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;
Stephanie Kalb, PhD, is an Associate Medical Director on Moderna’s Medical Affairs Team, focused on vaccines to address CMV and other latent viruses. Stephanie mainly supports healthcare provider education initiatives, scientific messaging and insights gathering, and patient advocacy efforts. She has a PhD in Neuroscience and prior to Moderna worked on Alzheimer’s disease for over 10 years.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
John Diaz-Decaro | Co-Author
John.Diaz-Decaro@modernatx.com;
John Diaz-Decaro is a Senior Director and Lead Epidemiologist at Moderna, where he leads epidemiologic strategy for the development of vaccines targeting Epstein-Barr virus (EBV) and other latent viruses. His work supports clinical development for Moderna’s EBV and CMV vaccine programs. Dr. Diaz-Decaro plays a key role in advancing non-interventional studies to assess disease burden, including EBV-associated conditions such as infectious mononucleosis, multiple sclerosis and post-transplant lymphoproliferative disorder. He also contributes to Moderna’s CMV epidemiology research portfolio supporting work on studies focused on investigating infant outcomes associated with congenital CMV, as well as CMV transmission dynamics in daycare settings.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
Colin Kunzweiler | Co-Author
colin.kunzweiler@modernatx.com;
Colin Kunzweiler, PhD is a Director and Epidemiologist for Moderna’s mRNA-1647 CMV vaccine candidate. Colin supports several epidemiology efforts within Moderna’s 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 in Epidemiology from the University of Illinois-Chicago School of Public Health.
ASHA DISCLOSURE
Financial - Receives Salary for Employment from Moderna Therapeutics, Inc..
Nonfinancial - No relevant nonfinancial relationship exists.
AAA DISCLOSURE
Financial - Receives support from Moderna Therapeutics, Inc. for Colin Kunzweiler is an employee of Moderna Therapeutics, Inc. and owns stock/stock options in the company..
Kevork Ourfalian | Co-Author
Kevork.Ourfalian@modernatx.com;
Kevork Ourfalian, PharmD, is a Senior Manager of Publications at Moderna, supporting the publication planning and medical communications for latent virus vaccines, including cytomegalovirus (CMV). He leads strategic publication initiatives across multiple therapeutic areas. Kevork earned his PharmD from MCPHS University in Boston, MA.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.
Harout Tossonian | Co-Author
Harout.Tossonian@modernatx.com;
Harout Tossonian, MD/PhD is a Director at Moderna for the latent vaccine portfolio including cytomegalovirus. Harout supports medical education, integrated evidence generation and data dissemination and collaborates with key opinion leaders, healthcare providers, medical societies and patient advocacy groups to address data and implementation gaps.
ASHA DISCLOSURE
Financial -
Nonfinancial -
AAA DISCLOSURE
Financial - No relevant financial relationship exists.