Change Removes Clinical Research Requirements for Kidney and Liver Transplants from Donors with HIV
A change in regulations will expand access to organ transplants for people with HIV, the U.S. Department of Health and Human Services (HHS) announced on Nov. 26. Until now, kidney and liver transplants between donors with HIV and recipients with HIV were only allowed through research studies. Such transplants needed to meet clinical research standards and to receive approval from institutional review boards.
“This action marks a significant step forward in increasing the availability of life-saving organs for all patients regardless of their HIV status while continuing to reduce barriers and stigma for people with HIV,” HHS said in a news release.
The National Organ Transplant Act, which sets the framework for organ donation across the country, was amended in 1988 to prohibit the transplantation of organs from donors with HIV. The HIV Organ Policy Equity (HOPE) Act, signed in 2013 and implemented in 2015, calls for the development and publication of research criteria relating to transplantation of HIV positive organs into HIV positive individuals. The first U.S. transplant from a deceased HIV-positive donor to an HIV-positive recipient took place in March 2016 at the Johns Hopkins Comprehensive Transplant Center. The first organ donation from a living HIV-positive donor to an HOV-positive recipient was in March 2019, also at Johns Hopkins.
The latest change in HHS regulations (known as a “final rule”) is allowed through the HOPE Act. It is supported by research demonstrating the safety and effectiveness of kidney and liver transplants between donors and recipients with HIV.
“We continue to do everything in our power to increase access to life-saving organs while addressing health inequities faced by people with HIV,” HHS Secretary Xavier Becerra said in a news release. “This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with HIV. This evidence-based policy update demonstrates our commitment to ensuring all Americans have access to the care they need.”
By increasing the pool of available organs and streamlining the transplantation process, this policy can save lives, reduce stigma and discrimination associated with HIV, and lower costs and wait times, according to HHS.
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