Leadership to H.O.P.E.: HIV-­Positive Donations

As Dorry Segev, a transplant surgeon at Johns Hopkins University in Baltimore, Maryland, sat answering reporters’ questions in March, his patient was in a nearby hospital bed, recovering from an organ transplant that would make news around the world.

Segev, MD, PhD, led the team that conducted the first living HIV-positive-to-HIV-positive kidney transplant. The procedure’s apparent success proved, Segev said, that people living with HIV could have healthy enough kidneys to donate and survive. And people living with HIV in need of transplants warranted them.

“The door is now open” for more such transplants, he told reporters. “This is what HIV looks like today.”

But opening that door was a leadership lesson years in the making. And leadership is still underway, as physicians spearhead changes in hospital and statewide policies to bring in line with federal law the last few states that still penalize people living with HIV for donating organs.

H.O.P.E. in Action

The leadership work started long before Congress passed the HIV Organ Policy Equity (HOPE) Act in 2013. In 2003, says David Hardy, MD, an adjunct professor of infectious disease at Johns Hopkins University School of Medicine and member of the HIV Medical Association board of directors, leadership came from academia. Before any such transplants could happen, physicians needed to know that it was safe and cost-effective. So the HOPE trial was born.

This was a major step, says Hardy, who was not involved in the study. HIV itself used to be a disqualifying illness for receiving a transplant. Plus, “the process and followup for transplant is so expensive,” that some financial calculus had to be done. Would transplanting the few kidneys available to people with HIV be a “waste of resources?”

Between 2003 and 2009, researchers in Atlanta, Georgia; Pittsburgh, Pennsylvania; San Francisco, California; New York, New York; Boston, Massachusetts; Philadelphia, Pennsylvania; Chicago, Illinois; Baltimore, Maryland; Miami, Florida; and Washington, D.C.; conducted transplants on 150 people people living with HIV. And the verdict was that survival was just as likely in people living with HIV than those without HIV.

“The next thing we had to do was look for available organs,” Hardy says. This was a challenge. Now a new group of people qualified for transplants, but the supply of new organs hadn’t increase in kind.

There was a source, though.

“People who were HIV-positive couldn’t donate an organ, when they were alive or after they died,” he says. “That was really a wasted resource because of the law.”

It was an idea with precedent. Elmi Muller, MBChB, MMED, a doctor at Groote Schurr Hospital in Cape Town, South Africa, had been doing transplants from deceased donors since 2008. Plus, U.S. physicians had been doing transplants of hepatitis C-positive livers into recipients with hepatitis C for some time.

Armed with those precedents and gold-standard research to back them up, Hardy, other HIVMA physicians and advocates began to push for the HOPE Act. They argued that the law banning organ donation was archaic, “from a time and place of high anxiety and high fear in the medical and general population.”

But with new treatments that could fully suppress HIV, the law was now “standing in the way of good health care for citizens and jurisdictions.”

“Now we had science,” he says. “We have scientific evidence and scientific advances that tell a different story. I think that’s what really made the HOPE Act so successful.”

When the law passed in 2013, on the most basic level, it made it legal for people living with HIV to fill out organ donation cards. More significantly, perhaps, it allowed physicians and surgeons to put organs from people living with well-controlled HIV into the organ donation system.

Aligning State and Federal Policy

But that was just in theory. Limitations remained in the form of state laws, most of them passed in the late 1980s before effective treatment, that still banned people living with HIV from donating blood, semen or organs, for fear of HIV transmission. According to Brianna Doby, an organ donation community consultant with Johns Hopkins Medical Center, 29 states have no laws on HIV-positive organ donation, thus deferring to federal law.

Sixteen more states have provisions in their laws that allow organ donations from people living with HIV to donate to save a person’s life or as part of research. Other states had bans on organ donation at the time that HOPE passed. But most have swiftly changed their laws to align with federal legislation.

California was one of these. Although the California Legislature didn’t modernize its criminal statutes on HIV disclosure until 2017, it eliminated a ban on organ donation in 2016, largely because of community and medical leadership.

Hardy, for instance, used his position at the time as director of the division of infectious diseases at Cedars-Sinai Medical Center in Los Angeles to influence his colleagues to get on board.

“We got the liver people on board very quickly,” Hardy says — perhaps because there wasn’t an option like dialysis that could keep people in need of new livers alive while they waited for an organ. But kidney surgeons and nephrologists were a harder nut to crack.

“It stands to reason — surgeons may not be up to date on the advances in HIV treatment,” he said.

So what Hardy did was talk to individual nephrologists and surgeons. And he held grand rounds where he invited the South Africa doctor who’d done such transplants to talk about the success and answer questions.

“I made sure the nephrologist and surgeon were invited,” he says. “One showed up, one didn’t.”

The grand rounds helped demonstrate to surgeons that HIV exposure during transplant was no longer a risk. It taught the remaining physicians how far HIV treatment had come. But it was still a hard sell. Part of this in some areas, he says, was because some kidney transplant centers saw this new batch of HIV-positive recipients as “an intrusion.”

He says the attitude in some quarters was, “Our people are already waiting eight to nine years, and now you want us to open up to a whole other area of recipients?”

This extended to people’s reaction to Muller’s grand rounds. They were enlightened, he recalls, maybe even a little interested. But they didn’t necessarily think those transplants should be done at their hospital.

“What I found with this was that even armed with the best medical evidence — a randomized controlled trial — certain people couldn’t be convinced at all. Others said they’d be willing, but not to do it here,” he says. “I said, ‘Why not? We’re doing [HIV-positive] livers here, and it’s worked out just fine.’ ”

Eventually, he got just enough people on board to make it happen. One surgeon, he said, wouldn’t do an HIV-positive kidney transplant at all. But a younger surgeon would. The older nephrologist wouldn’t participate either. But he agreed that he wouldn’t stand in the way of the younger nephrologist’s involvement.

Moving Backward

But not all states were as responsive as California. Hardy says he has presented his medical expertise on HIV-positive organ donation in South Dakota, Missouri and Arizona. Those states no longer exclude people with HIV from donating an organ.

“It really takes a local effort,” he says. “National organizations like HIVMA can provide advocacy and direction, but the state laws have to be challenged and changed by individuals in those states.”

That’s what’s happening in Indiana. In 2016, a survey of 171 providers of HIV services in Indiana found that the vast majority thought it was illegal for people living with HIV to even sign an organ donation card. It’s not. The researcher, Indiana University-Purdue University School of Liberal Arts sociologist Carrie Foote, says that since the 2016 survey, physicians, providers and state health department officials have been enthusiastic about correcting this misinformation and supporting the HOPE Act in their states.

Indiana University Medical Center nephrologist Tim Taber, MD, is one of those. Indiana University is a participant in the HOPE in Action trial, a clinical trial funded by the National Institute of Allergy and Infectious Diseases, designed to continue to study and report on HIV-to-HIV organ transplants. Since the HOPE Act passed, he says, the only thing that’s stopped them from doing more HIV-positive transplants has been paperwork.

But it’s not as simple as it sounds. Not long after the HOPE Act passed, Indiana added Title 410 to its Administrative Code, explicitly prohibiting organ donations by people living with HIV.

So, it leaves providers in a tough spot, Doby says.

“Any law or health code that causes confusion for people living with HIV, physicians, nurses and public health workers about whether or not it’s legal to be an organ donor as a person living with HIV in Indiana is a problem,” she says. “It’s an opportunity for leadership from physicians to get laws passed that align with the HOPE Act and their own medical practice.”