title: Cytomegalovirus prophylaxis with valganciclovir in African-American renal allograft recipients based on donor/recipient serostatus.
abstract: There is a paucity of data examining the efficacy of valganciclovir (VGC) for cytomegalovirus (CMV) prophylaxis in kidney transplant patients, particularly with regard to utilization of a risk-stratified dosing regimen. Eighty adult African-American (AA) renal allograft recipients transplanted from November 3, 2001 to May 28, 2003 and followed for 22 +/- 8 months received VGC once daily for 90 d post-transplant dosed according to donor/recipient (D/R) serostatus: high risk (D+/R-) received 900 mg (n = 12); moderate risk (D+/R+, D-/R+) received 450 mg (n = 60); and low risk (D-/R-) received no prophylaxis (n = 8). Thymoglobulin or basiliximab was used for induction, and mycophenolate mofetil, prednisone, and either tacrolimus or sirolimus for maintenance immunosuppression. Only six patients (7.5%) developed symptomatic CMV infection diagnosed by pp65 antigenemia, three in the high-risk (25%) and three in the moderate-risk (5%) group (p = 0.02). All patients were on tacrolimus for at least 3 months prior to diagnosis. There were no cases of tissue-invasive disease, resistance to treatment, or recurrence. D+/R- serostatus was the only significant independent predictor for CMV infection using multivariate analysis (odds ratio 10.5; p = 0.04). Thymoglobulin induction was not associated with CMV infection. None of 43 patients who were exposed to sirolimus for >30 d developed CMV infection, vs. six of 37 who were not (p = 0.006). We conclude that VGC dosed according to D/R serostatus provides safe and effective CMV prophylaxis in AA renal allograft recipients.
authors.affiliation: Section of Transplant Surgery, Department of Surgery, Wayne State University School of Medicine, Detroit, MI, USA.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Gruber
authors.forename: James
authors.initials: J
authors.lastname: Garnick
authors.forename: Katherina
authors.initials: K
authors.lastname: Morawski
authors.forename: Dale H
authors.initials: DH
authors.lastname: Sillix
authors.forename: Miguel S
authors.initials: MS
authors.lastname: West
authors.forename: Darla K
authors.initials: DK
authors.lastname: Granger
authors.forename: Jose M
authors.initials: JM
authors.lastname: El-Amm
authors.forename: George J
authors.initials: GJ
authors.lastname: Alangaden
authors.forename: Pranatharthi
authors.initials: P
authors.lastname: Chandrasekar
authors.forename: Abdolreza
authors.initials: A
authors.lastname: Haririan
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000956:Antigens, Viral / Q000097:blood; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000077552:Basiliximab; D003587:Cytomegalovirus / Q000276:immunology; D003586:Cytomegalovirus Infections / Q000175:diagnosis / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006801:Humans; D007168:IMP Dehydrogenase / Q000037:antagonists & inhibitors; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010750:Phosphoproteins / Q000097:blood; D011241:Prednisone / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D018570:Risk Assessment; D012698:Serologic Tests; D020123:Sirolimus / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use; D000077562:Valganciclovir; D014763:Viral Matrix Proteins / Q000097:blood
chemical_list: D000911:Antibodies, Monoclonal; D000956:Antigens, Viral; D000961:Antilymphocyte Serum; D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D010750:Phosphoproteins; D011993:Recombinant Fusion Proteins; D014763:Viral Matrix Proteins; C065418:cytomegalovirus matrix protein 65kDa; D000077552:Basiliximab; D007168:IMP Dehydrogenase; D000077562:Valganciclovir; D009173:Mycophenolic Acid; D015774:Ganciclovir; D011241:Prednisone; D020123:Sirolimus; D016559:Tacrolimus