In March of this year, Johns Hopkins Hospital became the first hospital in the United States to transplant the organs of an HIV-positive donor into HIV-positive recipients. The liver and kidney transplants saved the lives of two people.
“This is an unbelievably exciting day for our hospital and our team, but more importantly for patients living with both HIV and end-stage organ disease. For these individuals, this could mean a new chance at life,” said Dorry L. Segev, M.D., Ph.D., professor of surgery at the Johns Hopkins University School of Medicine in a statement.
The surgery was the result of the striking down of a 25-year-old law prohibiting HIV-positive organs from being used for transplant. Those two recipients of the organs are part of a study with 30 patients expected to be enrolled at six medical centers nationwide, with five of those HIV-positive patients to come from Atlanta, where they and the doctors at Emory University will take part in this new step in medical history.
And the development will not only help HIV-positive people on the waiting list for organs, but also the HIV-negative ones on the list who will then move up in priority once the HIV-positive ones get the transplants they need.
The path to President Obama’s desk
In 1988, Congress adopted a law that prevented patients from receiving organs from HIV-positive donors. The law made sense at the time considering the lack of treatment options available for HIV-positive people and the damage that the virus can do on the kidney and liver in particular. But as new treatment options became available over the years and HIV-positive individuals began living longer lives, doctors started looking at the issue again.
It began in 2011 when the authors of a study at Johns Hopkins University published an article in the American Journal of Transplantation saying that a change in the policy could save up to 1000 lives.
“Around the same time they approached us to see if it was an issue we would like to take on and our board really enthusiastically took it up,” says Kimberly Miller, senior policy officer at the HIV Medicine Association (HIVMA), a Virginia-based organization that is home to more than 5,000 physicians, scientists and other health care professionals who practice HIV medicine.
HIVMA developed a policy statement and, with Johns Hopkins, started organizing a coalition of groups and developing materials to go to Capitol Hill and educate people on the issue. It took a couple of years of work, but by February 2013 a bill with bipartisan support was introduced, it passed both houses of Congress in June, and on November 21, 2013, President Obama signed the HIV Organ Policy Equity Act (or HOPE Act) into law.
“Our country has come a long way in our understanding of HIV and in developing effective treatments. And as our knowledge has grown, the possibility of successful organ transplants between HIV-positive people has become more real. The HOPE Act lifts the research ban. In time, it could lead to these organ donations for people living with HIV. And that, in turn, would help save and improve lives and strengthen the national supply of organs for all who need them,” said President Obama in a statement at the time. “Improving care for people living with HIV is critical to fighting the epidemic, and it’s a key goal of my National HIV/AIDS Strategy. The HOPE Act marks an important step in the right direction, and I thank Congress for their action.”
Safeguards written into the law
Implementation of the law took some time due to a number of precautions put in place in the language of the bill.
“It’s really one of the most highly regulated medical procedures that’s out there,” HIVMA’s Miller says. “With this they obviously wanted to be especially careful setting up safeguards and making sure that they had protocol to ensure the safety of the organ supply and that the organs would be appropriately matched. Also it was set up so that these transplants are initially done under research protocols only.”
That meant transplant centers that are doing these procedures have to get the approval of an Institutional Review Board, a committee used in research that approves, monitors and reviews any research involving human subjects in the United States. Luckily there was a bit of a roadmap thanks to doctors overseas.
“There had been some experience to draw on from South Africa where these HIV-to-HIV transplants were taking place as early as 2010,” Miller says. “Those clinicians and researchers have been closely collaborating so that when we undertake this in the U.S. we can learn from what the South Africans did. But they had tremendous success with it. They saw their patients do very well and we expect that to be the same here.”
The IRBs across the country will review the research annually and, with time and success, they can begin to recommend that the IRB restriction be lifted and the procedure be a normal option of care.
Shortage of organs in Georgia, nationally
The passage of the law in 2013 and the beginning of such HIV-to-HIV surgeries couldn’t have come soon enough for those on the waiting list for an organ.
“There’s a real shortage of organs in this country,” Miller says. “It’s another innovative way to free up more organs to save more lives.”
The latest statistics from the U.S. Department of Health and Human Services shows that there are about 123,000 people on the waiting list for organs nationally, with nearly 5,700 of those living in Georgia (90 percent of which are in need of a kidney transplant). Just one donor could potentially benefit 60 people according to the LifeLink Foundation, a national nonprofit organization that facilitates the donation of organs and tissues. LifeLink of Georgia serves 193 hospitals across the state.
“LifeLink supports the HOPE Act as an opportunity to save more lives through organ transplantation, and it will be our honor to help the families of individuals who are HIV-positive fulfill their loved ones’ decision to give the gift of life through organ donation,” says Kaysha Cranon, senior public affairs coordinator in the Atlanta office of LifeLink.
The Emory study on HIV-to-HIV transplants is now being reviewed by the IRB and, once approved, will be open for enrollment of HIV-positive patients in need of a kidney transplant. So what do HIV-positive people in the Atlanta area who are in need of a kidney do to enroll?
“If they have kidney failure, they’d be under the care of a nephrologist, and they would need to request that their primary care team refer them to Emory for a kidney transplant,” says Dr. Tom Pearson, executive director of the Emory Transplant Center and professor of surgery at Emory University School of Medicine. “They would need to be evaluated here at Emory for a kidney transplant just like any other patient.”
The five patients enrolled in the study at Emory and 30 enrolled nationwide will be followed up with for up to three years, with study-wide completion estimated to occur by June 2019.
How To Become An Organ Donor
You can register as an organ donor when you get or renew your license at the Georgia Department of Driver Services. You can also designate your decision to be an organ donor online at www.donatelifegeorgia.org.