Seth Heldenbrand1,2, Chenghui Li3, Rosemary P Cross4, Kelly A DePiero5, Travis B Dick6, Kara Ferguson7, Miae Kim8,9, Erin Newkirk10, Jeong M Park11,12, Janice Sudaria-Kerr13, Eric M Tichy14, Kimi R Ueda15, Renee Weng16, Jesse Wisniewski13, Steven Gabardi9,17,18,19. 1. Division of Transplant Surgery, University of Arkansas for Medical Sciences (UAMS), University Hospital, Little Rock, AR, USA. 2. UAMS College of Pharmacy, Little Rock, AR, USA. 3. Division of Pharmaceutical Evaluation and Policy, UAMS, Little Rock, AR, USA. 4. Department of Transplant Services, Piedmont Hospital, Atlanta, GA, USA. 5. Department of Pharmacy Services, Lahey Clinic Medical Center, Burlington, MA, USA. 6. Department of Pharmacy Services, Intermountain Medical Center, Murray, UT, USA. 7. Department of Pharmacy Services, UAMS, Little Rock, AR, USA. 8. Department of Cardiology, Brigham and Women's Hospital (BWH), Boston, MA, USA. 9. Pharmacy Services, BWH, Boston, MA, USA. 10. Department of Pharmacy Services, Froedtert Hospital, Milwaukee, WI, USA. 11. Department of Pharmacy Services, University of Michigan Health System, Ann Arbor, MI, USA. 12. College of Pharmacy, University of Michigan, Ann Arbor, MI, USA. 13. Department of Pharmacy Services, University of California San Diego Health System, San Diego, CA, USA. 14. Department of Pharmacy Services, Yale New Haven Hospital, New Haven, CT, USA. 15. Department of Pharmacy Services, California Pacific Medical Center, San Francisco, CA, USA. 16. Department of Pharmacy Services, University of California Medical Center, Irvine, CA, USA. 17. Department of Transplant Surgery, BWH, Boston, MA, USA. 18. Renal Division, BWH, Boston, MA, USA. 19. Harvard Medical School, Boston, MA, USA.
Abstract
BACKGROUND: The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900 mg/day for 3 months in D+/R+ RTR. METHODS: A multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=89)×3 months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received study-approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12 months. RESULTS: The rates of graft loss, patient survival, T-cell and/or antibody-mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups. CONCLUSION: The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939).
BACKGROUND: The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900 mg/day for 3 months in D+/R+ RTR. METHODS: A multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=89)×3 months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received study-approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12 months. RESULTS: The rates of graft loss, patient survival, T-cell and/or antibody-mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups. CONCLUSION: The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939).