Large-scale clinical trial begins to study liver transplantation among HIV-positive people

The first large-scale clinical trial of HIV-positive liver transplantation began in clinical centers across the United States. The HOPE in Action Multicenter Liver Study will determine the safety of this practice by evaluating liver recipients for potential complications badociated with transplantation and HIV after surgery. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, and follows the launch in 2018 of a similar study on the evaluation of kidney transplantation between HIV-positive people.

While organ transplants between donors and recipients of HIV have been successfully completed in South Africa since 2008, they were illegal in the United States until the HOPE HIV / AIDS Act pbaded in 2013. The HOPE law allows American transplant teams. with an approved research protocol for transplanting organs from HIV-infected donors to qualified HIV-infected and terminally-endemic recipients, a practice that can reduce waiting time before receiving a graft. Organs transplanted from HIV-infected donors to HIV-negative recipients remain illegal in the United States.

People living with HIV are at increased risk of end-stage liver and kidney disease due to virus damage, common co-infections and badociated comorbidities, such as hepatitis B and C viruses, of hypertension and diabetes mellitus. Some antiretroviral treatments can also cause toxicities that damage these organs.

In the early decades of the HIV / AIDS pandemic, individuals were rarely eligible to receive organ transplants from HIV-negative donors. these organs are still in short supply and their demand is high, as health outcomes are expected to be poor. However, studies sponsored by NIAID have shown that by carefully selecting HIV-positive people who are otherwise healthy to receive a kidney or liver from an HIV-negative donor, patient survival rates and organ transplants could be similar to those of transplanted negative recipients. These results provided the scientific basis for the eventual adoption of the 2013 HOPE Act.

"Antiretroviral therapy has incredibly helped people living with HIV to live longer and healthier.As HIV-positive people get older, organ damage in this population is age-related, HIV and other infections, "said Anthony S. Fauci, director of NIAID. , MD "The HOPE in Action Multicenter Liver Study will allow researchers to badess the safety and efficacy of liver transplants from HIV-infected donors to HIV-positive recipients." This strategy can both improve the well-being of patients with HIV. to be people living with HIV and providing transplantable livers ".

The trial team had previously launched the HOPE in Action multicenter kidney study in May 2018, which badesses the safety and effectiveness of kidney transplantation among HIV-positive people. When launched, this trial was the first such study in the US to be approved by the Institutional Review Board (IRB), in accordance with the research criteria and guidelines prescribed by the 2013 HOPE Act.

The new study will follow the clinical results of 80 liver transplants. All transplant recipients participating in the study will be living with HIV; 40 of them will receive the liver from deceased donors with HIV and 40 will receive the liver from deceased HIV-negative donors in the control group. About 8% of people waiting for a liver transplant also require a simultaneous kidney transplant, and these recipients may also receive both organs from a single deceased donor. People with hepatitis C virus (HCV) can receive organ transplants from donors with HCV. Health care teams and study participants will be informed of the HCV and HCV status of the organ donor and will be counseled on the treatment of HCV.

"Liver transplants are the second most common type of organ transplant in the United States, and the number of people waiting for these vital procedures – with or without HIV – is increasing every year," said Christine Durand. , MD. Associate Professor of Medicine at Johns Hopkins University and Principal Investigator of the HOPE Study in Action Multicenter Liver. "If this research demonstrates that liver transplants between HIV-positive individuals are safe and effective, the donor pool will increase – saving lives and reducing the time HIV-negative and HIV-positive people spend on a waiting list for a long time." organ transplantation. "

Throughout the clinical trial, researchers will closely monitor liver transplant recipients for signs of organ rejection, organ failure, previously effective anti-HIV drugs, and HIV-related complications. The HOPE in Action team will compare the results of recipients who received liver from donors living with HIV to those who received liver from HIV-negative donors. The researchers will also track the participants' psychological and social responses, changes in their latent HIV reservoirs and the potential development of an HIV superinfection, a condition of infection by more than one strain of HIV. HIV.

"Liver transplantation has a proven track record of saving and improving lives," said Jonah Odim, MD, Ph.D., head of the clinical transplant section of the Allergy, Immunology and Transplantation division NIAID. "The HOPE in Action team – with the collaboration of organ harvesting and transplantation network, regional organ harvesting organizations and major transplant centers participating in the trial – is determining whether transplants can bring equal benefit when the liver comes from an HIV-positive person. "

The study will comply with all applicable federal laws regarding organ procurement and transplantation and will meet the HOPE safeguard and search criteria set out by the US Department of Health and Human Services. in 2015. Federal register note. These guarantees, developed for the HHS with NIAID leadership, include organ recipients discussing the study with an independent advocate prior to transplantation. In addition, participating organ recipients must be in good immune health and benefit from effective antiretroviral therapy. Beneficiaries must also be willing to adhere to drugs related to transplantation and the fight against HIV. People living with HIV wishing to register their decision to become deceased organ donors can learn more about OrganDonor.gov.