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 

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:

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

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

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