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Purpose: The cytomegalovirus (CMV) recipient-positive (D+/R+ or D-/R+) population represents the largest group of at-risk renal transplant recipients (RTR). Practice guidelines recommend valganciclovir (VGC) prophylaxis for 3-6 months in this population. This study compared the efficacy and safety of 3 vs. 6 months of low-dose VGC prophylaxis in moderate risk RTR following rabbit antithymocyte globulin induction.
Methods: This multicenter, retrospective analysis evaluated 723 adult RTR from 9/1/2005-10/31/2010. All received VGC 450mg/day: Group 1 (n=426) for 3 months, Group 2 (n=297) for 6 months. All patients were initially maintained on tacrolimus, mycophenolate (MPA) 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. In terms of immunosuppression, there were more patients receiving early steroid-withdrawal in Group 2. Tacrolimus concentrations were somewhat higher in Group 2 at months 6, 9 and 12, but MPA daily doses were slightly lower at months 1 and 3.
12 Month Efficacy Analysis | Group 1 | Group 2 | P-value |
| CMV disease | 19 (4.5%) | 12 (4.0%) | 0.86 |
| TCMR | 44 (10.3%) | 38 (12.8%) | 0.34 |
| AMR | 15 (3.5%) | 9 (3.0%) | 0.83 |
| Graft Loss | 16 (3.8%) | 9 (3.0%) | 0.19 |
| Patient Survival | 418 (98.1%) | 291 (98.0%) | 0.79 |
| OI | 86 (20.2%) | 63 (21.2%) | 0.78 |
Conclusion: Both regimens provide similar efficacy in CMV prophylaxis, but the prolonged course was associated with more leukopenia. The short-course of VGC may also provide significant cost avoidance.