In Brief | Paediatrics & Neonatology
Phase 3 Trial Confirms Ziresovir's Efficacy in Reducing RSV Symptoms in Infants
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Originally Published: 28 August 2024
Sourced: NEJM
Type of article: In Brief
MedED Catalogue Reference: MPIB0014
Category: Paediatrics & Neonatology
Cross Reference: Infectious Diseases
Keywords: paediatrics, RSV, infectious diseases, anti-viral drugs, Ziresovir
Phase 3 trial results indicate that Ziresovir, a new drug, significantly reduces respiratory syncytial virus (RSV) symptoms in infants, highlighting its potential as an effective treatment option.
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Originally published in NEJM, 25 September 2024
The human respiratory syncytial virus (RSV) is one of the most prevalent viral infections in children globally. It affects an astonishing 90% of children before they reach their second birthday and often occurs in older children and adults. Despite its widespread impact, there is currently no effective treatment for RSV infection.
The results of this recent phase 3, randomized, double-blind, placebo-controlled trial showed that Ziresovir – an anti-viral currently under investigation, significantly reduced RSV-related bronchiolitis symptoms in infants and young children.
The study, conducted in China, evaluated the efficacy and safety of Ziresovir in infants and young children aged 1 to 24 months who had been hospitalized with respiratory syncytial virus (RSV) infection.
The patients were randomly assigned (2:1 ratio) to receive either 10-40mg of Ziresovir (based on body weight) or a placebo, administered twice daily for five days.
The primary outcome was the change in the Wang bronchiolitis clinical score baseline to day 3. Secondary outcomes included reductions in RSV viral load by day 5.
A total of 244 participants were included in the intention-to-treat population, and 302 in the safety population.
The following findings were recorded:
By day 3, the Ziresovir group showed a significantly greater reduction in the Wang bronchiolitis score compared to the placebo group (−3.4 points vs. −2.7 points)
By day 5, the RSV viral load was reduced more in the Ziresovir group than in the placebo group (−2.5 vs. −1.9 log10 copies/mL) indicating enhanced anti-viral activity
Improvements were seen across subgroups, including those with a baseline bronchiolitis score of 8 or higher and participants aged 6 months or younger.
Adverse events were comparable across the two groups, (16% of the Ziresovir group and 13% of the placebo group) with diarrhoea, elevated liver enzymes, and rash being the most common.
Resistance-associated mutations were found in 9% of the Ziresovir group, but no significant safety concerns were identified overall.
These results suggest that Ziresovir effectively reduces RSV symptoms and viral load in infants with a favorable safety profile.
The researchers acknowledged several limitations in the study. Firstly, the Wang bronchiolitis clinical score used to measure outcomes is not fully validated for RSV infections. Secondly, since the study was conducted in China, the findings may not be generalizable to other regions. Additionally, the study did not track the time taken to discontinue supplemental oxygen or nebulizer use, which could serve as important indicators of clinical improvement.
Despite these limitations, the researchers concluded that ziresovir could be a promising therapeutic option for treating RSV in young children.
The trial was funded by Shanghai Ark Biopharmaceutical (ClinicalTrials.gov: NCT04231968).
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