Ten clinical trial participants were cured of hepatitis C after receiving a kidney transplant from deceased donors who were infected with the virus, according to a study led by Penn Medicine researchers.
The research, “Trial of Transplantation of HCV-Infected Kidneys into Uninfected Recipients,” was published in the New England Journal of Medicine.
Those needing a kidney transplant can be on a waiting list for five years before an opportunity arises. The study supports the notion that the medical profession needs strategies to increase the supply of kidneys for the nation’s 97,000-plus patients waiting for one.
Last year, Penn Medicine researchers started a clinical trial (NCT02743897) to evaluate the viability of transplanting kidneys from HCV-infected donors to uninfected patients on the kidney waitlist. Ten patients decided to try these otherwise unused kidneys instead of staying on the list.
All 10 were receiving dialysis treatment because of extensive kidney damage. They were between 40 and 65 years old, and had been on the transplant waiting list at least 18 months. All patients and their loved ones were informed of the risks involved.
Patients received a transplant an average of two months after enrolling in the trial. The waiting period ranged from 11 to 100 days.
Three days after surgery, each patient was tested for HCV – and all tested positive. The patients then received Zepatier (elbasvir and grazoprevir) for 12 weeks. The Merck antiviral therapy cured all 10 patients of the infection.
The U.S. Food and Drug Administration approved the therapy recently, after it proved highly effective in treating HCV.
Dr. David S. Goldberg, a Penn researcher involved in the trial, presented the results on April 30 at the 2017 American Transplant Congress in Chicago.
“We started this trial in the hopes that, if successful, we could open up an entirely new pool of donor organs, and effectively transplant hundreds, if not thousands, more patients who are awaiting a lifesaving organ,” Goldberg said in a press release.
“Historically, Hepatitis C-infected kidneys were often discarded, and were thought to be damaged or too high-risk. Our pilot data demonstrate the ability to cure the contracted virus following transplantation in this patient population. If future studies are successful, this may be a viable option for patients who may otherwise never see a transplant.” Goldberg added.
After the positive results, the team received an extension of the study to transplant 10 more patients. The researchers will also evaluate the approach in patients who need heart transplants. In the future, lung and liver transplants are expected to be tested for this approach as well.