Preliminary Research Abstract:
Background: Despite the emergence of new antiviral treatment options, cytomegalovirus (CMV) still remains a persistent threat to heart and lung transplantation recipients by increasing morbidity and mortality. Consequently, CMV infection can result in either direct organ damage or indirect modulation of the immune system, potentially leading to conditions such as acute or chronic rejection, other opportunistic infections, and malignancies. CMV hyperimmunoglobulin (CMVIG) has been widely used in thoracic transplant patients for decades, albeit with significant variability in its application across different centers. This study aims to examine the real-world usage of CMVIG and to evaluate its efficacy and safety profile across multiple European heart and lung transplant centers.
Methods: We will present a 12 month interim analysis from seven European transplant centers across three countries. This prospective non-interventional study aims to include a total of 500 patients over its duration. The study is designed as a single-arm investigation, enrolling heart and lung transplant recipients who receive CMVIG for either prophylaxis or treatment of CMV infection or disease within the first two years post-transplantation. All study patients are monitored for up to two years following the first CMVIG administration. Data have been extracted from medical charts regarding patient characteristics, CMV donor / recipient risk classification, treatment schedule and duration, concomitant treatments, clinical outcomes (e.g. graft dysfunctions, rejections, survival, immune system, kidney function) including adverse events and treatment related adverse drug reactions.
Expected outcome: This interim analysis of the largest known European non-interventional CMV study presents 12- month outcomes based on data from more than 50 patients. Endpoints that will be reported will include graft and overall survival, incidence of acute and chronic rejections and infections. The analysis will provide insights into the options with CMVIG to prevent and treat direct and indirect.