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

Autor: Kaminski H; Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, Bordeaux, France.; UMR 5164-ImmunoConcEpT, University of Bordeaux, CNRS, Bordeaux University, Bordeaux, France., Kamar N; Department of Nephrology and Organ Transplantation, CHU Toulouse, Toulouse, France.; INSERM U1043, IFR-BMT, Toulouse, France., Thaunat O; Department of Nephrology, Transplantation and Clinical Immunology of Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon-I University UFR Lyon Est, Lyon, France., Bouvier N; Department of Nephrology, Transplantation, Dialysis, CHU Caen, Caen, France., Caillard S; Department of Nephrology and Transplantation, CHU Strasbourg, Strasbourg, France., Garrigue I; Laboratory of Virology, CHU Bordeaux, Bordeaux, France., Anglicheau D; Department of Nephrology and Kidney Transplantation, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France., Rérolle JP; Department of Nephrology and Transplantation, CHU Limoges, Limoges, France., Le Meur Y; Department of Nephrology and Transplantation, Brest University Hospital, Brest, France., Durrbach A; Department of Nephrology and Kidney Transplantation, INSERM 1186, Henri Mondor Hospital, Assistance Publique-Hôpitaux de Paris, Paris Saclay University, Paris, France., Bachelet T; Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, Bordeaux, France., Savel H; CHU Bordeaux, Service d'information médicale, Bordeaux, France., Coueron R; CHU Bordeaux, Service d'information médicale, Bordeaux, France., Visentin J; UMR 5164-ImmunoConcEpT, University of Bordeaux, CNRS, Bordeaux University, Bordeaux, France.; Laboratory of Immunology and Immunogenetics, CHU Bordeaux, Bordeaux, France., Del Bello A; Department of Nephrology and Organ Transplantation, CHU Toulouse, Toulouse, France.; INSERM U1043, IFR-BMT, Toulouse, France., Pellegrin I; UMR 5164-ImmunoConcEpT, University of Bordeaux, CNRS, Bordeaux University, Bordeaux, France.; Laboratory of Immunology and Immunogenetics, CHU Bordeaux, Bordeaux, France., Déchanet-Merville J; UMR 5164-ImmunoConcEpT, University of Bordeaux, CNRS, Bordeaux University, Bordeaux, France., Merville P; Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, Bordeaux, France.; UMR 5164-ImmunoConcEpT, University of Bordeaux, CNRS, Bordeaux University, Bordeaux, France., Thiébaut R; CHU Bordeaux, Service d'information médicale, Bordeaux, France.; INSERM U1219 Bordeaux Population Health Research Center, Inria SISTM, Bordeaux University, Bordeaux, France., Couzi L; Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, Bordeaux, France.; UMR 5164-ImmunoConcEpT, University of Bordeaux, CNRS, Bordeaux University, Bordeaux, France.
Jazyk: angličtina
Zdroj: American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons [Am J Transplant] 2022 May; Vol. 22 (5), pp. 1430-1441. Date of Electronic Publication: 2022 Jan 19.
DOI: 10.1111/ajt.16946
Abstrakt: 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.
(© 2022 The American Society of Transplantation and the American Society of Transplant Surgeons.)
Databáze: MEDLINE
Externí odkaz: