Hearts and lungs from people infected with hepatitis C are safe for transplantation because the virus can be effectively treated in the recipient, new data show.
The cure for hepatitis C infection has been “a real medical breakthrough for an otherwise morbid disease,” said Michael Mulvihill, MD, from Duke University in Durham, North Carolina.
And it is “a highly actionable breakthrough when applied to the transplant population,” he said at the International Society for Heart and Lung Transplantation 2018 Scientific Sessions in Nice, France, where he presented a study on hepatitis C and lung transplant safety.
Mulvhill’s presentation was one of three at the meeting to look at the safety of organs transplanted from donors with hepatitis C into uninfected recipients.
Two of the studies showed that hepatitis C virus transmitted during transplantation can be safely eliminated. The other showed that the virus is not passed on when the donor’s virus is present and transmissible but not detectable in serum at the time of transplantation.
These findings could dramatically expand the organ donor pool, as previously described by Medscape Medical News.
Expanding the Organ Donor Pool
Preliminary data from the largest study presented — on 33 of 41 patients who underwent heart or lung transplantation — showed that viral replication in the recipient can be blocked with a pre-emptive hepatitis C regimen initiated on the day of transplantation.
What’s more, transmission of the virus was stopped altogether with a 4-week course of sofosbuvir and velpatasvir, rather than the regular 12- to 24-week course, said Ann Woolley, MD, from Brigham and Women’s Hospital in Boston.
With a baseline viral load proportional to the donor viral load, a sustained viral response at 12 weeks, indicating that the virus is undetectable, was achieved with 4 weeks of treatment and maintained during the follow-up period.
“Hep C cure can be achieved with a short duration — 4 weeks — initiated within hours of transplant, regardless of the hep C genotype,” Woolley pointed out.
To date, no adverse events have been reported, she added. At 1 and 6 months after transplantation, length of hospital stay and graft survival rates were similar whether or not organs came from donors infected with hepatitis C.
In another study, investigators assessed transmission in an ongoing study of 12 patients who received a heart or heart plus kidney from donors infected with hepatitis C.
The virus was transmitted by the 10 donors who were viremic at the time of transplantation, but not by the two who were not.
Outpatient Treatment Successful
“The two nonviremic transplant recipients did not require treatment,” said Saima Aslam, MD, from the University of California, San Diego.
“They have positive antibodies carried over from donor blood, but no evidence of the virus,” she told Medscape Medical News.
Aslam and her colleagues are still following the patients, 350 days after transplantation, and plan to do a long-term follow-up with biopsies. They say they are confident that the procedure is safe, so now want to bring it to clinical practice.
The community has to look hard at how this can be accessible to patients — especially when it comes to the healthcare system’s expenditure for hepatitis C treatment, which can range from $45,000 to $75,000, said Aslam.
“Our community needs to have this discussion and to devise a framework where hepatitis C–positive organ transplants can be safely performed, with standardization of outcomes and follow-up,” she explained.
I’m cautiously optimistic that we can use hepatitis C–positive organs to expand the donor pool.
For more than a decade, the donor pool has remained static while the number of people on the wait list has skyrocketed. “We need to think outside the box, in a safe manner. We are seeing evidence that we can treat hepatitis C in transplant patients,” she said. “I’m cautiously optimistic that we can use hepatitis C–positive organs to expand the donor pool.”
Nonviremic Donors
Using only nonviremic hepatitis C donors could speed up the standardization of this practice, according to another research team.
In a study of 64 patients, organs transplanted from the 13 donors who were nonviremic and who had hepatitis C antibodies but screened negative on nucleic antigen testing (NAT) did not transmit the virus, Mulvihill reported.
These 13 patients, who required no treatment, underwent hepatitis C antibody testing and NAT protocols at 2 and 12 months.
As of the presentation, “all recipients are alive and NAT-negative,” said Mulvihill.
The decision to accept an infected organ is still very much in the hands of the patient, but with a shortage of donors, many recipients are willing to take the risk. “We know that candidates want to wait for the best possible donor, but they need to survive long enough to receive a subsequent offer,” he explained.
Opioid Epidemic Deaths Increasing Number of Donors
The expanding donor pool is clouded by the shadow of the ongoing opioid epidemic, all the researchers acknowledge.
In the past 10 years, deaths in the United States related to drug overdoses have increased by 270%, and half of these people have hepatitis C when they die, said Woolley.
Most donors in all three studies were in their 30s, which is much younger than donors used to be.
“The opioid epidemic changes the demographic of the heart, lung, and kidney donor pool,” Mulvihill told Medscape Medical News. “This is the element we’re all trying to sort through right now.”
Woolley, Aslam, and Mulvihill have disclosed no relevant financial relationships.
International Society for Heart and Lung Transplantation (ISHLT) 2018 Scientific Sessions: Abstract 340, presented April 13, 2018. Abstracts 170 and 172, presented April 12, 2018.
Follow Medscape on Twitter @Medscape and Ingrid Hein @ingridhein
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