Use of Hepatitis C Nucleic Acid Test–Positive Liver Allografts in Hepatitis C Virus Seronegative Recipients

Abstract

Because of underutilization of liver allografts, our center previously showed that hepatitis C virus (HCV) antibody-positive/ nucleic acid test (NAT)-negative livers when transplanted into HCV nonviremic recipients were safe with a 10% risk of HCV transmission. Herein, we present our single-center prospective experience of using HCV NAT+ liver allografts transplanted into HCV NAT-recipients. An institutional review board-approved matched cohort study was conducted examining postliver transplantation (LT) outcomes of HCV-patients who received HCV NAT+ organs (treatment group) compared with matched recipients with HCV NAT-organs (matched comparator group) between June 2018 to October 2019. The primary endpoint was success of HCV treatment and elimination of HCV infection. The secondary outcomes included the 30-day and 1-year graft and patient survival as well as perioperative complications. There were 32 recipients enrolled into each group. Because of 1 death in the index admission, 30/31 patients (97%) were given HCV treatment at a median starting time of 47 days (18-140 days) after LT. A total of 19 (63%) patients achieved sustained virological response at week 12 (SVR12). Another 6 patients achieved end-of-treatment response, while 5 remained on therapy and 1 is yet to start treatment. No HCV treatment failure has been noted. There were no differences in 30-day and 1-year graft and patient survival, length of hospital stay, biliary or vascular complications, or cytomegalovirus viremia between the 2 groups. In this interim analysis of a matched cohort study, which is the first and largest study to date, the patients who received the HCV NAT+ organs had similar outcomes regarding graft function, patient survival, and post-LT complications.Liver Transplantation 26 673-680 2020 AASLD.

Liver Transplantation Using Hepatitis C Virus–Viremic Donors Into Hepatitis C Virus–Aviremic Recipients as Standard of Care

“…The length of HCV surveillance needed post‐LT is still not clear. Although most HCV aviremia conversion is observed in the first 2 weeks post‐LT, late conversion can occur, as evidenced by the conversion of 1 patient in the Anwar report at day 84 ( 22 ) and 1 patient in our study who remains HCV free 10 months post‐LT, indicating the need for long‐term HCV surveillance in persistent aviremic patients. Relapse, although unexpected, could occur as it happened in 1 of our patients who then required a second course of treatment.…”

“…This study reports our experience using DNAT+ livers in rHCV− as standard clinical practice. In contrast to previous case reports or clinical trials with restrictive inclusion criteria and unlimited access to DAAs, ( 1,15,16,21 ) as in the recent report from Anwar et al ( 22 ) in which the transplant center guaranteed to bear the cost of antiviral therapy, our study reports outcomes and safety of expanding access of HCV DNAT+ livers to all patients on the waiting list with a protocol consisting of patient education, informed consent, and confirmed DAA access prior to listing under real‐life conditions.…”

“…(26) Preemptive or short courses of DAA described for recipients of HCV Ab+/NAT− livers or for extrahepatic transplantation of DNAT+ organs (17,27) are not recommended at this point because of a larger virus reservoir and limited experience using DNAT+ in this specific population of rHCV−. (26) As others have reported, (22) we treated our study population reactively once the HCV viremia was confirmed. However, DAA pharmacokinetics could be a major limiting factor for DAAs initiation after LT. DAA therapy must be uninterrupted in order to reach maximum efficacy and minimize the development of virus resistance and treatment failure.…”

Best practice recommendations for the use of hepatitis C viremic donor organs for hepatitis C virus naïve recipients

“…The transplantation of HCV viremic donor organs into HCV uninfected recipients has increased since the publication of several clinical trials and case series demonstrating the safety and efficacy of pan-genotypic direct-acting antiviral agents (DAA's) in kidney, liver, pancreas, heart, and lung transplant recipients. [1][2][3][4][5][6][7][8][9][10][11][12][13] Incorporation of this practice, however, requires careful oversight as recipient infection is nearly universal. 14 Currently, there is limited guidance on the best practices governing the initiation, timing, or duration of DAA therapy.…”

Over 2 Decades of Transplanting Hepatitis C Virus–Positive Liver Allografts: Almost Full Circle With Encouraging Early Results

“…In the current issue, Anwar et al present an interim analysis of their prospective matched cohort study of LT with the use of HCV NAT+ livers into HCV– recipients. ( 7 ) The authors enrolled 32 HCV– patients who were age‐ and sex‐matched with matched comparators who received HCV NAT– allografts. HCV viremia was detected a median of 7 days after LT with 1 patient who had received pretransplant HCV treatment not developing viremia until day 84.…”