Insights from the BKEVER Trial comparing everolimus versus mycophenolate mofetil for BK Polyomavirus infection in kidney transplant recipients.
In kidney transplant patients with BK virus in the blood, switching mycophenolate to everolimus did not clear the virus better than simply halving mycophenolate; clearance was actually higher with the simpler approach.
Background
mTOR inhibitors have shown antiviral properties, and non-randomized studies suggested they may suppress BK polyomavirus replication.
Study design
Randomized, multicenter, controlled trial of 130 recipients with BKPyV DNAemia randomized 1:1 to replace mycophenolate with everolimus or halve the mycophenolate dose, both with lower calcineurin inhibitor troughs. Primary endpoint: viral clearance at six months; follow-up two years.
Key findings
Clearance at six months was 55.7% with everolimus versus 81.3% with reduced mycophenolate, and viral load fell more rapidly in the mycophenolate group. Biopsy-proven BKPyV nephropathy developed in 11 everolimus and 6 mycophenolate patients; two grafts were lost and four patients died overall.
Clinical implications
Switching to everolimus with reduced calcineurin inhibitor levels did not lead to more frequent or faster BKPyV clearance than simply reducing mycophenolate.
Category
Transplant
Source
Kidney International
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