title: Multicenter evaluation of efficacy and safety of low-dose versus high-dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D+/R+) renal transplant recipients.
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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Division of Transplant Surgery, University of Arkansas for Medical Sciences (UAMS), University Hospital, Little Rock, AR, USA.|UAMS College of Pharmacy, Little Rock, AR, USA.
authors.forename: Seth
authors.initials: S
authors.lastname: Heldenbrand
authors.affiliation: Division of Pharmaceutical Evaluation and Policy, UAMS, Little Rock, AR, USA.
authors.forename: Chenghui
authors.initials: C
authors.lastname: Li
authors.affiliation: Department of Transplant Services, Piedmont Hospital, Atlanta, GA, USA.
authors.forename: Rosemary P
authors.initials: RP
authors.lastname: Cross
authors.affiliation: Department of Pharmacy Services, Lahey Clinic Medical Center, Burlington, MA, USA.
authors.forename: Kelly A
authors.initials: KA
authors.lastname: DePiero
authors.affiliation: Department of Pharmacy Services, Intermountain Medical Center, Murray, UT, USA.
authors.forename: Travis B
authors.initials: TB
authors.lastname: Dick
authors.affiliation: Department of Pharmacy Services, UAMS, Little Rock, AR, USA.
authors.forename: Kara
authors.initials: K
authors.lastname: Ferguson
authors.affiliation: Department of Cardiology, Brigham and Women's Hospital (BWH), Boston, MA, USA.|Pharmacy Services, BWH, Boston, MA, USA.
authors.forename: Miae
authors.initials: M
authors.lastname: Kim
authors.affiliation: Department of Pharmacy Services, Froedtert Hospital, Milwaukee, WI, USA.
authors.forename: Erin
authors.initials: E
authors.lastname: Newkirk
authors.affiliation: Department of Pharmacy Services, University of Michigan Health System, Ann Arbor, MI, USA.|College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Jeong M
authors.initials: JM
authors.lastname: Park
authors.affiliation: Department of Pharmacy Services, University of California San Diego Health System, San Diego, CA, USA.
authors.forename: Janice
authors.initials: J
authors.lastname: Sudaria-Kerr
authors.affiliation: Department of Pharmacy Services, Yale New Haven Hospital, New Haven, CT, USA.
authors.forename: Eric M
authors.initials: EM
authors.lastname: Tichy
authors.affiliation: Department of Pharmacy Services, California Pacific Medical Center, San Francisco, CA, USA.
authors.forename: Kimi R
authors.initials: KR
authors.lastname: Ueda
authors.affiliation: Department of Pharmacy Services, University of California Medical Center, Irvine, CA, USA.
authors.forename: Renee
authors.initials: R
authors.lastname: Weng
authors.affiliation: Department of Pharmacy Services, University of California San Diego Health System, San Diego, CA, USA.
authors.forename: Jesse
authors.initials: J
authors.lastname: Wisniewski
authors.affiliation: Pharmacy Services, BWH, Boston, MA, USA.|Department of Transplant Surgery, BWH, Boston, MA, USA.|Renal Division, BWH, Boston, MA, USA.|Harvard Medical School, Boston, MA, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Gabardi
mesh_terms: D000328:Adult; D064591:Allografts / Q000821:virology; D019072:Antibiotic Prophylaxis / Q000379:methods*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003587:Cytomegalovirus / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D005260:Female; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006084:Graft Rejection / Q000453:epidemiology / Q000276:immunology; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D015994:Incidence; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000453:epidemiology; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D012698:Serologic Tests; D066027:Transplant Recipients; D016896:Treatment Outcome; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir
keywords: antivirals; cytomegalovirus; prophylaxis; valganciclovir