Expanding the Use of HCV-Positive Organs in Solid Organ Transplantation

The American Society of Transplantation has reached a consensus on how the treatment of hepatitis C virus with direct-acting antivirals could enable organ transplantations to HCV-negative recipients.

The gap continues to grow between those waiting for an organ transplant and the number of organs that are available to make that possible, presenting a crisis in the United States. Oftentimes, access to these procedures could mean life or death for sick patients; therefore, expanding access is imperative.

In an effort to come up with ways to do this, the American Society of Transplantation (AST) convened a meeting for experts to “review current data and develop the framework for the study of using hepatitis C virus (HCV) viremic organs in solid organ transplantation. Now, the AST has reached a consensus on how the treatment of HCV with direct-acting antivirals (DAAs) could enable organ transplantations to HCV-negative recipients, and thus, potentially save the lives of many stuck on transplant waitlists.

"The meeting participants thought that the availability of DAA therapy makes expansion of transplanting HCV-viremic organs into nonviremic recipients a possibility,” lead author Josh Levitsky, MD, professor of Medicine and Surgery at Northwestern University, and colleagues wrote in the consensus conference report. “This could result in saving a significant number of lives per year among organ failure patients.”

However, the researchers agreed unanimously that more research was needed before the practice became routine.

In an editorial accompanying the consensus report, Jay Fishman, MD, Transplant Center and Infectious Disease Division, Massachusetts General Hospital and Harvard Medical School, and Xavier Forns, MD, Liver Unit, Hospital Clinic, IDIBAPS and CIBEREHD, University of Barcelona, Barcelona, Spain, pointed out that said research will need to include an assessment of the limitations of DAA therapies.

"Each new application of DAA therapy requires evaluation for drug interactions with transplant immunosuppressive and other common medications," Drs Fishman and Forns wrote. "The benefits of early access to transplantation using organs from HCV-positive donors must be carefully balanced against the risk of unknown effects of drugs and therapies."

The consensus conference report acknowledged that current barriers to obtaining DAA treatment could also impede the expanded use of HCV-viremic organs.

"DAAs are normally approved for use in chronic HCV infection but may be restricted to patients with advanced hepatic fibrosis,” they wrote. “In contrast, the transplantation of HCV-viremic organs into nonviremic recipients involves treatment for acute, donor-derived infection before the development of liver injury or infection-related comorbidities, raising concerns that coverage may be denied.”

It would be necessary for transplantation protocols to ensure that the recipient would be guaranteed access to DAA therapy — with rare exceptions made for emergency lifesaving transplantations, according to the consensus conference report.

Even with this guaranteed access, however, they note that outcomes could be complicated by limitations of the transplant sites.

"Not all clinical centers will have the expertise to manage newer DAA therapies or relapses, viral resistance, or infections with multiple viral strains," they wrote.

Dr. Levitsky and colleagues echoed that concern and suggested a procedure to address it.

"Due to the increased complexity of decision-making involved as well as with public health service increased risk organs in general, the group thought that organ procurement organizations (OPOs) should consider contracting with transplant physicians knowledgeable about DAAs to provide real-time consultation regarding the appropriateness of allocating these organs, for both the OPO and transplant center considerations," Dr Levitsky and colleagues wrote.