Abstract Details
10/09/2023 | 2:30 PM - 2:55 PM | 6619
Advancing Clinical Practice Guidelines for cCMV Prevention and Care: A Targeted Literature Review
Abstract Summary
Cytomegalovirus (CMV) can be transmitted vertically during pregnancy and may lead to congenital CMV (cCMV) infection, which can cause serious lifelong health complications in newborns. Currently, no effective preventative or treatment interventions are approved for cCMV in the United States. While evidence-based clinical practice guidelines (CPGs) have been published, recommendations for prenatal and newborn screening and care vary, and most have not been recently updated. We performed a literature review to assess recent cCMV-related research and synthesized evidence to help identify gaps that may inform CPG development. A targeted literature search was conducted in PubMed to identify relevant articles published between March 2018 and March 2023 and restricted to clinical studies, meta-analyses, and observational studies; titles and abstracts of retrieved articles were manually screened to exclude non-relevant publications. Additional relevant publications were manually included as identified by the authors. Overall, 78 articles were evaluated and summarized in the context of recently published CPGs. Several studies highlighted the complexity of identifying cCMV-associated clinical manifestations, suggesting that commonly used targeted screening approaches may miss many cases. A few studies evaluated the validity and cost-effectiveness of different cCMV testing methods; expanding the available alternatives for testing could enable more widespread implementation of newborn screening. Clinical data on optimal dosing and timing of antiviral medications are limited, although these remain the primary treatment for cCMV in some regions. Studies of prenatal imaging demonstrated that cCMV and related outcomes are not reliably identified by these methods, and research on maternal risk factors for CMV transmission is still emerging. Evidence supporting effectiveness of preventative therapies and vaccines is heterogenous and limited, and a few studies have evaluated behavioral and educational prevention strategies. Our analysis of recent studies has identified gaps that can inform a research agenda for future evidence-based CPG advancement.
Learning Objectives
- Describe current clinical practice guidelines’ (CPGs) recommendations on prenatal and infant screening and treatment of congenital cytomegalovirus (cCMV).
- Summarize recent evidence related to cCMV epidemiology, disease burden, prevention, screening, and treatment that helps inform CPG development.
- Discuss opportunities to update and align current CPGs in the context of recent public health and legislative initiatives.
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Presenters
Stephanie Kalb | Primary Presenter, Author
Stephanie.kalb@modernatx.com;
Dr. Kalb is an associate medical director for CMV at Moderna, Inc. Dr. Kalb supports CMV awareness and education. She earned her Master of Arts degree in pathobiology from Brown University, a doctorate in philosophy degree in anatomy and neurobiology from the Boston University School of Medicine, and had a postdoctoral fellowship at Harvard Medical School.
ASHA DISCLOSURE
Financial - Receives Salary for Employment from Moderna, Inc.
Nonfinancial - No relevant nonfinancial relationship exists.
AAA DISCLOSURE
Financial - Receives support from Moderna, Inc for holds stock/stock options.
John Diaz-Decaro | Co-Author
John.Diaz-Decaro@modernatx.com;
Dr. Diaz-Decaro is Director and Lead Epidemiologist for Moderna’s mRNA-1647 CMV vaccine candidate. John supports all epidemiology-related activities for the CMV development program, including addressing evidence gaps in the field, highlighting the direct and indirect benefits of CMV vaccination, and supporting federal and state discussions on the importance of newborn screening. He received his PhD from the UCLA Fielding School of Public Health.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
Colin Kunzweiler | Co-Author
Colin.Kunzweiler@modernatx.com;
Dr. Kunzweiler is associate director and epidemiologist for Moderna’s mRNA-1647 CMV vaccine candidate. He supports several epidemiology efforts within the CMV development program, including long-term outcome studies, natural history studies, real-world feasibility assessments, administrative claims analyses, mathematical modeling, and literature reviews. He received his PhD from the University of Illinois–Chicago School of Public Health.
ASHA DISCLOSURE
Financial - Receives Salary,Ownership interest for Employment from Moderna, Inc..
Nonfinancial - Has a Professional (Employee) relationship for Other volunteer activities.
AAA DISCLOSURE
Financial - Receives support from Moderna, Inc. for Employee; holds stock/stock options.
Kevork Ourfalian | Co-Author
Kevork.Ourfalian@modernatx.com;
Dr. Ourfalian is senior manager of publications for Moderna, Inc., supporting all publication planning and medical communication deliverables for Moderna’s latent virus portfolio. Dr. Ourfalian graduated from the Massachusetts College of Pharmacy and Health Sciences University (MCPHS) with a Doctor of Pharmacy degree, followed by a postdoctoral fellowship at Becton Dickinson and MCPHS University.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
Harout Tossonian | Co-Author
Harout.Tossonian@modernatx.com;
Dr. Tossonian is a medical affairs director for CMV at Moderna, Inc. He has earned a BS in biology and MD and PhD degrees. He supports medical affairs-related activities for the CMV program as well as integrated evidence generation for latent viruses.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.