Date: Sunday, June 3, 2018
Session Time: 4:30pm-6:00pm
Presentation Time: 4:30pm-4:42pm
Location: Room 6E
Background: In 2016, 800 kidneys from HCV+ deceased donors were discarded. Short-term (6-month) data from the first 10 subjects in the THINKER-1 trial (NCT02743897; funder: Merck) suggested that kidneys from HCV-infected donors could be safely transplanted into HCV-negative patients. We report 12-month data on the 10 THINKER-1 recipients and 6-month data on 10 recipients from an expanded cohort (THINKER-2).
Methods: Patients aged 40-65 years on dialysis, waitlisted for kidney transplant (KT) with ≤548 days of wait time were approached. A three-step process of education and consent was used pre-enrollment. Donor HCV genotyping during allocation allowed us to restrict transplant only to kidneys from GT 1a or 1b donors, with Grazoprevir/Elbasvir treatment on day 3 post-transplant when recipient HCV was detected.
Results: From 1/27/16-6/20/17, 46 patients were contacted by phone, 31 (67%) attended an educational session, 29 (63%) consented for screening, and 25 (54%) were enrolled. 20 HCV- patients received HCV+ kidneys (median KDPI: 46, IQR: 33-54); 18 were genotype 1a. Median time from activation in UNET for HCV+ donors and KT was 57 days (IQR: 12-91days). All 20 patients had detectable HCV RNA on post-op day 3, but were undetectable within 4 weeks of HCV therapy. As of 12/1/2017, all 20 patients completed HCV treatment[mdash]16 were cured (SVR-12), two had SVR-8, and two had SVR-4. Median 12-month creatinine for THINKER-1 subjects was 1.11 mg/dL (IQR: 0.95-1.25), and 6-month creatinine for THINKER-2 subjects was 1.17mg/dL (IQR: 1.04-1.27). Early readmission rates were 10%, no patient had rejection, and three patients experienced brief transaminase elevations.
Conclusions: In this ongoing trial, we demonstrate safety and efficacy of transplanting kidneys from HCV-infected donors into HCV- patients, with durable HCV cure data as long as 12 months post-transplant. 6- and 12-month renal function remains excellent, which suggest that HCV-infected kidneys can be transplanted with good intermediate-term function. Future work is needed in a larger sample, but these results suggest that expanded use of HCV-infected kidneys could drive hundreds more transplants in the US.
CITATION INFORMATION: Goldberg D., Blumberg E., Abt P., Levine M., Porrett P., Naji A., Nazarian S., Sawinski D., Trofe-Clark J., Van Deerlin V., Gentile C., Smith J., Kaminski M., Sicilia A., Hasz R., Suplee L., Reddy R., Bloom R., Reese P. Transplanting Kidneys from HCV-Infected Donors into HCV-Negative Recipients: Longer-Term and Extended Results of the THINKER Trial Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:Goldberg D, Blumberg E, Abt P, Levine M, Porrett P, Naji A, Nazarian S, Sawinski D, Trofe-Clark J, Deerlin VVan, Gentile C, Smith J, Kaminski M, Sicilia A, Hasz R, Suplee L, Reddy R, Bloom R, Reese P. Transplanting Kidneys from HCV-Infected Donors into HCV-Negative Recipients: Longer-Term and Extended Results of the THINKER Trial [abstract]. https://atcmeetingabstracts.com/abstract/transplanting-kidneys-from-hcv-infected-donors-into-hcv-negative-recipients-longer-term-and-extended-results-of-the-thinker-trial/. Accessed March 1, 2021.
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