Abstract: SA-PO482

Long-Term Outcomes of Valganciclovir versus Valacyclovir for Cytomegalovirus Prophylaxis in Renal Transplantation: A Parallel Group, Open-Label Randomized Controlled Trial

Session Information

Category: Transplantation

  • 1702 Transplantation: Clinical and Translational

Authors

  • Reischig, Tomas, Charles Univ. Medical School and Teaching Hospital, Pilsen, Czechia
  • Kacer, Martin, Charles Univ. Medical School and Teaching Hospital, Pilsen, Czechia
  • Hruba, Petra, Institute for Clinical and Experimental Medicine, Prague, Czechia
  • Lysak, Daniel, Charles Univ. Medical School and Teaching Hospital, Pilsen, Czechia
  • Jindra, Pavel, Charles Univ. Medical School and Teaching Hospital, Pilsen, Czechia
  • Hes, Ondrej, Charles Univ. Medical School and Teaching Hospital, Pilsen, Czechia
  • Bouda, Mirko, Charles Univ. Medical School and Teaching Hospital, Pilsen, Czechia
Background

Both valganciclovir and high-dose valacyclovir are recommended for cytomegalovirus (CMV) prophylaxis after renal transplantation. Less early acute rejection was observed with valganciclovir, however long-term comparison is lacking.

Methods

In a randomized, open-label, single-center trial, renal transplant recipients (recipient or donor CMV seropositive) were randomly allocated (1:1) to 3-month prophylaxis with valganciclovir (900mg daily) or valacyclovir (2g four times daily). The primary outcome was moderate to severe interstitial fibrosis and tubular atrophy (IFTA) assessed by protocol biopsy at 3 years. Analysis was by intention-to-treat.

Results

A total of 119 patients were assigned to valganciclovir (n=60) or valacyclovir prophylaxis (n=59). At 3 years, the incidence of CMV DNAemia (36% vs 42%, P=0.272) and CMV disease (9% vs 2%, P=0.199) were comparable in both groups. Among the 101 patients with a protocol biopsy specimen available, 11 (22%) of the 51 patients in the valganciclovir group and 17 (34%) of the 50 patients in the valacyclovir group had moderate to severe IFTA. The risk of moderate to severe IFTA was significantly lower with valganciclovir after adjusting for baseline recipient and donor characteristics (adjusted odds ratio [aOR], 0.22; 95% confidence interval [CI], 0.07–0.70; P=0.011). A trend toward less acute rejection (24% vs 32%, adjusted hazard ratio [aHR], 0.53; 95% CI, 0.25-1.10; P=0.087) and more polyoma BK virus viremia (42% vs 26%; aHR, 1.91; 95% CI, 0.95–3.82; P=0.069) at 3 years was observed in the valganciclovir group. 4-year patient and graft survival was not significantly different between groups.

Conclusion

Valganciclovir prophylaxis compared to high-dose valacyclovir is associated with reduced risk of moderate to severe IFTA in late protocol biopsies in renal transplant recipients. (Trial registered at Australian New Zealand Clinical Trials Registry: ACTRN1260000016033)

Funding

  • Government Support - Non-U.S.