Patients who received kidneys with hepatitis C cured of the infection

Twenty patients who received kidney transplants from deceased donors who had hepatitis C have been cured of the condition, doctors at Penn Medicine report. Here are the details:

The background: Back in 2016, researchers launched a clinical trial to study kidney transplants from donors with hepatitis C into patients who weren't infected, but were waiting for a kidney. Infected organs typically aren't used for transplant. Patients in the study were treated with antiviral therapy to treat hepatitis C after the transplant.
The findings: In new study results published in Annals of Internal Medicine, the research team behind the trial says the 20 patients have kidney function that's similar to that of patients who received transplants from donors without hepatitis C. The study includes six-month results for 10 patients and 12-month results for the other 10.
The next steps: There's still a need for larger studies that follow patients over a longer period of time. The research team is also running a similar trial with heart transplant patients.

Twelve-Month Outcomes After Transplant of Hepatitis C–Infected Kidneys Into Uninfected Recipients: A Single-Group Trial

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

Article, Author, and Disclosure Information

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.

Primary Funding Source:

Merck.