Assessment of Ziresovir as a Treatment for RSV Infection in Hospitalized Pediatric Patients
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on November 6th, 2024
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Currently, respiratory syncytial virus (RSV) infection can be effectively treated with monoclonal antibodies such as palivizumab and nirsevimab. However, young children who are contraindicated for antibodies, ribavirin is the only treatment approved by the Food and Drug Administration. Another possible alternative is ziresovir, an antiviral that can bind to and inhibit the F protein of RSV. Thus, Shanghai Ark Biopharmaceutical had sponsored a study to assess the efficacy of ziresovir in treating RSV infection in pediatric patients.
The phase 3 clinical trial was conducted in China, and it included 311 participants between 1 to 24 months who were hospitalized with RSV infection, with a bit less half tested positive for subtype A. Baseline symptoms assessment with the Wang bronchiolitis scale yield an average score around 6.7, with a score of 12 being the most severe. RT-PCR assay was also performed on nasopharyngeal aspiration samples at the beginning of the study, and they found that the cohort had a mean viral load of 7.4 log copies per mL. The participants were randomly assigned to receive either placebo or ziresovir every 12 hours for 5 days. The dosage was varied based on the patient’s weight; the minimum dose of 10 mg was used for those between 2.5 and 5.0 kilograms, with the dose increased to 20 mg and 40 mg in patients between 5-10 kg and 10-20 kg, respectively. The researcher found that ziresovir usage significantly reduced disease severity by the 3rd day of treatment, as measured by a 3.4 reduction in Wang bronchiolitis score. Beside the significant difference in clinical outcomes, patients treated with ziresovir had a larger reduction in viral load than observed in the placebo group by the final day of treatment. The author noted that ziresovir need to be used with precaution to the development of resistance strains, as the study identified a resistance rate of 9%. Additionally, this study was only conducted in China, so it might not have reflected the efficacy of ziresovir in other conditions.
The phase 3 clinical trial was conducted in China, and it included 311 participants between 1 to 24 months who were hospitalized with RSV infection, with a bit less half tested positive for subtype A. Baseline symptoms assessment with the Wang bronchiolitis scale yield an average score around 6.7, with a score of 12 being the most severe. RT-PCR assay was also performed on nasopharyngeal aspiration samples at the beginning of the study, and they found that the cohort had a mean viral load of 7.4 log copies per mL. The participants were randomly assigned to receive either placebo or ziresovir every 12 hours for 5 days. The dosage was varied based on the patient’s weight; the minimum dose of 10 mg was used for those between 2.5 and 5.0 kilograms, with the dose increased to 20 mg and 40 mg in patients between 5-10 kg and 10-20 kg, respectively. The researcher found that ziresovir usage significantly reduced disease severity by the 3rd day of treatment, as measured by a 3.4 reduction in Wang bronchiolitis score. Beside the significant difference in clinical outcomes, patients treated with ziresovir had a larger reduction in viral load than observed in the placebo group by the final day of treatment. The author noted that ziresovir need to be used with precaution to the development of resistance strains, as the study identified a resistance rate of 9%. Additionally, this study was only conducted in China, so it might not have reflected the efficacy of ziresovir in other conditions.