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Ssmoking cigarettes and working in the paint and drywall business for 35 years silently ravaged Pete Bucciarelli's lungs. He did not learn how sick he was until 2010, after collapsing suddenly on the floor of his living room.
The doctors told him that he was suffering from severe emphysema and that despite surgical interventions and other treatments, his condition had deteriorated. He soon needed an oxygen tank. To clean his house became too painful, and he could no longer grocery shop: a puff of perfume or cologne made breathing difficult. In 2017, he was on the list of lung transplants.
"They told me that I only had a few months to live," said the 56-year-old from Bethlehem, NH. For patients like Bucciarelli, the median wait time for a lung transplant is nearly 13 months, and 40% longer than two years. . But he was offered a faster option – accepting the lungs of a donor infected with the hepatitis C virus, as part of a clinical trial to significantly expand the donor pool of # 39; organs.
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The results of this study, reported Wednesday, suggest that the lungs, as well as the hearts, can be safely transplanted from donors infected with the virus. A four-week antiviral cure prevented the infection of all recipients, and those followed for at least six months were doing well and remained uninfected.
The trial, published in the New England Journal of Medicine, is the largest of the cases where the safety of the infected lungs and heart is used. Researchers, led by Dr. Ann Woolley of Brigham and Women's Hospital, estimated that the use of organs from hepatitis C-infected donors could increase the supply of hearts and lungs by at least 25 people. %.
In the United States, 5,226 patients are currently waiting to be on the list of heart and lung transplants. There is a perpetual shortage of organs available for donation and it is estimated that about 1,000 patients die each year while waiting for a new heart or a new lung. . Many organs, including the heart and lungs, are discarded if it is proven or suspected that the donor was infected with the most common chronic hepatitis C virus (HCV) infection. in the United States, which is most often transmitted intravenously. use.
According to a newspaper editorial, in many parts of the country, nearly a third of the donor's organs now come from injecting drug users, many of whom are victims of the opioid crisis in the country. "At least in the short term," transplantation of HCV-infected donors into uninfected recipients is "a very promising way to speed up the transplantation of people and expand the donor pool," he said. Dr. Emily Blumberg, author of the editorial and professor of medicine at the University of Pennsylvania Hospital, told STAT.
In the past, HCV-positive donor transplants were associated with high levels of virus transmission to the recipient and increased mortality. The standard of care was to use these organs only in high-risk patients seeking a last resort or not using them at all. However, the arrival in 2014 of a new class of drugs targeting hepatitis C caused a radical change. These drugs are well tolerated, easy to take, and have a high cure rate for chronic HCV infections, although they are also very expensive.
This revolutionary change in the management of HCV has been the basis of the Brigham and Women Trial Protocol. Researchers began recruiting patients in March 2017. Donors and recipients were selected according to the same standard criteria for cardiac and pulmonary transplantation, except that donors were not disqualified they had already been infected with HCV. The antiviral treatment was started a few hours after the transplant and the patients were kept with these drugs for four weeks.
Bucciarelli was one of the first patients in the trial and said he had received a call informing him that a match had been made on July 4, 2017, just two months after the start of the registration procedure. "I'm going to go," he recalls to a friend. "Why do not you do it?" Replied the friend.
Five days after his transplant, he was told that there was no trace of HCV in his blood. Since then, he has spent two years without oxygen and has slowly returned to normal operation.
"I would recommend this medicine as strongly as possible," he said in an interview this week, during his visit to Brigham for a checkup. "It opens up a lot of possibilities for people."
Brigham researchers reported that 44 patients had cardiac or pulmonary transplantation positive for HCV. Thirty-five of them (28 lung recipients and seven hearts) had at least six months of follow-up, including 16 followed for one year. Immediately after transplantation, all recipients had hepatitis C viral loads in their bloodstream that were proportional to the viral load of the donors. Most patients were able to clear the infection after a few days of antiviral treatment and all had an undetectable viral load after two weeks of treatment.
There have been more cases of organ rejection in lung transplant patients than in a control group receiving uninfected lungs during the same period, but the researchers said this increase was not not statistically significant given the possible confusion between groups.
The test protocol has several advantages over those used in previous studies, the researchers reported. Since the drugs are active against all strains of HCV, treatment can be started immediately, without the delay that would be caused by testing the HCV strain in the donor. The team also preemptively treated the recipients without waiting for them to develop signs of infection. The belief is that it prevents the patient from getting infected in the first place and avoids infectious and non-infectious complications.
Finally, the drug regimen contrasts with the typical 12-week regimen. This significantly reduces the costs and burden of tablets for patients. Woolley said that, since the evidence suggests that patients participating in the trial had cleared the virus faster than four weeks, future studies might involve an even shorter duration of treatment.
Similar results were published by researchers at Vanderbilt University Medical Center and the University of Pennsylvania Hospital who studied cardiac grafts positive for HCV. Blumberg, one of the Penn trial investigators, said that the 10 patients who received a donor heart transplant for HCV-positive in this study were able to eliminate the infection. after 12 to 16 weeks of antiviral treatment.
Blumberg warned that these protocols are still in the research phase and require careful monitoring and investigation before being widely used. There are still many unanswered questions regarding the dosage and duration of antiviral drugs, the costs of treatment, applicability to all subpopulations of patients, and the best plans for long-term follow-up.
"We do not have long-term results," she said. "We do not know if 5, 10 or 20 years later [these drugs] will always work. … There are a lot of things about hepatitis C that we are just beginning to appreciate.
In the editorial, Blumberg expressed additional reservations about Brigham's findings: organ donors were "surprisingly young" and HCV carriers younger than non-infected donors. Infected organ recipients were also less severely affected than conventional cardiac or pulmonary transplant recipients. "Nevertheless, this article clearly argues in favor of a more in-depth review of the use of organs from HCV-infected donors," wrote Blumberg.
Previously, the topic of using HCV positive organs for transplantation was skeptical and reluctant to those working in the field of transplantation. But Woolley said she was optimistic that recent trials – not just transplant patients of the heart and lungs, but also kidneys and liver – will catalyze a paradigm shift in patient care transplanted. "We hope the transplant community will adopt it, which could lead to policy changes," she added.
Bucciarelli is equally optimistic and plans a trip to Italy. Rather than counting several months of life expectancy, he said he was looking forward to spending years with his new grandson and driving his Harley motorcycle.
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