title: Valganciclovir prophylaxis for cytomegalovirus infection in thoracic transplant patients: retrospective study of efficacy, safety, and drug exposure.
abstract: Oral ganciclovir (GCV) was replaced by prodrug valganciclovir (vGCV) for cytomegalovirus (CMV) prophylaxis. We assessed retrospectively (2005-2007) vGCV effectiveness and safety during prophylaxis and 4 months after, in heart (HTx) and lung transplantation (LTx), including lung transplant for cystic fibrosis (CFTx). Patients with stable renal function received vGCV 900 mg daily during 3-6 and 8-12 months in HTx and LTx. Effectiveness was assessed by antigenemia (pp65Ag) and a GCV therapeutic drug monitoring to document exposure. A total of 32 patients (11 HTx, 7 LTx, and 14 CFTx) received vGCV for 106+/-67 days in HTx versus 270+/-85 days in LTx and CFTx. Doses were 700+/-225, 915+/-60, and 820+/-150 mg/24 h in HTx, LTx, and CFTx showing acceptable mean trough GCV 0.75+/-0.5 mg/L. Two of 9 cases of neutropenia were attributable to vGCV. Three CMV donor-positive/recipient-negative CFTx patients presented positive pp65Ag; 2 developed CMV disease (6%). We found that vGCV 900 mg, adapted to renal function, was effective and safe for long CMV prophylaxis together with efficient exposure in thoracic transplantation.
authors.affiliation: Pharmacology Department, AP-HP, George Pompidou Hospital, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Lefeuvre
authors.forename: P
authors.initials: P
authors.lastname: Chevalier
authors.forename: C
authors.initials: C
authors.lastname: Charpentier
authors.forename: R
authors.initials: R
authors.lastname: Zekkour
authors.forename: L
authors.initials: L
authors.lastname: Havard
authors.forename: M
authors.initials: M
authors.lastname: Benammar
authors.forename: C
authors.initials: C
authors.lastname: Amrein
authors.forename: V
authors.initials: V
authors.lastname: Boussaud
authors.forename: A
authors.initials: A
authors.lastname: Lillo-Le Louët
authors.forename: R
authors.initials: R
authors.lastname: Guillemain
authors.forename: E M
authors.initials: EM
authors.lastname: Billaud
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018890:Chemoprevention; D003550:Cystic Fibrosis / Q000628:therapy; D003587:Cytomegalovirus / Q000187:drug effects / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D016903:Drug Monitoring; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016027:Heart Transplantation / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D016040:Lung Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D000077562:Valganciclovir; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir