ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

Abstract: SA-OR60

Reduction of Renal Graft Fibrosis with Valganciclovir Prophylaxis for Cytomegalovirus Prevention Compared to Preemptive Therapy: Long-Term Outcomes of Randomized Controlled Trial (OVERT Study)

Session Information

Category: Transplantation

  • 2102 Transplantation: Clinical

Authors

  • Reischig, Tomas, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
  • Vlas, Tomas, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
  • Drenko, Petr, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
  • Kielberger, Lukas, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
  • Richtrova, Pavlina, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czechia
Background

Prevention of cytomegalovirus (CMV) infection including CMV indirect effects is essential in kidney transplantation. The 12-month results of OVERT Study showed less subclinical rejection and a trend toward lower incidence of acute rejection in recipients receiving valganciclovir prophylaxis compared to preemptive therapy. Here we report long-term results of OVERT Study.

Methods

This was an open-label, single-center, randomized clinical trial of valganciclovir prophylaxis vs preemptive therapy in 140 kidney transplant recipients recruited between June 2013 and May 2018. CMV-seronegative recipients with negative donors (D-R-) were excluded. Patients were randomized 1:1 to receive either valganciclovir prophylaxis for 3 months (or 6 months in D+R-) (n=70) or preemptive valganciclovir for significant CMV DNAemia detected in predefined assessments through month 24 (n=70). The primary outcome was the incidence of moderate to severe interstitial fibrosis and tubular atrophy (IFTA) in protocol biopsy at 3 years. Key secondary outcomes included acute rejection, CMV disease and DNAemia, patient and graft survival.

Results

Among the 127 patients who had a protocol biopsy specimen available at 3 years, 5 (8%) of 66 patients in the prophylaxis group and 14 (23%) of 61 patients in the preemptive group had moderate to severe IFTA (P=0.015). At 3 years the incidence of acute rejection was lower with valganciclovir prophylaxis (13% vs 36%, P=0.052). In spite of 5 (7%) additional patients with CMV DNAemia after month 12 in the prophylaxis group in contrast to none in the preemptive group (P=0.025) the cumulative incidence at 2 years remained lower with prophylaxis (51% vs 75%, P<0.001). Both regimens prevented CMV disease (6% vs 4%, P=0.733). While the 4-year graft survival was comparable (96% vs 93%, P=0.460) patient survival was improved in the prophylaxis group (100% vs 94%, P=0.042).

Conclusion

Among kidney transplant recipients, the use of valganciclovir prophylaxis, compared with preemptive therapy, led to less severe IFTA at 3 years after transplantation.