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Incidence of cytomegalovirus infection in seropositive kidney transplant recipients treated with everolimus: A randomized, open-label, multicenter phase 4 trial.

Authors:
Hannah Kaminski Nassim Kamar Olivier Thaunat Nicolas Bouvier Sophie Caillard Isabelle Garrigue Dany Anglicheau Jean-Philippe Rérolle Yannick Le Meur Antoine Durrbach Thomas Bachelet Hélène Savel Roxane Coueron Jonathan Visentin Arnaud Del Bello Isabelle Pellegrin Julie Déchanet-Merville Pierre Merville Rodolphe Thiébaut Lionel Couzi

Am J Transplant 2022 May 19;22(5):1430-1441. Epub 2022 Jan 19.

Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, Bordeaux, France.

Cytomegalovirus (CMV) persists as the most frequent opportunistic infection among solid organ transplant recipients. This multicenter trial aimed to test whether treatment with everolimus (EVR) could decrease the incidence of CMV DNAemia and disease. We randomized 186 CMV seropositive kidney transplant recipients in a 1:1 ratio to receive EVR or mycophenolic acid (MPA) in association with basiliximab, cyclosporin, and steroids and 87 in each group were analyzed. No universal prophylaxis was administered to either group. The composite primary endpoint was the presence of CMV DNAemia, CMV treatment, graft loss, death, and discontinuation of the study at 6 months posttransplant. In the modified intent-to-treat analysis, 42 (48.3%) and 70 (80.5%) patients in the EVR and MPA groups reached the primary endpoint (OR = 0.21, 95% CI: 0.11-0.43, p < .0001). Fewer patients of the EVR group received treatment for CMV (21.8% vs. 47.1%, p = .0007). EVR was discontinued in 31 (35.6%) patients. Among the 56 patients with ongoing EVR treatment, only 7.4% received treatment for CMV. In conclusion, EVR prevents CMV DNAemia requiring treatment in seropositive recipients as long as it is tolerated and maintained.

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http://dx.doi.org/10.1111/ajt.16946DOI Listing
May 2022

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