Efficacy and Safety of 3 vs. 6 Months of Low-Dose Valganciclovir for Prevention of Cytomegalovirus Disease in Moderate-Risk (D+/R+) Renal Transplant Recipients Receiving Antilymphocyte Antibody Induction Therapy
Multicenter CMV Pharmacists Collaborative Study Group, Boston
Meeting: 2013 American Transplant Congress
Abstract number: 87
The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population represents the largest group of at-risk renal transplant recipients (RTR). Practice guidelines on the prevention of CMV recommend prophylaxis in D+/R+ RTR receiving antilymphocyte antibody therapy that includes the use of valganciclovir (VGC) for 3-6 months based on expert opinion. To our knowledge, no analysis has specifically evaluated the D+/R+ population alone. This study compared the efficacy and safety of 3 vs. 6 months of low-dose VGC prophylaxis in D+/R+ RTR following rabbit antithymocyte globulin (r-ATG) induction.
Methods: A multicenter, retrospective analysis evaluated 456 adult RTR between 9/1/2005 and 10/31/2010. All received VGC 450mg/day (dose adjusted for renal function), Group 1 (n=281) for 3 months, Group 2 (n=175) for 6 months. All patients received r-ATG induction therapy and initial maintenance immunosuppression with tacrolimus, mycophenolic acid and corticosteroids. The primary endpoint was CMV disease prevalence at 1 year. The rates of T-cell medicated rejection (TCMR), antibody-mediated rejection (AMR), graft loss, patient survival, opportunistic infections (OI), leukopenia and early VGC discontinuation (DC) were also assessed.
Results: Patient demographics and transplant characteristics were comparable, with the exception of Group 1 being slightly younger, containing more African-Americans and less Caucasians and utilizing fewer expanded criteria donors. Tacrolimus whole blood trough concentrations were similar between groups throughout the prophylaxis period.
| 12 Month Efficacy Analysis | Group 1 | Group 2 | P-value |
| CMV disease | 13 (4.6%) | 10 (5.7%) | 0.66 |
| TCMR | 28 (10.0%) | 23 (13.1%) | 0.37 |
| AMR | 7 (2.5%) | 4 (2.3%) | 0.89 |
| Graft Loss | 13 (4.6%) | 8 (4.6%) | 1.00 |
| Patient Survival | 275 (97.9%) | 170 (97.1%) | 0.76 |
| OI | 64 (22.8%) | 40 (22.9%) | 1.00 |
The safety analysis revealed Group 2 to have significantly more patients develop leukopenia at post-op months 4 (p=0.03) and 6 (p=0.02). The rate of early VGC DC due to myelosuppression was also higher in Group 2 (p=0.002).
Conclusions: Both regimens provide similar efficacy in prevention of CMV disease in RTR, but the prolonged course was associated with more leukopenia. The short-course of VGC may also provide significant cost avoidance.
To cite this abstract in AMA style:
Gabardi S, Cross R, DePiero K, Dick T, Maldonado A, Maxwell P, Nelson J, Park J, Ueda K, Weng R, Newkirk E. Efficacy and Safety of 3 vs. 6 Months of Low-Dose Valganciclovir for Prevention of Cytomegalovirus Disease in Moderate-Risk (D+/R+) Renal Transplant Recipients Receiving Antilymphocyte Antibody Induction Therapy [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/efficacy-and-safety-of-3-vs-6-months-of-low-dose-valganciclovir-for-prevention-of-cytomegalovirus-disease-in-moderate-risk-dr-renal-transplant-recipients-receiving-antilymphocyte-antibody-induct/. Accessed May 14, 2025.« Back to 2013 American Transplant Congress