Penn Medicine Launches Clinical Trial to Transplant Kidneys from HCV-positive Donors

Penn Medicine Launches Clinical Trial to Transplant Kidneys from HCV-positive Donors

A research team at Penn Medicine launched a clinical trial examining the effectiveness and safety of using kidneys from deceased donors who had hepatitis C virus (HCV) for patients without the infection, providing a potential opportunity for those who need a kidney transplant.

Dr. David S. Goldberg, MD, MSCE, and Dr. Peter Reese, MD, MSCE, both assistant professors of medicine and epidemiology at Penn Medicine, are the leading investigators of THINKER (NCT02743897), the pilot clinical trial currently enrolling patients ages 40 to 65 without HCV who are on chronic dialysis.

Researchers plan to transplant kidneys from deceased hepatitis C-positive donors into 10 patients in the pilot study. All patients will receive an extended treatment regimen of Merck’s Zepatier (elbasvir and grazoprevir). Treated patients will be classified as free from HCV infection if they have undetectable levels of the virus three months after completing the oral regimen.

The researchers said that if this transplant method shows long-term effectiveness, at least 500 more kidneys could become available for transplant 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 a news release.

The first participant in the clinical trial received a kidney transplant in July. After being treated with a full regimen of Zepatier, the patient’s doctors announced that there was no evidence of the virus in the patient’s blood. Before the trial, the patient was on weekly dialysis and was on a five-year or more kidney transplant waiting list.

“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. “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.”

Conventionally, a kidney infected with HCV would be offered only to transplant patients who already have the disease. Most organs that test positive for HCV are discarded and never used for transplants.

In the study, patients will only receive HCV genotype 1-infected kidneys because the viral treatment used in this study is most effective in eradicating that type of hepatitis C. Zepatier is and FDA-approved drug used to treat chronic HCV genotypes 1 or 4 infection in adults.

“Ultimately, our hope is that this trial will show that it is possible [to eradicate HCV from patients who contract it through transplant], and will then afford far more patients who are on the waiting list an opportunity to receive a lifesaving transplant much sooner,” Reese said.

Penn transplant specialists see HCV-infected kidneys as a potentially valuable opportunity to expand the pool for which 99,000 Americans are on a kidney transplant waiting list.

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