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Donor Derived Cell Free DNA (dd-cfDNA) May Aid in the Diagnosis of BK Virus Nephropathy

D. Brennan1, J. Bromberg2, J. Yee3, S. Dholakia3, M. Haas4

1Johns Hopkins, Baltimore, MD, 2University of Maryland School of Medicine, Baltimore, MD, 3CareDx, Brisbane, CA, 4Cedars-Sinai Medical Center, Los Angeles, CA

Meeting: 2019 American Transplant Congress

Abstract number: A365

Keywords: Infection, Renal dysfunction, Renal failure, Renal injury

Session Information

Session Name: Poster Session A: Transplant Infectious Diseases

Session Type: Poster Session

Date: Saturday, June 1, 2019

Session Time: 5:30pm-7:30pm

 Presentation Time: 5:30pm-7:30pm

Location: Hall C & D

*Purpose: Between 10% and 30% of renal transplant recipients (KTR) develop BK viremia; with 1-10% of KTR developing BK virus associated nephropathy (BKVAN), accounting for 7% of all renal allograft failures. Diagnosis currently requires biopsy confirmation with management using immunosuppression reduction having limited efficacy, often requiring re-biopsy to assess disease progression or resolution. Improved methods to diagnose BKVAN and follow disease progression or resolution are needed. We hypothesize that elevations (≥1%) of the level of donor derived cell free DNA (dd-cfDNA) may correlate with BKVAN, and potentially act as a surrogate to quantify the severity of viral injury for both diagnosis and management.

*Methods: We retrospectively analyzed the DART cohort of 384 KTR and 102 biopsies. BKV titers, biopsy results, and dd-cfDNA (AlloSure test) levels were correlated where available.

*Results: 11 patients with BK viremia had 14 paired dd-cfDNA and renal biopsy results, performed between 2015 and 2018. 7 KTR had BKV PCR titers that were correlated to dd-cfDNA results and biopsy pathology findings. Analysis showed a positive correlation of dd-cfDNA and BK viral load. Spearman correlation identified an r value = 0.874 (95% CI 0.35-0.98, p= 0.01). BK viremia without BKVAN had a median dd-cfDNA = 0.58% (IQR 0.43-1.15), while BKVAN had a median dd-cfDNA = 3.38% (IQR 2.3-4.56). KTR with biopsies meeting Banff criteria for acute cell-mediated rejection (TCMR; >Banff 1A) had a median BK PCR load = 4.42×105(IQR 2.1×103 – 5×105) while KTR not meeting criteria had median PCR load = 3.71×104 (IQR 1×105 – 2.2×107), these were not statistically different (p=0.45). Yet 5 of 7 BKVAN patients, but only 2 of 7 with isolated viremia, had biopsies meeting Banff criteria for TCMR, with median dd-cfDNA in non-rejection patients = 0.43% (IQR 0.29-0.91) versus 2.84% (IQR 1.49-4.29) in rejection patients, p=0.001.

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*Conclusions: Lower levels of dd-cfDNA may indicate BK viremia is not causing nephropathy. In patients with BK viremia with or without BKVAN, the highest dd-cfDNA values tended to occur in patients whose biopsies met Banff criteria for TCMR. Further studies are required to define the role of dd-cfDNA in the diagnosis and or following the clinical response to treatment.

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To cite this abstract in AMA style:

Brennan D, Bromberg J, Yee J, Dholakia S, Haas M. Donor Derived Cell Free DNA (dd-cfDNA) May Aid in the Diagnosis of BK Virus Nephropathy [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/donor-derived-cell-free-dna-dd-cfdna-may-aid-in-the-diagnosis-of-bk-virus-nephropathy/. Accessed June 1, 2025.

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