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

PP Reese, PL Abt, EA Blumberg… - Annals of internal …, 2018 - acpjournals.org
PP Reese, PL Abt, EA Blumberg, VM Van Deerlin, RD Bloom, VS Potluri, M Levine, P Porrett…
Annals of internal medicine, 2018acpjournals.org
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) …
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.
Primary Funding Source
Merck.
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