title: Cytomegalovirus Immunoglobulin for Prophylaxis and Treatment of Cytomegalovirus Infection in the (Val)Ganciclovir Era: A Single-Center Experience.
abstract: BACKGROUND
  Evidence concerning the effectiveness of anti-cytomegalovirus immunoglobulin (CMVIg) following lung transplantation in the era of new antiviral agents is limited and controversial.
  
  
  METHODS
  At-risk patients (donor seropositive/recipient seronegative [D+/R-] and R+) received valganciclovir for 3 months (R+) or 6 months (D+/R). CMVIg (2 mg/kg) was given to D+/R- patients on days 1, 4, 8, 15, and 30 post-transplant, then monthly for a further year. Patients with valganciclovir-induced leukopenia were switched to CMVIg (2 mg/kg) prophylaxis. Tissue-invasive disease was treated with intravenous ganciclovir with CMVIg (2 mg/kg) every other day for 1 week and then weekly until discharge.
  
  
  RESULTS
  Of 159 patients analyzed, 26 (17%) were D+/R-. Cytomegalovirus (CMV) viremia was more frequent in D+/R- recipients than in R+ patients (61% vs. 35%; P<0.05), but developed at a similar time (mean 10±6 vs. 11±7 months) and resolved in all cases following treatment. One patient developed clinical and laboratory signs of CMV syndrome (fever >38°C), leukopenia, and detection of CMV in blood. Ten patients developed tissue-invasive disease after completion of prophylaxis (5 pneumonitis and 5 gastrointestinal disease); all were successfully treated with combined intravenous ganciclovir and CMVIg. None of the 18 donor seropositive/recipient seronegative patients who were switched from valganciclovir to CMVIg for persistent leukopenia developed CMV viremia during treatment. No cases of CMV infection or disease were attributable to ganciclovir-resistant strains. During follow-up, 44 patients died (4/26 R+/D- [15%], 40/133 R+ [30%), none directly due to CMV infection.
  
  
  CONCLUSIONS
  Combined prophylaxis with valganciclovir and CMVIg delayed CMV viremia and tissue-invasive disease in D+/R- lung transplant recipients, and prevented CMV-related mortality and development of ganciclovir resistance. CMVIg monotherapy prophylaxis was effective in R+ patients with ganciclovir-related toxicity.
authors.affiliation: Department of Pulmonology, Hospital Puerta de Hierro, Majadahonda, Madrid, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Lopez Garcia-Gallo
authors.affiliation: Department of Pulmonology, Hospital Puerta de Hierro, Majadahonda, Madrid, Spain.
authors.forename: Christian
authors.initials: C
authors.lastname: García Fadul
authors.affiliation: Department of Pulmonology, Hospital Puerta de Hierro, Majadahonda, Madrid, Spain.
authors.forename: Rosalia
authors.initials: R
authors.lastname: Laporta
authors.affiliation: Department of Microbiology, Hospital Puerta de Hierro, Majadahonda, Madrid, Spain.
authors.forename: Francisca
authors.initials: F
authors.lastname: Portero
authors.affiliation: Department of Biostatistics, Hospital Puerta de Hierro, Majadahonda, Madrid, Spain.
authors.forename: Isabel
authors.initials: I
authors.lastname: Millan
authors.affiliation: Department of Pulmonology, Hospital Puerta de Hierro, Majadahonda, Madrid, Spain.
authors.forename: Piedad
authors.initials: P
authors.lastname: Ussetti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D003586:Cytomegalovirus Infections / Q000188:drug therapy* / Q000517:prevention & control*; D005260:Female; D015774:Ganciclovir / Q000031:analogs & derivatives; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007136:Immunoglobulins / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous; D016040:Lung Transplantation; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D000077562:Valganciclovir; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C045781:cytomegalovirus-specific hyperimmune globulin; D000077562:Valganciclovir; D015774:Ganciclovir