Feb. 15 (UPI) -- The country's first large-scale clinical trial to study the safety of liver transplants between people with HIV was launched on Thursday.
The new study -- sponsored by National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health -- will track the success of 80 liver transplants to HIV-positive people. Half of the livers will come from deceased HIV-positive donors and the other half will come from deceased HIV-negative donors.
This research comes after a 2018 study that similarly evaluated HIV-to-HIV kidney transplants.
Until the passage of the HIV Organ Policy Equity Act in 2013, liver transplants from an HIV-positive donor to an HIV-positive recipient were not legal in the U.S. This drove the demand for HIV-positive people with end-stage liver disease to receive the organ.
"Antiretroviral therapy has been incredibly successful in helping people with HIV live longer, healthy lives. As more people with HIV grow older, we see organ damage in this population linked to age, HIV and other infections," said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, in a news release. "The HOPE in Action Multicenter Liver Study will allow researchers to evaluate the safety and efficacy of transplanting livers from donors with HIV to HIV-positive recipients. This strategy has the potential to both improve the wellbeing of those with HIV and increase the overall supply of transplantable livers."
Three years after the HOPE Act passed, the country saw its first HIV-to-HIV liver and kidney transplants.
People with HIV have an increased risk of liver and kidney failure due to damage done to those organs by diabetes, the hepatitis B and C viruses and hypertension.
The world also has a shortage of kidneys to transplant. In the U.S. alone, there are more than 95,000 people in need of kidneys. That led the U.S. to ease its kidney donor restrictions.
"Liver transplants are the second most common type of organ transplant performed in the United States, and the number of people waiting for these life-saving procedures -- both with and without HIV -- increases every year," said Christine Durand, principal investigator of the HOPE in Action Multicenter Liver Study. "Should liver transplants between people with HIV be shown to be safe and effective through this research, the donor pool will expand -- saving lives and reducing the time that both HIV-negative and HIV-positive people spend on an organ transplant waiting list."
At the onset of the HIV pandemic, liver transplants to people with the virus from HIV-negative people were rarely successful. Recent studies, however, have shown that carefully selected HIV-negative people can donate livers and kidneys to HIV-positive patients who are otherwise healthy.
It is still illegal in the U.S. for people with HIV to donate any organ to HIV-negative recipients.
"Liver transplantation has a proven track record of saving and improving lives," said Jonah Odim, Chief of the Clinical Transplantation Section in National Institute of Allergy and Infectious Diseases' Division of Allergy, Immunology and Transplantation.
"The HOPE in Action team -- with the collaboration of the Organ Procurement and Transplantation Network, regional organ procurement organizations and the major transplantation centers participating in the trial -- is doing the important work of determining if transplants can provide equal benefit when the liver comes from a person with HIV."