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: Increasing Lung Transplant Survival Outcomes in High-Risk Patients
Overall, post-lung transplant survival is inferior to other organs,2 making the need to identify therapeutic strategies to improve survival chances extremely important. Cytomegalovirus (CMV) high-risk (D+/R–) mismatch is an independent risk factor for worse early and late outcomes for lung transplant recipients.1 The proportion of CMV mismatch is expected to rise, so minimizing the impact of CMV on long-term post-transplant outcomes is vital.2
A recent retrospective study of 319 lung recipients transplanted over a 5-year period2 found that high-risk patients who received a multimodal CMV prophylaxis treatment, including CYTOGAM plus an antiviral regimen, had survival chances that mirrored non-high-risk patients, despite being in worse health at the time of their transplant. 2
Compared to CMV serostatus matched or non-high-risk mismatched (D–/R+) patients, high-risk mismatched (D+/R–) patients experienced2:
- Similar 1-year survival (89% vs 92.7%, P=0.4)
- Similar 3-year survival (72.6% vs 73.2%, P=1.0)
STUDY DESIGN: Banga and colleagues classified patients (N=319) into 2 groups, high-risk CMV SOT patients (n=82) and non-high-risk CMV patients (n=237), and the groups were compared for patient demographics, comorbidities, and post-transplant variables. The primary endpoint was 3-year survival. With 3-year survival as the dependent variable, the association of CMV status with survival was analyzed using multivariate logistic regression analysis.2
Higher survival rates compared to SRTR data
At 1 year and 3 years, similar survival was observed in high-risk mismatched patients compared to serostatus matched or non-high-risk CMV mismatched patients2. These survival values are comparably higher than those in the Scientific Registry of Transplant Recipients (SRTR) study3 in 2021.
| 1-Year lung transplant survival | 3-Year lung transplant survival | |
|---|---|---|
| 2021 SRTR3 | 85.3% | 67% |
| Study2 (non-high-risk) | 89% | 72.6% |
| Study2 (high-risk) | 92.7% | 73.2% |
The data compares the UT Southwestern Medical Center (UTSW) survival data at 1 and 3 years to the national SRTR average.
Long-Term Efficacy in Lung Transplant Patients
In a study by Valantine and colleagues, lung transplant patients receiving CYTOGAM combination prophylaxis, evaluated at 3 years post-transplant, had4:
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. Outcome measures compared: 3-year incidence of CMV disease; fungal infection; acute rejection; survival; rates and severity of transplant coronary artery disease (in heart patients), defined by intimal thickness (ultrasound) and coronary artery stenosis (angiographic); and incidence and death from obliterative bronchiolitis, defined by pathological criteria on endobronchial biopsy specimens (in heart-lung/lung patients).4
Adding CYTOGAM to ganciclovir in lung transplant patients may demonstrate greater survival, and lower rates of CMV disease and obliterative bronchiolitis than in patients receiving ganciclovir alone.4
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. Banga A, Kanade R, Bollineni S, et al. Lung transplant recipients with high-risk CMV mismatch managed using a multimodality regimen over a five-year period. Poster presented at: IDWeek; October 11-15, 2023; Boston, MA. 3. Valapour M, Lehr CJ, Schladt DP, et al. OPTN/SRTR 2021 Annual Data Report: Lung. Am J Transplant. 2023;23(2 Suppl 1):S379-S442. doi:10.1016/j.ajt.2023.02.009. 4. 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.