title: Oral valganciclovir versus ganciclovir as delayed pre-emptive therapy for patients after allogeneic hematopoietic stem cell transplant: a pilot trial (04-0274) and review of the literature.
abstract: BACKGROUND
  Cytomegalovirus (CMV) infection is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplant (HSCT). This pilot prospective randomized clinical trial compares valganciclovir (VGV) to ganciclovir (GCV) as pre-emptive therapy for CMV viremia in the post-allogeneic HSCT population.
  
  
  METHODS
  Patients undergoing allogeneic HSCT who were at risk for CMV viremia were monitored post HSCT by weekly quantitative whole blood polymerase chain reaction. Pre-emptive therapy was delayed until the viral load (VL) was >10,000 copies/mL once, or >5000 copies/mL twice. Patients were randomized to either GCV 5 mg/kg twice a day (b.i.d.) for 7 days followed by daily GCV 5 mg/kg for up to 21 days, or VGV 900 mg b.i.d. for 7 days followed by 900 mg daily for up to 21 days. The primary endpoint was clearance of viremia (VL <5000 copies/mL) within 28 days of initiation of therapy.
  
  
  RESULTS
  In total, 37 patients were enrolled; 19 patients received treatment with VGV and 18 patients received treatment with GCV. The VGV was not inferior in efficacy to GCV as pre-emptive therapy, with rates of viral clearance at 28 days of 89.5% and 83%, respectively (P-value for non-inferiority = 0.030). Toxicities were similar between the 2 arms. No patients developed CMV disease.
  
  
  CONCLUSIONS
  In this trial, the rates of clearance of viremia appear to be similar with VGV and GCV.
authors.affiliation: Division of Oncology, Washington University School of Medicine, Saint Louis, Missouri 63110, USA.
authors.forename: J S
authors.initials: JS
authors.lastname: Chawla
authors.forename: A
authors.initials: A
authors.lastname: Ghobadi
authors.forename: J
authors.initials: J
authors.lastname: Mosley
authors.forename: L
authors.initials: L
authors.lastname: Verkruyse
authors.forename: K
authors.initials: K
authors.lastname: Trinkaus
authors.forename: C N
authors.initials: CN
authors.lastname: Abboud
authors.forename: A F
authors.initials: AF
authors.lastname: Cashen
authors.forename: K E
authors.initials: KE
authors.lastname: Stockerl-Goldstein
authors.forename: G L
authors.initials: GL
authors.lastname: Uy
authors.forename: P
authors.initials: P
authors.lastname: Westervelt
authors.forename: J F
authors.initials: JF
authors.lastname: DiPersio
authors.forename: R
authors.initials: R
authors.lastname: Vij
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003587:Cytomegalovirus / Q000187:drug effects; D003586:Cytomegalovirus Infections / Q000517:prevention & control* / Q000821:virology; D004305:Dose-Response Relationship, Drug; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D014184:Transplantation, Homologous; D000077562:Valganciclovir; D019562:Viral Load / Q000187:drug effects; D014766:Viremia / Q000517:prevention & control* / Q000821:virology; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir