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Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus Infection
Shunying Zhao1, Yunxiao Shang1, Yong Yin1
1From the Department of Respiratory Medicine (S.Z.), Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, National Clinical Research Center for Respiratory Diseases (S.Z., X.N.), National Center for Pediatric Cancer Surveillance, Key Laboratory of Major Diseases in Children, Ministry of Education (X.N), and the Department of Pediatric Medicine, Peking University Third Hospital (W.Z.), Beijing, the Department of Pediatrics, Shengjing Hospital of China Medical University, Shenyang (Y.S.), the Department of Pediatric Respiratory Medicine, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine (Y. Yin), the Department of Pulmonology, Shanghai Children's Hospital, and the School of Medicine, Shanghai Jiao Tong University (X.D.), and Shanghai Ark Biopharmaceutical (X.Z., T.J., Y.W., G.Z., K.R., J.Z.W.), Shanghai, the Department of Respiratory Medicine, Tianjin Children's Hospital, Machang Campus (Y. Zou), the Department of Respiratory Medicine, Tianjin Children's Hospital, Longyan Campus (Y.X.), and Tianjin University (Y. Zou, Y.X.), Tianjin, Children's Medical Center, Hunan Provincial People's Hospital, Changsha (L.Z.), the Departments of Respiratory Medicine and Pediatric Infectious Diseases, Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou (Hailin Zhang, Y.C.), the Department of Pediatrics, Sanya Central Hospital, Hainan Third People's Hospital, Sanya (Hua Zhang), the Department of Pediatric Respiratory Medicine, Children's Hospital of Nanjing Medical University (D.Z.), and the Department of Pediatric Medicine, First Affiliated Hospital with Nanjing Medical University (R.D.), Nanjing, the Department of Pediatrics, Women and Children's Hospital, and the School of Medicine, Xiamen University (T.S.), and the Department of Pediatric Respiratory Medicine, First Affiliated Hospital of Xiamen University (Y. Yang), Xiamen, the Department of Pediatrics, Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital, Zhongshan (D.H.), the Department of Pediatric Respiratory Medicine, Jiangxi Provincial Children's Hospital, Nanchang (Q.C.), the Department of Pediatric Respiratory Medicine, Liaocheng People's Hospital, Liaocheng (Q.Y.), the Department of Respiratory Medicine and Clinical Allergy Center, Wuxi Children's Hospital, Wuxi (L.L.), the Department of Pediatric Respiratory Medicine, Children's Hospital, Zhejiang University School of Medicine, Hangzhou (Z.C.), the Department of Respiratory Medicine, Children's Hospital of Chongqing Medical University, Chongqing (E.L.), the Department of Pediatric Respiratory Medicine, Women and Children's Medical Center Affiliated to Guangzhou Medical University, Guangzhou (L.D., W.J.), the Department of Pediatric Respiration, Children's Medical Center, First Hospital of Jilin University, Changchun (H.C.), the Department of Pediatrics, First Affiliated Hospital of Guangxi Medical University, Nanning (G.N.), the Department of Pediatric Respiratory Medicine, Third Affiliated Hospital of Zhengzhou University (X.W.), and the Respiratory Department, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, and Zhengzhou Children's Hospital (Z.S.), Zhengzhou, the Department of Respiratory Medicine, Shenzhen Children's Hospital, Shenzhen (Y. Zheng), the Department of Respiratory Medicine, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan (X.L.), the Department of Respiratory Medicine, Children's Hospital of Soochow University, Suzhou (C.H.), and the Department of Pediatric Respiratory and Immunology Medicine, West China Second University Hospital, Sichuan University, Chengdu (H.L.) - all in China.
Insights
Ziresovir significantly reduced respiratory syncytial virus (RSV) symptoms in hospitalized infants and children. This new treatment showed no safety concerns, offering a promising option for severe RSV infections.
Area of Science:
- Pediatrics
- Virology
- Clinical Pharmacology
Background:
- Respiratory syncytial virus (RSV) is a major cause of severe infant respiratory illness lacking effective treatments.
- Ziresovir has shown potential efficacy in treating hospitalized infants with RSV infection based on Phase 2 trial results.
Purpose of the Study:
- To evaluate the efficacy and safety of ziresovir in treating hospitalized infants and young children with RSV infection through a Phase 3 clinical trial.
Main Methods:
- A multicenter, double-blind, randomized, placebo-controlled Phase 3 trial enrolled 244 participants (1-24 months) with RSV infection.
- Participants received ziresovir or placebo twice daily for 5 days, with the primary endpoint being the change in the Wang bronchiolitis clinical score at Day 3.
Main Results:
- Ziresovir demonstrated a significantly greater reduction in the Wang bronchiolitis clinical score at Day 3 compared to placebo (P=0.002).
- A greater reduction in RSV viral load was observed in the ziresovir group by Day 5.
- Improvements were noted in key subgroups, and the incidence of drug-related adverse events was comparable to placebo.
Conclusions:
- Ziresovir effectively reduced the signs and symptoms of bronchiolitis in infants and young children hospitalized with RSV infection.
- The study identified no significant safety concerns associated with ziresovir treatment.
Background:
Respiratory syncytial virus (RSV) is a leading cause of severe illness in infants, with no effective treatment. Results of a phase 2 trial suggested that ziresovir may have efficacy in the treatment of infants hospitalized with RSV infection.
Methods:
In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial conducted in China, we enrolled participants 1 to 24 months of age who were hospitalized with RSV infection. Participants were randomly assigned, in a 2:1 ratio, to receive ziresovir (at a dose of 10 to 40 mg, according to body weight) or placebo, administered twice daily, for 5 days. The primary end point was the change from baseline to day 3 (defined as 48 hours after the first administration) in the Wang bronchiolitis clinical score (total scores range from 0 to 12, with higher scores indicating greater severity of signs and symptoms). The intention-to-treat population included all the participants with RSV-confirmed infection who received at least one dose of ziresovir or placebo; the safety population included all the participants who received at least one dose of ziresovir or placebo.
Results:
The intention-to-treat population included 244 participants, and the safety population included 302. The reduction from baseline in the Wang bronchiolitis clinical score at day 3 was significantly greater with ziresovir than with placebo (-3.4 points [95% confidence interval {CI}, -3.7 to -3.1] vs. -2.7 points [95% CI, -3.1 to -2.2]; difference, -0.8 points [95% CI, -1.3 to -0.3]; P = 0.002). The reduction in the RSV viral load at day 5 was greater in the ziresovir group than in the placebo group (-2.5 vs. -1.9 log10 copies per milliliter; difference, -0.6 log10 copies per milliliter [95% CI, -1.1 to -0.2]). Improvements were observed in prespecified subgroups, including in participants with a baseline bronchiolitis score of at least 8 and in those 6 months of age or younger. The incidence of adverse events related to the drug or placebo was 16% with ziresovir and 13% with placebo. The most common adverse events that were assessed by the investigator as being related to the drug or placebo were diarrhea (in 4% and 2% of the participants, respectively), an elevated liver-enzyme level (in 3% and 3%, respectively), and rash (in 2% and 1%). Resistance-associated mutations were identified in 15 participants (9%) in the ziresovir group.
Conclusions:
Ziresovir treatment reduced signs and symptoms of bronchiolitis in infants and young children hospitalized with RSV infection. No safety concerns were identified. (Funded by Shanghai Ark Biopharmaceutical; AIRFLO ClinicalTrials.gov number, NCT04231968.).
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