Twelve-month outcomes after transplant of hepatitis C–infected kidneys into uninfected recipients a single-group trial

Peter P. Reese, Peter L. Abt, Emily A. Blumberg, Vivianna M. Van Deerlin, Roy D. Bloom, Vishnu S. Potluri, Matthew Levine, Paige Porrett, Deirdre Sawinski, Susanna M. Nazarian, Ali Naji, Richard Hasz, Lawrence Suplee, Jennifer Trofe-Clark, Anna Sicilia, Maureen McCauley, Caren Gentile, Jennifer Smith, Bijan A. Niknam, Melissa BleicherK. Rajender Reddy, David S. Goldberg

Research output: Contribution to journalArticlepeer-review

125 Scopus citations

Abstract

Background: Organs from hepatitis C virus (HCV)–infected deceased donors are often discarded. Preliminary data from 2 small trials, including THINKER-1 (Transplanting Hepatitis C kidneys Into Negative KidnEy Recipients), suggested that HCV-infected kidneys could be safely transplanted into HCV-negative patients. However, intermediate-term data on quality of life and renal function are needed to counsel patients about risk. Objective: To describe 12-month HCV treatment outcomes, estimated glomerular filtration rate (eGFR), and quality of life for the 10 kidney recipients in THINKER-1 and 6-month data on 10 additional recipients. Design: Open-label, nonrandomized trial. (ClinicalTrials.gov: NCT02743897) Setting: Single center. Participants: 20 HCV-negative transplant candidates. Intervention: Participants underwent transplant with kidneys infected with genotype 1 HCV and received elbasvir–grazoprevir on posttransplant day 3. Measurements: The primary outcome was HCV cure. Exploratory outcomes included 1) RAND-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) quality-of-life scores at enrollment and after transplant, and 2) posttransplant renal function, which was compared in a 1:5 matched sample with recipients of HCV-negative kidneys. Results: The mean age of THINKER participants was 56.3 years (SD, 6.7), 70% were male, and 40% were black. All 20 participants achieved HCV cure. Hepatic and renal complications were transient or were successfully managed. Mean PCS and MCS quality-of-life scores decreased at 4 weeks; PCS scores then increased above pretransplant values, whereas MCS scores returned to baseline values. Estimated GFRs were similar between THINKER participants and matched recipients of HCV-negative kidneys at 6 months (median, 67.5 vs. 66.2 mL/min/1.73 m2; 95% CI for between-group difference, 4.2 to 7.5 mL/min/1.73 m2) and 12 months (median, 72.8 vs. 67.2 mL/min/1.73 m2; CI for between-group difference, 7.2 to 9.8 mL/min/1.73 m2). Limitation: Small trial. Conclusion: Twenty HCV-negative recipients of HCV-infected kidneys experienced HCV cure, good quality of life, and excellent renal function. Kidneys from HCV-infected donors may be a valuable transplant resource.

Original languageEnglish (US)
Pages (from-to)273-281
Number of pages9
JournalAnnals of internal medicine
Volume169
Issue number5
DOIs
StatePublished - Sep 4 2018
Externally publishedYes

ASJC Scopus subject areas

  • Internal Medicine

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