SAN FRANCISCO — Direct-acting antiviral medications can make the transplantation of organs infected with hepatitis C safe for recipients who do not have the virus, new research shows.
This finding could expand the pool of organs available for transplant, said Nikhil Kapila, MD, from the Cleveland Clinic Florida in Weston.
Because of the opioid crisis, "we're seeing a rise in the number of potential donors who are hepatitis C–positive," he said here at The Liver Meeting 2018.
Although the direct-acting antivirals are highly effective, many people go untreated because they don't know they are infected or because they don't have insurance plans that will pay for the treatment.
In addition, people in prison are often not treated, and they do enter back into the general population, Kapila told Medscape Medical News.
At the same time, wait times for people who need solid organ transplants can be long because of the lack of available donors, he explained.
To see if infected organs could be transplanted successfully, Kapila and his colleagues recruited 75 hepatitis-negative candidates for transplantation who agreed to receive an organ from a donor infected with hepatitis C. Acceptance of a viremic organ shortened the wait time for these patients.
Average age of the study participants was 66 years, 69% were men, 72% underwent kidney transplantation, 14.7% underwent liver transplantation, and 13.3% underwent heart transplantation.
|Table. Wait Times for Transplantation|
|Average Wait Time||Kidney (n = 54)||Liver (n = 11)||Heart (n = 10)|
|Days on waiting list||271||191||370|
|Days after agreeing to a viremic organ||31||48||33|
Most of the recipients became infected with the virus as a result of the transplant.
Treatment regimens — 33 patients received glecaprevir and pibrentasvir, 19 received sofosbuvir and ledipasvir, and two received sofosbuvir and velpatasvir — and duration of treatment were determined on the basis of genotype and renal function. No patient received ribavirin.
All therapy was covered by insurance, with the exception of one patient who was approved for only 2 months, but an additional month was provided by the drug manufacturer.
The virus is not detectable in any of the 27 recipients who have completed 12 weeks of treatment.
Of these 27 patients, three received livers and were infected with genotype 1a hepatitis C. Three received hearts and were infected with genotype 1a. And of the 21 who received kidneys, 12 were infected with genotype 1a, one with genotypes 2 and 3, one with genotype 4, two with genotype 2, and five with genotype 3.
Of the 45 patients who have completed 4 weeks of treatment, the virus is undetectable in 35.
"That's really quite incredible," said Tamar Taddei, MD, from the Yale School of Medicine in New Haven, Connecticut, who is a spokesperson for the American Liver Foundation. "We can offer the gift of life to many, many people."
Two patients died because of cardiopulmonary complications after liver transplantation. The most common adverse event was headache. No patients required discontinuation of direct-acting antiviral therapy.
Wait times were reduced when patients opted to receive an organ from a donor infected with hepatitis C. Kapila and his team plan to report those data in the future.
Waiting time is crucial, said Taddei. "Every day you wait you can succumb to complications. In my region of the country, patients can wait 12, 13, 24 months for a liver, and that is a very dicey waiting game."
Other data presented at the meeting also showed complete cures in patients who received an organ from a donor with hepatitis C, she pointed out. And in some of the studies, the approach was shown to be cost-effective, she added.
In a study presented by researchers from Massachusetts General Hospital in Boston, patients received a dose of antiviral therapy before transplantation surgery. It remains to be seen whether the duration of therapy can be shortened this way, said Taddei.
"I think we will do that work," she said. "Just this step is incredible. You're talking about hundreds of organs that would have gone in a garbage bin and instead they're been transplanted."
Already some transplant centers have started offering such organs to patients with long waits ahead of them, Taddei said. "I think this is happening all over the country." And this study provides validation for that approach, she said.
Kapila and Taddei have disclosed no relevant financial relationships.
The Liver Meeting 2018: American Association for the Study of Liver Diseases (AASLD): Abstract LB-19. Presented November 12, 2018.
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Cite this: Hepatitis C-Infected Organs Deemed Safe for Transplant - Medscape - Nov 14, 2018.