Increasing Utilization and Excellent Initial Outcomes Following Liver Transplant of Hepatitis C Virus (HCV)‐Viremic Donors Into HCV‐Negative Recipients: Outcomes Following Liver Transplant of HCV‐Viremic Donors

Abstract

Direct‐acting antiviral (DAA) therapy has altered the frequency and outcome of liver transplantation (LT) for hepatitis C virus (HCV). The high efficacy and tolerability of DAA therapy has also created a rationale for utilizing HCV‐viremic (HCV‐RNA–positive) donors, including into HCV‐negative recipients. We examined trends in frequency of organ utilization and graft survival in recipients of HCV‐viremic donors (HCV‐RNA positive as measured by nucleic acid testing [NAT]). Data were collected from the Scientific Registry of Transplant Recipients (SRTR) on adult patients who underwent a primary, single‐organ, deceased donor LT from January 1, 2008 to January 31, 2018. Outcomes of HCV‐negative transplant recipients (R–) who received an allograft from donors who were HCV‐RNA positive (DNAT+) were compared to outcomes for R– patients who received organs from donors who were HCV‐RNA negative (DNAT–). There were 11,270 DNAT–/R–; 4,748 DNAT–/R+; 87 DNAT+/R–; and 753 DNAT+/R+ patients, with 2‐year graft survival similar across all groups: DNAT–/R– 88%; DNAT–/R+ 88%; DNAT+/R– 86%; and DNAT+/R+ 90%. Additionally, there were 2,635 LTs using HCV antibody‐positive donors (DAb+): 2,378 DAb+/R+ and 257 DAb+/R–. The annual number of DAb+/R– transplants increased from seven in 2008 to 107 in 2017. In the post‐DAA era, graft survival improved for all recipients, with 3‐year survival of DAb+/R– patients and DAb+/R+ patients increasing to 88% from 79% and to 85% from 78%, respectively. Conclusion: The post‐DAA era has seen increased utilization of HCV‐viremic donor livers, including HCV‐viremic livers into HCV‐negative recipients. Early graft outcomes are similar to those of HCV‐negative recipients. These results support utilization of HCV‐viremic organs in selected recipients both with and without HCV infection.

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

“…Despite annual increases in the number of liver transplantations performed in the United States in the 10‐year period from 2009 through 2018, more than 14,000 liver transplantation candidates died awaiting the procedure . Given the sizable chasm between the number of waitlisted liver transplantation candidates and the pool of available organs, some transplant programs are turning to a previously untapped pool of organs from deceased HCV‐viremic donors; historically, these organs were discarded with rare exception . Coincident with the marked increase in drug overdose deaths among PWID in the United States, this pool of donor organs has sadly increased substantially .…”

“…In stark contrast to this tragic loss of life, the development of safe and highly effective DAA therapy provides an opportunity to consider use of allografts from HCV‐viremic donors in HCV‐negative recipients because iatrogenic HCV infection can be cured with retention of allograft function in the majority of cases. Recent data indicate increasing acceptance of these organs among HCV‐negative recipients . Although early outcome data are encouraging, the overall experience is limited, and many ethical issues and scientific questions remain, such as avoidance of selection bias, the optimal timing of DAA therapy, detailed evaluation of drug–drug interactions between DAAs and immunosuppressants, and long‐term graft and patient outcomes.…”

When Theory Becomes Reality: Navigating the Ethics of Transplanting Hepatitis C Virus–Positive Livers Into Negative Recipients

“…Grafts from these donors are attractive to transplant providers and resulted in a 2‐fold increase in HCV + LT from 2013 to 2016 . Should these HCV + organs, from not only otherwise suitable but often more favored donors, be discarded when preliminary, short‐term data show equivalent patient and graft survival data and excellent HCV SVR rates?…”

“…26 Should these HCV + organs, from not only otherwise suitable but often more favored donors, be discarded when preliminary, short-term data show equivalent patient and graft survival data and excellent HCV SVR rates? [12][13][14][15] JUsTiCe Justice in medical ethics means fairness, with impartiality and equity toward scarce resources, patients' rights, and laws. 2 Given that HCV D + /R − LT is already occurring, ensuring its fairness nationwide and justice for patients in need of LT is paramount.…”

“…12,13 Similarly, a case series analysis of 10 patients who underwent HCV D + /R − LT between March 2017 and January 2018 with subsequent DAA treatment reported a 100% SVR rate without patient death or graft failure. 14 In addition, a 2019 retrospective study by Cotter et al 15 comparing HCV D + /R − LT with HCV D + /R + , D − /R + , and D − /R − LT from 2014 to 2018 found that short-term graft survival rates were not significantly different between all groups. The pertinent ethical issue of HCV D + /R − LT regarding nonmaleficence and beneficence is whether the risks of knowingly infecting the patient with HCV-and exposing the patient to the sequelae of HCV infection, including the possibility of fibrosing cholestatic hepatitis (FCH), increased rates of graft rejection, and DAA side effects or treatment failure with resultant chronic HCV infectionoutweigh the benefits, which may be preventing wait-list dropout because of prolonged wait-list times and patient death, particularly in an era of donor graft scarcity.…”