients without the infection on the kidney transplant wait list.
The pilot study, known as THINKER, is spearheaded by David S. Goldberg, MD, MSCE, and Peter Reese, MD, MSCE, assistant professors of medicine and epidemiology at Penn Medicine, and is enrolling patients aged 40 to 65 years without HCV who are receiving chronic dialysis. The goal is to transplant infected kidneys to 10 patients who will be treated with an extended treatment regimen of Zepatier (elbasvir/grazoprevir, Merck). Treated patients will be classified as HCV-free only if they have undetectable levels of the virus 3 months after the oral regimen is complete, according to a press release.
Reese and Goldberg believe if this method of transplantation shows long-term efficacy, a minimum of 500 more kidneys could become available for transplantation each year.
“If we can demonstrate that it’s possible to eradicate HCV from patients who contract the virus from a transplant, this approach could open up access to an entirely new pool of donor organs that are currently being discarded,” Reese said in the release.
The first patient enrolled in the study received a kidney transplant in July, and after being treated with a full regimen of elbasvir/grazoprevir, there was no evidence of the virus in her blood, according to the release. The patient faced 5 years or more on the transplant waiting list with weekly dialysis before the trial.
The researchers said if this approach to transplantation works, there is the potential to provide a chance at a lifesaving kidney transplant for hundreds of additional patients annually, including patients without HCV.
David S. Goldberg
“We are aiming to evaluate safety and efficacy in only the most viable organs in this initial pilot phase of the clinical trial,” Goldberg said in the release. “We realized that the amazing transformation of treatment options for hepatitis C should also transform how we think about organs with hepatitis C. At this very early point in the study, we are pleased with how our first patients have responded to transplantation and antiviral treatment.”
Currently, patients with HCV are only eligible to donate organs to recipients who also have the virus. However, most organs positive for HCV are discarded and never used for transplantation.
The kidneys transplanted in the study will be HCV genotype 1-positive only, since the treatment regimen is most effective in this type of HCV infection. The researchers said there is a risk for patients who receive the HCV-positive kidney to become infected with HCV and never clear the virus despite the medication regimen.
“Ultimately, our hope is that this trial will show that it is possible [to eradicate HCV from patients who contract it through transplantation], and will then afford far more patients who are on the waiting list an opportunity to receive a lifesaving transplant much sooner,” Reese said.
There are currently more than 99,000 Americans are on the kidney transplant wait list, according to the release.
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