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An Improved and High Throughput Respiratory Syncytial Virus RSV Micro-neutralization Assay
Published on: January 26, 2019
Nirsevimab: Expansion of Respiratory Syncytial Virus Prevention Options in Neonates, Infants, and At-Risk Young
J Hunter Fly1,2, Lea S Eiland3, Jeremy S Stultz4
1Department of Clinical Pharmacy and Translational Science, College of Pharmacy, The University of Tennessee Health Science Center, Memphis, TN, USA.
Insights
Nirsevimab significantly reduces medically attended lower respiratory tract infections and hospitalizations in infants due to respiratory syncytial virus (RSV). This monoclonal antibody is well-tolerated and recommended for broad infant use.
Area of Science:
- Immunology
- Pediatrics
- Infectious Diseases
Background:
- Respiratory syncytial virus (RSV) poses a significant health risk to infants, causing lower respiratory tract infections.
- Current prophylactic measures for RSV are limited, necessitating novel therapeutic strategies.
Purpose of the Study:
- To review clinical trial data on nirsevimab for respiratory syncytial virus (RSV) prophylaxis in infants and children.
- To evaluate the efficacy and safety of nirsevimab.
- To explore nirsevimab's clinical utility and identify remaining questions.
Main Methods:
- Literature search of PubMed using "nirsevimab" and "medi8897".
- Inclusion of relevant clinical trials, pharmacology, pharmacokinetics, and pharmacoeconomics data.
- Review of organizational guidelines and regulatory presentations.
Main Results:
- Nirsevimab, a long-acting monoclonal antibody, reduced RSV-associated medically attended lower respiratory tract infections by 79.5% and hospitalizations by 77.3% in placebo-controlled trials.
- Nirsevimab demonstrated a safety profile comparable to placebo, with minor dermatologic reactions as the most common adverse event.
Conclusions:
- Nirsevimab is clinically effective in preventing RSV-associated lower respiratory tract infections and hospitalizations in infants.
- The drug is well-tolerated and has received regulatory approval and recommendations for broad infant administration.
- Further research is needed on efficacy in extremely premature infants and economic considerations.
Objective:
Review available data from clinical trials of nirsevimab for efficacy and safety in the setting of respiratory syncytial virus (RSV) prophylaxis in infants and children, while exploring nirsevimab's role in clinical practice and highlighting continuing questions.
Data Sources:
A literature search of PubMed was conducted utilizing the phrases "nirsevimab" and "medi8897." Additional references were identified through found references. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized.
Study Selection And Data Extraction:
Relevant clinical trials investigating nirsevimab in infants and children were included as well as other references on pharmacology, pharmacokinetics, and pharmacoeconomics.
Data Synthesis:
Nirsevimab, a once-a-season monoclonal antibody, demonstrated a 79.5% (95% CI, 65.9-87.7; P < 0.00001) lower incidence of RSV-associated medically attended lower respiratory tract infections (MA RSV-associated LRTI) and 77.3% (95% CI, 50.3-89.7; P = 0.0002) reduction in hospitalizations for RSV-associated MA-LRTI across 2 placebo-controlled studies. Nirsevimab demonstrated comparable safety to placebo with minor dermatologic reactions being the most common adverse event (0.9% vs 0.6%).
Relevance To Patient Care And Clinical Practice In Comparison With Existing Agents:
Nirsevimab was approved by the US Food and Drug Administration, and recommended by the Advisory Committee on Immunization Practices and American Academy of Pediatrics for broad administration to infants entering their first RSV season and at risk patients during their second RSV season. Questions remain over efficacy in infants born < 29-week gestation and other economical considerations.
Conclusions:
Nirsevimab demonstrated clinical efficacy in reducing RSV-associated MA-LRTI and RSV-associated hospitalizations in infants and was well tolerated.
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