Efficacy
The use of CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) in patients undergoing solid organ transplantation (SOT) has been shown in studies to confer additional protection to an antiviral in preventing CMV infection, particularly in those at high risk of CMV infection or disease, compared with controls; it is generally well tolerated.1
CYTOGAM: Proven Efficacy in High-Risk Heart Transplant Patients
In a clinical study by Potena and colleagues, heart transplant patients demonstrated the following2:
In this study, heart transplant patients receiving CYTOGAM in combination with antiviral prophylaxis (ganciclovir for 4 weeks + valganciclovir for 2 months) showed a rejection-free survival longer than patients treated with ganciclovir alone (for 4 weeks), reaching significance 6 months after IV ganciclovir discontinuation.2
STUDY DESIGN: A prospective cohort study by Potena and colleagues of 66 heart transplant recipients compared aggressive CMV prophylaxis (n=21, CMV hyperimmune globulin [CMV-IGIV] plus 4 weeks of intravenous ganciclovir followed by 2 months of valganciclovir) with standard prophylaxis (n=45, intravenous ganciclovir for 4 weeks). Prophylaxis was based on pretransplant donor and recipient CMV serology: D+/R– received aggressive prophylaxis and R+ received standard prophylaxis. Outcome measures were: CMV infection assessed by DNA-polymerase chain reaction on peripheral blood polymorphonuclear leukocytes, acute rejection, and cardiac allograft vascular disease (CAV) assessed by intravascular ultrasound. All patients completed 1 year of follow-up.2
Multiple Benefits Found in Heart Transplant Patients Who Received Combination Therapy3
In another clinical study by Valantine and colleagues, heart transplant patients on combination therapy experienced the following at 3 years compared with the patients treated with ganciclovir alone (P<0.01)3:
Cumulative survival (%) of heart transplant patients over 3 years3
Survival was significantly higher 1 year after heart transplantation in CYTOGAM-treated patients compared with controls: 80% survival in patients receiving a combination of CYTOGAM and ganciclovir vs 60% in the ganciclovir group (P≤0.01). 3
STUDY DESIGN: In a long-term study by Valantine and colleagues, the population receiving CMV-IGIV (n=80) were 27 heart transplant recipients (D+/R–) and 53 heart-lung and lung transplant recipients (R+ and/or D+) matched with historical controls who had undergone transplantation in the preceding 2–3 years. Comparative outcome measures included the 3-year incidence of CMV disease; acute rejection; survival; and incidence and death from obliterative bronchiolitis.3
Longer rejection-free survival in heart transplantation was demonstrated with CYTOGAM combination prophylaxis.2
References: 1. Barten MJ, Baldanti F, Staus A, Hüber CM, Glynou K, Zuckermann A. Effectiveness of prophylactic human cytomegalovirus hyperimmunoglobulin in preventing cytomegalovirus infection following transplantation: a systematic review and meta-analysis. Life. 2022;12:361. doi:10.3390/life12030361 2. Potena L, Holweg CTJ, Chin C, et al. Acute rejection and cardiac allograft vascular disease is reduced by suppression of cytomegalovirus infection. Transplantation. 2006;82:398-405. doi:10.1097/01.tp.0000229039.87735.76 3. Valantine HA, Luikart H, Doyle R, et al. Impact of cytomegalovirus hyperimmune globulin on outcome after cardiothoracic transplantation: a comparative study of combined prophylaxis with CMV hyperimmune globulin versus ganciclovir alone. Transplantation. 2001;72(10):1647-1652