Background: More than 500 kidneys from HCV+ deceased donors are discarded each year, even though direct acting antiviral therapies have cure rates exceeding 95%. We performed a pilot trial of transplanting kidneys from HCV+ donors into HCV- recipients (THINKER; NCT02743897; sponsor: Merck).

Methods: HCV- 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. We performed HCV donor genotyping during allocation, and only used kidneys from genotype 1a or 1b donors. We treated recipients with Grazoprevir/Elbasvir when recipient HCV NAT was detected.

Results: From 6/1/16-11/11/16, 43 patients were contacted by phone, 22 (51.1%) attended an in-person educational session, 19 (86.4%) consented for screening, and 15 (78.9%) were enrolled. 10 HCV- patients received HCV+ kidneys (median KDPI: 42, IQR: 34-53); 9 were genotype 1a. Median time from activation in UNET for HCV+ donors and KT was 58 days (range 11-130 days). All 10 patients had detectable HCV RNA on post-op day 3, but were undetectable within 4 weeks of starting HCV therapy. As of 12/1/2016, 6 patients completed 12 weeks of HCV treatment[mdash]one had sustained virologic response (SVR)-12 ('cure'), two had SVR-6, two had SVR-4, and one had SVR-2, while the other four had undetectable virus on treatment. All had excellent allograft function. There were no adverse events related to HCV transmission or treatment.

Conclusions: In this pilot trial, we demonstrate safety and efficacy of transplanting kidneys from HCV+ donors into HCV- patients. Future work is needed in a larger sample, but these results suggest that HCV+ kidneys may be valuable to a wide range of candidates.

CITATION INFORMATION: Goldberg D, Blumberg E, Reddy R, Nazarian S, Van Deerlin V, Trofe-Clarke J, Levine M, Sawinski D, Bloom R, Abt P, Reese P. Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients [THINKER] Trial. Am J Transplant. 2017;17 (suppl 3).

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