Imagine that you’re living with HIV and you’ve just been diagnosed with liver failure. Your only hope is to receive an organ donation and undergo a liver transplant. But the chances of receiving a healthy liver are slim. Every ten minutes, someone is added to the national organ transplant waiting list, and, on average, 22 people die each day while waiting for a transplant. Many of them are HIV-positive patients who have liver or kidney disease.
However, HIV-positive patients are now gaining access to more donated organs—from people who had HIV. Thirteen institutions nationwide have been granted permission to conduct clinical trials of such organ transplants as of November 2016. Yale Medicine is the first in New England to receive approval.
“It’s an opportunity to decrease the waiting times for organ transplants for both HIV-positive and negative patients,” says Maricar Malinis, MD, medical director of transplant infectious disease at Yale Medicine.
We spoke to Dr. Malinis about Yale’s HIV-positive to HIV-positive organ transplant clinical trial, which is currently enrolling patients.
How did Yale Medicine get approved to start doing these transplants?
In 2014, transplant experts across the United States met to discuss the possibility of conducting a multicenter study on HIV-positive to HIV-positive transplant. Because of my interest in this effort, I discussed this with Drs. David Mulligan,Sanjay Kulkarni (Transplant Surgery), Richard Formica (Transplant Nephrology) and Merceditas Villanueva (AIDS program). All have given their unconditional full support to this endeavor. Our transplant center agreed to participate in the HOPE in Action program, which is a multi-center study led by the Johns Hopkins Hospital transplant team. In June 2016, we obtained approval from the Institutional Review Board and United Network for Organ Sharing.
What kinds of transplants are possible under the HOPE in Action study?
If you have HIV and chronic kidney disease, contact your kidney doctor or primary care doctor and discuss the option of kidney transplant. Your doctor can send a referral to the transplant center. (Contact Ricarda Tomlin either by email, firstname.lastname@example.org, or phone, 203-785-2073. Your information will then be sent to me or Dr. Villanueva.) An appointment will be scheduled to discuss whether or not you are a good candidate for a HIV-positive to HIV-positive organ transplant. Generally, we’re looking to see if you have well-controlled-HIV and if your medication is compatible with the anti-rejection drugs you will have to take after the transplant.
Why should patients consider getting an HIV-positive to HIV-positive organ transplant?
One of the biggest issues facing HIV patients seeking an organ transplant is the long waitlist. There are currently over 93,000 people on the kidney transplant waiting list in the United States and the wait for a kidney from a deceased donor can be up to 10 years.
Participating in our clinical trial is one way for HIV-positive patients to get off the broader organ donor waitlist. In addition, by getting HIV-positive patients off the organ transplant waitlist, we’re also freeing up organs for HIV-negative patients. So it’s good news for HIV-positive patients and HIV-negative patients.
Why wasn’t HIV to HIV organ transplant possible before? What has changed?
First of all, we’re just better at organ transplants in general. Over the years, there has been improvement in surgical techniques, immunosuppression drugs and prevention of post-transplant infections.
We also have better understanding of HIV. We have effective anti-retroviral treatments. HIV strains of both the donor and transplant candidate will be carefully reviewed by our team. Based on this, the appropriate anti-retroviral regimen will be given.
Are there risks associated with the HIV-positive to HIV-positive organ transplant?
The risks are similar to the risks associated with any standard transplant procedure—infection, or rejection of donated organ. There may also be a risk of a super-infection, which is when a person gets infected with a different strain of HIV. However, transplants in South Africa, HIV-positive recipients had reduced levels of HIV in their blood after kidney transplantation.
What are some things people should consider before deciding to enroll in the clinical trial?
If you participate in the clinical trial, you will be monitored for three years to see how you do. We’ll be doing regular blood work, monitoring your HIV and monitoring your graft function. Talk to your primary care doctor, HIV provider or kidney doctor to get a referral.
If I’m interested in participating, who should I contact?
Patients or their physicians can contact Ricarda Tomlin either by email email@example.com or phone 203-785-2073.