Journal article- Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants

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Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants


Source: NEJM, Published July 30,2020

Respiratory syncytial virus is the most common cause of lower respiratory tract infection and one of the major cause of hospitalization in children.

Palivizumab  and ribavirin are the only therapeutic options for the disease caused by this virus. However,  Palivizumab isn't recommended for evey children and the efficacy of Ribavirin is not good.

Nirsevimab, a recombinant human immune globulin G1 kappa monoclonal antibody which was the drug under study and the outcome has been presented in this article.
Nirsevimab R&D investor event - Sanofi

What was the methodology?


This trial was conducted in both northern and southern hemispheres. Nirsevimab was evaluated for the prevention of RSV-associated lower respiratory tract infection in healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation). 

Infants were assigned in a 2:1 ratio to receive nirsevimab, at a dose of 50 mg in a single intramuscular injection, or placebo at the start of an RSV season. 

The primary end point was medically attended RSV-associated lower respiratory tract infection through 150 days after administration of the dose.

The secondary efficacy end point was hospitalization for RSV-associated lower
respiratory tract infection through 150 days after administration of the dose.

What were the results?

969 infants received nirsevimab & 484 received placebo at the start of the RSV season. 

The incidence of medically attended RSV-associated lower respiratory tract infection was 70.1% lower (95% confidence interval [CI], 52.3 to 81.2) with nirsevimab prophylaxis than with placebo (2.6% [25 infants] vs. 9.5%
[46 infants]; P<0.001) and the incidence of hospitalization for RSV-associated
lower respiratory tract infection was 78.4% lower (95% CI, 51.9 to 90.3) with nirsevimab than with placebo (0.8% [8 infants] vs. 4.1% [20 infants]; P<0.001).

Adverse events were similar in the two trial groups, with no notable hypersensitivity reactions.

This study was funded by Funded by AstraZeneca and Sanofi Pasteur; .

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